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Irbesartan Dexcel 75mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Irbesartan Dexcel 75mg Film-Coated Tablets Irbesartan Dexcel 150mg Film-Coated Tablets Irbesartan Dexcel 300mg Film-Coated Tablets

(Referred to as Irbesartan Tablets throughout this document)

irbesartan

Read all of this leaflet carefully before you start taking this medicine.

• 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 Tablets belong 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 Tablets prevent the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Tablets slow the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan Tablets are used in adult patients to:

• treat high blood pressure (essential hypertension)

• protect 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 (hypersensitive) to irbesartan or any other ingredients of Irbesartan Tablets

• more than 3 months pregnant. (It is also better to avoid Irbesartan Tablets in early pregnancy - see pregnancy section)

Irbesartan Tablets should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan Tablets 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 Tablets 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

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan Tablets are 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).

Use in children

This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

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 Tablets do 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 Tablets with food and drink

Irbesartan Tablets 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 Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Tablets. Irbesartan Tablets are 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 Tablets are 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 Tablets are 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.

3. HOW TO TAKE IRBESARTAN TABLETS

Always take Irbesartan Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan Tablets are for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).

You can take Irbesartan Tablets 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 Tablets until your doctor tells you otherwise.

• Patients with high blood pressure

The usual dose is 150mg once a day (for Irbesartan 75mg tablets - two tablets a day). The dose may later be increased to 300mg (for Irbesartan 75mg tablets - four tablets a day, for Irbesartan 150mg tablets - two tablets 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, 300mg (for Irbesartan 75mg tablets -four tablets a day, for Irbesartan 150mg tablets - two 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.

Children should not take Irbesartan Tablets

Irbesartan Tablets should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Irbesartan Tablets 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.

4. POSSIBLE SIDE EFFECTS

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:

Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. As with similar medicines, rare cases of allergic skin reactions (rash, hives), 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 Tablets 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 Tablets 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 Tablets but the frequency for them to occur is not known. These undesirable effects are: feeling of spinning, 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 TABLETS

Keep out of the reach and sight of children.

Do not use Irbesartan Tablets 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.

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.

6. FURTHER INFORMATION

What Irbesartan Tablets contain

• The active substance is irbesartan.

Each tablet of Irbesartan 75mg contains 75mg irbesartan.

Each tablet of Irbesartan 150mg contains 150mg irbesartan.

Each tablet of Irbesartan 300mg contains 300mg irbesartan.

• The other ingredients are:

Core: calcium hydrogen phosphate dihydrate, Microcrystalline cellulose (E460), povidone K-30 (E1201), croscarmellose sodium (E468), silica colloidal anhydrous (E551), magnesium stearate (E572).

Film-coatingr. hypromellose (E464), titanium dioxide (E-171), macrogol, carnauba wax.

What Irbesartan Tablets looks like and contents of the pack

Irbesartan 75mg tablets are white, film coated, oval shaped tablets.

Irbesartan 150mg tablets tablets are white, film coated, oval shaped tablets, scored on one side. The tablet can be divided in equal halves.

Irbesartan 300mg tablets are white, film coated, oblong shaped tablets, scored on one side. The tablet can be divided in equal halves.

Pack sizes: Irbesartan Tablets are supplied in packs of 7, 10, 14, 28, 30, 56, 60, 80, 84, 90, 98, or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer.

Marketing Authorisation Holder

Dexcel®-Pharma Ltd.

7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK

Manufacturer

Dexcel ^®-Pharma Ltd.

7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK

This medicinal product is authorised in the Member States of the EEA under the following names.

France: - Irbesartan Dexcel 75mg comprimEs pelliculEs

- Irbesartan Dexcel 150mg comprimEs pelliculEs

- Irbesartan Dexcel 300mg comprimEs pelliculEs

Germany: - Irbesartan Dexcel 75mg Filmtabletten

- Irbesartan Dexcel 150mg Filmtabletten

- Irbesartan Dexcel 300mg Filmtabletten

Ireland: - Irbesartan Dexcel 75mg Film-Coated Tablets

- Irbesartan Dexcel 150mg Film-Coated Tablets

- Irbesartan Dexcel 300mg Film-Coated Tablets

The Netherlands: - Irbesartan Dexcel 75mg filmomhulde tabletten

- Irbesartan Dexcel 150mg filmomhulde tabletten

- Irbesartan Dexcel 300mg filmomhulde tabletten

The UK: - Irbesartan Dexcel 75mg Film-Coated Tablets