Irbesartan 75 Mg Film-Coated Tablets
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Irbesartan
The name of your medicine is:
Irbesartan 75 mg, 150 mg and 300 mg Film-coated Tablets, which will be referred to as Irbesartan tablet throughout the rest of this document.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Irbesartan tablets are and what they are used for
2. Before you take Irbesartan tablets
3. How to take Irbesartan tablets
4. Possible side effects
5. How to store Irbesartan tablets
6. Further information
1. WHAT IRBESARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Irbesartan tablet 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 tablet prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan tablet slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan tablet is used
• to treat high blood pressure (essential hypertension)
• to treat the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
2. BEFORE YOU TAKE IRBESARTAN TABLETS Do not take Irbesartan tablets
• If you are allergic to (hypersensitive) to irbesartan or any of the other excipients of Irbesartan Tablets.
• if you are more than 3 months pregnant. (It is also better to avoid Irbesartan tablet in early pregnancy - see pregnancy section)
Take special care with Irbesartan tablet Tell your doctor if any of the following apply to you:
• if you get excessive vomiting or diarrhoea
• if you suffer from kidney problems
• if you suffer from heart problems
• if you receive Irbesartan tablet 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
• if you are going to have an operation (surgery) or be given anaesthetics
Irbesartan tablets should not be given to children and adolescents (under 18 years).
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan 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).
Using 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.
Irbesartan tablet does not usually interact with other medicines.
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 Tablet with food and drink
Irbesartan tablet can be taken with or without food.
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 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 tablet. Irbesartan tablet 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 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 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.
Important information about some of the ingredients of Irbesartan tablets
Irbesartan tablet contains lactose. 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 medicinal product.
3. HOW TO TAKE IRBESARTAN TABLET Posology
Always take Irbesartan Tablet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Method and routes of administration
Irbesartan tablet is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan 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 tablet until your doctor tells you otherwise.
• Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets of 75 mg a day). The dose may later be increased to 300 mg (four tablets of 75 mg a day) once daily depending on blood pressure response.
• Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
If you take more Irbesartan tablet than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan tablets
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.
POSSIBLE SIDE EFFECTS
4.
Like all medicines, Irbesartan tablets 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 localized 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 tablet 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 tablet 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: heart rate increased, flushing, cough, diarrhoea,
indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Some undesirable effects have been reported since marketing of Irbesartan tablet 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE IRBESARTAN TABLET
Keep out of the reach and sight of children.
Do not use Irbesartan tablet 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.
This medicinal product does not require any 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.
FURTHER INFORMATION
6.
What Irbesartan tablet contain
The active substance is Irbesartan.
Each film-coated tablet contains 75 mg, 150 mg and 300 mg Irbesartan.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, silica colloidal anhydrous, magnesium stearate.
Tablet coating: Opadry 32F38977 White (lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 3000)
What Irbesartan tablet looks like and contents of the pack
Irbesartan 75 mg Film-coated Tablets are supplied as White to off white, biconvex, oval shaped, film coated tablets with ‘U21’ engraved on one side and plain on the other side.
Irbesartan 150 mg Film-coated Tablets are supplied as White to off white, biconvex, oval shaped, film coated tablets with ‘U22’ engraved on one side and plain on the other side.
Irbesartan 300 mg Film-coated Tablets are supplied as White to off white, biconvex, oval shaped, film coated tablets with ‘U23’ engraved on one side and plain on the other side.
Irbesartan 75 mg, 150 mg and 300 mg Film-coated Tablets are available in blisters containing 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets or in HDPE bottles containing 100, and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
The marketing authorisation holder is USV Europe Limited, The Podium, I Eversholt Street, Euston, London NW1 2DN, United Kingdom.
Manufacturer
The manufacturer Accord Healthcare Limited, Sage house, 319 Pinner Road, north Harrow, Middlesex HA1 4HF United Kingdom.
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Irbesartan 75 mg Film-coated Tablets
Irbesartan 150 mg Film-coated Tablets Irbesartan 300 mg Film-coated Tablets
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France: |
Irbesartan USV Europe 75 mg comprime pellicule Irbesartan USV Europe 150 mg comprime pellicule Irbesartan USV Europe 300 mg comprime pellicule |
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Germany: |
Irbesartan USV Europe 75 mg Filmtabletten Irbesartan USV Europe 150 mg Filmtabletten Irbesartan USV Europe 300 mg Filmtabletten |
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The Netherland: |
Irbesartan USV Europe 75 mg, filmomhulde tabletten Irbesartan USV Europe 150 mg, filmomhulde tabletten Irbesartan USV Europe 300 mg, filmomhulde tabletten |
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Poland: |
Irbesartan USV |
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Portugal: |
Irbesartan USV Europe |
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Slovak Republic: |
Irbesartan 75 mg film-obalene tablety Irbesartan 150 mg film-obalene tablety Irbesartan 300 mg film-obalene tablety |
This leaflet was last approved in 07/2011
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