Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Ενδείξεις και αγωγές Βρείτε θεραπευτικές ενδείξεις και αγωγές για νόσους, συμπτώματα και ιατρικές πράξεις
Γνωρίζατε ότι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

ZOLMITRIPTAN Orodispersible tablets (2019)

Αναφορές

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

Περιεχόμενα

Name of the medicinal product

Zolmitriptan 5mg Orodispersible Tablets.

Qualitative and quantitative composition

Each 5mg orodispersible tablet contains 5mg zolmitriptan. Excipient with known effect: Each 5mg orodispersible tablet contains 8 mg aspartame. For the full list of excipients, see section 6.1.

Pharmaceutical form

Orodispersible tablet. Zolmitriptan 5mg Orodispersible Tablets are white and round flat tablets with the diameter 9.5 mm.

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 2.5mg. 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 (5HT<sub>1B/1D</sub> ...

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 20mg 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 50mg 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

Mannitol (E421) Calcium silicate Microcrystalline cellulose Aspartame (E951) Sodium starch glycolate Type A Crospovidone Type B Colloidal anhydrous silica Magnesium stearate Orange Cream Flavour (containing ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Peelable aluminium/aluminium blisters. Pack sizes: 2, 3, 6 or 12 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

0142/1207

Date of first authorization / renewal of the authorization

28/07/2009 Renewal Approved: 03/07/2013

Date of revision of the text

19/09/2019

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.