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PREDUCTAL MR
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- Stock: Zabrana online prodaje
- Brand: SERVIER
- Model: BR-1675645641
Preductal MR 35 mg was a modified-release tablet containing 35 mg of trimetazidine dihydrochloride. It was used in adults as add-on symptomatic treatment for stable angina when first-line antianginal treatment did not provide adequate control or was not tolerated.
The Serbian Medicines and Medical Devices Agency issued a decision terminating the marketing authorisation for Preductal MR 35 mg, pack of 60 tablets, on 9 July 2024.
The currently authorised presentation in Serbia is Preductal 80 mg, 30 prolonged-release hard capsules. Patients must not switch between the 35 mg tablets and 80 mg capsules without a doctor's instructions.
Preductal MR 35 mg – former use and safety information
What was Preductal MR used for?
It was authorised as add-on symptomatic treatment for stable angina in adults whose condition was inadequately controlled by first-line antianginal treatment or who could not tolerate that treatment.
Trimetazidine supports energy metabolism in heart-muscle cells during reduced oxygen supply. It does not remove coronary narrowing and does not replace other cardiovascular medicines.
Preductal MR was not intended for immediate relief of sudden chest pain, initial treatment of unstable angina or treatment of myocardial infarction.
New, severe or persistent chest pain, breathing difficulty, cold sweating, nausea, weakness or pain spreading to the arm, back, neck or jaw requires urgent medical assessment.
Former approved dosage
- Adults with normal kidney function: one 35 mg tablet in the morning and one in the evening during meals.
- Moderate kidney impairment: usually one 35 mg tablet in the morning with breakfast.
- Patients over 75 years: individual adjustment according to kidney function and tolerability.
The response to treatment was to be reassessed after three months. A missed dose was not replaced with a double dose.
Preductal MR 35 mg and current Preductal 80 mg are not identical
| Feature | Preductal MR | Current Preductal |
|---|---|---|
| Strength | 35 mg | 80 mg |
| Form | Modified-release tablet | Prolonged-release hard capsule |
| Usual schedule | Twice daily | Once daily in the morning |
A doctor must determine any switch to another trimetazidine product. Patients must not calculate an equivalent number of tablets or capsules themselves.
When was it contraindicated?
- allergy to trimetazidine or an excipient;
- Parkinson's disease;
- parkinsonian symptoms, tremor, restless legs syndrome or another movement disorder;
- severe kidney impairment with creatinine clearance below 30 mL/min;
- patients under 18 years of age.
Movement disorders and falls
Trimetazidine may cause or worsen tremor, muscle stiffness, slowed movement, restless legs syndrome and an unstable gait. These symptoms require medical review and may require treatment to be stopped.
Dizziness, postural hypotension and impaired balance may increase the risk of falls, particularly in older patients.
Pregnancy, breastfeeding and driving
Use was not recommended during pregnancy or breastfeeding. Dizziness and drowsiness may impair driving and the operation of machinery.
Possible side effects
Common effects included dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, rash, itching, hives and weakness.
Palpitations, extra heartbeats, postural hypotension, fainting, falls, movement disorders, sleep disturbance, constipation, angioedema, severe skin reactions, blood-cell abnormalities and liver disorders were also reported.
- new, severe or persistent chest pain;
- breathing difficulty, cold sweating or sudden weakness;
- swelling of the face, lips, tongue or throat;
- a blistering or peeling rash;
- new tremor, stiffness, slowed movement or unstable walking;
- fainting or a markedly irregular heartbeat;
- yellow skin or eyes, dark urine or very pale stools;
- fever, repeated infections, bruising or unusual bleeding.
Former composition and pack
- Active ingredient: 35 mg trimetazidine dihydrochloride per tablet.
- Form: modified-release tablet.
- Appearance: round, biconvex, pink film-coated tablet.
- Pack: 60 tablets in two blisters of 30.
- Former authorisation holder: Servier d.o.o., Belgrade.
- ATC code: C01EB15.
- Former JKL: 1109120.
- Former supply status: prescription only.
The authorisation for Preductal MR 35 mg ceased to be valid on 9 July 2024. The product should not be displayed as currently available and no current price should be shown.
The currently authorised Serbian presentation is Preductal 80 mg, 30 prolonged-release capsules. Any treatment change must be made by an internist or cardiologist.
A patient holding an older prescription or medical report for Preductal MR 35 mg should not independently purchase another trimetazidine product or switch to the 80 mg capsules. The prescriber must confirm the current product, strength, form and dosing schedule.
Trimetazidine is not a rescue medicine for sudden chest pain. Coenzyme Q10 and omega supplements are not substitutes for prescribed antianginal treatment.
Ljubica Barbulović, Master of Pharmacy
Related category
Explore: Ischemic heart disease and angina pectoris.
Important: dietary supplements do not replace Preductal, trimetazidine or other medicines prescribed for coronary disease.
Is Preductal MR 35 mg still authorised in Serbia?
No. Its marketing authorisation ceased to be valid on 9 July 2024.
Which Preductal presentation is currently authorised?
Preductal 80 mg in a pack of 30 prolonged-release hard capsules.
Can two 35 mg tablets be replaced with one 80 mg capsule?
Not without medical instructions. The strength, formulation and release profile are different.
Does trimetazidine stop an acute angina attack?
No. It is not a rescue medicine for sudden chest pain.
Can it be used in Parkinson's disease?
No. Parkinson's disease and other movement disorders are contraindications.
Sources: former Preductal MR 35 mg patient leaflet; ALIMS decision terminating the authorisation; current Preductal 80 mg patient leaflet.
Former Preductal MR leaflet |
Authorisation-termination decision |
Current Preductal 80 mg leaflet
Sources checked: 3 August 2026.
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