ZOLMITRIPTAN Film-coated tablet (2019)
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
Name of the medicinal product
Zolmitriptan 2.5 mg film-coated tablets.
Qualitative and quantitative composition
Each 2.5 mg film-coated tablet contains 2.5 mg zolmitriptan Excipient with know effect: Each 2.5 mg film-coated tablet contains 87.7 mg lactose anhydrous. For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Film-coated tablet. Zolmitriptan 2.5 mg film-coated tablets are light yellow, round, biconvex tablets with ZL 2.5 debossed on one side.
Therapeutic indications
Acute treatment of migraine headache with or without aura.
Posology and method of administration
Posology For doses not realisable/practicable with this strength other strengths of this medicinal product are available. The recommended dose of zolmitriptan to treat a migraine attack is 2.5 mg. It is ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Moderate or severe hypertension, and mild uncontrolled hypertension. This class of compounds (5HT1B/1D receptor ...
Special warnings and precautions for use
Zolmitriptan should only be used where a clear diagnosis of migraine has been established. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, ...
Interaction with other medicinal products and other forms of interaction
Interaction studies were performed with caffeine, ergotamine, dihydroergotamine, paracetamol, metoclopramide, pizotifen, fluoxetine, rifampicin and propranolol and no clinically relevant differences in ...
Fertility, pregnancy and lactation
Pregnancy The safety of this medical product for use in human pregnancy has not been established. Evaluation of experimental animals studies does not indicate direct teratogenic effects. However, some ...
Effects on ability to drive and use machines
In a small group of healthy individuals there was no significant impairment of performance of psychomotor tests with doses up to 20 mg zolmitriptan. Caution is recommended in patients performing skilled ...
Undesirable effects
Possible undesirable effects are typically transient, tend to occur within four hours of dosing, and are no more frequent following repeated dosing and resolve spontaneously without additional treatment. ...
Overdose
Volunteers receiving single oral doses of 50 mg commonly experienced sedation. The elimination half-life of zolmitriptan tablets is 2.5 to 3 hours, (see section 5.2) and therefore monitoring of patients ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective serotonine (5HT1) agonists. ATC code: N02CC03 Mechanism of action Zolmitriptan has been demonstrated to be a selective agonist for 5HT1B/1D receptors mediating vascular ...
Pharmacokinetic properties
Absorption Following oral administration of zolmitriptan conventional tablets, zolmitriptan is rapidly and well absorbed (at least 64%) after oral administration to man. The mean absolute bioavailability ...
Preclinical safety data
Preclinical effects in single and repeat dose toxicity studies were observed only at exposures well in excess of the maximum human exposure. The findings from in vitro and in vivo genetic toxicity studies ...
List of excipients
Tablet core: Lactose, anhydrous Microcrystalline cellulose Sodium starch glycolate (Type A) Magnesium stearate Tablet coating: Hypromellose (E464) Titanium dioxide (E171) Polydextrose Talc Maltodextrin ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminium/aluminium blisters. Pack sizes: 3, 6, 12 or 18 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/1196
Date of first authorization / renewal of the authorization
28/07/2009 / 03/07/2013
Date of revision of the text
11/07/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
