75 mg, 150 mg, and 300 mg film-coated tablets
irbesartan

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 you will find information about:
1. What Ifirmasta is and what it is used for
2. What you need to know before using Ifirmasta
3. How to use Ifirmasta
4. Possible side effects
5. How to store Ifirmasta
6. Contents of the packaging and other information

1. What Ifirmasta is and what it is used for

Ifirmasta 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. Ifirmasta prevents the binding of angiotensin -II to these receptors, which causes the blood vessels to relax and the blood pressure to drop. Ifirmasta delays the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

Ifirmasta is used in adult patients

  • in the treatment of hypertension ( essential hypertension )
  • to protect the kidneys in patients with high blood pressure , type 2 diabetes and renal impairment, detected in laboratory tests.

2. What you need to know before using Ifirmasta

Do not use Ifirmasta

  • if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6).
  • Pregnant women should not use Ifirmasta during the last 6 months of pregnancy . (Even earlier in pregnancy, it is good to avoid Ifirmasta, see Pregnancy and breast-feeding).
  • 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 or pharmacist before taking Ifirmasta and if any of the following apply to you:

  • if you experience severe vomiting or diarrhea
  • if you suffer from kidney problems
  • if you suffer from heart problems
  • if you are receiving Ifirmasta for diabetes-related kidney disease . Then your doctor may take regular blood tests, especially to measure the level of potassium in the blood in case of poor kidney function.
  • 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 are going to have surgery or get anesthesia
  • 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 take Ifirmasta”.

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Ifirmasta is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breastfeeding.

Children and young people

This medicine should not be used by children and adolescents (<18 years) as the safety and efficacy of the medicine have not been fully evaluated.

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 take other precautions:

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

You may need to take blood samples if you use:

  • potassium supplement
  • salt substitutes containing potassium
  • potassium-sparing medicines (eg certain diuretics )
  • medicines containing lithium
  • repaglinide (medicines used to lower blood sugar levels)

If you use certain painkillers, so-called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 Ifirmasta before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Ifirmasta should not be used in early 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. Ifirmasta 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 premature.

Driving and using machines

Ifirmasta 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.

Ifirmasta contains castor oil

3. How to use Ifirmasta

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

Method of administration

Ifirmasta is taken by mouth. Swallow the tablets with a sufficient amount of drink (eg a glass of water). You can take Ifirmasta with or without food. Try to take your daily dose at about the same time each day. You must continue to take Ifirmasta until your doctor tells you otherwise.

  • Patients with high blood pressureThe usual dose is 150 mg once daily (two tablets daily). The dose can then be increased to 300 mg (four tablets daily) once daily depending on the effect on blood pressure .
  • Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes , 300 mg (four tablets daily) once daily is preferred as the maintenance dose.

The doctor may, especially when starting treatment, prescribe a lower dose to certain patients e.g. those treated with hemodialysis, or those older than 75 years.

Maximum reduction in blood pressure is obtained 4-6 weeks after starting treatment.

Use for children and adolescents

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

If you use more Ifirmasta than you should 

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

If you forget to use Ifirmasta

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 tablet.

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 attention.

As with similar medications, 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 taking irbesartan. If you get any of these symptoms or if you have difficulty breathing, stop taking Ifirmasta and contact a doctor immediately.

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

  • Very common: may affect more than 1 in 10 people
  • Common: may affect up to 1 in 10 patients
  • Uncommon: may affect up to 1 in 100 people

In clinical trials, the following adverse reactions were reported in patients treated with Ifirmasta:

  • Very common (may affect more than 1 in 10 people): if you have 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, nausea / vomiting, fatigue and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness was reported when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, and joint or muscle pain and decreased levels of a protein in the red blood cells ( hemoglobin ).
  • Uncommon (may affect up to 1 in 100 people): palpitations, redness , cough, diarrhea, indigestion / heartburn, impaired sexual ability and chest pain.

Some side effects have been reported since Ifirmasta hit the market. Side effects without known frequency are dizziness, headache, taste changes, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells ( anemia – symptoms may include fatigue, headache, shortness of breath when exercising, dizziness, and pallor), decreased number platelets, liver effects, increased potassium levels in the blood, impaired renal function, inflammation of fine blood vessels especially in the skin (a condition called leukocytoclastic vasculitis ), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Jaundice (yellowing of the skin and/or whites of the eyes) has, as a less common side effect, also been reported.

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 Ifirmasta

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 blister after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

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 substance is irbesartan.Ifirmasta 75 mg: Each tablet contains 75 mg of irbesartan as irbesartan hydrochloride.Ifirmasta 150 mg: Each tablet contains 150 mg of irbesartan as irbesartan hydrochloride.Ifirmasta 300 mg: Each tablet contains 300 mg of irbesartan as irbesartan hydrochloride.
  • The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose ( LH- 21), low-substituted hydroxypropylcellulose ( LH- 11), talc, macrogol 6000 and hydrogenated castor oil in the tablet core, polyvinyl alcohol, titanium dioxide (mac17), toluene, dioxin (film).

What the medicine looks like and contents of the pack

Ifirmasta film-coated tablets are white and oval

Ifirmasta film-coated tablets: available in packs of 14, 28, 56, and 98 film-coated tablets in blisters and for packs of 56 x 1 film-coated tablets with perforated blisters.

Not all pack sizes may be marketed.

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

Muhammad Nadeem

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