IRBESARTAN TEVA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Teva 300mg film-coated tablets EFG

Irbesartan

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.

Contents of the pack:

1. What is Irbesartan Teva and what is it used for
2. What you need to know before you take Irbesartan Teva
3. How to take Irbesartan Teva
4. Possible side effects
5. Storage of Irbesartan Teva
6. Contents of the pack and further information

1. What is Irbesartan Teva and what is it used for

Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This narrowing of blood vessels increases blood pressure. Irbesartan Teva prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and lowering blood pressure. Irbesartan Teva slows the progression of kidney damage in patients with high blood pressure and type 2 diabetes.

Irbesartan Teva is used in adult patients

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type 2 diabetes, and evidence of kidney damage.

2. What you need to know before you take Irbesartan Teva

Do not take Irbesartan Teva

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Irbesartan Teva during the first trimester of pregnancy - see section pregnancy)
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor before starting to take Irbesartan Teva and if any of the following apply to you:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Teva for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to measure potassium levels in case of impaired kidney function
• if you have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes.
• if you are going to have surgery(surgical intervention) or if you are going to be given anesthetics
• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartan Teva”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. It is not recommended to use Irbesartan Teva during the first trimester of pregnancy (first 3 months), and in any case, it must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section pregnancy).

Children and adolescents

This medicine should not be given to children under 18 years of age, as the safety and efficacy have not been fully established. If a child swallows several tablets, contact your doctor immediately.

Taking Irbesartan Teva with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Your doctor may need to modify your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan Teva” and “Warnings and precautions”).

You may need to have blood tests if you are taking:

• potassium supplements
• potassium-sparing diuretics (such as certain water tablets)
• lithium-containing medicines
• repaglinide (a medicine used to reduce blood sugar levels)

If you are using a type of painkiller called non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Irbesartan 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 Teva. It is not recommended to use Irbesartan Teva during the first trimester of pregnancy, and in any case, it must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding, as it is not recommended to take Irbesartan Teva during this period. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

It is unlikely that Irbesartan Teva will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before driving or using machines.

Irbesartan Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Irbesartan Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration

Irbesartan Teva is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Teva can be taken with or without food. You should try to take your daily dose at the same time each day. It is important that you continue to take Irbesartan Teva until your doctor tells you to stop.

• Patients with high blood pressure

The usual dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily.

• Patients with high blood pressure and type 2 diabetes with kidney damage

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of kidney damage is 300 mg once daily.

Your doctor may advise a lower dose, especially when starting treatment, in certain patients, such as those on hemodialysisor over 75 years of age.

The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting treatment.

If you take more Irbesartan Teva than you should

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

In case of overdose or accidental ingestion, contact the emergency department of the nearest hospital, your doctor, or call the Toxicology Information Service, telephone 915 620 420.

If you forget to take Irbesartan Teva

If you accidentally miss a dose, simply take your normal dose when it is due. Do not take a double dose to make up for forgotten doses.

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 side effects can be serious and may require medical attention.

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) and localized swelling (in the face, lips, and/or tongue) have been reported in patients treated with irbesartan. If you think you have had an allergic reaction, stop taking Irbesartan Teva and go to a hospital immediately.

List of side effects:

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show high potassium levels.

• Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and blood tests may show high levels of an enzyme that measures muscle and heart function (creatine kinase).

In patients with high blood pressure and type 2 diabetes with kidney damage, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

• Uncommon (may affect up to 1 in 100 people): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, and sexual dysfunction (sexual function disorders) and chest pain.

Not known (cannot be estimated from the available data): feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms may include tiredness, headaches, difficulty breathing when exercising, dizziness, and paleness), reduced number of platelets, abnormal liver function, high potassium levels in the blood, kidney failure, inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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. Storage of Irbesartan Teva

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 after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

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 protect the environment.

6. Contents of the pack and further information

Composition of Irbesartan Teva

• The active substance is irbesartan.

• Each film-coated tablet of Irbesartan Teva 300 mg contains 300 mg of irbesartan.

• The other ingredients are:

• Core of the tablet: povidone, pregelatinized maize starch, poloxamer 188, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.
• Coating: polydextrose, titanium dioxide, hypromellose, and macrogol 4000.

Appearance of the product and pack contents

Irbesartan Teva 300 mg film-coated tablets are white to off-white and capsule-shaped. One side of the tablet is marked with the number “93”. The other side of the tablet is marked with the number “7466”.

Irbesartan Teva is available in pack sizes of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, and 100 film-coated tablets in non-perforated blisters; single-dose packs of 50x1 and 56x1 film-coated tablets and a 28 film-coated tablet calendar blister pack.

Not all pack sizes may be marketed.

Marketing authorization holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer:

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

Netherlands

You can get more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/