IFIRMASTA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ifirmasta 300 mg 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 Package Leaflet:

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

1. What is Ifirmasta and what is it used for

Ifirmasta 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. Ifirmasta prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure.

Ifirmasta slows the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Ifirmasta 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 clinically impaired kidney function.

2. What you need to know before you take Ifirmasta

Do not take Ifirmasta

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6),
• - if you are pregnant more than 3 months.(In any case, it is better to avoid taking this medicine also at the start of your 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 or pharmacist before starting to take Ifirmasta and if any of the following apply to you:

Warnings:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• - if you are taking Ifirmasta 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 are going to have surgery(surgical intervention) or if you are going to be administered 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 Ifirmasta”.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. The use of Ifirmasta is not recommended during the first three months of pregnancy and is contraindicated during the second and third trimesters of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

Children and adolescents

This medicine should not be used in children and adolescents (<18 years) since the safety and efficacy have not been fully established.< p>

Taking Ifirmasta with other medicines

Inform 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 Ifirmasta” and “Warnings and precautions”).

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

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing diuretics (such as certain water tablets)
• lithium-containing medicines.

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Ifirmasta before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as your doctor may decide to prescribe a different treatment that is more suitable for you, especially if you are breastfeeding a newborn or premature infant.

Driving and using machines

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

3. How to take Ifirmasta

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Method of administration

Ifirmasta is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Ifirmasta 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 this medicine until your doctor tells you to stop.

• Patient with high blood pressure

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

• Patient with high blood pressure and type 2 diabetes with impaired kidney function

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

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

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

Use in children and adolescents

Ifirmasta should not be given to children under 18 years of age. If a child accidentally takes several tablets, contact your doctor immediately.

If you take more Ifirmasta than you should

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

If you forget to take Ifirmasta

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 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 side effects can be serious and may require medical attention.

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips, and/or tongue have been reported in patients treated with irbesartan. If you think you may have a reaction of this type or experience difficulty breathing, stop taking Ifirmasta and contact a medical center immediately.

The following side effects have been reported:

Very common: May affect more than 1 in 10 people

Common: May affect up to 1 in 10 people

Uncommon: May affect up to 1 in 100 people

The following side effects were reported in clinical trials in patients treated with Ifirmasta:

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with impaired kidney function, blood tests may show a rise in potassium levels.
• Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, and 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 impaired kidney function, 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, sexual dysfunction (sexual function disorders), and chest pain.

Since the marketing of Ifirmasta, the following side effects have been reported:

Frequency not known: Cannot be estimated from the available data

The following side effects have been reported: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased platelet count, abnormal liver function, elevated potassium levels in the blood, impaired kidney function, and inflammation of small blood vessels, mainly in the skin area (a condition known as leucocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). 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 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ifirmasta

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

Do not store above 30°C.

Store in the original package to protect from moisture.

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

What Ifirmasta contains

• The active substance is irbesartan. Each film-coated tablet contains 300 mg of irbesartan (as hydrochloride).

The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose (LH-21), low-substituted hydroxypropylcellulose (LH-11), talc, macrogol 6000, and hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, and talc in the film coating.

Appearance and packaging

Ifirmasta 300 mg film-coated tablets are white and oval.

Ifirmasta 300 mg film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90, and 98 tablets and in packs of 56 x 1 film-coated tablet in a unit dose blister.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarjeska cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicine, contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet: {Month/Year}.

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