Avasart Plus

Package Leaflet: Information for the Patient

Avasart Plus, 5 mg + 80 mg, film-coated tablets

Avasart Plus, 5 mg + 160 mg, film-coated tablets

Avasart Plus, 10 mg + 160 mg, film-coated tablets

Amlodipine + Valsartan

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

1. What Avasart Plus is and what it is used for

Avasart Plus tablets contain two active substances: amlodipine and valsartan. Both substances help to control high blood pressure.

• Amlodipine belongs to a group of medicines called calcium channel blockers. It works by preventing calcium from entering the cells of the heart and blood vessel walls, leading to lower blood pressure.
• Valsartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to narrow, leading to higher blood pressure. Valsartan blocks the action of angiotensin II.

Both active substances in Avasart Plus work together to further reduce blood pressure.

2. What you need to know before you take Avasart Plus

Do not take Avasart Plus

• if you are allergic to amlodipine or valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other calcium channel blockers, such as dihydropyridines (e.g., nifedipine, nimodipine).
• if you have severe liver disease or biliary cirrhosis.
• if you are more than 3 months pregnant (it is also better to avoid Avasart Plus in early pregnancy – see section “Pregnancy and breast-feeding”).
• if you have very low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or if you are in cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney problems and are taking aliskiren, a medicine used to treat high blood pressure.

If any of the above applies to you, do not take Avasart Plus and tell your doctor.

Warnings and precautions

Before taking Avasart Plus, tell your doctor if:

• you have kidney disease or have had a kidney transplant.
• you have liver disease.
• you have heart failure or have had a heart attack.
• you have had a narrowing of the valves in your heart or an enlargement of the septum (the wall separating the two halves of the heart).
• 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 disease caused by diabetes; aliskiren.

Your doctor may want to check your kidney function, blood pressure, and the levels of certain chemicals in your blood (e.g., potassium). See also section “Do not take Avasart Plus”.

If any of the above applies to you, tell your doctor before taking Avasart Plus.

Children and adolescents

Avasart Plus is not recommended for children and adolescents under 18 years of age.

Avasart Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• ACE inhibitors or aliskiren (see also sections “Do not take Avasart Plus” and “Warnings and precautions”);
• diuretics (also known as water pills, which increase urine production);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes;
• certain pain relievers (non-steroidal anti-inflammatory drugs, or NSAIDs), such as ibuprofen or naproxen;
• antiepileptic medicines (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort (a herbal remedy);
• glyceryl trinitrate or other nitrates, or other vasodilators;
• medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat bacterial infections (e.g., rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil or diltiazem (medicines used to treat heart conditions);
• simvastatin (a medicine used to lower cholesterol levels);
• dantrolene (a medicine used to treat certain types of muscle spasticity);
• medicines used to prevent the rejection of transplanted organs (cyclosporin).

Avasart Plus with food and drink

Do not eat grapefruit or drink grapefruit juice while taking Avasart Plus, as it may increase the levels of amlodipine in your blood, leading to an unpredictable increase in the blood pressure-lowering effect of Avasart Plus.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or think you may be pregnant, tell your doctor. Your doctor will normally advise you to stop taking Avasart Plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Avasart Plus. You must not take Avasart Plus if you are more than 3 months pregnant, as it may harm your baby. Breast-feeding

If you are breast-feeding or plan to breast-feed, tell your doctor. Avasart Plus is not recommended for women who are breast-feeding, and your doctor may prescribe a different medicine for you if you want to breast-feed, especially if you are feeding a newborn or premature baby. Amlodipine passes into breast milk in small amounts.

Driving and using machines

Avasart Plus may cause dizziness or affect your ability to concentrate. Do not drive, operate machinery, or perform tasks that require your full attention until you know how Avasart Plus affects you.

Avasart Plus contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Avasart Plus

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet per day.

• Take your dose at the same time each day.
• Swallow the tablet with a glass of water.
• Avasart Plus can be taken with or without food. Do not take Avasart Plus with grapefruit or grapefruit juice.

Depending on how you respond to treatment, your doctor may increase or decrease the dose of Avasart Plus. Do not take more than the recommended dose.

Avasart Plus in elderly patients (65 years or older)

Your doctor will be cautious when increasing the dose.

If you take more Avasart Plus than you should

If you have taken too many tablets, contact your doctor immediately.

If you forget to take Avasart Plus

If you forget to take a dose, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Avasart Plus

Stopping treatment with Avasart Plus may cause your blood pressure to rise. Do not stop taking Avasart Plus without talking to your doctor first.

4. Possible side effects

Like all medicines, Avasart Plus can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention.

These serious side effects are rare (may affect up to 1 in 1,000 people).

If you experience any of the following, tell your doctor immediately:

• allergic reaction with symptoms such as rash, itching, swelling of the face, lips, tongue, or throat, difficulty breathing, low blood pressure (feeling faint or dizzy).

Other possible side effects of Avasart Plus

Common (may affect up to 1 in 10 people):

• flu-like symptoms;
• nasal congestion, sore throat, and discomfort when swallowing;
• headache;
• swelling of the arms, hands, legs, ankles, or feet;
• fatigue;
• weakness;
• redness of the skin and feeling of warmth on the face and/or neck.

Uncommon (may affect up to 1 in 100 people):

• dizziness due to low blood pressure;
• nausea and abdominal pain;
• dry mouth;
• drowsiness, tingling, or numbness of the hands or feet;
• spinning sensation (vertigo);
• rapid heartbeat, including palpitations;
• dizziness when standing up;
• cough;
• diarrhea;
• constipation;
• skin rash, redness of the skin;
• swelling of the joints, back pain;
• joint pain.

Rare (may affect up to 1 in 1,000 people):

• feeling anxious;
• ringing in the ears (tinnitus);
• fainting;
• passing more urine than usual or feeling an urgent need to urinate;
• impotence;
• feeling heavy;
• low blood pressure with symptoms such as dizziness, fainting;
• excessive sweating;
• skin rash all over the body;
• itching;
• muscle cramps.

If any of the above side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor.

Side effects reported with amlodipine or valsartan alone, which have not been observed with Avasart Plus or have been reported more frequently with Avasart Plus.

Amlodipine

If you experience any of the following, tell your doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing great difficulty in breathing;
• severe skin reactions, including intense rash, itching, redness of the skin all over the body, severe itching, blistering, peeling, and shedding of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, abnormal heart rhythm;
• inflammation of the pancreas, which may cause severe abdominal pain, radiating to the back, with a very severe general feeling of being unwell.

The following side effects have been reported. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor.

Common (may affect up to 1 in 10 people):

dizziness due to low blood pressure, drowsiness, palpitations (feeling of heartbeat), sudden redness of the face, especially the face, swelling of the ankles (edema), abdominal pain, nausea.

Uncommon (may affect up to 1 in 100 people):

mood changes, anxiety, depression, insomnia, tremors, taste disturbances, fainting, lack of pain, vision disturbances, worsening of vision, ringing in the ears, low blood pressure, sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis), indigestion, vomiting, hair loss, excessive sweating, itching of the skin, discoloration of the skin, urinary disturbances, increased need to urinate at night, increased frequency of urination, impotence, discomfort or enlargement of the breasts in men, pain, general feeling of being unwell, muscle pain, muscle cramps.

Rare (may affect up to 1 in 1,000 people):

confusion.

Very rare (may affect up to 1 in 10,000 people):

reduced number of white blood cells, which may cause fever, sore throat, or infections; reduced number of blood platelets, which may cause unusual bruising or bleeding; increased blood sugar levels (hyperglycemia); gum swelling; abdominal bloating (gastritis); liver disorders, including inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which can be detected in blood tests; muscle stiffness, inflammation of blood vessels, often with skin rash; sensitivity to sunlight; disorders that include stiffness, shaking, and difficulty moving.

Unknown frequency (cannot be estimated from the available data):

reduced number of red blood cells, which may cause anemia; fever, sore throat, or mouth ulcers due to infections; spontaneous bleeding or bruising; high levels of potassium in the blood; abnormal liver function tests; worsening of kidney function and severe kidney problems; swelling, mainly of the face and throat; muscle pain; skin rash; purple spots on the skin; fever; itching; allergic reaction; blistering of the skin (pemphigus). If you experience any of these side effects, tell your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 “Further information” section.

5. How to store Avasart Plus

Do not store above 30°C.

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 use this medicine if you notice that the packaging is damaged.

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 Avasart Plus contains

• The active substances are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.
• The active substances are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.
• The active substances are amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.
• The other ingredients are microcrystalline cellulose, povidone, sodium croscarmellose, talc, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E 171), [5 mg + 80 mg and 5 mg + 160 mg tablets]:yellow iron oxide (E 172).

What Avasart Plus looks like and contents of the pack

Avasart Plus, 5 mg + 80 mg (8 mm in diameter), are round, biconvex, yellow film-coated tablets with “I” engraved on one side and “LD” engraved on the other side.

Avasart Plus, 5 mg + 160 mg (13.5 mm x 7 mm), are oval, biconvex, yellow film-coated tablets with “2” engraved on one side and “LD” engraved on the other side.

Avasart Plus, 10 mg + 160 mg (13.5 mm x 7 mm), are oval, biconvex, white film-coated tablets with “3” engraved on one side and “LD” engraved on the other side.

Avasart Plus is available in packs of 28, 30, 56, 60, 90, 98, or 280 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Polfarmex S.A.

ul. Józefów 9

99-300 Kutno

Poland

Tel.: 24 357 44 44

Fax: 24 357 45 45

e-mail: polfarmex@polfarmex.pl

Manufacturer

Balkanpharma Dupnitza AD

3 Samokovsko Shosse Str.

Dupnitza 2600

Bulgaria

Date of last revision of the leaflet: March 2023

Further information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu