IRBESARTAN 300 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Irbesartan Aurovitas, 150 mg, tablets
3. Irbesartan Aurovitas, 300 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
   3. What is Irbesartan Aurovitas and what is it used for
   4. Irbesartan Aurovitas is used in adult patients:
4. Important information before taking Irbesartan Aurovitas
   1. When not to take Irbesartan Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Irbesartan Aurovitas and other medicines
   5. A blood test may be necessary if you are taking:
   6. Taking Irbesartan Aurovitas with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Pregnancy
   9. Breastfeeding
   10. Driving and using machines
5. How to take Irbesartan Aurovitas
   1. Method of administration
   2. Patients with high blood pressure
   3. Patients with high blood pressure and type 2 diabetes with kidney disease
   4. Overdose of Irbesartan Aurovitas
   5. Use in children and adolescents
   6. Missed dose of Irbesartan Aurovitas
6. Possible side effects
   1. Reporting side effects
7. How to store Irbesartan Aurovitas
8. Contents of the pack and other information
   1. What Irbesartan Aurovitas contains
   2. What Irbesartan Aurovitas looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the package leaflet: 03/2021

Package Leaflet: Information for the User

Irbesartan Aurovitas, 150 mg, tablets

Irbesartan Aurovitas, 300 mg, tablets

Irbesartan

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Irbesartan Aurovitas and what is it used for
• 2. Important information before taking Irbesartan Aurovitas
• 3. How to take Irbesartan Aurovitas
• 4. Possible side effects
• 5. How to store Irbesartan Aurovitas
• 6. Contents of the pack and other information

1.

What is Irbesartan Aurovitas and what is it used for

Irbesartan Aurovitas belongs to a group of medicines known as 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 results in an increase in blood pressure.
Irbesartan Aurovitas prevents angiotensin II from binding to these receptors, causing blood vessels to widen and blood pressure to decrease. Irbesartan Aurovitas slows down the progression of kidney disease in patients with high blood pressure and type 2 diabetes.

Irbesartan Aurovitas 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 laboratory signs of kidney damage.

2. Important information before taking Irbesartan Aurovitas

When not to take Irbesartan Aurovitas

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant for more than 3 months.(It is also recommended to avoid taking Irbesartan Aurovitas during early pregnancy - see section "Pregnancy")
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Irbesartan Aurovitas, and if any of the following apply to you, consult your doctor:

• if you have severe vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if Irbesartan Aurovitas is taken due to kidney disease caused by diabetes. In this case, your doctor may regularly perform blood tests, especially to check potassium levels in the blood in case of poor kidney function
• if you are going to have surgery or be given anesthesia
• if you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Irbesartan Aurovitas".
Your doctor must be informed of suspected or planned pregnancy. It is not recommended to take Irbesartan Aurovitas during early pregnancy and it should not be taken if you are pregnant for more than 3 months, as it may be very harmful to the baby.

Children and adolescents

The medicine should not be used in children and adolescents, as its safety and efficacy have not been fully established.

Irbesartan Aurovitas and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Your doctor may need to change the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Irbesartan Aurovitas" and "Warnings and precautions").

A blood test may be necessary if you are taking:

• potassium supplements
• potassium-containing salt substitutes
• potassium-sparing diuretics (e.g., certain diuretics)
• lithium-containing medicines.

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

Taking Irbesartan Aurovitas with food and drink

Irbesartan Aurovitas can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

Your doctor must be informed of suspected or planned pregnancy. Your doctor will usually advise you to stop taking Irbesartan Aurovitas before becoming pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead of Irbesartan Aurovitas. It is not recommended to take Irbesartan Aurovitas during early pregnancy and it should not be taken if you are pregnant for more than 3 months, as it may be very harmful to the baby.

Breastfeeding

Your doctor must be informed if you are breastfeeding or planning to breastfeed. Irbesartan Aurovitas is not recommended for use in breastfeeding women. Your doctor may prescribe a different treatment if you are planning to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

The effect on driving and using machines has not been studied. Irbesartan Aurovitas does not affect the ability to drive or use machines. However, dizziness or fatigue may occur during treatment of high blood pressure. If these symptoms occur, consult your doctor before driving or using machines.

3. How to take Irbesartan Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Irbesartan Aurovitas is for oral use. The tablets should be swallowed with a sufficient amount of fluid (e.g., a glass of water). Irbesartan Aurovitas can be taken with or without food. Try to take your daily dose at the same time each day. It is important to continue taking Irbesartan Aurovitas for as long as your doctor prescribes it.

Patients with high blood pressure

150 mg
The usual dose is 150 mg once daily. The dose may be increased to 300 mg (two tablets once daily) depending on blood pressure response.
300 mg
The usual dose is 150 mg once daily. The dose may be increased to 300 mg once daily, depending on blood pressure response.

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

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

Overdose of Irbesartan Aurovitas

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

Use in children and adolescents

Irbesartan Aurovitas should not be given to children under 18 years of age. If a child swallows several tablets, contact your doctor immediately.

Missed dose of Irbesartan Aurovitas

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects are usually mild or moderate and disappear quickly.
As with similar medicines, rare cases of skin reactions (rash, urticaria) and facial, lip, and/or tongue swelling have been reported in patients taking irbesartan. If you experience any of these symptoms or difficulty breathing, stop taking Irbesartan Aurovitas and contact your doctor immediately.
The frequency of side effects is defined as follows:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
The following side effects have been reported in clinical trials with Irbesartan Aurovitas:
Very common (may affect more than 1 in 10 people):if you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show high potassium levels.
Common (may affect up to 1 in 10 people):dizziness, nausea/vomiting, fatigue, and increased activity of enzymes that indicate muscle and heart function (creatine kinase) in blood tests. In clinical trials in patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when standing up, low blood pressure when standing up, joint and muscle pain, and decreased hemoglobin levels in red blood cells were also reported.
Uncommon (may affect up to 1 in 100 people):rapid heartbeat, hot flushes, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual problems), chest pain.
Some side effects have been reported since the marketing of Irbesartan Aurovitas. The frequency of these side effects is unknown:
feeling of spinning, headache, taste disturbance, ringing in the ears, painful muscle cramps, joint and muscle pain, decreased platelet count, liver function disorders, high potassium levels in the blood, kidney function disorders, and inflammation of small blood vessels, mainly in the skin (known as leukocytoclastic vasculitis). Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
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 Irbesartan Aurovitas

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 after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicinal product.
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 pack and other information

What Irbesartan Aurovitas contains

• The active substance is irbesartan. Each tablet contains 150 mg of irbesartan. Each tablet contains 300 mg of irbesartan.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium carboxymethylcellulose (type A), hypromellose (5 cp), talc, polysorbate 80, colloidal anhydrous silica, sodium stearyl fumarate.

What Irbesartan Aurovitas looks like and contents of the pack

Tablet.
Irbesartan Aurovitas, 150 mg, tablets
White or almost white, biconvex, oval tablets without coating with "H 29" embossed on one side and smooth on the other side. Dimensions 13.70 mm x 7.00 mm.
Irbesartan Aurovitas, 300 mg, tablets
White or almost white, biconvex, oval tablets without coating with "H 30" embossed on one side and smooth on the other side. Dimensions 17.30 mm x 9.50 mm.
Irbesartan Aurovitas, tablets are available in PVC/PVDC/Aluminum blisters.
Pack sizes:
14, 28, or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Irbesartan Aurovitas 150 mg/ 300 mg tablets
Hungary:
Irbesartan Aurovitas 150mg/ 300 mg tabletta
Poland:
Irbesartan Aurovitas
Portugal:
Irbesartan Ritisca
Spain:
Irbesartán Aurovitas 75 mg/ 150 mg/ 300 mg comprimidos EFG

Date of last revision of the package leaflet: 03/2021