Package Insert: Information for the Patient

Ifirmasta 75 mg Film-Coated Tablets EFG

Irbesartan

Read this entire package insert carefully before starting to take the medication because it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• - This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• - If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ifirmasta belongs to a group of medications known as angiotensin-II receptor antagonists.

Angiotensin-II is a substance produced in the body that binds to receptors, causing blood vessels to constrict. This results in an increase in blood pressure. Ifirmasta prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure.

Ifirmasta slows the deterioration of renal function in patients with high blood pressure and type 2 diabetes.

Ifirmasta is used in adult patients

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type 2 diabetes, and clinical evidence of altered renal function.

Do not take Ifirmasta

• if you are allergic to irbesartan or any of the other components of this medication (including those listed in section 6),
• - if you are more than 3 months pregnant.
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ifirmasta and if any of the following affect you:

the following aspects affect you:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• - if you are taking Ifirmasta for diabetic nephropathy. In this case, your doctor may perform regular blood tests, especially to measure potassium levels in case of impaired renal function
• if you are to be operated on (surgical intervention) orif you are to be administered anesthetics
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may monitor your renal function, blood pressure, and blood electrolyte levels (such as potassium), at regular intervals.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. It is not recommended to use Ifirmasta at the beginning of pregnancy (first 3 months), and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

Children and adolescents

This medication should not be used in children and adolescents (<18

Taking Ifirmasta with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may need to modify 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 have blood tests if you are taking:

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing medications (such as certain diuretics)
• medications containing lithium.

If you are using a type of analgesic, known as nonsteroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. In general, your doctor will advise you to stop taking Ifirmasta before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. It is not recommended to use Ifirmasta at the beginning of pregnancy and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you plan to initiate or are in the breastfeeding period, as it is not recommended to administer Ifirmasta to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

It is unlikely that Ifirmasta will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration Form

Ifirmasta is administeredorally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Ifirmasta can be taken with or without food. You should try to take your daily dose at the same time every day. It is essential that you continue taking this medication until your doctor advises you otherwise.

-Patients with High Blood Pressure

The usual dose is 150 mg once a day (two tablets a day). Subsequently, and depending on the blood pressure response, this dose may be increased to 300 mg once a day (four tablets a day).

-Patients with High Blood Pressure and Type 2 Diabetes with Kidney Impairment

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated kidney impairment is 300 mg once a day (four tablets a day).

Your doctor may advise a lower dose, especially at the beginning of treatment, in certain patients, such as those undergoinghemodialysisor thoseover 75 years old.

The maximum blood pressure-reducing effect should be achieved within 4-6 weeks after starting treatment.

Use in Children and Adolescents

Ifirmasta should not be administered to children under 18 years old. If a child swallows several tablets, contact your doctor immediately.

If You Take More Ifirmasta Than You Should

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

If You Forget to Take Ifirmasta

If you accidentally forget to take a dose, simply take your regular dose when it is due next. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

However, some of these side effects can be serious and may require medical attention.

Like with similar medicines, in rare cases, there have been reports of skin allergic reactions (skin rash, urticaria) as well as localized inflammation in the face, lips, and/or tongue in patients treated with irbesartan. If you think you may be having this type of reaction or experience shortness of breath,stop taking Ifirmasta and seek immediate medical attention.

The side effects listed below are grouped by frequency:

Very common: Could affect more than 1 in 10 people

Common: Could affect up to 1 in 10 people

Uncommon: Could affect up to 1 in 100 people

The side effects reported in clinical trials conducted in patients treated with Ifirmasta were:

• Very common (could affect more than 1 in 10 people): If you have high blood pressure and type 2 diabetes with kidney impairment, blood tests may show an increase in potassium levels.
• Common (could affect up to 1 in 10 people): Dizziness, nausea/vomiting, and fatigue, and blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney impairment, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).
• Uncommon (could affect up to 1 in 100 people): Tachycardia, skin redness, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function alterations), and chest pain.

Since the marketing of Ifirmasta, some side effects have been reported. The side effects observed with unknown frequency are: feeling of spinning, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, increased potassium levels in the blood, kidney function impairment, and inflammation of small blood vessels, mainly in the skin area (condition known as leukocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). Cases of rare jaundice (yellowing of the skin and/or white of the eyes) have also been observed.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD and on the blister pack after EXP. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. By doing so, you will help protect the environment.

Composition of Ifirmasta

• The active ingredient is irbesartan. Each film-coated tablet contains 75 mg of irbesartan (as hydrochloride).

The other components are mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose (LH-21), low-substituted hydroxypropylcellulose (LH-11), talc, macrogol 6000, and hydrogenated castor oil in the core of the tablet, and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, and talc in the film coating.

Appearance of the product and contents of the pack

Ifirmasta 75 mg film-coated tablets are white and oval-shaped.

Ifirmasta 75 mg film-coated tablets are available in boxes, in blisters of 14, 28, 30, 56, 84, 90, and 98 tablets, and in boxes of 56 x 1 film-coated tablets in pre-cut single-dose blisters.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarjeska cesta 6, 8501 Novo mesto, Slovenia

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: {Month/year}.

Further information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu/.