Irprestan

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
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Irprestan is and what it is used for
2. What you need to know before you take 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 Irprestan is and what it is 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. Irprestan prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and a reduction in blood pressure. Irprestan slows the progression of kidney damage in patients with high blood pressure and type 2 diabetes. Irprestan is used in adult patients:

• for the treatment of high blood pressure (essential hypertension)
• for the protection of kidneys in patients with high blood pressure and type 2 diabetes who have laboratory-confirmed kidney function impairment.

2. Important information before using Irprestan

When not to use Irprestan

• if the patient is allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
• after the third month of pregnancy. Irprestan should also be avoided in early pregnancy – see section "Pregnancy"
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting Irprestan, discuss this with your doctor.

• if there are severe vomiting or diarrhoea
• if there are kidney problems
• if there are heart problems
• if the patient is taking Irprestan due to kidney disease caused by diabetes. In such a case, the doctor may recommend regular blood tests, especially to monitor blood potassium levels, if kidney function worsens
• 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 surgery or anaesthesia is planned
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor – for example enalapril, lisinopril, ramipril, particularly if the patient has kidney problems related to diabetes
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium).
See also the section "When not to use Irprestan".
The patient must inform the doctor of suspected (or planned) pregnancy. Irprestan is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").
Children and adolescents
Irprestan should not be used in children and adolescents (under 18 years of age), as its safety and efficacy have not been fully established.
Irprestan with other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
The doctor may recommend adjusting the dose and/or taking additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Irprestan" and "Warnings and precautions").

Blood tests may be necessary when taking:

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

The effect of irbesartan may be reduced when certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) are taken at the same time.
Irprestan with food and drink
Irprestan may be taken with or without food. Swallow the tablets with water.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The patient must inform the doctor of suspected (or planned) pregnancy. The doctor will usually advise stopping Irprestan before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend using another medicine instead of Irprestan. Irprestan is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform the doctor if you are breastfeeding or plan to breastfeed. Irprestan is not recommended during breastfeeding. The doctor may recommend using another medicine, especially if the patient intends to breastfeed a newborn or premature infant.
Driving and operating machinery
It is unlikely that Irprestan will affect the ability to drive or operate machinery. However, during treatment for high blood pressure, dizziness or tiredness may rarely occur. If such symptoms occur, consult your doctor before performing these activities.
Irprestan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. this medicine is considered "sodium-free".

3. How to use Irprestan

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Irprestan is available in the following strengths: 75 mg, 150 mg, 300 mg.
Method of administration
Irprestan is administered orally, during a meal or independently of meals. The tablets should be swallowed whole with water. It is recommended to take the daily dose at approximately the same time each day. It is important to continue taking Irprestan for as long as your doctor has prescribed.
Patients with high blood pressure
The recommended dose is 150 mg once daily. Your doctor may subsequently increase the dose to 300 mg once daily, depending on your blood pressure readings.
Patients with high blood pressure, type 2 diabetes and coexisting kidney disease
In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for treating coexisting kidney disease is 300 mg once daily.
Your doctor may prescribe a lower dose, especially when initiating treatment in certain patients, such as those undergoing hemodialysis and patients over 75 years of age.
Maximum blood pressure-lowering effect should be achieved within 4–6 weeks after starting treatment.
Use in children and adolescents
Irprestan must not be given to children under 18 years of age. In case any amount of tablets is accidentally swallowed by a child, contact a doctor immediately.
Taking more Irprestan than prescribed
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose may include hypotension and tachycardia, or possibly bradycardia.
If you miss a dose of Irprestan
If you accidentally miss a daily dose, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Some of these may be serious and may require medical attention.
As with similar medicines, allergic skin reactions (rash, urticaria) as well as localised swelling of the face, lips and (or) tongue have been reported in patients taking irbesartan. If any of these symptoms occur or if difficulty breathing develops, stop taking Irprestan and contact your doctor immediately.

The following adverse reactions have been reported in clinical trials involving patients treated with irbesartan:

Very common (may affect at least 1 in 10 people):
Increased blood potassium levels detected in blood tests in patients with high blood pressure, type 2 diabetes and concomitant kidney disease.

Common (may affect less than 1 in 10 people):
Dizziness, nausea/vomiting, fatigue, and increased activity of an enzyme reflecting muscle and heart function (creatine kinase), detected in blood tests.
In patients with high blood pressure, type 2 diabetes and concomitant kidney disease: dizziness upon standing from a lying or sitting position, low blood pressure upon standing from a lying or sitting position, joint or muscle pain, and decreased levels of the protein haemoglobin in red blood cells.

Uncommon (may affect less than 1 in 100 people):
Increased heart rate, sudden flushing of the face, cough, diarrhoea, indigestion/heartburn, sexual dysfunction, chest pain.

Some adverse reactions have been reported after irbesartan was placed on the market. Adverse reactions with unknown frequency include: sensation of spinning (vertigo), headache, taste disturbances, tinnitus, muscle cramps, joint and muscle pain, liver function abnormalities, increased blood potassium levels, reduced number of red blood cells (anaemia – symptoms may include fatigue, headache, shortness of breath during exercise, dizziness and pallor), reduced platelet count, kidney function impairment, inflammation of small blood vessels, mainly in the skin (a condition called leukocytoclastic vasculitis), anaphylactic reaction (anaphylactic shock), and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and (or) eyes) have also been reported.

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Irprestan

Keep this medicine out of sight and reach of children.
Do not use 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 stated month.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Irprestan contains

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

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

  Irprestan 300 mg, 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;
  Coating: Opadry 20F280002 White: hydroxypropylcellulose, 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 coated tablets, marked with "I" on one side and "75" on the other.
Irprestan 150 mg: white, oval, biconvex coated tablets, marked with "I" on one side and "150" on the other.
Irprestan 300 mg: white, oval, biconvex coated tablets, marked with "I" on one side and "300" on the other.
The tablets are packed in blisters.
Pack sizes: 28, 30, 56 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

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

For more detailed information about the medicine and its names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.