Ifirmacom 300 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ifirmacombi 150 mg/12.5 mg film-coated tablets EFG

Ifirmacombi 300 mg/12.5 mg film-coated tablets EFG

Ifirmacombi 300 mg/25 mg film-coated tablets EFG

Irbesartan/Hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Ifirmacombi is and what it is used for

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 constrict. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, thereby relaxing blood vessels and reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that lower blood pressure by increasing the amount of urine produced.

The two active substances in Ifirmacombi work together to achieve a greater reduction in blood pressure than either of them alone.

Ifirmacombi is used to treat high blood pressure when treatment with irbesartan alone or hydrochlorothiazide alone does not provide adequate control of your blood pressure.

2. What you need to know before taking Ifirmacombi

Do not take Ifirmacombi

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicine
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking Ifirmacombi also during early pregnancy – see Pregnancy section)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if your doctor finds that you have persistently high levels of calcium or low levels of potassium in your blood
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions

Consult your doctor before starting to take Ifirmacombi and in any of the following cases:

• if you have excessive vomiting or diarrhea
• if you have kidney disorders or have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you have systemic lupus erythematosus (also known as lupus or SLE)
• if you have primary hyperaldosteronism (a condition related to excessive production of the hormone aldosterone, leading to sodium retention and, in turn, increased blood pressure)
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Ifirmacombi.
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Ifirmacombi”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Ifirmacombi is not recommended during early pregnancy (first three months), and it must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby (see Pregnancy section).

You should also inform your doctor:

• if you are on a low-salt diet
• if you experience any of the following symptoms: feeling thirsty, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Ifirmacombi)
• if you experience increased skin sensitivity to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are scheduled for surgery or if you will receive anesthetics
• if you experience changes in vision or pain in one or both eyes while taking Ifirmacombi. This could be a sign of developing glaucoma, increased pressure in your eyes. You should stop taking Ifirmacombi and seek medical attention immediately.

The hydrochlorothiazide contained in this medicine may cause positive results in doping tests.

Children and adolescents

Ifirmacombi must not be administered to children and adolescents (under 18 years of age).

Use of Ifirmacombi with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Diuretics such as hydrochlorothiazide contained in Ifirmacombi may interact with other medicines. You must not take lithium-containing preparations together with Ifirmacombi without medical supervision.

Your doctor may need to adjust your dose and/or take additional precautions:

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Ifirmacombi” and “Warnings and precautions”).

You may need blood tests if you are taking:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines or other diuretics (tablets that increase urine production)
• certain laxatives
• medicines used in the treatment of gout
• vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral agents or insulin)
• carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, arthritis medicines, or cholestyramine or colestipol resins to lower blood cholesterol.

Taking Ifirmacombi with food, drinks, and alcohol

Ifirmacombi can be taken with or without food.

Due to the hydrochlorothiazide contained in Ifirmacombi, if you drink alcohol while being treated with this medicine, you may experience increased dizziness upon standing, especially when rising from a sitting position.

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Ifirmacombi before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Ifirmacombi is not recommended during pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed, as Ifirmacombi is not recommended for women during this period. Your doctor may choose a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Driving and use of machines

It is unlikely that Ifirmacombi will affect your ability to drive or operate machinery.

However, dizziness or fatigue may occasionally occur during antihypertensive treatment. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Ifirmacombi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Ifirmacombi

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dose of Ifirmacombi 150 mg/12.5 mg

The recommended dose of Ifirmacombi 150 mg/12.5 mg is one tablet daily. Your doctor will generally prescribe Ifirmacombi 150 mg/12.5 mg when previous treatments you have received have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to Ifirmacombi.

If this dose does not sufficiently lower your blood pressure, your doctor may prescribe you Ifirmacombi 300 mg/12.5 mg.

Dose of Ifirmacombi 300 mg/12.5 mg

The recommended dose of Ifirmacombi 300 mg/12.5 mg is one tablet daily. Your doctor will generally prescribe Ifirmacombi 300 mg/12.5 mg when previous treatments you have received have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to Ifirmacombi.

If this dose does not sufficiently lower your blood pressure, your doctor may prescribe you Ifirmacombi 300 mg/25 mg.

Dose of Ifirmacombi 300 mg/25 mg

The recommended dose of Ifirmacombi 300 mg/25 mg is one tablet daily. This dose must not be increased. Your doctor will generally prescribe Ifirmacombi 300 mg/25 mg when previous treatments you have received have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to Ifirmacombi.

If this medicine does not sufficiently lower your blood pressure, your doctor may prescribe an additional treatment.

Method of administration

Ifirmacombi is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). You may take Ifirmacombi with or without food. You should try to take your daily dose at the same time each day. It is important that you continue taking Ifirmacombi until your doctor advises you otherwise.

Maximum blood pressure-lowering effect should be achieved within 6–8 weeks after starting treatment.

If you take more Ifirmacombi than you should

If you accidentally take too many tablets, contact your doctor immediately.

Children must not take Ifirmacombi

Ifirmacombi must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.

If you forget to take Ifirmacombi

If you accidentally forget to take a dose, simply take your normal dose when it is time for your next dose. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

Some of these effects may be serious and may require medical attention.

Rare cases of skin allergic reactions (rash, urticaria) have been reported in patients treated with irbesartan, as well as localized swelling of the face, lips and/or tongue. If you experience any of the above symptoms or have shortness of breath, stop taking Ifirmacombi and contact your doctor immediately.

The adverse effects reported in clinical studies for patients treated with Ifirmacombi were:

Frequent adverse effects (may affect up to 1 in 10 patients):

• nausea/vomiting,
• abnormalities in urination,
• fatigue,
• dizziness (including dizziness upon standing up from a lying or sitting position),
• blood tests may show elevated levels of an enzyme measuring muscle and heart function (creatine kinase) or elevated levels of substances measuring kidney function (blood urea nitrogen, creatinine).

If any of these adverse effects cause you problems, consult your doctor.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• diarrhea,
• low blood pressure,
• fainting,
• palpitations,
• flushing,
• swelling due to fluid retention (edema),
• sexual dysfunction (alterations in sexual function),
• blood tests may show low levels of sodium and potassium in your blood.

If any of these adverse effects cause you problems, consult your doctor.

Adverse effects reported since marketing of the combination irbesartan and hydrochlorothiazide

Since the marketing of Ifirmacombi, some adverse effects have been reported. The adverse effects observed with unknown frequency are:

• headache,
• tinnitus (ringing in the ears),
• cough,
• altered taste,
• indigestion,
• joint and muscle pain,
• liver function abnormalities and kidney failure,
• elevated levels of potassium in your blood, and
• allergic reactions such as rash, urticaria, swelling of the face, lips, mouth, tongue or throat.

Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

As with all fixed combinations of two active substances, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated solely with irbesartan

In addition to the adverse effects described above, chest pain, severe allergic reactions (anaphylactic shock), and decreased platelet count (a blood cell essential for blood clotting) have also been observed.

Adverse effects associated with hydrochlorothiazide in monotherapy:

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 characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; decreased platelet count (blood cells essential for blood clotting), decreased red blood cell count (anemia) characterized by tiredness, headaches, shortness of breath during exercise, dizziness and paleness; kidney disease; lung disorders including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and spasms; irregular heartbeat; drop in blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in certain types of blood fats; high levels of uric acid in the blood, which may cause gout.

It is known that adverse effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ifirmacombi

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 CAD/EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ifirmacombi

• The active substances are irbesartan and hydrochlorothiazide.

Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg of irbesartan (as irbesartan hydrochloride) and 12.5 mg of hydrochlorothiazide.

Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg of irbesartan (as irbesartan hydrochloride) and 12.5 mg of hydrochlorothiazide.

Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg of irbesartan (as irbesartan hydrochloride) and 25 mg of hydrochlorothiazide.

• The other components of Ifirmacombi 150 mg/12.5 mg are: mannitol, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, sodium glycolate starch, talc, macrogol 6000 and 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”.
• The other components of Ifirmacombi 300 mg/12.5 mg are: mannitol, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, sodium glycolate starch, talc, macrogol 6000 and hydrogenated castor oil in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), macrogol and talc in the film coating. See section 2 “Ifirmacombi contains sodium”.
• The other components of Ifirmacombi 300 mg/25 mg are: mannitol, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, sodium glycolate starch, talc, macrogol 6000 and 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”.

Appearance of Ifirmacombi and contents of the pack

Ifirmacombi 150 mg/12.5 mg

Film-coated tablet (tablet) is pale pink, biconvex and oval-shaped.

Ifirmacombi 300 mg/12.5 mg

Film-coated tablet (tablet) is white, biconvex and capsule-shaped.

Ifirmacombi 300 mg/25 mg

Film-coated tablet (tablet) is pale pink, biconvex and capsule-shaped.

Ifirmacombi film-coated tablets are available in blister packs containing 14, 28, 30, 56, 56x1, 84, 90 and 98 film-coated tablets.

Only certain 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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/.