Avasart

Package leaflet: Information for the patient

AVASART, 80 mg, film-coated tablets
AVASART, 160 mg, film-coated tablets
Valsartanum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Avasart is and what it is 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 Avasart is and what it is 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 activity of angiotensin II. As a result, blood vessels dilate and blood pressure decreases.
Avasart, 80 mg and 160 mg, film-coated tablets are used in the treatment of:

• high blood pressure,
• symptomatic heart failure.

Avasart may be used in adult patients for the treatment of symptomatic heart failure. Avasart is used when a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or Avasart may be used concomitantly with ACE inhibitors when other medicines used in the treatment of heart failure cannot be administered.

2. Important information before using Avasart

When not to use Avasart

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver disease,
• if the patient is in the third month of pregnancy or beyond (Avasart should also be avoided before the third month of pregnancy; see section 2: Pregnancy and breastfeeding),
• in children and adolescents under 18 years of age,

Warnings and precautions
Before starting treatment with Avasart, discuss this with your doctor or pharmacist.

• if the patient has liver disease,
• if the patient has severe kidney disease or is undergoing dialysis procedures (so-called artificial kidney),
• if the patient has renal artery stenosis,
• if the patient has recently undergone kidney transplantation,
• if the patient is being treated for heart attack or heart failure. The doctor may order monitoring of kidney function,
• if the patient has severe heart disease other than heart failure or heart attack,
• if the patient is taking medicines that increase potassium levels in blood (e.g. potassium supplements or potassium-containing salt substitutes), potassium-sparing agents, and heparin. Regular monitoring of blood potassium levels may be necessary,
• if the patient has aldosteronism (a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone),
• if the patient has experienced significant fluid loss (dehydration) due to diarrhea, vomiting, or use of high doses of diuretic medicines,
• if the patient is taking any of the following medicines for high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney impairment related to diabetes,
  • aliskiren,
• if the patient is being treated with an ACE inhibitor in combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Avasart,
discuss this with the doctor. The doctor will decide on further treatment. Do not make decisions
about stopping Avasart on your own.
The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels
(e.g. potassium) at regular intervals.
See also information under the heading "When not to take Avasart."

Avasart with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Avasart with certain medicines may affect treatment. Dose adjustment, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines.
Inform the doctor if the patient is taking any of the following medicines:

• diuretics (so-called water tablets), e.g. furosemide, as this may cause a sudden drop in blood pressure,
• medicines that increase potassium levels in blood,
• painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen,
• lithium (a medicine used in the treatment of certain psychiatric disorders),
• ACE inhibitors (medicines used to treat high blood pressure, heart failure, and heart attack),
• beta-adrenergic blocking agents (medicines used to treat high blood pressure and certain heart conditions).

The treating doctor may need to adjust the dose and/or take additional precautions:
If the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to take Avasart" and "Warnings and precautions").
If the patient is taking an ACE inhibitor together 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.
Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, as Avasart may harm the unborn baby. The doctor will prescribe an alternative medicine instead of Avasart.
Avasart is not recommended during early pregnancy (i.e. up to the 3rd month of pregnancy). It must not be used after the 3rd month of pregnancy, as it may cause serious harm to the unborn baby.
Inform the doctor if the patient is breastfeeding or intends to breastfeed.
Avasart is not recommended for breastfeeding mothers. The doctor will recommend an alternative treatment for patients who intend to breastfeed, especially if the infant is a newborn or premature.

Driving and operating machinery
Avasart may cause dizziness and affect the ability to concentrate. If such symptoms occur, do not drive, operate machinery, or perform any activities requiring concentration.

Important information about certain 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 the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Avasart

This medicine should always be used exactly as your doctor has instructed.
If in doubt, consult your doctor or pharmacist.
People with high blood pressure often do not experience any symptoms and many feel quite well.
For this reason, it is important to keep seeing your doctor regularly, even if you feel well.
Method of administration:
Avasart may be taken with or without food.
Avasart should be swallowed with a glass of water.
Avasart should be taken at the same time each day.
The tablet may be divided in half.
Usual dose:
High blood pressure
80 mg (one Avasart 80 mg tablet or half an Avasart 160 mg tablet) once daily.
In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg).
Your doctor may also prescribe Avasart together with another medicine (e.g. a diuretic).
Heart failure
The starting dose is 40 mg (half an Avasart 80 mg tablet) twice daily.
Your doctor will gradually increase the dose (over several weeks) up to the maximum dose of
160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.
Avasart may be given together with other medicines used in the treatment of heart failure.
Your doctor will decide which treatment is appropriate for the individual condition.
Use in children and adolescents
Due to lack of data on safety and efficacy, Avasart is not recommended for use in children and adolescents under 18 years of age.
Taking more Avasart than prescribed
If you take more tablets than prescribed, inform your doctor or pharmacist immediately.
Overdose of this medicine may cause severe dizziness and/or fainting. Lie down and contact your doctor immediately.
Missed dose of Avasart
If you miss a dose, take it as soon as possible and continue treatment as directed by your doctor.
Do not take a double dose to make up for a missed dose.
Stopping Avasart
Stopping Avasart may cause worsening of disease symptoms. Do not stop taking this medicine on your own, even if you feel better.
The duration of treatment is determined by your doctor.
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 they do not occur in everyone.
Adverse reactions may occur with a certain frequency defined as follows:
common: occur in 1 to 10 patients out of 100;
uncommon: occur in 1 to 10 patients out of 1,000;
very rare: occur in less than 1 in 10,000 people;
unknown: 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,
• urticaria (pinkish, itchy blisters on the skin).

If any of these symptoms occur, contact a doctor immediately.

Other adverse reactions:

Common:

• dizziness related to change in body position,
• low blood pressure with symptoms such as dizziness, fainting,
• kidney function disorders.

Uncommon:

• severe kidney function disorders,
• shortness of breath, difficulty breathing while lying down,
• swelling of feet or legs,
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhoea,
• feeling of fatigue,
• weakness,
• heart failure,
• hyperkalaemia.

Very rare:

• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Unknown:

• skin rash, sometimes with fever, joint and muscle pain, lymph node enlargement (these are symptoms of serum sickness),
• purple-red skin spots, fever, itching (these are symptoms of vasculitis),
• increased risk of bleeding and bruising (due to reduced platelet count),
• muscle pain,
• fever, sore throat or oral ulceration due to infection (due to low white blood cell count),
• decreased haemoglobin concentration and red blood cell count (which may lead to anaemia),
• increased blood potassium concentration (which in severe cases may cause muscle cramps and heart rhythm disturbances),
• jaundice (yellowing of the skin and whites of the eyes, itchy skin, dark urine),
• increased blood creatinine and blood urea concentration (due to impaired kidney function),
• skin rash (red, itchy lumps on the skin), dizziness, facial swelling, lip, tongue or throat swelling, difficulty breathing or swallowing, dizziness, sudden loss of consciousness (these are symptoms of an allergic reaction).

The frequency of some adverse reactions may vary depending on the underlying disease.
For example, adverse reactions such as dizziness and kidney function disorders have been observed less frequently in patients treated for high blood pressure.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Avasart

Keep this medicine out of 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 specified month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use Avasart if the packaging is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
  Coating of the tablet (Avasart, 80 mg): hypromellose 6cP, lactose monohydrate, polyethylene glycol 6000, titanium dioxide (E171), red iron oxide (E172).
  Coating of the tablet (Avasart, 160 mg): hypromellose 6cP, lactose monohydrate, polyethylene glycol 6000, titanium dioxide (E171), yellow iron oxide (E172).

What Avasart looks like and contents of the pack
Avasart 80 mg, film-coated tablets: pink, elongated, film-coated tablet, without spots or damage, with a score line on one side.
The pack contains 28 film-coated tablets.
Avasart 160 mg, film-coated tablets: yellow, elongated, film-coated tablet, without spots or damage, with a score line on one side.
The pack contains 14 or 28 film-coated tablets.

Marketing Authorisation 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 medicinal product, please contact the local representative of the Marketing Authorisation Holder.