Label: information for the user

Irbesartán Teva 300mg film-coated tablets

Irbesartán

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. 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 ingredients of this medicine (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-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Irbesartán Teva andif any of the following affects 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
• if you havelow blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing, or paleness, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes.
• ifyou are to be operated on(surgical intervention) or ifyou are to receive anesthetics
• if you are taking any of the following medicines 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 blood electrolyte levels (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 be, orif you plan to become pregnant, you must inform your doctor. Irbesartán Teva is not recommended for use at the beginning of pregnancy (first 3 months), and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby (see pregnancy section).

Children and adolescents

This medicine 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 medicines

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

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-sparing salt substitutes
• potassium-saving medicines (such as certain diuretics)
• litium-containing medicines
• 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 irbesartán may be reduced.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect that you may be, orif you plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartán Teva before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medicine instead of Irbesartán Teva. Irbesartán Teva is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

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

Driving and operating machines

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

Irbesartan Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 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.

Method of Administration

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 regular dose when it is due again. Do not take a double dose to make up for the missed dose.

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. However, some of these side effects can be serious and may require medical attention.

Like with similar medicines, in rare cases, patients treated with irbesartan have reported cases of skin allergic reactions (skin rash, urticaria), as well as localized inflammation in the face, lips, and/or tongue. If you think you may be having 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 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 (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,decreased red blood cell count (anemia - symptoms may include fatigue, headaches, difficulty breathing during exercise, dizziness, and paleness),reduced platelet count, abnormal liver function, elevated potassium levels in blood, kidney function impairment, inflammation of small blood vessels, mainly in the skin area (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 white of the eyes) have also been observed.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed 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.

Medications 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. This will help protect the environment.

Composition of Irbesartán Teva

• The active ingredient is irbesartan.

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

Appearance of the product and contents of the pack

The film-coated tablets of Irbesartán Teva 300 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 “7466”.

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; single-dose formats of 50x1 and 56x1 film-coated tablets; and a 28 film-coated tablet blister pack.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

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

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Holland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

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