MOLIPAXIN Capsule (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Molipaxin 50 mg Capsules/Trazodone hydrochloride 50 mg Capsules.
2. Qualitative and quantitative composition
Trazodone hydrochloride 50 mg per capsule. <u>Excipients with known effect:</u> Each tablet contains 78.3 mg lactose. For a full list of excipients, see 6.1.
3. Pharmaceutical form
Capsules.
4.1. Therapeutic indications
Anxiety, depression, mixed anxiety and depression.
4.2. Posology and method of administration
Route of administration: Oral. DEPRESSION Adults Initially 150 mg/day in divided doses after food or as a single dose on retiring. This may be increased up to 300 mg/day in a single or divided doses. The ...
4.3. Contraindications
Known sensitivity to trazodone or to any of the excipients. Alcohol intoxication and intoxication with hypnotics. Acute myocardial infarction.
4.4. Special warnings and precautions for use
Use in children and adolescents under 18 Molipaxin/Trazodone should not be used in children and adolescents under 18 years old. Suicidal behaviour (suicidal attempt and suicidal planning) and hostility ...
4.5. Interaction with other medicinal products and other forms of interaction
General: The sedative effects of antipsychotics, hypnotics, sedatives, anxiolytics, and antihistaminic drugs may be intensified; dosage reduction is recommended in such instances. The metabolism of antidepressants ...
4.6. Pregnancy and lactation
Pregnancy Trazadone should only be administered during pregnancy if considered essential by the physician. Data on a limited number (<200) of exposed pregnancies indicate no adverse effects of Molipaxin/Trazodone ...
4.7. Effects on ability to drive and use machines
Molipaxin/Trazodone has minor or moderate influence on the ability to drive and use machines. As with all other drugs acting on the central nervous system, patients should be cautioned against the risks ...
4.8. Undesirable effects
Cases of suicidal ideation and suicidal behaviours have been reported during Molipaxin/Trazodone therapy or early after treatment discontinuation (see section 4.4). Molipaxin/Trazodone has had no effect ...
4.9. Overdose
Features of toxicity The most frequently reported reactions to overdose have included drowsiness, dizziness, nausea and vomiting. In more serious cases coma, tachycardia, hypotension, hyponatraemia, convulsions ...
5.1. Pharmacodynamic properties
<b>ATC code:</b> N06AX05. Other antidepressants. Molipaxin/Trazodone is a potent antidepressant. It also has anxiety reducing activity. Molipaxin/Trazodone is a triazolopyridine derivative chemically unrelated ...
5.2. Pharmacokinetic properties
Trazodone is rapidly absorbed from the gastro-intestinal tract and extensively metabolised. Paths of metabolism of trazodone include n-oxidation and hydroxylation. The metabolic m-chlorophenylpiperazine ...
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Lactose Magnesium stearate Gelatin Titanium dioxide E171 Erythrosine E127 Indigo carmine E132 Yellow iron oxide E172 Ink (black iron oxide E172, shellac, propylene glycol and ammonium hydroxide (pH adjustment) ...
6.2. Incompatibilities
None stated.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
<u>Blister packs:</u> Store below 30°C in a dry place. <u>Glass bottles and securitainers:</u> Store below 30°C.
6.5. Nature and contents of container
Amber glass bottles with jay-cap closures: contents 100 capsules. PVdC coated 250μm PVC blisters sealed with 20μm aluminium foil: contents 84 and 100 capsules. Securitainers: contents 1000 capsules. ...
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Trading as: Zentiva, 12 New Fetter Lane, London EC4A 1JP, United Kingdom
8. Marketing authorization number(s)
PL 17780/0617
9. Date of first authorization / renewal of the authorization
13/05/1999
10. Date of revision of the text
04/03/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
