Ifirmasta 300 mg film-coated tablets

Ifirmasta 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. Ifirmasta prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Ifirmasta slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Ifirmasta is used

• 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.

Do not take Ifirmasta

• if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Ifirmasta,
• if you are more than 3 months pregnant. (It is also better to avoid Ifirmasta in early pregnancy ? see pregnancy section)

Ifirmasta should not be given to children and adolescents (< 18 years)

Take special care with Ifirmasta

Tell your doctor if any of the following aply to you:

• if you get excessive vomiting or diarrhoea,
• if you suffer from kidney problems
• if you suffer from heart problems,
• if you receive Ifirmasta 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.

You must tell your doctor if you think you are ( or might become) pregnant. Ifirmasta 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).

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Ifirmasta does not usually interact with other medicines.
Blood tests may be neccessary if you take:

• potassium supplements,
• potassium-containing salt substitutes,
• potassium-sparing medicines that increase the amount of urine (diuretics) or
• lithium-containing medicines.

As with other blood pressure lowering medicinal products, the effect of irbesartan may be reduced when you take non-steroidal anti-inflammatory medicinal products (for example, ibuprofen).

Taking Ifirmastawith food and drink
Ifirmasta can be taken with or without food. The tablets should be swallowed with a drink of water.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You must tell your doctor if you think you are ( or might 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 instead of Ifirmasta. Ifirmasta 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. Ifirmasta 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
Ifirmasta is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or tiredness may occur during treatment of high blood pressure. If you experience these symptoms, you should consult your doctor before driving or using machines.

Important information about some of the ingredients of Ifirmasta

This medicinal product contains castor oil which may cause stomach upset and diarrhoea.

Always take Ifirmasta exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Ifirmasta is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Ifirmasta 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 Ifirmasta 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 Ifirmastathan you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.

Children should not take Ifirmasta

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

If you forget to take Ifirmasta
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 product, ask your doctor or pharmacist.

Like all medicines, Ifirmasta 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 and seek immediate medical attention.

The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more
Common: at least 1 in 100 and less than 1 in 10 patients
Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported in clinical studies for patients treated with irbesartan were:

• Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
• Common: dizziness, feeling sick/vomiting, and 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 renal disease, dizziness when getting up from a 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: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of irbesartan but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired renal function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Ifirmasta after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order 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 to protect the environment.

What Ifirmasta contains

• The active substance is irbesartan. Each film-coated tablet contains 300 mg irbesartan (as hydrochloride).
• The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, castor oil, hydrogenated in the core of tablet and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in film-coating.

What Ifirmasta looks like and contents of the pack

Ifirmasta 300 mg film-coated tablets are: white, oval film-coated tablets.

Ifirmasta 300 mg film-coated tablets: available in boxes of 14, 28, 56, 84 and 98 film-coated tablets in blister packs and in boxes of 56 x 1 film-coated tablets in perforated unit dose blister pack. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 LuxembourgLuxemburg KRKA, d.d., Novo mesto TélTel 32 03 321 63 52

KRKA Te. 359 02 962 34 50 Magyarország KRKA Magyarország Kereskedelmi Kft. Tel. 361 0 355 8490

eská republika KRKA R, s.r.o. Tel 420 0 221 115 150 Malta KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66

Danmark KRKA Sverige AB Tlf 46 08 643 67 66 SE Nederland KRKA, d.d., Novo mesto Tel 32 3 321 63 52 BE

Deutschland TAD Pharma GmbH Tel 49 0 4721 6060 Norge KRKA Sverige AB Tlf 46 08 643 67 66 SE

Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel 372 06 671 654 Österreich KRKA Pharma GmbH, Wien Tel 43 01 66 24 300

QUALIA PHARMA S.A. 30 0210 2832941 Polska KRKA-POLSKA Sp. z o.o. Tel. 48 022 573 7500

España KRKA, d.d., Novo mesto Tel 34 061 5089 809 Portugal KRKA Farmacêutica, Unipessoal Lda. Tel 351 021 46 43 650

France KRKA, d.d., Novo mesto Tél 32 3 321 63 52 BE România KRKA Romania S.R.L., Bucharest Tel 402 01 310 66 05

Ireland KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 Slovenija KRKA, d.d., Novo mesto Tel 386 0 1 47 51 100

Ísland KRKA Sverige AB Sími 46 08 643 67 66 SE Slovenská republika KRKA Slovensko, s.r.o., Tel 421 0 2 571 04 501

Italia KRKA, d.d., Novo mesto Tel 39 069448827 SuomiFinland KRKA Sverige AB PuhTel 46 08 643 67 66 SE

Kipa Pharmacal Ltd. 357 24 651 882 Sverige KRKA Sverige AB Tel 46 08 643 67 66 SE

Latvija KRKA, d.d., Novo mesto Tel 371 0733 8610 United Kingdom Consilient Health UK Ltd. Tel 44 02089562310

Lietuva

KRKA, d.d., Novo mestoTel: + 370 5 236 27 40

This leaflet was last approved in {MM/YYYY}.