Patient leaflet - Irbesartan/Hydrochlorothiazide Teva
B. PACKAGE LEAFLET
Package leaflet: information for the patient
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
■ Keep this leaflet. You may need to read it again.
-
■ If you have any further questions, ask your doctor or pharmacist.
-
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
-
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
-
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Teva
-
3. How to take Irbesartan/Hydrochlorothiazide Teva
-
4. Possible side effects
-
5. How to store Irbesartan/Hydrochlorothiazide Teva
-
6. Contents of the pack and other information
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
Irbesartan/Hydrochlorothiazide Teva is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone.
Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
2. What you need to know before you take Irbesartan/Hydrochlorothiazide TevaDo not take Irbesartan/Hydrochlorothiazide Teva
if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazole or to any other sulfonamide-derived medicines
if you are more than 3 months pregnant (it is also better to avoid Irbesartan/Hydrochlorothiazide Teva in early pregnancy – see pregnancy section).
if you have severe liver or kidney problems.
if you have difficulty in producing urine.
if your doctor determines that you have persistently high calcium or low potassium levels in your blood.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Teva and if any of the following apply to you:
■ if you get excessive vomiting or diarrhoea
if you suffer from kidney problems or have a kidney transplantation
if you suffer from heart problems
if you suffer from liver problems
if you suffer from diabetes
if you suffer from lupus erythematosus (also known as lupus or SLE)
if your suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure)
if you are taking any of the following medicines used to treat high blood pressure:
-
– an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-
– aliskiren
if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Teva
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/Hydrochlorothiazide Teva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
You should also tell your doctor:
-
■ if you are on a low-salt diet
-
■ if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Teva).
-
■ if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal
-
■ if you are going to have an operation (surgery) or be given anaesthetics
-
■ if you have changes in your vision or pain in one or both of your eyes while taking
Irbesartan/Hydrochlorothiazide Teva. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan/Hydrochlorothiazide Teva treatment and seek medical attention.
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Children and adolescents
Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years). If a child swallows some tablets, contact your doctor immediately.
Other medicines and Irbesartan/Hydrochlorothiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiaizde Teva may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiaizde Teva without close supervision by your doctor.
You may need to have blood checks if you take:
-
■ potassium supplements
-
■ salt substitutes containing potassium
-
■ potassium sparing medicines or other diuretics (water tablets)
-
■ some laxatives
-
■ medicines for the treatment of gout
-
■ therapeutic vitamin D supplements
-
■ medicines to control heart rhythm
-
■ medicines for diabetes (oral agents or insulins)
-
■ carbamazepine (a medicine for the treatment of epilepsy).
It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Irbesartan/Hydrochlorothiazide Teva with alcohol
Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan/Hydrochlorothiazide Teva. Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan/Hydrochlorothiazide Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.
Irbesartan/Hydrochlorothiazide Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take Irbesartan/Hydrochlorothiazide Teva
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one or two tablets a day. Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Teva.
Method of administration
Irbesartan/Hydrochlorothiazide Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide Teva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you otherwise.
The maximal blood pressure lowering effect should be reached 6–8 weeks after beginning treatment.
If you take more Irbesartan/Hydrochlorothiazide Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan/Hydrochlorothiazide Teva
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.
Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.
Side effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were:
Common side effects (may affect up to 1 in 10 people):
-
■ nausea/vomiting
-
■ abnormal urination
-
■ fatigue
-
■ dizziness (including when getting up from a lying or sitting position)
-
■ blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
If any of these side effects causes you problems , talk to your doctor.
Uncommon side effects (may affect up to 1 in 100 people):
-
■ diarrhoea
-
■ low blood pressure
-
■ fainting
-
■ heart rate increased
-
■ flushing
-
■ swelling
-
■ sexual dysfunction (problems with sexual performance)
-
■ blood tests may show lowered levels of potassium and sodium in your blood.
If any of these side effects causes you problems , talk to your doctor.
Some undesirable effects have been reported since the marketing of the combination of irbesartan and hydrochlorothiazide. Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Side effects associated with irbesartan alone:
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Side effects associated with hydrochlorothiazide alone are:
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as yellowing of the skin and/or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma); lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Frequency ‘not known’: Skin and lip cancer (Non-melanoma skin cancer)
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Irbesartan/Hydrochlorothiazide Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC – aluminium blisters: Do not store above 30°C.
For Irbesartan/Hydrochlorothiazide Teva packaged in aluminium – aluminium blisters: This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Irbesartan/Hydrochlorothiazide Teva contains
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■ The active ingredients are irbesartan and hydrochlorothiazide.
Each Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
-
■ The other ingredients are:
Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
Tablet coating for 150 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
What Irbesartan/Hydrochlorothiazide Teva looks like and contents of the pack
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets are light pink to pink, film coated capsule shaped tablets. One side of the tablet is debossed with the number “93" and the other side of the tablet is debossed with the number „7238“.
Irbesartan/Hydrochlorothiazide Teva is available in pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 × 1 film coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
Manufacturers:
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31–546 Krakow
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi ut 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Efcarapua TeBa OapMa EAfl Tea: +359 24899585 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 Danmark Teva Denmark A/S Tlf: +45 44985511 | Lietuva UAB Teva Baltics Tel: +370 52660203 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 38207373 Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400 Malta Teva Pharmaceuticals Ireland L-Irlanda |
Tel: +44 2075407117
| Deutschland Teva GmbH Tel: +49 73140208 | Nederland Teva Nederland B.V. Tel: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España Teva Pharma, S.L.U. Tel: +34 913873280 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal Teva Pharma – Produtos Farmaceuticos, Lda Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o Tel: + 385 13720000 | Romania Teva Pharmaceuticals S.R.L Tel: +40 212306524 |
| Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
| Ísland Teva Finland Oy Finnland | Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Puh/Tel: +358 201805900
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| Kùnpoç Specifar A.B.E.E. EZZàôa | Sverige Teva Sweden AB Tel: +46 42121100 |
Tql: +30 2118805000
| Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site:
Package leaflet: information for the patient
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
■ Keep this leaflet. You may need to read it again.
-
■ If you have any further questions, ask your doctor or pharmacist.
-
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
-
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
-
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Teva
-
3. How to take Irbesartan/Hydrochlorothiazide Teva
-
4. Possible side effects
-
5. How to store Irbesartan/Hydrochlorothiazide Teva
-
6. Contents of the pack and other information
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
Irbesartan/Hydrochlorothiazide Teva is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone.
Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
2. What you need to know before you take Irbesartan/Hydrochlorothiazide TevaDo not take Irbesartan/Hydrochlorothiazide Teva
if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazole or to any other sulfonamide-derived medicines
if you are more than 3 months pregnant (it is also better to avoid Irbesartan/Hydrochlorothiazide Teva in early pregnancy – see pregnancy section).
if you have severe liver or kidney problems.
if you have difficulty in producing urine.
if your doctor determines that you have persistently high calcium or low potassium levels in your blood.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Teva and if any of the following apply to you:
■ if you get excessive vomiting or diarrhoea
if you suffer from kidney problems or have a kidney transplantation
if you suffer from heart problems
if you suffer from liver problems
if you suffer from diabetes
if you suffer from lupus erythematosus (also known as lupus or SLE)
if your suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure)
if you are taking any of the following medicines used to treat high blood pressure:
-
– an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-
– aliskiren
if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Teva
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/Hydrochlorothiazide Teva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
You should also tell your doctor:
-
■ if you are on a low-salt diet
-
■ if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Teva).
-
■ if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal
-
■ if you are going to have an operation (surgery) or be given anaesthetics
-
■ if you have changes in your vision or pain in one or both of your eyes while taking
Irbesartan/Hydrochlorothiazide Teva. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan/Hydrochlorothiazide Teva treatment and seek medical attention.
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Children and adolescents
Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years). If a child swallows some tablets, contact your doctor immediately.
Other medicines and Irbesartan/Hydrochlorothiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiaizde Teva may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiaizde Teva without close supervision by your doctor.
You may need to have blood checks if you take:
-
■ potassium supplements
-
■ salt substitutes containing potassium
-
■ potassium sparing medicines or other diuretics (water tablets)
-
■ some laxatives
-
■ medicines for the treatment of gout
-
■ therapeutic vitamin D supplements
-
■ medicines to control heart rhythm
-
■ medicines for diabetes (oral agents or insulins)
-
■ carbamazepine (a medicine for the treatment of epilepsy).
It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines or colestyramine and colestipol resins for lowering blood cholesterol.
Irbesartan/Hydrochlorothiazide Teva with alcohol
Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan/Hydrochlorothiazide Teva. Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan/Hydrochlorothiazide Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.
Irbesartan/Hydrochlorothiazide Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take Irbesartan/Hydrochlorothiazide Teva
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one tablet a day.
Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Teva.
Method of administration
Irbesartan/Hydrochlorothiazide Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide Teva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you otherwise.
The maximal blood pressure lowering effect should be reached 6–8 weeks after beginning treatment.
If you take more Irbesartan/Hydrochlorothiazide Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan/Hydrochlorothiazide Teva
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.
Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.
Side effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were:
Common side effects (may affect up to 1 in 10 people):
-
■ nausea/vomiting
-
■ abnormal urination
-
■ fatigue
-
■ dizziness (including when getting up from a lying or sitting position)
-
■ blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
If any of these side effects causes you problems , talk to your doctor.
Uncommon side effects (may affect up to 1 in 100 people):
-
■ diarrhoea
-
■ low blood pressure
-
■ fainting
-
■ heart rate increased
-
■ flushing
-
■ swelling
-
■ sexual dysfunction (problems with sexual performance)
-
■ blood tests may show lowered levels of potassium and sodium in your blood.
If any of these side effects causes you problems , talk to your doctor.
Some undesirable effects have been reported since the marketing of the combination of irbesartan and hydrochlorothiazide. Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Side effects associated with irbesartan alone:
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Side effects associated with hydrochlorothiazide alone are:
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as yellowing of the skin and/or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma); lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Frequency ‘not known’: Skin and lip cancer (Non-melanoma skin cancer)
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Irbesartan/Hydrochlorothiazide Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC – aluminium blisters: Do not store above 30°C.
For Irbesartan/Hydrochlorothiazide Teva packaged in aluminium – aluminium blisters: This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Irbesartan/Hydrochlorothiazide Teva contains
-
■ The active ingredients are irbesartan and hydrochlorothiazide.
Each Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
-
■ The other ingredients are:
Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
Tablet coating for 300 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
What Irbesartan/Hydrochlorothiazide Teva looks like and contents of the pack
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets are light pink to pink, round film coated tablets. One side of the tablet debossed with the number “2” and plain on the other side.
Irbesartan/Hydrochlorothiazide Teva is available in pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 × 1 film coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
Manufacturers:
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31–546 Kraków
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Efcnrapua TeBa OapMa EAfl Ten: +359 24899585 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 | Lietuva UAB Teva Baltics Tel: +370 52660203 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 38207373 Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400 |
| Danmark Teva Denmark A/S Tlf: +45 44985511 | Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 |
| Deutschland Teva GmbH Tel: +49 73140208 | Nederland Teva Nederland B.V. Tel: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España Teva Pharma, S.L.U. Tel: +34 913873280 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal Teva Pharma – Produtos Farmacêuticos, Lda Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o Tel: + 385 13720000 | România Teva Pharmaceuticals S.R.L Tel: +40 212306524 |
| Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
| Ísland Teva Finland Oy Finnland | Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Puh/Tel: +358 201805900
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| Kùnpoç Specifar A.B.E.E. EZZàôa | Sverige Teva Sweden AB Tel: +46 42121100 |
Tql: +30 2118805000
| Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site:
Package leaflet: information for the patient
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan / hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
■ Keep this leaflet. You may need to read it again.
-
■ If you have any further questions, ask your doctor or pharmacist.
-
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
-
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
-
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Teva
-
3. How to take Irbesartan/Hydrochlorothiazide Teva
-
4. Possible side effects
-
5. How to store Irbesartan/Hydrochlorothiazide Teva
-
6. Contents of the pack and other information
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
Irbesartan/Hydrochlorothiazide Teva is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone.
Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
2. What you need to know before you take Irbesartan/Hydrochlorothiazide TevaDo not take Irbesartan/Hydrochlorothiazide Teva
if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazole or to any other sulfonamide-derived medicines
if you are more than 3 months pregnant (it is also better to avoid Irbesartan/Hydrochlorothiazide Teva in early pregnancy – see pregnancy section).
if you have severe liver or kidney problems.
if you have difficulty in producing urine.
if your doctor determines that you have persistently high calcium or low potassium levels in your blood.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Teva and if any of the following apply to if you get excessive vomiting or diarrhoea
you:
■
■
if you suffer from kidney problems or have a kidney transplantation
-
■ if you suffer from heart problems
-
■ if you suffer from liver problems
-
■ if you suffer from diabetes
-
■ if you suffer from lupus erythematosus (also known as lupus or SLE)
-
■ if your suffer from primary aldosteronism (a condition related to high production of the hormone
aldosterone, which causes sodium retention and, in turn, an increase in blood pressure)
-
■ if you are taking any of the following medicines used to treat high blood pressure:
-
– an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-
– aliskiren
-
■ if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Teva
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/Hydrochlorothiazide Teva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
You should also tell your doctor:
if you are on a low-salt diet
if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Teva).
if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal
if you are going to have an operation (surgery) or be given anaesthetics
if you have changes in your vision or pain in one or both of your eyes while taking Irbesartan/Hydrochlorothiazide Teva. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan/Hydrochlorothiazide Teva treatment and seek medical attention.
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Children and adolescents
Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years). If a child swallows some tablets, contact your doctor immediately.
Other medicines and Irbesartan/Hydrochlorothiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiaizde Teva may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiaizde Teva without close supervision by your doctor.
You may need to have blood checks if you take:
-
■ potassium supplements
salt substitutes containing potassium
potassium sparing medicines or other diuretics (water tablets) some laxatives
medicines for the treatment of gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral agents or insulins) carbamazepine (a medicine for the treatment of epilepsy).
It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Irbesartan/Hydrochlorothiazide Teva with alcohol
Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan/Hydrochlorothiazide Teva. Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan/Hydrochlorothiazide Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.
Irbesartan/Hydrochlorothiazide Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take Irbesartan/Hydrochlorothiazide Teva
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one tablet a day.
Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Teva.
Method of administration
Irbesartan/Hydrochlorothiazide Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide Teva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you otherwise.
The maximal blood pressure lowering effect should be reached 6–8 weeks after beginning treatment.
If you take more Irbesartan/Hydrochlorothiazide Teva than you should If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan/Hydrochlorothiazide Teva
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.
Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.
Side effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were:
Common side effects (may affect up to 1 in 10 people):
-
■ nausea/vomiting
-
■ abnormal urination
-
■ fatigue
-
■ dizziness (including when getting up from a lying or sitting position)
-
■ blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
If any of these side effects causes you problems , talk to your doctor.
Uncommon side effects (may affect up to 1 in 100 people):
-
■ diarrhoea
-
■ low blood pressure
-
■ fainting
-
■ heart rate increased
-
■ flushing
-
■ swelling
-
■ sexual dysfunction (problems with sexual performance)
-
■ blood tests may show lowered levels of potassium and sodium in your blood.
5. How to store Irbesartan/Hydrochlorothiazide Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC – aluminium blisters: Do not store above 30°C.
For Irbesartan/Hydrochlorothiazide Teva packaged in aluminium – aluminium blisters: This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Irbesartan/Hydrochlorothiazide Teva contains
The active ingredients are irbesartan and hydrochlorothiazide.
Each Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablet contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
The other ingredients are:
Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
Tablet coating for 300 mg/25 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, Indigotine (Indigo carmine aluminium lake FD&C blue #2) and iron oxide black.
What Irbesartan/Hydrochlorothiazide Teva looks like and contents of the pack
Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets are light pink to pink, film coated capsule shaped tablets. One side of the tablet is debossed with the number “93" and the other side of the tablet is debossed with the number „7238“.
Irbesartan/Hydrochlorothiazide Teva is available in pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 × 1 film coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
Manufacturers:
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31–546 Krakow
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi ut 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Efcarapua TeBa OapMa EAfl Tea: +359 24899585 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 Danmark Teva Denmark A/S Tlf: +45 44985511 | Lietuva UAB Teva Baltics Tel: +370 52660203 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 38207373 Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400 Malta Teva Pharmaceuticals Ireland L-Irlanda |
Tel: +44 2075407117
| Deutschland Teva GmbH Tel: +49 73140208 | Nederland Teva Nederland B.V. Tel: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España Teva Pharma, S.L.U. Tel: +34 913873280 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal Teva Pharma – Produtos Farmaceuticos, Lda Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o Tel: + 385 13720000 | Romania Teva Pharmaceuticals S.R.L Tel: +40 212306524 |
| Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
| Ísland Teva Finland Oy Finnland | Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Puh/Tel: +358 201805900
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| Kùnpoç Specifar A.B.E.E. EZZàôa | Sverige Teva Sweden AB Tel: +46 42121100 |
Tql: +30 2118805000
| Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site:
Package leaflet: information for the patient
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets irbesartan / hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
■ Keep this leaflet. You may need to read it again.
-
■ If you have any further questions, ask your doctor or pharmacist.
-
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
-
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
-
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Teva
-
3. How to take Irbesartan/Hydrochlorothiazide Teva
-
4. Possible side effects
-
5. How to store Irbesartan/Hydrochlorothiazide Teva
-
6. Contents of the pack and other information
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
Irbesartan/Hydrochlorothiazide Teva is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone.
Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
2. What you need to know before you take Irbesartan/Hydrochlorothiazide TevaDo not take Irbesartan/Hydrochlorothiazide Teva
if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazole or to any other sulfonamide-derived medicines
if you are more than 3 months pregnant (it is also better to avoid Irbesartan/Hydrochlorothiazide Teva in early pregnancy – see pregnancy section).
if you have severe liver or kidney problems.
if you have difficulty in producing urine.
if your doctor determines that you have persistently high calcium or low potassium levels in your blood.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Teva and if any of the following apply to you:
■ if you get excessive vomiting or diarrhoea
if you suffer from kidney problems or have a kidney transplantation
if you suffer from heart problems
if you suffer from liver problems
if you suffer from diabetes
if you suffer from lupus erythematosus (also known as lupus or SLE)
if your suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure)
if you are taking any of the following medicines used to treat high blood pressure:
-
– an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-
– aliskiren
if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Teva
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/Hydrochlorothiazide Teva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
You should also tell your doctor:
-
■ if you are on a low-salt diet
-
■ if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Teva).
-
■ if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal
-
■ if you are going to have an operation (surgery) or be given anaesthetics
-
■ if you have changes in your vision or pain in one or both of your eyes while taking
Irbesartan/Hydrochlorothiazide Teva. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan/Hydrochlorothiazide Teva treatment and seek medical attention.
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Children and adolescents
Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years). If a child swallows some tablets, contact your doctor immediately.
Other medicines and Irbesartan/Hydrochlorothiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiaizde Teva may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiaizde Teva without close supervision by your doctor.
You may need to have blood checks if you take:
-
■ potassium supplements
-
■ salt substitutes containing potassium
-
■ potassium sparing medicines or other diuretics (water tablets)
-
■ some laxatives
-
■ medicines for the treatment of gout
-
■ therapeutic vitamin D supplements
-
■ medicines to control heart rhythm
-
■ medicines for diabetes (oral agents or insulins)
-
■ carbamazepine (a medicine for the treatment of epilepsy).
It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines or colestyramine and colestipol resins for lowering blood cholesterol.
Irbesartan/Hydrochlorothiazide Teva with alcohol
Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan/Hydrochlorothiazide Teva. Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan/Hydrochlorothiazide Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.
Irbesartan/Hydrochlorothiazide Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take Irbesartan/Hydrochlorothiazide Teva
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one tablet a day.
Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Teva.
Method of administration
Irbesartan/Hydrochlorothiazide Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide Teva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you otherwise.
The maximal blood pressure lowering effect should be reached 6–8 weeks after beginning treatment.
If you take more Irbesartan/Hydrochlorothiazide Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan/Hydrochlorothiazide Teva
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.
Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.
Side effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were:
Common side effects (may affect up to 1 in 10 people):
-
■ nausea/vomiting
-
■ abnormal urination
-
■ fatigue
-
■ dizziness (including when getting up from a lying or sitting position)
-
■ blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
If any of these side effects causes you problems , talk to your doctor.
Uncommon side effects (may affect up to 1 in 100 people):
-
■ diarrhoea
-
■ low blood pressure
-
■ fainting
-
■ heart rate increased
-
■ flushing
-
■ swelling
-
■ sexual dysfunction (problems with sexual performance)
-
■ blood tests may show lowered levels of potassium and sodium in your blood.
If any of these side effects causes you problems , talk to your doctor.
Some undesirable effects have been reported since the marketing of the combination of irbesartan and hydrochlorothiazide. Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Side effects associated with irbesartan alone:
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Side effects associated with hydrochlorothiazide alone are:
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as yellowing of the skin and/or whites of the eyes; inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma); lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Frequency ‘not known’: Skin and lip cancer (Non-melanoma skin cancer)
It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Irbesartan/Hydrochlorothiazide Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
For Irbesartan/Hydrochlorothiazide Teva packaged in white opaque PVC-PVdC – aluminium blisters: Do not store above 30°C.
For Irbesartan/Hydrochlorothiazide Teva packaged in aluminium – aluminium blisters: This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Irbesartan/Hydrochlorothiazide Teva contains
-
■ The active ingredients are irbesartan and hydrochlorothiazide.
Each Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
-
■ The other ingredients are:
Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
Tablet coating for 300 mg/12.5 mg strength: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), iron oxide red, iron oxide yellow and iron oxide black.
What Irbesartan/Hydrochlorothiazide Teva looks like and contents of the pack
Irbesartan/Hydrochlorothiazide Teva 300 mg/12.5 mg film-coated tablets are light pink to pink, round film coated tablets. One side of the tablet debossed with the number “2” and plain on the other side.
Irbesartan/Hydrochlorothiazide Teva is available in pack sizes of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 × 1 film coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
Manufacturers:
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31–546 Kraków
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Efcnrapua TeBa OapMa EAfl Ten: +359 24899585 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 | Lietuva UAB Teva Baltics Tel: +370 52660203 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 38207373 Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400 |
| Danmark Teva Denmark A/S Tlf: +45 44985511 | Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 |
| Deutschland Teva GmbH Tel: +49 73140208 | Nederland Teva Nederland B.V. Tel: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España Teva Pharma, S.L.U. Tel: +34 913873280 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal Teva Pharma – Produtos Farmacêuticos, Lda Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o Tel: + 385 13720000 | România Teva Pharmaceuticals S.R.L Tel: +40 212306524 |
| Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
| Ísland Teva Finland Oy Finnland | Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Puh/Tel: +358 201805900
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| Kùnpoç Specifar A.B.E.E. EZZàôa | Sverige Teva Sweden AB Tel: +46 42121100 |
Tql: +30 2118805000
| Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site:
Package leaflet: information for the patient
Irbesartan/Hydrochlorothiazide Teva 300 mg/25 mg film-coated tablets irbesartan / hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
■ Keep this leaflet. You may need to read it again.
-
■ If you have any further questions, ask your doctor or pharmacist.
-
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
-
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
-
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Teva
-
3. How to take Irbesartan/Hydrochlorothiazide Teva
-
4. Possible side effects
-
5. How to store Irbesartan/Hydrochlorothiazide Teva
-
6. Contents of the pack and other information
1. What Irbesartan/Hydrochlorothiazide Teva is and what it is used for
Irbesartan/Hydrochlorothiazide Teva is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure.
The two active ingredients in Irbesartan/Hydrochlorothiazide Teva work together to lower blood pressure further than if either was given alone.
Irbesartan/Hydrochlorothiazide Teva is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
2. What you need to know before you take Irbesartan/Hydrochlorothiazide TevaDo not take Irbesartan/Hydrochlorothiazide Teva
if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazole or to any other sulfonamide-derived medicines
if you are more than 3 months pregnant (it is also better to avoid Irbesartan/Hydrochlorothiazide Teva in early pregnancy – see pregnancy section).
if you have severe liver or kidney problems.
if you have difficulty in producing urine.
if your doctor determines that you have persistently high calcium or low potassium levels in your blood.
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide Teva and if any of the following apply to if you get excessive vomiting or diarrhoea
you:
■
■
if you suffer from kidney problems or have a kidney transplantation
-
■ if you suffer from heart problems
-
■ if you suffer from liver problems
-
■ if you suffer from diabetes
-
■ if you suffer from lupus erythematosus (also known as lupus or SLE)
-
■ if your suffer from primary aldosteronism (a condition related to high production of the hormone
aldosterone, which causes sodium retention and, in turn, an increase in blood pressure)
-
■ if you are taking any of the following medicines used to treat high blood pressure:
-
– an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
-
– aliskiren
-
■ if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Teva
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Irbesartan/Hydrochlorothiazide Teva”.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan/Hydrochlorothiazide Teva is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
You should also tell your doctor:
if you are on a low-salt diet
if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Teva).
if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal
if you are going to have an operation (surgery) or be given anaesthetics
if you have changes in your vision or pain in one or both of your eyes while taking Irbesartan/Hydrochlorothiazide Teva. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Irbesartan/Hydrochlorothiazide Teva treatment and seek medical attention.
The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Children and adolescents
Irbesartan/Hydrochlorothiazide Teva should not be given to children and adolescents (under 18 years). If a child swallows some tablets, contact your doctor immediately.
Other medicines and Irbesartan/Hydrochlorothiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
Diuretic agents such as the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiaizde Teva may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan/Hydrochlorothiaizde Teva without close supervision by your doctor.
You may need to have blood checks if you take:
-
■ potassium supplements
salt substitutes containing potassium
potassium sparing medicines or other diuretics (water tablets) some laxatives
medicines for the treatment of gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral agents or insulins) carbamazepine (a medicine for the treatment of epilepsy).
It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers, arthritis medicines, or colestyramine and colestipol resins for lowering blood cholesterol.
Irbesartan/Hydrochlorothiazide Teva with alcohol
Due to the hydrochlorothiazide contained in Irbesartan/Hydrochlorothiazide Teva, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, especially when getting up from a sitting position.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan/Hydrochlorothiazide Teva. Irbesartan/Hydrochlorothiazide Teva is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan/Hydrochlorothiazide Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Irbesartan/Hydrochlorothiazide Teva is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.
Irbesartan/Hydrochlorothiazide Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. How to take Irbesartan/Hydrochlorothiazide Teva
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Irbesartan/Hydrochlorothiazide Teva is one tablet a day.
Irbesartan/Hydrochlorothiazide Teva will usually be prescribed by your doctor when your previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the previous treatment to Irbesartan/Hydrochlorothiazide Teva.
Method of administration
Irbesartan/Hydrochlorothiazide Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide Teva with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan/Hydrochlorothiazide Teva until your doctor tells you otherwise.
The maximal blood pressure lowering effect should be reached 6–8 weeks after beginning treatment.
If you take more Irbesartan/Hydrochlorothiazide Teva than you should If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan/Hydrochlorothiazide Teva
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.
Rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan/Hydrochlorothiazide Teva and contact your doctor immediately.
Side effects reported in clinical studies for patients treated with the combination of irbesartan and hydrochlorothiazide were:
Common side effects (may affect up to 1 in 10 people):
-
■ nausea/vomiting
-
■ abnormal urination
-
■ fatigue
-
■ dizziness (including when getting up from a lying or sitting position)
-
■ blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine).
If any of these side effects causes you problems , talk to your doctor.
Uncommon side effects (may affect up to 1 in 100 people):
-
■ diarrhoea
-
■ low blood pressure
-
■ fainting
-
■ heart rate increased
-
■ flushing
-
■ swelling
-
■ sexual dysfunction (problems with sexual performance)
-
■ blood tests may show lowered levels of potassium and sodium in your blood.