Prectazidine MR 35 mg. 60 tablets

WHAT PRECTAZIDIN MR IS AND WHAT IT IS USED FOR
Prodottide MR is intended for use in adults, in combination with other medicines to treat stable angina pectoris (chest pain caused by coronary artery disease).

2. BEFORE YOU TAKE PREKTAZIDINE MR
Do not take Prectazidine MR:

if you are hypersensitive to trimetazidine or any of the other ingredients of the product (listed in section 6);
if you have Parkinson's disease: brain disease that affects the movements (trembling, stiff posture, slowing movements and tugging, unbalanced gait);
if you have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prestazid MR.
This medicine is not intended for the management of angina pectoris attacks as well as for the treatment of unstable angina or myocardial infarction.
Tell your doctor in case of an angina attack. Additional research and treatment alterations may be necessary.
This medicine can cause or aggravate symptoms such as trembling, stiff posture, slowing movements, and tingling, unbalanced gait, especially in the elderly, which should be investigated and reported to your doctor who may reassess treatment.

Children and adolescents
Predctazidine MR is not recommended for children under 18 years of age.

Using other medicines
No adverse interactions of trimetazidine with other medicinal products and foods are known.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Use of Prectazidine MR with food and drink
The tablets are taken with a glass of water during meals.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, if you think you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Due to insufficient clinical experience with the safety of the product during pregnancy, it is advisable not to use it during this period.

Breastfeeding
Due to the lack of data on emesis with breast milk, treatment during breast-feeding is not recommended.

Driving and using machines
This medicine can cause dizziness and drowsiness, which may affect your ability to drive and use machines.

Important information about some of the ingredients of Prectazidine MR
Not applicable.

3. HOW TO TAKE PREKTAZIDIN MR
Always take your prescription exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Prectazidine MR is one tablet in the morning and evening with a glass of water during meals.
If you have kidney problems or are over 75 years old, your doctor may adjust the recommended dose.

If you take more than the required dose of Prectazidine MR
Talk to your doctor or pharmacist immediately.

If you forget to take Prectazidine MR
Continue treatment as usual. Do not take a double dose to make up for the missed tablet.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, it can cause side effects, although not everybody gets them.

The frequency of adverse reactions by frequency is as follows:

Very common: more than 1 in 10 patients treated;
Common: less than 1 in 10 but more than 1 in 100 treated patients;
Uncommon: Less than 1 in 100 but more than 1 in 1,000 treated patients
Rare: less than 1 per 1000 but more than 1 per 10000 treated patients;
Very rare: less than 1 per 10000 treated patients incl. individual cases;
Frequency not known - frequency can not be calculated from available data;
Other side effects - Other side effects have occurred in very few people, but their exact frequency is unknown.
Common:

Dizziness, headache, abdominal pain, diarrhea, indigestion, nausea, nausea, vomiting, rash, pruritus, hives and a feeling of weakness.
Rare:

Accelerated or irregular heartbeat (called palpitations), abnormal heartbeats, accelerated heart rhythm, drop in blood pressure when standing up, causing dizziness, mild stun or fainting, fainting, dizziness, falling, reddening of the face.
Not known:

Extrapyramidal symptoms (abnormal movements, including shaking and twisting of the hands and fingers, twisting movements of the body, instability of the gait and general stiffness of the arms and legs), which are usually reversible after discontinuation of treatment;
Sleep disorder (insomnia, somnolence), constipation, severe generalized redness of the skin with blistering, swelling of the face, lips, mouth, tongue or throat, which may cause swallowing and breathing difficulties;
A marked decrease in the number of white blood cells, which makes the occurrence of infections more likely,
HOW TO STORE PREKTAZIDIN MR
Store in the original package in a dry and protected area from direct sunlight at temperatures below 25 ° C. Keep out of the reach and sight of children.
Do not use Prodactin MR after the expiry date stated on the outer carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
What Prestazidine MR contains
The active substance is trimetazidine dihydrochloride.
The other ingredients are: sodium chloride, povidone, magnesium stearate, hypromellose, cellulose acetate.

What it looks like and what the package contains
White to off-white, round, biconvex, film-coated tablets, smooth on both sides.
10 tablets in PVC blister / aluminum foil.
6 blisters, together with the instruction manual, in a single cardboard box.

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