AVASART 5 mg/80 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Avasart Plus, 5 mg + 80 mg, film-coated tablets
3. Avasart Plus, 5 mg + 160 mg, film-coated tablets
4. Avasart Plus, 10 mg + 160 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Avasart Plus and what is it used for
6. Important information before taking Avasart Plus
   1. When not to take Avasart Plus
   2. If any of the above conditions apply to you, do not take Avasart Plus and consult your doctor.
   3. Warnings and precautions
   4. If any of the above conditions apply to you, tell your doctor before taking Avasart Plus.
   5. Children and adolescents
   6. Avasart Plus with other medicines
   7. Avasart Plus with food and drink
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Avasart Plus contains sodium
7. How to take Avasart Plus
   1. Avasart Plus in elderly patients (65 years or older)
   2. Taking more than the recommended dose of Avasart Plus
   3. Missing a dose of Avasart Plus
   4. Stopping treatment with Avasart Plus
8. Possible side effects
   1. Some side effects can be serious and may require immediate medical attention.
   2. If you experience any of the following symptoms, contact your doctor immediately:
   3. Other possible side effects of Avasart Plus
   4. If the intensity of any of the above symptoms is severe, consult your doctor.
   5. 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.
   6. If you experience any of the following very rare but serious side effects, contact your doctor immediately:
   7. Uncommon (may affect up to 1 in 100 people):
   8. Rare (may affect up to 1 in 1,000 people):
   9. Very rare (may affect up to 1 in 10,000 people):
9. How to store Avasart Plus
10. Contents of the pack and other information
    1. What Avasart Plus contains
    2. What Avasart Plus looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Manufacturer
    5. Date of last revision of the leaflet: March 2023
    6. Other sources of information

Leaflet attached to the packaging: patient information

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 the 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, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Avasart Plus and what is it used for
• 2. Important information before taking 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 is Avasart Plus and what is it used for

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

• Amlodipine belongs to a group of medicines called calcium antagonists. It prevents the influx of calcium ions into the walls of blood vessels, which inhibits the constriction of blood vessels.
• 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 constrict, thereby increasing blood pressure. Valsartan blocks the action of angiotensin II.

Both active substances inhibit the constriction of blood vessels. As a result, blood vessels dilate, and blood pressure decreases. Avasart Plus is used to treat high blood pressure in adults who are not adequately controlled by amlodipine or valsartan alone.

2. Important information before taking Avasart Plus

When not to take Avasart Plus

If any of the above conditions apply to you, do not take Avasart Plus and consult your doctor.

Warnings and precautions

Before taking Avasart Plus, discuss with your doctor if:

• you have gastrointestinal disorders (vomiting or diarrhea).
• you have liver or kidney problems.
• you have had a kidney transplant or have been diagnosed with renal artery stenosis.
• you have been diagnosed with primary hyperaldosteronism, a condition where the adrenal glands produce too much aldosterone.
• you have heart failure or have had a heart attack. Your doctor will closely monitor your condition and may adjust your dose. Your doctor may also monitor your kidney function.
• you have been diagnosed with aortic or mitral stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (thickening of the heart muscle).
• you have experienced swelling, especially of the face and throat, after taking other medicines (including ACE inhibitors). If you experience such symptoms, stop taking Avasart Plus and consult your doctor immediately. Do not take Avasart Plus again.
• you are taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease;
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See also section "When not to take Avasart Plus".

If any of the above conditions apply 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 about all medicines you are taking, have recently taken, or might take. Your doctor may need to adjust your dose and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for certain medicines, such as:

• ACE inhibitors or aliskiren (see also sections "When not to 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, potassium-containing salt substitutes, and other substances that increase potassium levels in the blood;
• certain pain relievers, such as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors - your doctor may recommend monitoring kidney function;
• antiepileptic drugs (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• glyceryl trinitrate and 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 (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (medicines used to treat heart conditions);
• simvastatin (a medicine used to lower cholesterol levels);
• dantrolene (a medicine used to treat severe body temperature disorders);
• medicines used to prevent organ rejection (cyclosporine).

Avasart Plus with food and drink

Do not eat grapefruits or drink grapefruit juice while taking Avasart Plus, as they may increase the levels of one of the active substances - amlodipine - in your blood. This may lead to unpredictable and increased blood pressure-lowering effects of Avasart Plus.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. 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. Do not take Avasart Plus during the first 3 months of pregnancy, and do not take it after the 3rd month of pregnancy, as it may seriously harm your baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Avasart Plus while breastfeeding - your doctor may prescribe a different medicine if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.
Amlodipine passes into breast milk in small amounts.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

This medicine may cause dizziness, which may affect your ability to concentrate. Do not drive, operate machinery, or perform tasks that require 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 film-coated tablet, which is essentially sodium-free.

3. How to take Avasart Plus

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
This will help you get the best results from your treatment and reduce the risk of side effects.
The usual dose of Avasart Plus is one tablet per day.

• It is recommended to take the medicine at the same time every day.
• Swallow the tablets 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 your response 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 exercise caution when increasing the dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Taking more than the recommended dose of Avasart Plus

If you have taken too many Avasart Plus tablets or if someone else has taken your tablets, contact your doctor immediately.

Missing a dose of Avasart Plus

If you forget to take a dose, take it as soon as you remember. Then take the next tablet 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.

Stopping treatment with Avasart Plus

Stopping treatment with Avasart Plus may worsen your condition. Do not stop taking your medicine without consulting your doctor.

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 may require immediate medical attention.

Such serious side effects have been reported in a small number of patients (rare - may affect up to 1 in 1,000 people).

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

• allergic reaction with symptoms such as rash, itching, swelling of the face, lips, or tongue, 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;
• flushing and feeling of warmth in the face and neck.

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

• central nervous system dizziness;
• nausea and abdominal pain;
• dry mouth;
• drowsiness, tingling, or numbness of the hands or feet;
• vertigo (dizziness of labyrinthine origin);
• rapid heartbeat, including palpitations;
• orthostatic hypotension (dizziness when standing up);
• cough;
• diarrhea;
• constipation;
• skin rash, flushing;
• joint swelling, back pain;
• joint pain.

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

• anxiety;
• ringing in the ears (tinnitus);
• fainting;
• excessive urination or sudden urge to urinate;
• impotence;
• feeling of heaviness;
• low blood pressure with symptoms such as dizziness, fainting;
• excessive sweating;
• skin rash all over the body;
• itching;
• muscle cramps.

If the intensity of any of the above symptoms is severe, consult 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 very rare but serious side effects, contact your doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing severe difficulty breathing;
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, or other allergic reactions;
• heart attack, abnormal heart rhythm;
• pancreatitis, which may cause severe abdominal pain radiating to the back and very severe general feeling of being unwell.

The following side effects have been reported. If any of them are troublesome or persist for more than a week, consult your doctor.
Common (may affect up to 1 in 10 people):
central nervous system dizziness, drowsiness, palpitations (feeling of heartbeat), sudden reddening, especially of 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 sensation, vision disturbances, impaired vision, ringing in the ears, low blood pressure, sneezing/runny nose due to nasal inflammation (rhinitis), indigestion, vomiting, hair loss, excessive sweating, itching, skin discoloration, urinary disturbances, increased need to urinate at night, frequent urination, impotence, breast discomfort or enlargement 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 white blood cell count, reduced platelet count, which may lead to unusual bruising or bleeding, increased blood sugar levels (hyperglycemia), gum swelling, abdominal bloating (gastritis), liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in some diagnostic tests, increased muscle tension, blood vessel inflammation, often with skin rash, hypersensitivity to light, disorders including stiffness, tremors, and/or difficulty moving.
Valsartan
Frequency not known (cannot be estimated from the available data):
reduced red blood cell count, fever, sore throat or mouth ulcers due to infection, spontaneous bleeding or bruising, high potassium levels in the blood, abnormal liver function test results, worsening of kidney function and severe kidney function disorders, swelling, mainly of the face and throat, muscle pain, rash, purple spots, fever, itching, allergic reaction, blistering of the skin (a condition called bullous pemphigoid).
If you experience any of these symptoms, contact your doctor immediately.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49-21-301, fax: 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 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. This 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" on one side and "LD" on the other.
Avasart Plus, 5 mg + 160 mg (13.5 mm x 7 mm), are oval, biconvex, yellow film-coated tablets with "2" on one side and "LD" on the other.
Avasart Plus, 10 mg + 160 mg (13.5 mm x 7 mm), are oval, biconvex, white film-coated tablets with "3" on one side and "LD" on the other.
Avasart Plus is available in packs containing 28, 30, 56, 60, 90, 98, or 280 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]

Manufacturer

Balkanpharma Dupnitza AD
3 Samokovsko Shosse Str.
Dupnitza 2600,
Bulgaria

Date of last revision of the leaflet: March 2023

Other sources of information

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