Patient leaflet - IRBESARTAN 150 MG TABLETS
Irbesartan 75mg
tablets
Irbesartan 150mg
tablets
Irbesartan 300mg
tablets
(irbesartan)
Read all of this leaflet carefully before you start taking this medicine.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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– If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
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1. What Irbesartan is and what it is used for
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2. Before you take Irbesartan
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3. How to take Irbesartan
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4. Possible side effects
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5. How to store Irbesartan
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6. Further information
1. what irbesartan is and what it is used for
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body which 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.
Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan is used
- to treat high blood pressure (essential hypertension)
- to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
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2. BEFORE YOU TAKE IRBESARTAN
Do not take Irbesartan
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– if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan tablets – if you are more than 3 months pregnant. (It is also better to avoid Irbesartan in early
pregnancy – see pregnancy section)
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– if you have diabetes mellitus or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Irbesartan should not be given to children and adolescents (under 18 years).
Take special care with Irbesartan
Tell your doctor if any of the following apply to you:
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– if you get excessive vomiting or diarrhoea;
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– if you suffer from kidney problems;
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– if you suffer from heart problems;
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– if you receive irbesartan for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function;
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– if you are going to have an operation (surgery) or be given anaesthetics;
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– if you are taking any of the following medicines used to treat high blood pressure:
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– an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems
– aliskiren
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”.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan 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 at that stage (see pregnancy section).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 heading “Do not take Irbesartan” and “Take special care with Irbesartan”).
You may need to have blood checks if you take:
- potassium supplements
- salt substitutes containing potassium
- potassium-sparing medicines (such as certain diuretics)
- medicines containing lithium
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.
Taking Irbesartan with food and drink
Irbesartan can be taken with or without food.
Pregnancy and breast-feeding
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan. Irbesartan is not recommended in early 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 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 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.
Important information about some of the ingredients of Irbesartan
Irbesartan contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. how to take irbesartan
Always take irbesartan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method of administration
Irbesartan is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take irbesartan 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 until your doctor tells you otherwise.
If you take more Irbesartan than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children should not take Irbesartan
Irbesartan should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.
If you forget to take Irbesartan
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 product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, irbesartan can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.
As with similar medicines, 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 and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: at least 1 in 10 patients or more
Common: at least 1 in 100 and less than 1 in 10 patients
Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Side effects reported in clinical studies for patients treated with irbesartan were:
- Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
- Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
- Uncommon: increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Some undesirable effects have been reported since marketing of Irbesartan but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store irbesartan
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use irbesartan 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.
No special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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6. FURTHER INFORMATION
What Irbesartan contains
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– The active substance is irbesartan.
Each Irbesartan 75 mg tablet contains 75 mg irbesartan.
Each Irbesartan 150 mg tablet contains 150 mg irbesartan.
Each Irbesartan 300 mg tablet contains 300 mg irbesartan.
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– The other ingredients are lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, hypromellose, pregelatinized starch, magnesium stearate, titanium dioxide (E171) and macrogol 4000.
What Irbesartan looks like and contents of the pack
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– Irbesartan 75 mg tablets are white to off-white, oval shaped, tablets debossed with “J” on one side and “75” on the other.
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– Irbesartan 150 mg tablets are white to off-white, oval shaped, tablets debossed with “J” on one side and “150” on the other.
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– Irbesartan 300 mg tablets are white to off-white, oval shaped, tablets debossed with “J” on one side and “300” on the other.
Marketing Authorisation Holder:
Waymade Plc
Trading as: Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
United Kingdom
Manufacturer:
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Waymade Plc
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
United Kingdom
This leaflet was last revised in December 2015