150 mg / 12.5 mg, 300 mg / 12.5 mg, 300 mg / 25 mg film-coated tablets
irbesartan / hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Ifirmacombi is and what it is used for
2. What you need to know before you use Ifirmacombi
3. How to use Ifirmacombi
4. Possible side effects
5. How to store Ifirmacombi
6. Contents of the packaging 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 called angiotensin -II receptor antagonists. Angiotensin -II is a substance, which is produced in the body, and which binds to certain structures ( receptors ) in the blood vessels and causes them to constrict. This leads to increased blood pressure. Irbesartan prevents the binding of angiotensin -II to these receptors, causing the blood vessels to relax and the blood pressure to drop.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase the excretion of urine and thereby lower blood pressure.

The two active substances in Ifirmacombi work together so that the blood pressure is lowered more than if the substances were given separately.

Ifirmacombi is used to treat high blood pressure, as treatment with irbesartan or hydrochlorothiazide alone has not provided adequate control of blood pressure.

2. What you need to know before using Ifirmacombi

Do not use 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 of the other sulfonamide-based medicines
  • pregnant women should not use Ifirmacombi during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Ifirmacombi, see Pregnancy and breast-feeding)
  • if you have severe liver or kidney problems
  • if you have difficulty ‘throwing water’
  • if your doctor thinks you have a condition associated with persistent high calcium or low potassium levels in your blood
  • if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren

Warnings and cautions

Talk to your doctor before taking Ifirmacombi and if any of the following apply to you:

  • if you experience severe vomiting or diarrhea
  • 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, tremors, headache, redness or paleness, numbness, having a fast, throbbing heart rhythm), especially 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 associated with high production of the hormone et aldosterone , which causes decreased sodium secretion and in turn an increase in blood pressure )
  • if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide , especially long-term use with high doses , may increase the risk of certain types of skin and lip cancer (non- melanoma skin 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:
    • an ACE inhibitor (such as enalapril , lisinopril, ramipril), especially if you have diabetes-related kidney problems.
    • aliskiren

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

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

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Ifirmacombi is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause harm to the unborn child, see section Pregnancy and breast-feeding.

You should also tell your doctor:

  • if you are on a low salt diet
  • if you have symptoms such as abnormal thirst, dry mouth , general weakness, drowsiness, muscle aches or cramps, nausea, vomiting, or an abnormally fast heart rate which may indicate an excessive effect of hydrochlorothiazide (found in Ifirmacombi)
  • if you notice increased sun sensitivity of the skin , which burns (with redness , itching , swelling, blistering) faster than usual
  • if you are going to have surgery or get anesthesia
  • if you experience vision changes or pain in one or both of your eyes while taking Ifirmacombi. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or a sign that you have developed glaucoma (increased pressure in your eyes) and may occur within hours to weeks after taking Ifirmacombi. This can lead to permanent vision loss, if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this. You should then end treatment with Ifirmacombi and see a doctor.

Hydrochlorothiazide contained in this medicine may give a positive result in doping tests.

Children and young people

Ifirmacombi should not be given to children or adolescents (under 18 years of age).

Other medicines and Ifirmacombi

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

Diuretics such as hydrochlorothiazide in Ifirmacombi may affect other medicines. Medicines containing lithium should not be taken with Ifirmacombi without the careful supervision of your doctor.

Your doctor may need to change your dose and/or take other precautions:

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

You may need to have blood tests done if you are taking:

  • potassium supplement
  • salt substitute containing potassium
  • potassium sparing medicines or other diuretic drugs
  • certain laxatives
  • drugs for the treatment of gout
  • therapeutic vitamin D supplementation
  • drugs to control heart rhythm
  • drugs against diabetes (tablets repaglinide or insulin )
  • carbamazepine (a medicine used to treat epilepsy )

It is also important to tell your doctor if you are taking other medicines to lower your blood pressure, steroids and medicines to treat cancer, painkillers, anti-inflammatory drugs or cholestyramine, and cholestipol resins to lower your cholesterol levels.

Ifirmacombi with food, drink and alcohol

Ifirmacombi can be taken with or without food.

Due to the hydrochlorothiazide content of Ifirmacombi, if you drink alcohol during treatment with this medicine, you may have an increased feeling of dizziness when standing up, especially when standing up from a sitting position.

Pregnancy, breastfeeding and fertility

Pregnancy

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking Ifirmacombi before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Ifirmacombi should not be used during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.

Breast-feeding

Tell your doctor if you are breastfeeding or planning to start breastfeeding. Ifirmacombi is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or prematurely born.

Driving and using machines

Ifirmacombi is unlikely to affect your ability to drive or use machines. Occasionally, however, dizziness or fatigue may occur during treatment of high blood pressure. If you experience this, talk to your doctor before driving or using machines.

Ifirmacombi contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is next to “sodium-free”.

3. How to use Ifirmacombi

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage of Ifirmacombi 150 mg / 12.5 mg

The recommended dose of Ifirmacombi 150 mg / 12.5 mg is one tablet daily. Ifirmacombi 150 mg / 12.5 mg is usually prescribed by your doctor when previous treatment for high blood pressure did not lower your blood pressure sufficiently. Your doctor will tell you how to switch from the previous treatment to Ifirmacombi.

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

Dosage Ifirmacombi 300 mg / 12.5 mg

The recommended dose of Ifirmacombi 300 mg / 12.5 mg is one tablet daily. Ifirmacombi 300 mg / 12.5 mg is usually prescribed by your doctor when previous treatment for high blood pressure did not lower your blood pressure sufficiently. Your doctor will tell you how to switch from the previous treatment to Ifirmacombi.

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

Dosage Ifirmacombi 300 mg / 25 mg

The recommended dose of Ifirmacombi 300 mg / 25 mg is one tablet daily. This dosage should not be increased. Ifirmacombi 300 mg / 25 mg is usually prescribed by your doctor when previous treatment for high blood pressure did not lower your blood pressure sufficiently. Your doctor will tell you how to switch from the previous treatment to Ifirmacombi.

If this medicine does not lower your blood pressure enough, your doctor will prescribe further treatment.

Intake

Ifirmacombi is used orally. Swallow the tablets with a sufficient amount of liquid (eg a glass of water). You can take Ifirmacombi with or without food. You should try to take the 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 maximum lowering of blood pressure should be achieved 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 should not take Ifirmacombi

Ifirmacombi should not be given to children under 18 years of age. Contact your doctor immediately if a child swallows any tablets.

If you forget to use Ifirmacombi

If you accidentally skip a daily dose, just take the next dose normally. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and may require medical treatment.

Rare cases of allergic skin reactions (skin rash, hives ) as well as local swelling of the face, lips, and/or tongue have been reported in patients treated with irbesartan.

If you get any of the above symptoms or become short of breath, stop taking Ifirmacombi and contact your doctor immediately.

The frequency of side effects listed below is defined according to the following convention:

Common: may affect up to 1 in 10 users

Uncommon: may affect up to 1 in 100 people

Adverse reactions reported in clinical trials in patients treated with Ifirmacombi were:

Common side effects are (may affect up to 1 to 10)

  • nausea / vomiting
  • altered urination
  • fatigue
  • dizziness (also when getting up from a lying or sitting position)
  • Blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of substances that measure kidney function (s- urea , creatinine ).

If any of these side effects get you down, talk to your doctor.

Less common side effects are (may affect up to 1 in 100)

  • diarrhea
  • low blood pressure
  • fainting sensation
  • palpitation
  • redness
  • swelling
  • impaired sexual ability
  • Blood tests may show decreased levels of potassium and sodium in the blood

If any of these side effects get you down, talk to your doctor.

The adverse event is reported after the combination of irbesartan and hydrochlorothiazide has come on the market

Some side effects have been reported since the launch of Ifirmacombi. Side effects without a known frequency are:

  • headache
  • ringing in the ears
  • cough
  • taste changes
  • indigestion
  • joint and muscle pain
  • impaired liver function and impaired renal function
  • increased levels of potassium in the blood
  • allergic reactions such as skin rash, hives, swelling of the face, lips, mouth tongue or throat.
  • jaundice (yellowing of the skin and / or whites of the eyes) has, as a less common side effect , also been reported

As with all combinations of two active substances, side effects associated with each individual active substance cannot be ruled out.

Side effects are associated with irbesartan alone

In addition to the side effects described above, chest pain, severe allergic reactions (anaphylactic shock ), decreased red blood cell count ( anemia – symptoms may include fatigue, headache, shortness of breath when exercising, dizziness and pallor), decreased platelet count ( a blood cell needed for the blood to coagulate) and low blood sugar levels have been reported.

Side effects are associated with hydrochlorothiazide alone

Skin and lip cancer (non- melanoma skin cancer), loss of appetite; stomach upset; stomach cramps; constipation; jaundice (yellowing of the skin and / or whites of the eyes); inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disorders; Depression; dimsyn; impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ); lack of white blood cells , which can lead to frequent infection , fever; decreased number of platelets (a blood cell needed for the blood to coagulate), decreased number of red blood cells( anemia ) characterized by fatigue, headache, shortness of breath on exertion, dizziness and pallor; kidney disease; lung problems including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin on the whole body; cutaneous lupus erythematosus, which is identified by a skin rash that may occur on the face, neck and scalp; allergic reactions; weakness and muscle twitching; altered heart rate; decreased blood pressure with altered posture; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increased levels of certain types of blood fats; high uric acid levels in the blood, which can causegout .

It is known that side effects associated with hydrochlorothiazide may increase with the higher dose you

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store 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 carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • 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 .
  • 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) red iron oxide (i17dr) red iron oxide. 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) red iron oxide (i17dr) red iron oxide. See section 2 “Ifirmacombi contains sodium”.

What the medicine looks like and contents of the pack

Ifirmacombi 150 mg / 12.5 mg:

Slightly 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

Slightly pink, biconvex, capsule-shaped, film-coated tablets (tablets).

Packs of 14, 28, 30, 56, 56×1, 84, 90 and 98 film-coated tablets in blisters are available.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

KRKA Sverige AB

Tel: + 46 (0) 8 643 67 66 (SE)

Muhammad Nadeem

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