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Amlovask 10 mg. 30 tablets

Product Code: Amlovask 10 mg. 30 tablets
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1. What Amlovasc is and what it is used for
Amlovasc contains the active substance amlodipine and belongs to the group of so-called calcium antagonists.

Amlovasc is used to treat high blood pressure (hypertension) or to treat chest pain, so-called angina pectoris, as well as a rare form of angina pectoris (Prinzmetal's angina).

In patients with high blood pressure, this medicine works by widening the blood vessels so that blood can pass through them more easily. In patients with angina pectoris, Amlovasc improves the blood supply to the heart muscle, supplying it with more oxygen and thus preventing chest pain. The medicine does not have an immediate effect on chest pain.

2. What you need to know before you take Amlovasc
Do not take Amlovasc:
if you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to other calcium antagonists. Allergy may manifest as itching, redness of the skin or shortness of breath;
if you have severely low blood pressure (hypotension);
if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body);
if you suffer from heart failure after a heart attack.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amlovasc if you have or have had any of the following conditions:

you have recently had a heart attack;
you suffer from heart failure (a heart disease that can cause fatigue, shortness of breath, swelling of the ankles, etc.);
severely high blood pressure (hypertensive crisis);
liver disease;
if you are elderly and your dose needs to be increased.
Children and adolescents
Amlodipine has not been studied in children under 6 years of age. Amlodipine is only used in children and adolescents with high blood pressure aged 6 to 17 years (see section 3).

Ask your doctor for more information.

Other medicines and Amlovasc
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Amlodipine may affect or be affected by other medicines, such as:

ketoconazole, itraconazole (antifungal medicines);

ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV-positive patients);

rifampicin, erythromycin, clarithromycin (antibiotics);

St. John's wort (Hypericum perforatum);

verapamil, diltiazem (heart medicines);

dantrolene (if given in infusion for severe body temperature disorders);
simvastatin (to lower cholesterol);
tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to change the way your immune system works);
ciclosporin (a medicine that suppresses the immune system).
Amlodipine can lower your blood pressure more if used at the same time as other medicines to treat high blood pressure.

Amlovasc with food and drink and alcohol
Patients being treated with Amlovasc should not consume grapefruit and grapefruit juice, which can increase the levels of the active substance amlodipine in the blood and thus Amlovasc can unpredictably lower your blood pressure.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The safety of amlodipine during pregnancy has not been established. If you think you are pregnant or are planning to have a baby, tell your doctor before taking Amlovasc.

Breast-feeding
Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding, tell your doctor before taking Amlovasc.

Driving and using machines
Amlodipine may affect your ability to drive and use machines. If you feel sick, dizzy or tired after taking the tablets, or have a headache, do not drive or use machines and contact your doctor immediately.

Amlovasc contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially sodium-free.

3. How to take Amlovasc
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The usual starting dose of Amlovasc is 5 mg once a day. The dose of Amlovasc may be increased to 10 mg once a day.

The medicine can be taken before and after food and drink. You should take the medicine at the same time of day with a glass of water. Amlovasc should not be taken with grapefruit juice.

The tablet can be divided into equal doses.

Use in children and adolescents
Children with high blood pressure aged 6 to 17 years
dini:

The recommended starting dose for children and adolescents aged 6 to 17 years is 2.5 mg once a day. The maximum recommended daily dose is 5 mg.

It is important to continue taking the tablets. Do not let the tablets run out before your next consultation with your doctor.

If you take more Amlovasc than you should
When taking a large number of amlodipine tablets, blood pressure values ​​can fall significantly and become dangerously low. You may feel dizzy, light-headed, tired or weak. If your blood pressure drops suddenly and significantly, shock may occur. Your skin may become cold and clammy and you may lose consciousness. Increased fluid may accumulate in the lungs (pulmonary oedema), causing shortness of breath, which may develop within 24-48 hours after taking it. If you have taken more tablets, seek medical help immediately.

If you forget to take Amlovasc
Don't worry. If you forget to take a tablet, take the usual dose at the next regular time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amlovasc
Your doctor will advise you how long to take the medicine. Your condition may get worse again if you stop using the medicine before your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects after taking the medicine, see 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, which may make breathing very difficult;

Severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and swelling 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, accompanied by severe pain in the abdomen and back and feeling very unwell.
The following very serious side effects have been reported. If any of these cause you problems or if they last for more than a week, you should contact your doctor.

Very common side effects (may affect more than 1 in 10 people):
Swelling (fluid retention).
The following common side effects have been reported. If any of these cause you problems or last for more than a week, you should contact your doctor.

Common (may affect up to 1 in 10 people)
Headache, dizziness, drowsiness (especially at the beginning of treatment);
Pain in the heart (increased feeling of the heartbeat), flushing;
Stomach pain, nausea;
Swelling of the ankles;
Change in the usual bowel movements, diarrhoea, constipation, indigestion;
Tiredness, weakness;
Visual disturbances, double vision;
Muscle cramps.
Other side effects that have been reported are listed below. If any of the side effects get serious or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Uncommon (may affect up to 1 in 100 people)
Mood changes, anxiety, depression, insomnia;
Tremor, taste disturbance and change, nausea;
Numbness or tingling in the limbs, loss of pain sensation;
Tinnitus;
Low blood pressure;
Sneezing/runny nose, due to inflammation of the nasal mucosa (rhinitis);
Cough
Dry mouth, vomiting (nausea);
Hair loss, increased sweating, itchy skin, redness of the skin, skin discoloration;
Urinary disorders, nighttime urination, frequent urination;
Inability to achieve an erection, discomfort or enlargement of the breasts in men;
Pain, malaise;
Joint or muscle pain, back pain;
Weight gain or loss.
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, which increases the risk of infections; reduced platelet count, which increases the risk of bleeding or bruising;
Increased blood sugar levels (hyperglycaemia);
Impaired peripheral nerve function, which leads to muscle weakness, numbness or tingling;
Enlarged gums, bleeding gums;
Inflammation of the stomach lining and bloating (gastritis);
Impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which may affect some medical tests;
Increased muscle tone;
Inflammation of the blood vessels, often accompanied by a skin rash;
Photosensitivity;
Combined disorders of rigidity, tremor and/or movement disorders.
Not known (frequency cannot be estimated from the available data)
Trembling, rigid posture, expressionless mask-like face (mask-like face), slow movements and shuffling and unbalanced gait

5. How to store Amlovasc
Store below 25°C.
Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not use it if you notice any change in the appearance of the tablets.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Amlovasc contains
The active substance is amlodipine besylate. Each tablet contains amlodipine besylate equivalent to 5 mg or 10 mg amlodipine.
The other ingredients are: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; sodium starch glycolate; magnesium stearate.
What Amlovasc looks like and contents of the pack
Description

Amlovasc 5 mg - white, round, flat tablets, 8 mm in diameter, with a score on one side and AB 5 marking on the other.
Amlovasc 10 mg - white, round, flat tablets, 10 mm in diameter, with a score on one side and AB 10 marking on the other.
The tablet can be divided into two equal doses.

Packaging types

10 tablets in a PVC/PVDC/aluminium foil blister. 3 blisters in a box.
14 tablets in a PVC/PVDC/aluminium foil blister. 2 blisters in a box.
28 ​​and 30 tablets in a polyethylene bank. 1 bank in a cardboard box.

 

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