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trivastal retard 50 |
Les Laboratoires Servier - SEn VIER trivastal® retard 50 • Read all of this leaflet carefully before you start taking this medicine. It contains important information on your treatment.
• If you have any further questions, ask your doctor or pharmacist
• Keep this leaflet. You may need to read it again.
• If the symptoms worsen or persist, consult your doctor. Composition: Each tablet contains: 50 mg of Piribedil.
Excipients : q.s.f. one tablet. Presentation: - Box containing one blister of 10 sustained release coated tablets. — - Box containing two blisters of 10 sustained release coated tablets each. - Box containing three bleters of 10 sustained release coated tablets each. Pharmacotherapeutic class: DOPAMINERGIC AGONISTS Therapeutic indications: This medicine is indicated in:
• the treatment of age-related minor neurological disoiders,
• adjunctive treatment of lowec limb arteritis (disease of the leg arteries that causes painful cramps on walking),
• visual disorders of circulatory origin,
• certain forms of Parlcinsons dlaease-. Contraindications: This medicine should not be used lIt the following cases:
• history of allergy to piribedil,
• myocardial infarction or other serious cardiovascular disease,
• combined with: - antiemetic neuroleptics (see Interactions with other drugs and other forms of interactions). - antipsychotic neuroleptics (except dozapine) in nonparkinsonian patients (see Interactions with other drugs and other forms of interactions). IF IN DOUBT, IT IS ESSENTIAL THAT YOU ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Special warnings: You must consult your doctor in case of excessive drowsiness or sudden sleeping fits during your TRIVASTAL treatment
Cases of cravings andlor impulsive behaviour (compulsive attraction to gambling or increase in sexual drive) have been reported in patients suffering from Parkinson’s disease treated with TRIVASTAL. These cases occurred mainly in patients treated with high doses and were generally reversible after decreasing the doses or stopping the treatment.
This medicine should not be used in case of fructose intolerance, glucose and galactose malabsorplion syndrome or sucrase-isomaltase deficiency (rare metabolic diseases), due to the presence of sucrose. Precautions for use: It is preferable to take the tablets at the end of a meal. IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR
PHARMACIST FOR ADVICE. Interactions with other drugs and other fom,s of interactions: This medicine must not be used combined with certain medicines (see Contraindications).
• If you have any further questions, ask your doctor or pharmacist
• Keep this leaflet. You may need to read it again.
• If the symptoms worsen or persist, consult your doctor. Composition: Each tablet contains: 50 mg of Piribedil.
Excipients : q.s.f. one tablet. Presentation: - Box containing one blister of 10 sustained release coated tablets. — - Box containing two blisters of 10 sustained release coated tablets each. - Box containing three bleters of 10 sustained release coated tablets each. Pharmacotherapeutic class: DOPAMINERGIC AGONISTS Therapeutic indications: This medicine is indicated in:
• the treatment of age-related minor neurological disoiders,
• adjunctive treatment of lowec limb arteritis (disease of the leg arteries that causes painful cramps on walking),
• visual disorders of circulatory origin,
• certain forms of Parlcinsons dlaease-. Contraindications: This medicine should not be used lIt the following cases:
• history of allergy to piribedil,
• myocardial infarction or other serious cardiovascular disease,
• combined with: - antiemetic neuroleptics (see Interactions with other drugs and other forms of interactions). - antipsychotic neuroleptics (except dozapine) in nonparkinsonian patients (see Interactions with other drugs and other forms of interactions). IF IN DOUBT, IT IS ESSENTIAL THAT YOU ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Special warnings: You must consult your doctor in case of excessive drowsiness or sudden sleeping fits during your TRIVASTAL treatment
Cases of cravings andlor impulsive behaviour (compulsive attraction to gambling or increase in sexual drive) have been reported in patients suffering from Parkinson’s disease treated with TRIVASTAL. These cases occurred mainly in patients treated with high doses and were generally reversible after decreasing the doses or stopping the treatment.
This medicine should not be used in case of fructose intolerance, glucose and galactose malabsorplion syndrome or sucrase-isomaltase deficiency (rare metabolic diseases), due to the presence of sucrose. Precautions for use: It is preferable to take the tablets at the end of a meal. IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR
PHARMACIST FOR ADVICE. Interactions with other drugs and other fom,s of interactions: This medicine must not be used combined with certain medicines (see Contraindications).
IN ORDER TO AVOID POSSIBLE INTERACTIONS BEtWEEN SEVERAL MEDICINES and in particular neuroleptics (except clozapine) and some medicines used for the prevention of nausea and vomiting, YOU MUST ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER CURRENT TREATMENT. Pregnancy and Breast-feeding: IN GENERAL, YOU SHOULD ALWAYS ASK YOUR DOCTOR OR
PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICINE
DURING PREGNANCY AND BREAST-FEEDING. Drivers and machine operators: TRIVASTAL can induce drowsiness and sudden sleeping fits. In such cases, you must not drive nor perform any activity for which an
impairment in your vigilance could expose you or other persons to a nsk of serious accident or death (for example the use of machinery) until the disappearance of such effects. List of excipients whose knowledge is necessary for risk- free use in some patients: Sucrose, cochineal red A (E124) Dosage and administration: Oral route. The dosage is strictly individual. It is defined by your doctor. ALWAYS USE AS INDICATED IN YOUR DOCTOR’S PRESCRIPTION. THIS MEDICINE WAS PERSONALLY DISPENSED OR PRESCRIBED TO YOU FOR A SPECIFIC SITUATION:
• IT CANNOT BE ADAPTED TO ANOTHER CASE.
• DO NOT RECOMMEND IT TO ANOTHER PERSON. The tablets should be swallowed, without chewing, with half a glass of water atilie eird of the meal.
Do not stop treatment without medical advice. Overdosage: inform your doctor immediately in case of massive absorption. Side effects: liKE ALL MEDICINES, THIS PRODUCT MAY, IN CERTAIN INDIVIDUALS, GIVE RISE TO VARYING DEGREES OF UNPLEASANT EFFECTS: - minor digestive disorders, (nausea, vomiting, flatulence), which may disappear with a decrease in the dose;, - drowsiness, sudden sleep fits; - more rarely: nervousness or agitation that disappear on stopping the treatment; - exceptionally: orthostatic hypotension (decrease in blood pressure in the standing position that could be accompanied by dizziness); - risk of allergic reactions due the presence of Cochineal red A (E124). Cases of pathological gambling (gambling compulsion), hypersexuality and increase in libido have been reported with TRIVASTAL. INFORM YOUR DOCTOR OR PHARMACIST OF ANY UNDESIRABLE AND UNPLEASANTEFFECTNOTMENTIONED IN THIS LEAFLET. Shelf life: —=— - ,--,...--- Do not use after the expiry date marked on the outer packaging. Storage conditions: Store below 300 C in a dry place.
PHARMACIST FOR ADVICE BEFORE TAKING ANY MEDICINE
DURING PREGNANCY AND BREAST-FEEDING. Drivers and machine operators: TRIVASTAL can induce drowsiness and sudden sleeping fits. In such cases, you must not drive nor perform any activity for which an
impairment in your vigilance could expose you or other persons to a nsk of serious accident or death (for example the use of machinery) until the disappearance of such effects. List of excipients whose knowledge is necessary for risk- free use in some patients: Sucrose, cochineal red A (E124) Dosage and administration: Oral route. The dosage is strictly individual. It is defined by your doctor. ALWAYS USE AS INDICATED IN YOUR DOCTOR’S PRESCRIPTION. THIS MEDICINE WAS PERSONALLY DISPENSED OR PRESCRIBED TO YOU FOR A SPECIFIC SITUATION:
• IT CANNOT BE ADAPTED TO ANOTHER CASE.
• DO NOT RECOMMEND IT TO ANOTHER PERSON. The tablets should be swallowed, without chewing, with half a glass of water atilie eird of the meal.
Do not stop treatment without medical advice. Overdosage: inform your doctor immediately in case of massive absorption. Side effects: liKE ALL MEDICINES, THIS PRODUCT MAY, IN CERTAIN INDIVIDUALS, GIVE RISE TO VARYING DEGREES OF UNPLEASANT EFFECTS: - minor digestive disorders, (nausea, vomiting, flatulence), which may disappear with a decrease in the dose;, - drowsiness, sudden sleep fits; - more rarely: nervousness or agitation that disappear on stopping the treatment; - exceptionally: orthostatic hypotension (decrease in blood pressure in the standing position that could be accompanied by dizziness); - risk of allergic reactions due the presence of Cochineal red A (E124). Cases of pathological gambling (gambling compulsion), hypersexuality and increase in libido have been reported with TRIVASTAL. INFORM YOUR DOCTOR OR PHARMACIST OF ANY UNDESIRABLE AND UNPLEASANTEFFECTNOTMENTIONED IN THIS LEAFLET. Shelf life: —=— - ,--,...--- Do not use after the expiry date marked on the outer packaging. Storage conditions: Store below 300 C in a dry place.
Keep all mCdicaments out of the reach and sight of children Manufactured by: SERVIER EGYPT INDUSTRIES LIMITED
6th October City - GUIZA - A.R.E. Under Licence of: Los Laboratoires Servier - France 02—472 F
6th October City - GUIZA - A.R.E. Under Licence of: Los Laboratoires Servier - France 02—472 F
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