Irbesartan aurovitas

Package leaflet: Information for the user

Irbesartan Aurovitas, 150 mg, tablets
Irbesartan Aurovitas, 300 mg, tablets
Irbesartanum
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, 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 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 leaflet

1. What Irbesartan Aurovitas is and what it is used for
2. What you need to know before you take 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 Irbesartan Aurovitas is and what it is 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 which binds to receptors in blood vessels, causing them to narrow. This leads to increased blood pressure. Irbesartan Aurovitas prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and lowering of blood pressure. Irbesartan Aurovitas slows down the worsening of kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan Aurovitas is used in adult patients

• for the treatment of high blood pressure (essential hypertension)
• to protect the kidneys in patients with hypertension, type 2 diabetes, and laboratory evidence of impaired kidney function.

2. What you need to know before you take Irbesartan Aurovitas

Do not 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 more than 3 months pregnant. (It is also better to avoid Irbesartan Aurovitas in early pregnancy - see section "Pregnancy")
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting Irbesartan Aurovitas and if any of the following apply to you, discuss this with your doctor:

• if you have severe vomiting or diarrhoea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Aurovitas due to kidney disease caused by diabetes. In such cases, your doctor may regularly perform blood tests, particularly to monitor blood potassium levels in case of poor kidney function.
• if you experience 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 you are being treated for diabetes
• if you are going to have surgery or will be given general anaesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "Do not take Irbesartan Aurovitas".
Your doctor must be informed if you suspect (or are planning) pregnancy. Irbesartan Aurovitas is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may be highly harmful to the unborn child if used during this period (see section "Pregnancy").
If you experience abdominal pain, nausea, vomiting or diarrhoea after taking Irbesartan Aurovitas, discuss this with your doctor. Your doctor will decide whether treatment should continue. Do not stop taking Irbesartan Aurovitas on your own.

Children and adolescents
Irbesartan Aurovitas should not be used in children and adolescents, as its safety and efficacy have not been fully established.

Irbesartan Aurovitas with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Irbesartan Aurovitas" and "Warnings and precautions").
Blood tests may be necessary if you are taking:

• potassium supplements
• salt substitutes containing potassium
• medicines that prevent potassium loss (e.g. certain diuretics)
• medicines containing lithium
• repaglinide (a medicine used to reduce blood sugar levels)

If you are taking certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Taking Irbesartan Aurovitas with food and drink
Irbesartan Aurovitas can be taken with or without food.

Pregnancy, breast-feeding and fertility
Pregnancy
Your doctor must be informed if you suspect (or are planning) pregnancy. Your doctor will usually advise stopping Irbesartan Aurovitas before becoming pregnant or as soon as you know you are pregnant, and will switch you to another medicine. Irbesartan Aurovitas is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may be highly harmful to the unborn child if used after the third month of pregnancy.

Breast-feeding
Your doctor must be informed if you are breast-feeding or intend to breast-feed. Irbesartan Aurovitas is not recommended for use in breast-feeding women. Your doctor may choose an alternative treatment if you intend to breast-feed, especially if the infant is a newborn or premature.

Driving and using machines
Irbesartan Aurovitas has no influence on the ability to drive or use machines. However, rarely, dizziness or tiredness may occur during treatment for high blood pressure. If you experience these symptoms, talk to your doctor before driving or operating machinery.

Irbesartan Aurovitas contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Irbesartan Aurovitas

This medicine should always be taken exactly as your doctor has told you. If you are unsure, please
contact your doctor or pharmacist.
Method of administration
Irbesartan Aurovitas is intended for oral use. The tablets should be swallowed whole with a sufficient
amount of liquid (e.g. a glass of water). Irbesartan Aurovitas can be taken with or without food.
It is recommended to take the daily dose at the same time each day. It is important to continue
treatment with Irbesartan Aurovitas for as long as your doctor has not advised otherwise.
Patients with high blood pressure
150 mg
The usual dose is 150 mg once daily. The dose may subsequently be increased to 300 mg (two tablets
per day) once daily, depending on blood pressure response.
300 mg
The usual dose is 150 mg once daily. The dose may subsequently be increased to 300 mg once daily,
depending on 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, the recommended maintenance dose for
treatment of concomitant kidney disease is 300 mg (150 mg x two tablets per day; 300 mg x one tablet
per day) once daily.
Your doctor may recommend lower doses, especially when starting treatment in certain patients, such
as patients undergoing haemodialysis and patients over 75 years of age.
Maximum blood pressure-lowering effect should be achieved within 4–6 weeks after starting treatment.
Taking more Irbesartan Aurovitas than recommended
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 has swallowed
several tablets, contact your doctor immediately.
If you forget to take a dose of Irbesartan Aurovitas
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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These adverse reactions are usually mild or moderate in intensity and resolve quickly.
As with similar medicines, rare cases of skin hypersensitivity reactions (rash, urticaria) as well as facial swelling, around the lips and (or) tongue, have been reported in patients taking irbesartan. If such symptoms occur or if you experience difficulty breathing, stop taking Irbesartan Aurovitas immediately and contact your doctor without delay.

The frequency of adverse reactions listed below is defined as follows:
Very common: may occur in more than 1 out of 10 people
Common: may occur in up to 1 out of 10 people
Uncommon: may occur in up to 1 out of 100 people
Rare: may occur in up to 1 out of 1,000 people

Adverse reactions reported in clinical trials in patients treated with irbesartan include:

Very common (may occur in more than 1 out of 10 people): in patients with high blood pressure and type 2 diabetes with kidney disease, blood tests may show increased potassium levels.

Common (may occur in up to 1 out of 10 people): dizziness, nausea/vomiting, feeling of fatigue, and increased activity of enzymes indicating muscle and heart function (creatine kinase) in blood tests. In clinical trials in patients with high blood pressure and type 2 diabetes with concomitant kidney disease, dizziness upon standing from lying or sitting position, low blood pressure upon standing from lying or sitting position (orthostatic hypotension), joint and muscle pain, and decreased haemoglobin concentration in red blood cells have also been reported.

Uncommon (may occur in up to 1 out of 100 people): rapid heartbeat, hot flushes, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some adverse reactions have been reported after Irbesartan Aurovitas was introduced into the market. The frequency of these adverse reactions is unknown. They include: sensation of spinning (vertigo), headache, taste disturbances, tinnitus (ringing in the ears), painful muscle cramps, joint and muscle pain, reduced number of red blood cells (anaemia – symptoms may include fatigue, headache, shortness of breath during exercise, dizziness and pallor), reduced platelet count, liver function disorders, increased blood potassium levels, kidney function impairment, inflammation of small blood vessels, mainly in the skin (known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or the whites of the eyes) have also been reported.

Rare (may occur in up to 1 out of 1,000 people): angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Irbesartan Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 carboxymethyl starch (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, uncoated tablets, embossed with "H 29" 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, uncoated tablets, embossed with "H 30" 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/Aluminium blisters.
Pack sizes:
Blister packs: 14, 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warszawa
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 authorised in the Member States of the European Economic Area under the following names:
Poland: Irbesartan Aurovitas
Portugal: Irbesartan Aurovitas
Spain: Irbesartán Aurovitas 75 mg/ 150 mg/ 300 mg comprimidos EFG