Irprestan

Leaflet attached to the packaging: 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 leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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 pack and other information

1. What is Irprestan and what is it used for

Irprestan belongs to a group of medicines 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 medicine Irprestan prevents angiotensin II from binding to these receptors, causing blood vessels to widen and lowering blood pressure. The medicine Irprestan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.
The medicine 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 Irprestan

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

Warnings and precautions

Before starting to take Irprestan, the patient should discuss it with their doctor.

• if the patient experiences severe vomiting or diarrhea
• if the patient experiences kidney function disorders
• if the patient experiences heart function disorders
• if the patient is taking 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 flushing or paleness of the face, numbness, rapid heartbeat), especially if the patient is being treated for diabetes
• if the patient is planning to undergo surgeryor receive anesthesia
• if the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitor - such as 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 (such as potassium) in the blood.
See also the "When not to take Irprestan" section.
The patient must inform their doctor if they suspect (or plan) pregnancy. It is not recommended to take Irprestan during early pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the fetus (see the "Pregnancy" section).

Children and adolescents

The medicine must 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 medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
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 Irprestan" and "Warnings and precautions" sections).

Blood tests may be necessary when taking:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing diuretics (such as certain diuretics)
• lithium-containing medicines
• repaglinide (a medicine used to lower blood sugar levels)

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

Irprestan with food and drink

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 baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

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

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Irprestan during breastfeeding. The doctor may recommend taking a different medicine, especially if the patient plans to breastfeed a newborn or premature baby.

Driving and using machines

It is unlikely that Irprestan will affect the patient's ability to drive or use 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.
Irprestan contains sodium
This medicine 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 medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Irprestan is available in the following strengths: 75 mg, 150 mg, 300 mg.

Method of administration

Irprestan is taken orally, with or without food. The tablets should be swallowed with water. The patient should try to take the daily dose at the same time every day. It is important to continue taking 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

Irprestan must not be given to children under 18 years of age. If a child accidentally swallows any tablets, the patient should immediately consult their doctor.

Taking a higher dose of Irprestan than recommended

If the patient accidentally takes too many tablets, they should immediately consult their doctor. Symptoms of overdose may include: low blood pressure and rapid heartbeat, or possibly slow heartbeat.

Missing a dose of Irprestan

If the patient misses a daily dose, they should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Irprestan can cause side effects, although not everybody gets them.
Some of them may be serious and may require medical attention.
As with similar medicines, in patients taking irbesartan, rare cases of allergic skin reactions (rash, urticaria) have been reported, as well as local swelling of the face, lips, and/or tongue. If any of these symptoms occur or if the patient experiences difficulty breathing, they should stop taking Irprestan and immediately consult their doctor.
The following side effects have been reported in clinical trials 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, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction, chest pain.
Some side effects have been reported after Irprestan 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, reduced red blood cell count (anemia - symptoms may include fatigue, headaches, shortness of breath during exercise, dizziness, and paleness), reduced 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. Rare cases of jaundice (yellowing of the skin and/or eyes) have also been reported.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. 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, tel.: +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 to gather more information on the safety of this medicine.

5. How to store Irprestan

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the outer packaging or blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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.

• The 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 contents of the pack

Irprestan, 75 mg: white, oval, biconvex film-coated tablets, with the marking "I" on one side and "75" on the other side.
Irprestan, 150 mg: white, oval, biconvex film-coated tablets, with the marking "I" on one side and "150" on the other side.
Irprestan, 300 mg: white, oval, biconvex film-coated tablets, with the marking "I" on one side and "300" on the other side.
The tablets are packaged in blisters.
Pack sizes:28, 30, 56 film-coated tablets.
Not all pack 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 on the medicine and its names in other EU countries, please contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:May 2023