Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ifirmacombi

Document Subject

Generated Narrative: MedicinalProductDefinition mp12999fc304ebe011ca5072982dc85b85

identifier: http://ema.europa.eu/identifier/EU/1/11/673/001-008

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ifirmacombi 150 mg/12.5 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-12999fc304ebe011ca5072982dc85b85

identifier: http://ema.europa.eu/identifier/EU/1/11/673/001-008

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - ifirmacombi

Attesters

What is in this leaflet

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

Ifirmacombi is a combination of two active substances, irbesartan and hydrochlorothiazide. Irbesartan 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 in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicines (called thiazide diuretics) that causes increased urine output and so causes a lowering of blood pressure. The two active ingredients in Ifirmacombi work together to lower blood pressure further than if either was given alone. Ifirmacombi is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

Do not take Ifirmacombi

if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)

if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines

if you are more than 3 months pregnant. (It is also better to avoid Ifirmacombi in early pregnancy see pregnancy section)

if you have severe liver or kidney problems

if you have difficulty in producing urine

if your doctor determines that you have persistently high calcium or low potassium levels in your blood

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 Ifirmacombi and if any of the following apply to you:

if you get excessive vomiting or diarrhoea

if you suffer from kidney problems or have a kidney transplant

if you suffer from heart problems

if you suffer from liver problems

if you suffer from diabetes

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 suffer from lupus erythematosus (also known as lupus or SLE)

if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).

if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Ifirmacombi.

if you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Ifirmacombi, seek medical attention immediately.

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 Ifirmacombi . You must tell your doctor if you think you are (or might become) pregnant. Ifirmacombi 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). You should also tell your doctor:

if you are on a low-salt diet

if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Ifirmacombi)

if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal

if you are going to have an operation (surgery) or be given anaesthetics

if you have changes in your vision or pain in one or both of your eyes while taking Ifirmacombi. This could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or a sign that you are developing glaucoma, increased pressure in your eye(s), and can happen within hours to weeks of taking Ifirmacombi. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this. You should discontinue Ifirmacombi treatment and seek medical attention. The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test. Children and adolescents Ifirmacombi should not be given to children and adolescents (under 18 years). Other medicines and Ifirmacombi Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Diuretic agents such as the hydrochlorothiazide contained in Ifirmacombi may have an effect on other medicines. Preparations containing lithium should not be taken with Ifirmacombi without close supervision by your doctor. 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 Ifirmacombi and Warnings and precautions ) You may need to have blood checks if you take:

potassium supplements

salt substitutes containing potassium

potassium sparing medicines or other diuretics (water tablets)

some laxatives

medicines for the treatment of gout

therapeutic vitamin D supplements

medicines to control heart rhythm

medicines for diabetes (oral agents as repaglinide or insulins)

carbamazepine (a medicine for the treatment of epilepsy). It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, and medicines to treat cancer, pain killers, arthritis medicines or colestyramine and colestipol resins for lowering blood cholesterol. Ifirmacombi with food, drink and alcohol Ifirmacombi can be taken with or without food. Due to the hydrochlorothiazide contained in Ifirmacombi, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position. Pregnancy and breast-feeding Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Ifirmacombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ifirmacombi. Ifirmacombi is not recommended during 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. Ifirmacombi 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 Ifirmacombi 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. Ifirmacombi contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium- free".

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dosage of Ifirmacombi 150 mg/12.5 mg The recommended dose of Ifirmacombi 150 mg/12.5 mg is one tablet a day. Ifirmacombi 150 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Ifirmacombi. If this dose does not help to reduce your blood pressure as required, the doctor may prescribe Ifirmacombi 300 mg/12.5 mg to you. Dosage of Ifirmacombi 300 mg/12.5 mg The recomended dose of Ifirmacombi 300 mg /12.5 mg is one tablet a day. Ifirmacombi 300 mg/12.5 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Ifirmacombi. If this dose does not help to reduce your blood pressure as required, the doctor may prescribe Ifirmacombi 300 mg/25 mg to you. Dosage of Ifirmacombi 300 mg/25 mg The recommended dose of Ifirmacombi 300 mg/25 mg is one tablet a day. This dose should not be increased. Ifirmacombi 300 mg/25 mg will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough. Your doctor will instruct you how to switch from the previous treatment to Ifirmacombi. If this medicine does not help to reduce your blood pressure as required, the doctor will prescribe additional treatment to you. Method of administration Ifirmacombi is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Ifirmacombi 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 Ifirmacombi until your doctor tells you otherwise. The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment. If you take more Ifirmacombi than you should If you accidentally take too many tablets, contact your doctor immediately. Children should not take Ifirmacombi Ifirmacombi 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 Ifirmacombi 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. 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 the above symptoms or get short of breath, stop taking Ifirmacombi and contact your doctor immediately. The frequency of the side effects listed below is defined using the following convention: Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Very rare: may affect up to 1 in 10,000 people Side effects reported in clinical studies for patients treated with Ifirmacombi were: Common side effects (may affect up to 1 in 10 people):

nausea/vomiting

abnormal urination

fatigue

dizziness (including when getting up from a lying or sitting position)

blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase) or raised levels of substances that measure kidney function (blood urea nitrogen, creatinine). If any of these side effects causes you problems, talk to your doctor. Uncommon side effects (may affect up to 1 in 100 people):

diarrhoea

low blood pressure

fainting

heart rate increased

flushing

swelling

sexual dysfunction (problems with sexual performance)

blood tests may show lowered levels of potassium and sodium in your blood. If any of these side effects causes you problems, talk to your doctor. Side effects reported since the launch of the combination of Irbesartan and Hydrochlorothiazide Some undesirable effects have been reported since marketing of Ifirmacombi. Undesirable effects where the frequency is not known are:

headache,

ringing in the ears,

cough,

taste disturbance,

indigestion,

pain in joints and muscles,

liver function abnormal and impaired kidney function,

increased level of potassium in your blood and

allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.

uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. As for any combination of two active substances, side effects associated with each individual component cannot be excluded. Side effects associated with irbesartan alone In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), decreased number of red blood cells (anaemia symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) and low blood sugar levels have also been reported. Side effects associated with hydrochlorothiazide alone Skin and lip cancer (non-melanoma skin cancer); loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma); lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout. Very rare side effects (may affect up to 1 in 10,000 people): Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion). It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide. 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 packaging after EXP. The expiry date refers to the last day of that month. This medicine 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.

What Ifirmacombi contains

The active substances are irbesartan and hydrochlorothiazide. Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide. Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.

The other ingredients are: Ifirmacombi 150 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating. See section 2 "Ifirmacombi contains sodium". Ifirmacombi 300 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc in the film-coating. See section 2 "Ifirmacombi contains sodium". Ifirmacombi 300 mg/25 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating. See section 2 "Ifirmacombi contains sodium". What Ifirmacombi looks like and contents of the pack Ifirmacombi 150 mg/12.5 mg Pale pink, biconvex, oval, film-coated tablets (tablets). Ifirmacombi 300 mg/12.5 mg White, biconvex, capsule shaped, film-coated tablets (tablets). Ifirmacombi 300 mg/25 mg Pale pink, biconvex, capsule shaped, film-coated tablets (tablets). Boxes of 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets in blisters are available. 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) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: