IRBESARTAN HYDROCHLOROTHIAZIDE 300 MG / 12.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Irbesartan-Hydrochlorothiazide 300 mg/12.5 mg film-coated Tablets

What is in this leaflet

• 1. What Irbesartan-Hydrochlorothiazide film-coated tablet is and what it is used for.

• 2. What you need to know before you take Irbesartan-Hydrochlorothiazide film-coated tablet.

• 3. How to take Irbesartan-Hydrochlorothiazide film-coated tablet.

• 4. Possible side effects.

• 5. How to store Irbesartan-Hydrochlorothiazide film-coated tablet.

• 6. Contents of the pack and other information.

1. what irbesartan-hydrochlorothiazide film-coated tablet is and what it is used for

Irbesartan-Hydrochlorothiazide film-coated tablet 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 film-coated tablet work together to lower blood pressure further than if either was given alone. Irbesartan-Hydrochlorothiazide film-coated tablet 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 film-coated tablet_____________

Do not take Irbesartan-Hydrochlorothiazide film-coated tablet

• If you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines.
• If you are more than 3 months pregnant. (It is also better to avoid Irbesartan-Hydrochlorothiazide film-coated tablet in early pregnancy – see “Warnings and Precautions” and “Pregnancy” sections).
• 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 film-coated tablet and if any of the following apply to you :

• If you get excessive vomiting or diarrhoea.
• If you suffer from kidney problems or have had a kidney transplant.
• 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 you 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, ramipiril), 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 (nonmelanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan Hydrochlorothiazide tablets.

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 film-coated tablet”.

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan-Hydrochlorothiazide film-coated tablet 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 film-coated tablet).
• 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 experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Irbesartan Hydrochlorothi­azide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.

Children and adolescents

Irbesartan-Hydrochlorothiazide film-coated tablet should not be given to children and adolescents (under 18 years).

Other medicines and Irbesartan-Hydrochlorothiazide film-coated tablet Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Diuretic agents such as the hydrochlorothiazide contained in Irbesartan-Hydrochlorothiazide film-coated tablet may have an effect on other medicines. Preparations containing lithium should not be taken with Irbesartan-Hydrochlorothiazide film-coated tablet without close supervision by your doctor.

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 film-coated tablet” and “Warnings and precautions”).

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 to reduce cholesterol in your blood, nondepolarizing skeletal muscle relaxants (e.g. tubocurarine), anticholinergic agents (e.g. atropine, beperiden) or amantadine.

Irbesartan-Hydrochlorothiazide film-coated tablet with food and drink Irbesartan-Hydrochlorothiazide film-coated tablet can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan-Hydrochlorothiazide film-coated tablet, 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 film-coated tablet 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 film-coated tablet. Irbesartan-Hydrochlorothiazide film-coated tablet 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 film-coated tablet 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

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan-Hydrochlorothiazide film-coated tablet 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 film-coated tablet contains lactose Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Irbesartan-Hydrochlorothiazide film-coated tablet contains lecithine (derived from soya bean (E 322))

Contains lecithin (derived from soya bean (E 322)), if you are allergic to peanut or soya, do not use medicinal product.

3. how to take irbesartan-hydrochlorothiazide film-coated tablet

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 film-coated tablet is one a day. Irbesartan-Hydrochlorothiazide film-coated tablet will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Irbesartan-Hydrochlorothiazide film-coated tablet.

Method of administration

Irbesartan-Hydrochlorothiazide film-coated tablet is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan-Hydrochlorothiazide film-coated tablet 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 film-coated tablet until your doctor tells you otherwise.

The maximal blood pressure lowering effect should be reached 6–8 weeks after beginning treatment.

Use in Children and adolescents

Irbesartan-Hydrochlorothiazide film-coated tablet should not be given to children and adolescents under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Irbesartan-Hydrochlorothiazide film-coated tablet than you should

If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan-Hydrochlorothiazide film-coated tablet 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, hives), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.

If you get any of the above symptoms or get short of breath, stop taking Irbesartan-Hydrochlorothiazide film-coated tablet and contact your doctor immediately.

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).

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. Yellowing of the skin and/or whites of the eyes (jaundice).

Not known (frequency cannot be estimated from the available data): headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal, inflammation of the liver causing yellowing of the skin or eyes, impaired kidney function, kidney failure, increased level of potassium in your blood, allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.

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 the following have also been reported:

Uncommon (may affect up to 1 in 100 people):

• Chest pain has also been reported.

Not known (frequency cannot be estimated from the available data):

• Decrease in the number of platelets (a blood cell essential for the clotting of the blood).
• Severe allergic reactions (anaphylactic shock).

Side effects associated with hydrochlorothiazide alone

Not known (frequency cannot be estimated from the available data): Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (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); yellow vision; 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; dizziness at height; numbness, tingling or pins and needles; light-headedness; restlessness; electrolyte imbalance (including hypokalaemia and hyponatraemia); changes in vision or pain in one or both eyes; 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 Yellow Card Scheme at: Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store irbesartan hydrochlorothiazide film-coated tablet

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.

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 film-coated tablet contains

• The active substances are irbesartan and hydrochlorothi­azide.

What Irbesartan-Hydrochlorothiazide film-coated tablet looks like and contents of the pack

Irbesartan-Hydrochlorothiazide 300 mg/12.5 mg film-coated tablets are pink, biconvex, oval-shaped [(15.6–15.9) mm x (8.1–8.4) mm] film-coated tablets, BS18 debossed on one side and plain on the other. The pack size of 28 tablets (2 × 14) is registered.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sciecure Pharma Limited

5 Millmead, Guildford,

Surrey, GU2 4BE, United Kingdom.

This leaflet was last revised in July 2020

BSUKP1