IRPRESTAN 75 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Irprestan, 75 mg, Film-Coated Tablets
3. Irprestan, 150 mg, Film-Coated Tablets
4. Irprestan, 300 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
5. What is Irprestan and What is it Used For
6. Important Information Before Taking Irprestan
   1. When Not to Take the Medication Irprestan
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Irprestan and Other Medications
   5. Blood Tests May be Necessary When Taking:
   6. Irprestan with Food and Drink
   7. Pregnancy and Breastfeeding
   8. Pregnancy
   9. Breastfeeding
   10. Driving and Operating Machines
7. How to Take Irprestan
   1. Method of Administration
   2. Patients with High Blood Pressure
   3. Patients with High Blood Pressure and Type 2 Diabetes with Kidney Disease
   4. Use in Children and Adolescents
   5. Overdose of Irprestan
   6. Missing a Dose of Irprestan
8. Possible Side Effects
   1. Reporting Side Effects
9. How to Store Irprestan
10. Contents of the Package and Other Information
    1. What Irprestan Contains
    2. What Irprestan Looks Like and What the Package Contains
    3. Marketing Authorization Holder
    4. Manufacturer
    5. To Obtain More Detailed Information About the Medication and Its Names in Other EU Member States, Contact the Representative of the Marketing Authorization Holder:

Package Leaflet: Information for the User

Irprestan, 75 mg, Film-Coated Tablets

Irprestan, 150 mg, Film-Coated Tablets

Irprestan, 300 mg, Film-Coated Tablets

Irbesartan

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.

Table of Contents of the Leaflet

• 1. What is Irprestan and What is it Used For
• 2. Important Information Before Taking Irprestan
• 3. How to Take Irprestan
• 4. Possible Side Effects
• 5. How to Store Irprestan
• 6. Contents of the Package and Other Information

1. What is Irprestan and What is it Used For

Irprestan belongs to a group of medications called angiotensin II receptor antagonists.
Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This in turn increases blood pressure. The medication Irprestan prevents angiotensin II from binding to these receptors, causing blood vessels to widen and blood pressure to decrease. The medication Irprestan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.
The medication Irprestan is used in adult patients:

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure and type 2 diabetes, as well as laboratory-confirmed kidney function disorders.

2. Important Information Before Taking Irprestan

When Not to Take the Medication Irprestan

• if the patient is allergicto irbesartan or any of the other ingredients of this medication (listed in section 6)
• after the third month of pregnancy. The medication Irprestan should also be avoided during early pregnancy - see the "Pregnancy" section
• if the patient has diabetes or kidney function disordersand is being treated with a blood pressure-lowering medication containing aliskiren.

Warnings and Precautions

The doctor should be consulted before starting to take the medication Irprestan.

• if there are severe vomiting or diarrhea
• if there are kidney function disorders
• if there are heart function disorders
• if the patient is taking the medication Irprestan due to kidney diseasecaused by diabetes. In this case, the doctor may recommend regular blood tests, especially to check potassium levels in the blood, in case of worsening kidney function
• if the patient experiences low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, sudden reddening or paleness of the face, numbness, rapid heartbeat), especially if the patient is being treated for diabetes
• if surgery is plannedor anesthesia is to be administered
• if the patient is taking any of the following medications used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor - for example, enalapril, lisinopril, ramipril, especially if the patient has kidney function disorders associated with diabetes
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the "When Not to Take the Medication Irprestan" section.
The patient must inform the doctor about suspected (or planned) pregnancy. It is not recommended to take the medication Irprestan during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see the "Pregnancy" section).

Children and Adolescents

The medication should not be taken by children and adolescents (under 18 years of age), as its safety and efficacy have not been fully established.

Irprestan and Other Medications

The doctor or pharmacist should be informed about all medications currently being taken or recently taken, as well as any medications planned to be taken.
The doctor may recommend changing the dose and/or taking other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also the "When Not to Take the Medication Irprestan" and "Warnings and Precautions" sections).

Blood Tests May be Necessary When Taking:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing diuretics (such as some diuretics)
• medications containing lithium
• repaglinide (a medication used to lower blood sugar levels)

When taking certain pain medications, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Irprestan with Food and Drink

The medication Irprestan can be taken with or without food. The tablets should be swallowed with water.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

Pregnancy

The patient must inform the doctor about suspected (or planned) pregnancy. The doctor will usually recommend stopping the medication Irprestan before planned pregnancy or immediately after confirming pregnancy, and recommend taking a different medication instead of Irprestan. It is not recommended to take the medication Irprestan during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

The doctor should be informed about breastfeeding or if the patient plans to breastfeed. It is not recommended to take the medication Irprestan during breastfeeding. The doctor may recommend taking a different medication, especially if the patient plans to breastfeed a newborn or premature baby.

Driving and Operating Machines

It is unlikely that the medication Irprestan will affect the ability to drive or operate machines. However, during treatment for high blood pressure, dizziness or fatigue may rarely occur. If such symptoms occur, the patient should consult their doctor before performing these activities.
The medication Irprestan contains sodium
This medication contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to Take Irprestan

This medication should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The medication Irprestan is available in the following doses: 75 mg, 150 mg, 300 mg.

Method of Administration

Irprestan is taken orally, with or without food. The tablets should be swallowed with water. It is recommended to take the daily dose at the same time every day. It is important to continue taking the medication Irprestan for as long as the doctor recommends.

Patients with High Blood Pressure

The recommended dose is 150 mg once daily. The doctor may then increase the dose to 300 mg once daily, depending on the blood pressure values obtained.

Patients with High Blood Pressure and Type 2 Diabetes with Kidney Disease

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of kidney disease is 300 mg once daily.
The doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those undergoing hemodialysis and people over 75 years of age.
The maximum blood pressure-lowering effect should be achieved within 4-6 weeks of starting treatment.

Use in Children and Adolescents

The medication Irprestan should not be given to children under 18 years of age. If a child accidentally swallows any tablets, the doctor should be contacted immediately.

Overdose of Irprestan

In case of accidental overdose, the doctor should be contacted immediately. Symptoms of overdose may include: low blood pressure and rapid heartbeat, or possibly slow heartbeat.

Missing a Dose of Irprestan

In case of missing a daily dose, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about taking this medication, the doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.
Some of them may be serious and may require medical attention.
As with similar medications, in patients taking irbesartan, rare cases of allergic skin reactions (rash, hives) have been reported, as well as local swelling of the face, lips, and/or tongue. If any of these symptoms occur or difficulty breathing, the medication Irprestan should be stopped and the doctor contacted immediately.
The following side effects have been reported in clinical trials with patients treated with irbesartan:
Very Common(may affect more than 1 in 10 patients):
In patients with high blood pressure and type 2 diabetes with kidney disease, increased potassium levels have been found in blood tests.
Common(may affect less than 1 in 10 patients):
Dizziness, nausea/vomiting, fatigue, and increased activity of the enzyme that reflects muscle and heart function (creatine kinase), found in blood tests.
In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when standing up from a lying or sitting position, low blood pressure when standing up from a lying or sitting position, joint or muscle pain, as well as decreased hemoglobin levels in red blood cells.
Uncommon(may affect less than 1 in 100 patients):
Rapid heartbeat, sudden reddening of the face, cough, diarrhea, indigestion/heartburn, sexual disorders (sexual dysfunction), chest pain.
Some side effects have been reported after the medication was marketed. The frequency of these side effects is unknownand includes: feeling of spinning, headache, taste disorders, ringing in the ears, muscle cramps, joint and muscle pain, liver function disorders, increased potassium levels in the blood, decreased red blood cell count (anemia - symptoms may include fatigue, headaches, shortness of breath during exercise, dizziness, and paleness), decreased platelet count, kidney function disorders, and inflammation of small blood vessels, mainly in the skin (a condition called leukocytoclastic vasculitis) and anaphylactic reaction (anaphylactic shock) and low blood sugar levels. There have also been rare cases of jaundice (yellowing of the skin and/or eyes).

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Irprestan

The medication should be stored out of sight and reach of children.
The medication should not be taken after the expiration date stated on the outer packaging or blister after: EXP. The expiration date refers to the last day of the specified month.
There are no special storage precautions.
Medications should not be disposed of in the sewage system or household waste containers. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the Package and Other Information

What Irprestan Contains

• The active substance is irbesartan. Irprestan 75 mg, film-coated tablets Each tablet contains 75 mg of irbesartan.

Irprestan 150 mg, film-coated tablets
Each tablet contains 150 mg of irbesartan.
Irprestan 300 mg, film-coated tablets.
Each tablet contains 300 mg of irbesartan.

• Other ingredients are: tablet core: croscarmellose sodium, microcrystalline cellulose, hypromellose 15 cP, mannitol, magnesium stearate, colloidal anhydrous silica; coatingOpadry 20F280002 White: hydroxypropyl cellulose, hypromellose 3 cP, hypromellose 50 cP, macrogol 6000, titanium dioxide (E 171).

What Irprestan Looks Like and What the Package Contains

Irprestan, 75 mg: white, oval, biconvex film-coated tablets, with the inscription "I" on one side and "75" on the other side.
Irprestan, 150 mg: white, oval, biconvex film-coated tablets, with the inscription "I" on one side and "150" on the other side.
Irprestan, 300 mg: white, oval, biconvex film-coated tablets, with the inscription "I" on one side and "300" on the other side.
The tablets are packaged in blisters.
Package sizes:28, 30, 56 film-coated tablets.
Not all package sizes may be marketed.

Marketing Authorization Holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

To Obtain More Detailed Information About the Medication and Its Names in Other EU Member States, Contact the Representative of the Marketing Authorization Holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, phone: (22) 345 93 00.
Date of Last Revision of the Leaflet:May 2023