AVASART 80 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. AVASART, 80 mg, film-coated tablets
3. AVASART, 160 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Avasart and what is it used for
   1. Avasart, 80 mg and 160 mg, film-coated tablets are used to treat:
5. Important information before taking Avasart
   1. When not to take Avasart
   2. Warnings and precautions
   3. Before taking Avasart, discuss it with your doctor or pharmacist.
   4. Avasart and other medicines
   5. Taking Avasart with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Important information about some ingredients of Avasart
6. How to take Avasart
   1. Method of administration:
   2. Normally used dose:
   3. High blood pressure
   4. Heart failure
   5. Use in children and adolescents
   6. Overdose of Avasart
   7. Missing a dose of Avasart
   8. Stopping treatment with Avasart
7. Possible side effects
   1. Some symptoms require immediate medical attention:
   2. In case of any of these symptoms, contact your doctor immediately.
   3. Other side effects:
   4. Very rare:
   5. Not known:
   6. Reporting side effects
8. How to store Avasart
9. Contents of the pack and other information
   1. What Avasart contains
   2. What Avasart looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

AVASART, 80 mg, film-coated tablets

AVASART, 160 mg, film-coated tablets

Valsartan

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

• 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Avasart and what is it used for

Avasart belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Avasart works by blocking the action of angiotensin II. As a result, blood vessels expand and blood pressure decreases.

Avasart, 80 mg and 160 mg, film-coated tablets are used to treat:

• high blood pressure,
• symptomatic heart failure.

Avasart may be used in adult patients to treat symptomatic heart failure. Avasart is used when a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors) (medicines used to treat heart failure) cannot be used or Avasart may be used in combination with ACE inhibitors when other medicines used to treat heart failure cannot be used.

2. Important information before taking Avasart

When not to take Avasart

Warnings and precautions

Before taking Avasart, discuss it with your doctor or pharmacist.

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Avasart, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Avasart on your own. 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 Avasart" and "Warnings and precautions".

Avasart and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Taking Avasart with some medicines may affect your treatment. A dose change, other precautions, or discontinuation of one of the medicines may be necessary. This applies to both prescription and non-prescription medicines. Inform your doctor if you are taking any of the following medicines:

• diuretics (water pills), e.g., furosemide, as this may cause a sudden drop in blood pressure,
• medicines that increase the amount of potassium in your blood,
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen,
• lithium (a medicine used to treat certain mental illnesses),

• ACE inhibitors (medicines used to treat high blood pressure, heart failure, and heart attack),
• beta-blockers (medicines used to treat high blood pressure and certain heart diseases).

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 Avasart" and "Warnings and precautions"). If you are taking an ACE inhibitor with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Taking Avasart with food and drink

Avasart can be taken with or without food.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, as Avasart may harm your unborn baby. Your doctor will prescribe a different medicine instead of Avasart. Avasart is not recommended in early pregnancy (i.e., up to 3 months of pregnancy). It must not be taken by pregnant women who are more than 3 months pregnant, as it may seriously harm your baby. Inform your doctor if you are breastfeeding or plan to breastfeed. Avasart is not recommended for mothers who are breastfeeding. Your doctor will recommend a different treatment for you, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Avasart may cause dizziness and affect your ability to concentrate. If you experience these symptoms, do not drive, operate machinery, or perform other activities that require concentration.

Important information about some ingredients of Avasart

Avasart, 80 mg contains 0.00191 g of lactose (0.000955 g glucose and 0.000955 g galactose) per tablet. Avasart, 160 mg contains 0.00384 g of lactose (0.00192 g glucose and 0.00192 g galactose) per tablet. This should be taken into account in patients with diabetes. If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Avasart

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. People with high blood pressure often do not feel unwell. Many of them feel quite well. Therefore, it is important to see your doctor regularly, even if you feel fine.

Method of administration:

Avasart can be taken with or without food. Avasart should be swallowed with a glass of water. Avasart should be taken every day at the same time. The tablet can be divided into two halves.

Normally used dose:

High blood pressure

80 mg (one Avasart, 80 mg tablet or half a tablet of Avasart, 160 mg) per day. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Your doctor may also prescribe Avasart in combination with another medicine (e.g., a diuretic).

Heart failure

The initial dose is 40 mg (half a tablet of Avasart, 80 mg) twice a day. Your doctor will gradually increase the dose (over several weeks) to achieve the maximum dose: 160 mg twice a day. The final dose depends on your tolerance to the medicine. Avasart can be given in combination with other medicines used to treat heart failure. Your doctor will decide which treatment is suitable for your particular condition.

Use in children and adolescents

Due to the lack of data on the safety and efficacy of the medicine, Avasart is not recommended for use in children under 18 years of age.

Overdose of Avasart

If you have taken more tablets than prescribed, tell your doctor or pharmacist immediately. In case of overdose, this medicine may cause severe dizziness and/or fainting. Lie down and contact your doctor immediately.

Missing a dose of Avasart

If you miss a dose, take it as soon as you remember and continue with your regular schedule. Do not take a double dose to make up for the missed dose.

Stopping treatment with Avasart

Stopping treatment with Avasart may worsen your condition. Do not stop taking this medicine without consulting your doctor, even if you feel better. The duration of treatment is decided by your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Avasart can cause side effects, although not everybody gets them. Side effects may occur with a certain frequency, defined as follows: common:occur in 1 to 10 patients in 100; uncommon:occur in 1 to 10 patients in 1,000; very rare:occur in less than 1 in 10,000 patients; not known:frequency cannot be estimated from the available data.

Some symptoms require immediate medical attention:

• swelling of the face, tongue, or throat,
• difficulty swallowing or breathing,
• hives (red, itchy blisters on the skin).

In case of any of these symptoms, contact your doctor immediately.

Other side effects:

Common:

• orthostatic hypotension (dizziness when standing up),
• low blood pressure with symptoms such as dizziness, fainting,
• kidney problems.

Uncommon:

• severe kidney problems,
• shortness of breath, difficulty breathing while lying down,
• swelling of the feet or ankles,
• headache,
• cough,
• stomach pain,
• nausea,
• diarrhea,
• feeling tired,
• weakness,
• heart failure,
• hyperkalemia.

Very rare:

• intestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.

Not known:

• rash, sometimes with fever, joint pain, and muscle pain, swollen lymph nodes (these are symptoms of a condition called serum sickness),
• purple-red spots on the skin, fever, itching (these are symptoms of a condition called vasculitis),
• increased risk of bleeding and bruising (due to a decrease in platelet count),
• muscle pain,
• fever, sore throat, or mouth ulcers due to infection (due to a low white blood cell count),
• decreased hemoglobin and red blood cell count (which may cause anemia),
• increased potassium levels in the blood (which may cause muscle cramps and heart problems in severe cases),
• jaundice (yellowing of the skin and whites of the eyes, itching of the skin, and dark urine),
• increased creatinine and urea levels in the blood (due to kidney problems),
• rash (red, itchy bumps on the skin), dizziness, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, dizziness, sudden loss of consciousness (these are symptoms of an allergic reaction).

The frequency of some side effects may vary depending on the disease. For example, side effects such as dizziness and kidney problems are observed less frequently in patients treated for high blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Avasart

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. Do not store above 30°C. Store in the original package to protect from moisture. Do not use Avasart if you notice damage to the packaging or signs of tampering. 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 Avasart contains

• The active substance is valsartan. Each tablet contains 80 mg or 160 mg of valsartan.
• The other ingredients are: povidone, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate. Tablet coating (Avasart, 80 mg): hypromellose 6cP, lactose monohydrate, macrogol 6000, titanium dioxide (E171), iron oxide red (E172). Tablet coating (Avasart, 160 mg): hypromellose 6cP, lactose monohydrate, macrogol 6000, titanium dioxide (E171), iron oxide yellow (E172).

What Avasart looks like and contents of the pack

Avasart, 80 mg, film-coated tablets: film-coated tablet, pink, elongated, without spots and damage, with a dividing line on one side. The pack contains 28 film-coated tablets. Avasart, 160 mg, film-coated tablets: film-coated tablet, yellow, elongated, without spots and damage, with a dividing line on one side. The pack contains 14 or 28 film-coated tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A. ul. Józefów 9 99-300 Kutno Tel.: +48 24 357 44 44 Fax: +48 24 357 45 45 e-mail: [email protected] For more detailed information on this medicine, contact your local representative of the marketing authorization holder.

Date of last revision of the leaflet: