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
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 personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Avasart Plus is and what it is used for
What you need to know before taking Avasart Plus
How to take Avasart Plus
Possible side effects
How to store Avasart Plus
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 control high blood pressure.

Amlodipine belongs to a group of medicines called calcium channel blockers. It works by preventing calcium ions from entering the walls of blood vessels, thereby reducing blood vessel constriction.
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, thus increasing blood pressure. Valsartan blocks the action of angiotensin II.

Both active substances help reduce blood vessel constriction. As a result, blood vessels widen and blood pressure decreases.
Avasart Plus is used to treat high blood pressure in adults whose blood pressure is not adequately controlled by amlodipine or valsartan alone.

2. Important information before using Avasart Plus

When not to use Avasart Plus

if the patient is allergic to amlodipine or to any medicine in the group of calcium antagonists. Symptoms of allergy include itching, redness of the skin or difficulty breathing.
if the patient is allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6). If in doubt whether the patient is allergic, consult a doctor before using Avasart Plus.
if the patient has severe liver or biliary tract disorders, such as biliary cirrhosis or cholestasis.
if the patient is more than 3 months pregnant (during early pregnancy it is also better not to take Avasart Plus – see section "Pregnancy and breastfeeding").
if the patient has very low blood pressure (hypotension).
if the patient has aortic valve stenosis (narrowing of the aortic valve) or is in cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body's cells).
if the patient has heart failure due to myocardial infarction.
if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, do not take Avasart Plus and contact a doctor.
Warnings and precautions
Before starting to take Avasart Plus, discuss with your doctor if:

the patient has gastrointestinal disorders (vomiting or diarrhoea).
the patient has liver or kidney problems.
the patient has had a kidney transplant or has renal artery stenosis.
the patient has been diagnosed with an adrenal gland disorder called primary hyperaldosteronism.
the patient has heart failure or has had a myocardial infarction. Strictly follow the doctor's recommendations regarding the initial dose. The doctor may also monitor the patient's kidney function.
the patient has been diagnosed with heart valve stenosis (aortic or mitral stenosis) or abnormal thickening of the heart muscle (hypertrophic obstructive cardiomyopathy).
the patient has experienced swelling, especially of the face and throat, after taking other medicines (including angiotensin-converting enzyme inhibitors). If such symptoms occur, stop taking Avasart Plus immediately and contact a doctor. Avasart Plus must never be used again.
the patient is taking any of the following medicines for high blood pressure:
ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disease due to diabetes;
aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium).
See also section "When not to use Avasart Plus".
If any of the above conditions apply, inform the doctor before taking Avasart Plus.
Children and adolescents
Avasart Plus is not recommended for use in children and adolescents (under 18 years of age).
Avasart Plus and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken or planned to be taken. The doctor may recommend adjusting the dose and/or taking other precautions. In some cases, it may be necessary to discontinue one of the medicines. This particularly applies to:

ACE inhibitors or aliskiren (see also sections "When not to use Avasart Plus" and "Warnings and precautions");
diuretics (also called water tablets, 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 blood potassium levels;
certain painkillers, so-called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) – the doctor may recommend monitoring kidney function;
antiepileptic medicines (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
St John's wort (Hypericum perforatum);
glyceryl trinitrate and other nitrates or other vasodilating substances;
medicines used to treat HIV/AIDS infection (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 in heart conditions);
simvastatin (a medicine used when cholesterol levels are high);
dantrolene (a medicine given by infusion in cases of significant body temperature disorders);
medicines used to prevent rejection of transplanted organs (cyclosporine).

Avasart Plus with food and drink
While taking Avasart Plus, do not eat grapefruit or drink grapefruit juice, as they may increase blood levels of one of the active substances – amlodipine. This could lead to an unpredictable intensification of the blood pressure-lowering effect of Avasart Plus.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant or are planning a pregnancy. Your doctor will usually recommend stopping Avasart Plus before planning a pregnancy or immediately after confirming pregnancy and will recommend an alternative medicine. Avasart Plus is not recommended during early pregnancy (first 3 months) and must not be taken after the 3rd month of pregnancy, as use during this period may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Avasart Plus is not recommended during breastfeeding – your doctor may recommend an alternative medicine, especially if breastfeeding a newborn or premature infant.
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 impair the ability to concentrate. Do not drive, operate machinery or perform tasks requiring concentration until you know how Avasart Plus affects you individually.
Avasart Plus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".
3. How to use Avasart Plus
Always use this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor.
This will help achieve the best treatment results and reduce the risk of adverse effects.
The usual dose of Avasart Plus is 1 tablet per day.

It is recommended to take the medicine at the same time each day.
Tablets should be swallowed 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 the patient's response to treatment, the doctor may recommend a higher or lower dose.
Do not take a higher dose than recommended.
Avasart Plus in elderly patients (65 years of age or older)
The doctor will exercise caution when increasing the dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Taking more Avasart Plus than recommended
If too many tablets of Avasart Plus have been taken or if someone else has taken the tablets, contact a doctor immediately.
Missing a dose of Avasart Plus
If a dose is missed, take it as soon as remembered. Then take the next tablet at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.
Stopping Avasart Plus
Stopping Avasart Plus may worsen the condition. Do not stop taking the medicine without medical advice.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention.
Such severe adverse reactions have occurred in a small number of patients (rarely – may occur in less than 1 in 1,000 people).
If any of the following symptoms occur, seek medical advice 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 adverse reactions of Avasart Plus
Common (may occur in less than 1 in 10 people):

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

Uncommon (may occur in less than 1 in 100 people):

central dizziness;
nausea and abdominal pain;
dryness of the oral mucosa;
drowsiness, tingling or numbness in hands or feet;
sensation of spinning (vestibular dizziness);
increased heart rate, including palpitations;
dizziness upon standing;
cough;
diarrhoea;
constipation;
skin rash, skin redness;
joint swelling, back pain;
joint pain.

Rare (may occur in less than 1 in 1,000 people):

feeling of anxiety;
ringing in the ears (tinnitus);
fainting;
passing larger than usual amounts of urine or sudden urge to urinate;
inability to achieve or maintain erection;
feeling of heaviness;
low blood pressure with symptoms such as dizziness, lightheadedness;
excessive sweating;
skin rash all over the body;
itching;
muscle cramps.

If any of the above symptoms become severe, consult a doctor.
Adverse reactions reported after use of amlodipine alone or valsartan alone, which have not been observed after use of Avasart Plus or which occurred more frequently with amlodipine or valsartan alone than with Avasart Plus.
Amlodipine
If any of the following very rare, serious adverse reactions occur after taking the medicine, consult a doctor immediately:

sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing;
swelling of eyelids, face or lips;
swelling of the tongue and throat causing significant breathing difficulties;
severe skin reactions, including intense rash, urticaria, redness of the entire body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
myocardial infarction, abnormal heart function;
pancreatitis, which may cause severe abdominal pain radiating to the back, accompanied by general malaise.

The following adverse reactions have been reported. If any of them are troublesome for the patient or persist for more than one week, contact a doctor.
Common (may occur in less than 1 in 10 people):
central dizziness, drowsiness, palpitations (awareness of heartbeat), sudden flushing, especially of the face, ankle swelling (edema), abdominal pain, nausea.
Uncommon (may occur in less than 1 in 100 people):
mood changes, anxiety, depression, insomnia, tremor, taste disturbances, fainting, lack of pain sensation, visual disturbances, worsening of vision, tinnitus, low blood pressure, sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis), indigestion, vomiting, hair loss, excessive sweating, skin itching, skin discoloration, urinary problems, increased need to urinate at night, increased frequency of urination, inability to achieve erection, discomfort or enlargement of breasts in men, pain, malaise, muscle pain, muscle cramps, increased or decreased body weight.
Rare (may occur in less than 1 in 1,000 people):
confusion.
Very rare (may occur in less than 1 in 10,000 people):
decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising or easy bleeding, increased blood glucose levels (hyperglycaemia), gum swelling, abdominal bloating (gastritis), liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in certain diagnostic tests, increased muscle tone, vasculitis, often with skin rash, photosensitivity, movement disorders involving stiffness, tremor and (or) difficulty moving.
Valsartan
Frequency unknown (cannot be estimated from available data):
decreased number of red blood cells, 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-red spots, fever, itching, allergic reaction, blistering of the skin (symptom of a disease called bullous pemphigoid).
If any of the above symptoms occur, contact a doctor immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Avasart Plus

Do not store above 30°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after
"EXP:". The expiry date refers to the last day of the stated 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 (in the form of amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.
The active substances are amlodipine (in the form of amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.
The active substances are amlodipine (in the form of amlodipine besylate) and valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.
Other ingredients: microcrystalline cellulose, povidone, sodium croscarmellose, talc, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E 171), [tablets 5 mg + 80 mg and 5 mg + 160 mg]: 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), round, biconvex, yellow film-coated tablets
with the marking “I” on one side and “LD” on the other side.
Avasart Plus, 5 mg + 160 mg (13.5 mm x 7 mm), oval, biconvex, yellow film-coated tablets
with the marking “2” on one side and “LD” on the other side.
Avasart Plus, 10 mg + 160 mg (13.5 mm x 7 mm), oval, biconvex, white film-coated tablets
with the marking “3” on one side and “LD” on the other side.
Avasart Plus is available in packs containing: 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: [email protected]
Manufacturer
Balkanpharma Dupnitza AD
3 Samokovsko Shosse Str.
Dupnitza 2600,
Bulgaria
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website
http://www.ema.europa.eu