Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ifirmasta

Document Subject

Generated Narrative: MedicinalProductDefinition mp245a99986bb61c23af35c57856a26746

identifier: http://ema.europa.eu/identifier/14 tablets: EU/1/08/480/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ifirmasta 75 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-245a99986bb61c23af35c57856a26746

identifier: http://ema.europa.eu/identifier/14 tablets: EU/1/08/480/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ifirmasta

Attesters

What is in this leaflet

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

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 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.

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 more than 3 months pregnant. (It is also better to avoid Ifirmasta 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 or pharmacist before taking Ifirmasta 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 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 develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes,

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 Ifirmasta . 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). Children and adolescents This medicine should not be used in children and adolescents (< 18 years) because the 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 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 Ifirmasta 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,

repaglinide (medication used for lowering blood sugar levels). If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Always take this medicine exactly as your doctor or pharmacist has told you. 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 (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) 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 (four tablets a day) 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. Use in children and adolescents Ifirmasta should not be given to children under 18 years of age. If a child swallows some 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 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.

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

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 1 in 10 people): 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 (may affect up to 1 in 100 people): 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. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired renal 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 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 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. 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.

What Ifirmasta contains

The active substance is irbesartan. Each film-coated tablet contains 75 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 75 mg film-coated tablets are: white, oval film-coated tablets. Ifirmasta 75 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia Manufacturer KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Stra e 5, 27472 Cuxhaven, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E. J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0 Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) Consilient Health Limited Tel: + 353 (0)1 2057This leaflet was last revised in . Detailed information on this medicine is available on the European Medicines Agency web site: