Irbesartan Teva 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartan Teva 300 mg film-coated tablets EFG

Irbesartan

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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, causing blood vessels to constrict. This leads to an increase in blood pressure. Irbesartan Teva prevents angiotensin-II from binding to these receptors, thereby relaxing blood vessels and reducing 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 kidney in patients with high blood pressure, type 2 diabetes, and clinical evidence of impaired kidney function.

2. What you need to know before taking Irbesartan Teva

Do not take Irbesartan Teva

• if you are allergic to irbesartan or to 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 better to avoid taking Irbesartan Teva even in early pregnancy – see pregnancy section)
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

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

• if you have excessive vomiting or diarrhoea

• 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 carry out regular blood tests, especially to measure potassium levels if kidney function is impaired

• if you have low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes.

• if you are going to have surgery or if you are to be given anaesthetics

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly 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 might be pregnant, or are planning to become pregnant, you must inform your doctor. Use of Irbesartan Teva is not recommended during the first trimester of pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby (see pregnancy section).

Children and adolescents

This medicine should not be given to children under 18 years of age, as safety and efficacy have not yet been 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 need to use any other medicines.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also 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
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain diuretics)
• medicines containing lithium
• repaglinide (a medicine used to reduce blood sugar levels)

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

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will usually advise you to stop taking Irbesartan Teva before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Irbesartan Teva is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breast-feeding

Inform your doctor if you are planning to start or are currently breast-feeding, as Irbesartan Teva is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breast-feed, especially if your baby is a newborn or premature.

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, discuss with 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 Irbesartán Teva

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Irbesartán Teva is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartán 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 taking Irbesartán Teva until your doctor advises you otherwise.

• Patients with high blood pressure

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

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

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

Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients such as those on haemodialysis or those 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 Irbesartán Teva than you should

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

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

If you forget to take Irbesartán Teva

If you accidentally miss a dose, simply take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. However, some of these adverse effects can be serious and may require immediate medical attention.

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) and localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be having a reaction of this type or experience shortness of breath, stop taking Irbesartán Teva immediately and go to a medical facility right away.

List of adverse effects:

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

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

In patients with high blood pressure and type 2 diabetes with kidney impairment: 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 (haemoglobin).

• Uncommon (may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (disturbances in sexual function), and chest pain.

Not known (cannot be estimated from available data): sensation of spinning, headache, taste disturbances, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, reduction in the number of red blood cells (anaemia – symptoms may include tiredness, headaches, shortness of breath on exertion, dizziness and pallor), reduction in platelet count, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels, mainly in the skin (a condition known as leukocytoclastic 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 observed.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components are:

• Tablet core: povidone, pregelatinized starch (corn), 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 contents of the pack

Irbesartan Teva 300 mg film-coated tablets are white to off-white, capsule-shaped tablets. One side of the tablet is marked with the number “93”. The other side 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; unit dose packs of 50x1 and 56x1 film-coated tablets; and a pack of 28 film-coated tablets in a non-perforated calendar blister.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

The 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

The Netherlands

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on Irbesartan Teva is available on the website of the European Medicines Agency http://www.ema.europa.eu/