Ifirmacombi
irbesartan, hydrochlorothiazide
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.
What Ifirmacombi is and what it is used for
What you need to know before you take Ifirmacombi
How to take Ifirmacombi
Possible side effects
How to store Ifirmacombi
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.
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
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).
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.
Ifirmacombi should not be given to children and adolescents (under 18 years).
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”)
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 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.
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.
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.
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.
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.
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.
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.
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.
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 accidentally take too many tablets, contact your doctor immediately.
Ifirmacombi should not be given to children under 18 years of age. If a child swallows some tablets,
contact your doctor immediately.
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.
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:
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).
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.
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.
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.
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.
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.
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.
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".
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.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62
UAB KRKA Lietuva Tel: + 370 5 236 27 40
КРКА България ЕООД Teл.: + 359 (02) 962 34 50
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150
KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
E. J. Busuttil Ltd.
Tel: + 356 21 445 885
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)
KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)
KRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613
KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300
KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80
KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25
KRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100
KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710
KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100
LYFIS ehf.
Sími: + 354 534 3500
KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330
KI.PA. (PHARMACAL) LIMITED Τηλ: + 357 24 651 882
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)
KRKA Latvija SIA Tel: + 371 6 733 86 10
Consilient Health Limited Tel: + 353 (0)1 2057760