IRBESARTAN TEVA 75 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. what irbesartan teva is and what it is used for

Irbesartan Teva belongs 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 Teva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan Teva slows the decrease of kidney function 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 laboratory

evidence of impaired kidney function.

2. what you need to know before you take irbesartan tevado 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 (it is also better to avoid Irbesartan Teva in early

pregnancy – see pregnancy section).

• ■ if you have diabetes or impaired kidney function and you are treated with a blood pressure

lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor before taking Irbesartan Teva and 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 Teva 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.

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

• – an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems

• – aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

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

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

Children and adolescents

This medicinal product should not be given to children under 18 years of age because the safety and efficacy have not yet been fully established. If a child swallows some tablets, contact your doctor immediately.

Other medicines and Irbesartan Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

If you are taking an 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 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.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think that you are (or might 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. Irbesartan Teva is 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 Teva is 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

Irbesartan Teva is 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.

Irbesartan Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. how to take irbesartan teva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan Teva is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan Teva 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 Teva until your doctor tells you otherwise.

• ■ Patients with high blood pressure

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg 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, 300 mg 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.

If you take more Irbesartan Teva than you should:

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

If you forget to take Irbesartan Teva

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 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 effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised 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 Teva and contact your doctor immediately.

List of side effects:

• ■ Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and

type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

• ■ Common (may affect up to 1in 10 people): 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 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 (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea,

indigestion/he­artburn, sexual dysfunction (problems with sexual performance), chest pain.

Not known (frequency cannot be estimated from the available data): feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects

If you get any side effects,talk to your doctor or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store irbesartan teva

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

Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat irbesartan teva contains■     the active substance is irbesartan.

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

■ The other ingredients are:

• Tablet core: povidone, pregelatinized starch (maize), poloxamer 188, microcrystalline cellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate.
• Tablet coating: polydextrose, titanium dioxide, hypromellose and macrogol 4000.

What Irbesartan Teva looks like and contents of the pack

Irbesartan 75 mg film-coated tablets are white to off white capsule shaped, film coated tablet. One side of the tablet debossed with the number “93”. The other side of the tablet debossed with number “7464”.

Irbesartan Teva is available in pack sizes of7, 14, 28, 30, 56, 60, 80, 84, 90, 98 and 100 film-coated tablets in non-perforated blisters; pack sizes of 50 × 1 and 56 × 1 film-coated tablet in unit dose blisters and pack size of 28 film-coated tablets in non-perforated calendar blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Teva UK Limited,

Ridings Point,

Whistler Drive,

Castleford,

WF10 5HX,

United Kingdom

Manufacturers:

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80

31–546 Krakow

Poland

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

This leaflet was last revised in June 2021

PLGB 00289/2469

This is a representation of an electronic record that was signed electronically and this PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V

Approvals

REG0281487

Version 0.3

Approved

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