Leaflet: information for the user

Irbesartán Teva 75mg film-coated tablets

Irbesartán

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Irbesartán Teva 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 results in an increase in blood pressure. Irbesartán Teva prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartán Teva slows the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

Irbesartán 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 clinical evidence of altered renal function.

Do not take Irbesartán Teva

• if you areallergicto irbesartán or to any of the other components of this medication (listed in section 6).
• if you aremore than 3 months pregnant. (In any case, it is better to avoid taking Irbesartán Teva also at the beginning of your pregnancy – see pregnancy section)
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Irbesartán Teva andif any of the following affect you:

• if you haveexcessive vomiting or diarrhea
• if you havekidney problems
• if you haveheart problems
• if you are taking Irbesartán Teva fordiabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function.
• ifyou are to be operated(surgical intervention) or ifyou are to be administered anesthetics.
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• a 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 renal function, blood pressure, and electrolyte levels in the blood (e.g. potassium), at regular intervals.

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

If you are pregnant, if you suspect that you may beor if you plan to become pregnant, you must inform your doctor. It is generally recommended that you stop taking Irbesartán Teva before becoming pregnant or as soon as you become pregnant and your doctor will recommend taking another antihypertensive medication instead of Irbesartán Teva. Irbesartán Teva should not be used at the beginning of pregnancy (first 3 months) and should not be administered at all from the third month of pregnancy, as it may cause serious harm to your baby (see pregnancy section).

Children and adolescents

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

Taking Irbesartán Teva and other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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 Irbesartán Teva” and “Warnings and precautions”).

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

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing medications (such as certain diuretics)
• medications containing lithium

If you are using a type of pain reliever, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartán may be reduced.

Pregnancy and lactation

Pregnancy

You must inform your doctor if you are pregnant, if you suspect that you may beor if you plan to become pregnant. Generally, your doctor will advise you to stop taking Irbesartán Teva before becoming pregnant or as soon as you become pregnant and will recommend taking another antihypertensive medication instead of Irbesartán Teva. Irbesartán Teva should not be used at the beginning of pregnancy (first 3 months) and should not be administered at all from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Lactation

Inform your doctor if you plan to start or are breastfeeding, as it is not recommended to administer Irbesartán Teva during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

It is unlikely that Irbesartán Teva will affect your ability to drive vehicles or use machines. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or using machines.

Irbesartan Teva contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration Method

Irbesartán Teva is administeredorally. 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 every day. It is essential that you continue taking Irbesartán Teva until your doctor advises you otherwise.

• Patients with High Blood Pressure

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

• 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 300mg once a day

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as thoseundergoing hemodialysisor those75 years old or older.

The maximum blood pressure-lowering effect should be achieved within 4-6weeks 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 the nearest hospital emergency service, your doctor, or call the Toxicology Information Service at 915 620 420.

If you forget to take Irbesartán Teva

If you accidentally forget to take a dose, simply take your normal dose when it is due again. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Nevertheless, some of these side effects can be serious and may require medical attention.

Like with similar medicines, in rare cases, there have been reported cases of skin allergic reactions (skin rash, urticaria) as well as localized inflammation in the face, lips, and/or tongue in patients treated with irbesartan. If you think you may have this type of reaction or experience shortness of breath,stop taking Irbesartan Teva and seek immediate medical attention.

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 impairment, blood tests may show an increase in 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).

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 (hemoglobin).

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

Not known (cannot be estimated from available data): feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis)and severe allergic reactions (anaphylactic shock). Rare cases of jaundice (yellowing of the skin and/or white of the eyes) have also been observed.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán Teva

• The active ingredient is irbesartan.

• Each film-coated tablet of Irbesartán Teva 75 mg contains 75 mg of irbesartan.

Appearance of the product and contents of the pack

The film-coated tablets of Irbesartán Teva 75 mg 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 “7464”.

Irbesartán Teva is available in formats of 7, 14, 28, 30, 56, 60, 80, 84, 90, 98, and 100 film-coated tablets in unperforated blisters; formats of 50x1 and 56x1 film-coated tablets in single-dose blisters; and formats of 28 film-coated tablets in unperforated calendar blisters.

Only some sizes of packaging may be commercially available.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization:

Teva B.V.

Swensweg 5

2031 GA Haarlem

Holland

Responsible for manufacturing:

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

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Holland

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

Last review date of this leaflet:

The detailed information about Irbesartán Teva is available on the website of the European Medicines Agency http://www.ema.europa.eu/