Ifirmasta: detailed information

Patient Information Leaflet

Ifirmasta 75 mg film-coated tablets

irbesartan
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ifirmasta is and what it is used for
What you need to know before taking Ifirmasta
How to take Ifirmasta
Possible side effects
How to store Ifirmasta
Contents of the pack and other information

1. What Ifirmasta is and what it is used for

Ifirmasta belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors on blood vessels, causing them to constrict. This results in an increase in blood pressure. Ifirmasta prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease. Ifirmasta slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.
Ifirmasta is used in adult patients

to treat high levels of blood pressure ( essential arterial hypertension )
to protect the kidneys in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. What you need to know before taking Ifirmasta

Do not take Ifirmasta

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 better to avoid taking Ifirmasta even in the early stages of pregnancy – see Pregnancy section)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions
Talk to your doctor before taking Ifirmasta if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you suffer from kidney disorders
if you suffer from heart disorders
if you are taking Ifirmasta for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of impaired kidney function
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
if you are scheduled for surgery or require anaesthetics
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Ifirmasta". You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Ifirmasta is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).

Children and adolescents
This medicine should not be used in children and adolescents (< 18 years) as safety and efficacy have not yet been fully established.

Other medicines and Ifirmasta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may consider it necessary to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also sections "Do not take Ifirmasta" and "Warnings and precautions").
You may need blood tests if you are taking:
- potassium supplements
- salt substitutes containing potassium
- potassium-sparing medicines (such as certain diuretics)
- lithium-containing medicines
- repaglinide (a medicine used to lower blood sugar levels).
  If you are taking certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Ifirmasta before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Ifirmasta is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or about to start breast-feeding. Ifirmasta is not recommended for women who are breast-feeding. Your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Ifirmasta will affect your ability to drive or use machines. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, consult your doctor before driving or operating machinery.

3. How to take Ifirmasta

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Ifirmasta is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g.: a glass of water). You may take Ifirmasta with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure The usual dose is 150 mg once daily (two tablets per day). The dose may be increased to 300 mg per day (four tablets per day) depending on the response of the arterial pressure.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg per day (four tablets per day) for the treatment of associated kidney disease. Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age. Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents Ifirmasta must not be given to children under 18 years of age. If a child accidentally swallows any 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 forget to take a dose, continue your treatment as usual. Do not take a double dose to make up for the missed dose. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some of these effects can be serious and may require immediate 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 experience any of these symptoms or have difficulty breathing, stop taking Ifirmasta and contact a doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
Very common: may occur in more than 1 out of 10 people
Common: may occur in up to 1 out of 10 people
Uncommon: may occur in up to 1 out of 100 people

The side effects reported in clinical studies in patients treated with Ifirmasta are:

Very common (may occur in more than 1 out of 10 people): if you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show elevated levels of potassium.
Common (may occur in up to 1 out of 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney disease, the following have also been reported: dizziness upon standing up from lying or sitting position, low blood pressure upon standing up from lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin).
Uncommon (may occur in up to 1 out of 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.
From post-marketing experience with Ifirmasta, the following side effects have been reported. Side effects with unknown frequency are: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased potassium levels in blood, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Uncommon 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 and blister after EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ifirmasta contains

The active substance is irbesartan. Each film-coated tablet of Ifirmasta contains 75 mg of irbesartan (as hydrochloride).
The excipients are: mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, hydrogenated castor oil within the tablet, and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in the coating film.

Description of the appearance of Ifirmasta and contents of the pack

Ifirmasta 75 mg film-coated tablets are: white, oval, film-coated tablets.
Ifirmasta 75 mg film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90 and 98 tablets in blister packs, and in cartons containing 56 x 1 film-coated tablets in single-dose perforated blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България Luxembourg/Luxemburg
КРКА България ЕООД KRKA Belgium, SA.
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490

Danmark Malta
KRKA Sverige AB E. J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885

Deutschland Nederland
TAD Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (BE)

Eesti Norge
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα Österreich
KRKA ΕΛΛΑΣ ΕΠΕ KRKA Pharma GmbH, Wien
Τηλ: + 30 2100101613 Tel: + 43 (0)1 66 24 300

España Polska
KRKA Farmacéutica, S.L. KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 81 Tel.: + 48 (0)22 573 7500

France Portugal
KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650

Hrvatska România
KRKA - FARMAd.o.o. KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 100 Tel: + 4 021 310 66 05

Ireland Slovenija
KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto
Tel: + 353 1 413 3710 Tel: + 386 (0) 1 47 51 100

Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.
Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501

Italia Suomi/Finland
KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy
Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330

Κύπρος Sverige
KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 KRKA Sverige AB
24 651 882 Tel: + 46 (0)8 643 67 66 (SE)

Latvija United Kingdom (Northern Ireland)
KRKA Latvija SIA Consilient Health Limited
Tel: + 371 6 733 86 10 Tel: + 353 (0)1 2057760

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Patient Information Leaflet

Ifirmasta 150 mg film-coated tablets

irbesartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Never give it to other people, even if they have the same symptoms as you, because it could be dangerous.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
1. What Ifirmasta is and what it is used for
2. What you need to know before taking Ifirmasta
3. How to take Ifirmasta
4. Possible side effects
5. How to store Ifirmasta
6. Contents of the pack and other information

1. What Ifirmasta is and what it is used for

Ifirmasta belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict. This results in an increase in blood pressure. Ifirmasta prevents angiotensin-II from binding to these receptors, allowing blood vessels to relax and blood pressure to decrease. Ifirmasta slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Ifirmasta is used in adult patients

to treat high blood pressure (essential arterial hypertension)
to protect the kidneys in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. What you need to know before taking Ifirmasta

Do not take Ifirmasta

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 better to avoid taking Ifirmasta even in the early stages of pregnancy – see Pregnancy section),
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Tell your doctor before taking Ifirmasta if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you have kidney disorders
if you have heart problems
if you are taking Ifirmasta for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, rapid and pounding heartbeat), particularly if you are being treated for diabetes
if you are due to undergo surgery or receive anaesthetics
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
- aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Ifirmasta". You must inform your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Ifirmasta is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).

Children and adolescents
This medicine must not be used in children and adolescents (< 18 years) as safety and efficacy have not yet been established.

If you are taking an ACE inhibitor or aliskiren (see also sections "Do not take Ifirmasta" and "Warnings and precautions"). You may need blood tests if you are taking:
- potassium supplements,
- potassium-containing salt substitutes,
- potassium-sparing medicines (such as certain diuretics),
- medicines containing lithium,
- repaglinide (a medicine used to lower blood sugar levels).
  If you are taking certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor. Ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must inform your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Ifirmasta before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Ifirmasta is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or about to start breastfeeding. Ifirmasta is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Ifirmasta will affect your ability to drive or use machines. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or using machines.

3. How to take Ifirmasta

Patients with high blood pressure The usual dose is 150 mg once daily. The dosage may be increased to 300 mg daily (two tablets once daily) depending on the reduction in arterial pressure levels.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg daily (two tablets once daily) for the treatment of associated kidney disease. Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age. The maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents Ifirmasta must not be given to children under 18 years of age. If a child ingests any 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, continue your treatment as usual. Do not take a double dose to make up for the missed dose. If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some of these effects may be serious and may require medical intervention.
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 experience any of these symptoms or have difficulty breathing, stop taking Ifirmasta and contact a doctor immediately.

The frequency of the side effects listed below is defined using the following convention:
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 side effects reported in clinical studies for patients treated with Ifirmasta are:

Very common (may affect more than 1 in 10 people): if you have high blood pressure, type 2 diabetes and kidney disease, blood tests may show elevated potassium levels.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure, type 2 diabetes and kidney disease, dizziness upon standing from lying or sitting position, low blood pressure upon standing from lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Additional side effects have been reported since the marketing of Ifirmasta. The side effects with unknown frequency are: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Uncommon 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 effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 and blister after EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ifirmasta contains

The active substance is irbesartan. Each Ifirmasta film-coated tablet contains 150 mg of irbesartan (as hydrochloride).
The excipients are: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose (LH-21), low-substituted hydroxypropylcellulose (LH-11), talc, macrogol 6000, hydrogenated castor oil within the tablet, and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, and talc in the coating film.

Description of the appearance of Ifirmasta and contents of the pack
Ifirmasta 150 mg film-coated tablets are: white, oval, film-coated tablets.
Ifirmasta 150 mg film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90 and 98
in blister packs and in cartons containing 56 x 1 film-coated tablets in single-dose perforated blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 629 Tel: + 370 5 236 27 40

България Luxembourg/Luxemburg
КРКА България ЕООД KRKA
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)