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

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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 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, causing blood vessels to widen and blood pressure to lower. Irprestan slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.
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 with laboratory evidence of kidney damage.

2. What you need to know before you take Irprestan

Do not take Irprestan

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant (see also section “Pregnancy”)
• if you have diabetes or kidney disease and you are treated with aliskiren

Warnings and precautions

Before taking Irprestan, talk to your doctor:

• if you have severe vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irprestan for kidney disease caused by diabetes. In this case, your doctor may check your blood regularly, especially for potassium levels, if your kidney function gets worse
• if you have low blood sugar (hypoglycaemia) (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, sudden palpitations, or pale skin)
• if you are going to have surgery or receive anaesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren

Your doctor may check your kidney function, blood pressure, and potassium levels in your blood. See also section “Do not take Irprestan”
A female patient should inform her doctor if she is pregnant, intends to become pregnant, or is breastfeeding. She should not take Irprestan if she is pregnant or breastfeeding, as it may harm her baby.
Irprestan should not be used in early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the baby (see section “Pregnancy”).

Children and adolescents

Irprestan should not be used in children and adolescents (under 18 years) because the safety and efficacy of Irprestan in children and adolescents have not been established.

Irprestan with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and about any medicines you plan to take.
Your doctor may need to change the dose or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also sections “Do not take Irprestan” and “Warnings and precautions”)

Monitoring of blood tests

May be necessary when taking:

• potassium supplements
• potassium-sparing diuretics (such as certain water tablets)
• lithium (a medicine used to treat some types of depression)
• repaglinide (a medicine used to reduce blood sugar levels)

When taking certain painkillers (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. Swallow the tablets with a glass of water.

Pregnancy and breastfeeding

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

A female patient should inform her doctor if she is pregnant, intends to become pregnant, or is breastfeeding. Irprestan should not be used in early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to the baby (see section “Pregnancy”).

Breastfeeding

A female patient should inform her doctor if she is breastfeeding or intends to breastfeed. Irprestan is not recommended during breastfeeding, and your doctor may prescribe a different medicine if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Irprestan is unlikely to affect your ability to drive or use machines. However, during treatment of high blood pressure, dizziness or fatigue may occur. If you experience these symptoms, consult your doctor before performing these activities.
Irprestan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

3. How to take Irprestan

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Irprestan is available in 75 mg, 150 mg, and 300 mg strengths.

Method of administration

Irprestan is taken orally, with or without food. Swallow the tablets with a glass of water. Try to take your daily dose at the same time each day. It is important to continue taking Irprestan for as long as your doctor prescribes it.

Patients with high blood pressure

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

Patients with high blood pressure and type 2 diabetes with kidney disease

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

Use in children and adolescents

Irprestan should not be given to children under 18 years of age. If a child accidentally takes some tablets, consult your doctor immediately.

Overdose

If you accidentally take too many tablets, consult your doctor immediately. Symptoms of overdose may include low blood pressure and rapid heartbeat, possibly with slow heartbeat.

Missed dose

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
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 medicines, rare cases of allergic reactions (rash, urticaria), as well as localised swelling of the face, lips, and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irprestan and contact your doctor immediately.
The following side effects have been reported in clinical trials with irbesartan:
Very common(may affect more than 1 in 10 people):
In patients with high blood pressure and type 2 diabetes with kidney disease, high levels of potassium in the blood have been seen in blood tests.
Common(may affect up to 1 in 10 people):
Dizziness, nausea/vomiting, fatigue, and increased levels of an enzyme that shows muscle and heart damage (creatinine kinase) in the blood.
In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when standing up or sitting down, low blood pressure when standing up or sitting down, joint or muscle pain, and low levels of red blood cells (anaemia) have been reported.
Uncommon(may affect up to 1 in 100 people):
Rapid heartbeat, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction, chest pain.
Some side effects have been reported since the marketing of irbesartan. Their frequency is not known (cannot be estimated from the available data). These include: dizziness, headache, taste disturbance, ringing in the ears, muscle cramps, joint or muscle pain, liver function disorders, high levels of potassium in the blood, low levels of red blood cells (anaemia – symptoms may include tiredness, headaches, shortness of breath when exercising, dizziness, and pale skin), low levels of platelets, kidney problems, 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 of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the “Contact details for the reporting of side effects” section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irprestan

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 expiry date refers to the last day of that month.
There are no special storage conditions.
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 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: 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 film-coated tablets, with “I” on one side and “75” on the other side.
Irprestan, 150 mg: white, oval, biconvex film-coated tablets, with “I” on one side and “150” on the other side.
Irprestan, 300 mg: white, oval, biconvex film-coated tablets, with “I” on one side and “300” on the other side.
The tablets are packed in blisters.
Pack sizes:28, 30, 56 film-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 information about this medicine, including its other names, please contact the Marketing Authorisation Holder:

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