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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

MAXALT Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

MAXALT 5 mg Tablets. MAXALT 10 mg Tablets.

Qualitative and quantitative composition

MAXALT 5 mg Tablets: Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding to 5 mg of the rizatriptan). Excipient(s) with known effect: Lactose monohydrate 30.25 mg in the 5 mg tablet. ...

Pharmaceutical form

Tablet. MAXALT 5 mg tablets: 5 mg tablets are pale pink, capsule shaped, coded MSD on one side and 266 on the other. MAXALT 10 mg tablets: 10 mg tablets are pale pink, capsule-shaped, coded MAXALT on one ...

Therapeutic indications

Acute treatment of the headache phase of migraine attacks with or without aura in adults.

Posology and method of administration

Method of administration MAXALT should not be used prophylactically. The oral tablets should be swallowed whole with liquid. Effect of Food The absorption of rizatriptan is delayed by approximately 1 hour ...

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Concurrent administration of monoamine oxidase (MAO) inhibitors or use within two weeks of discontinuation ...

Special warnings and precautions for use

MAXALT should only be administered to patients in whom a clear diagnosis of migraine has been established. MAXALT should not be administered to patients with basilar or hemiplegic migraine. MAXALT should ...

Interaction with other medicinal products and other forms of interaction

Ergotamine, ergot derivatives (including methysergide), other 5-HT<sub>1B/1D</sub> receptor agonists Due to an additive effect, the concomitant use of rizatriptan and ergotamine, ergot derivatives (including ...

Fertility, pregnancy and lactation

Fertility Effects on human fertility have not been investigated. Animal studies only revealed minimal effects on fertility at plasma concentrations far in excess of human therapeutic concentrations (more ...

Effects on ability to drive and use machines

Migraine or treatment with MAXALT may cause somnolence in some patients. Dizziness has also been reported in some patients receiving MAXALT. Patients should, therefore, evaluate their ability to perform ...

Undesirable effects

MAXALT (as the tablet and oral lyophilisate formulation) was evaluated in 8630 adult patients for up to one year in controlled clinical studies. The most common side effects evaluated in clinical studies ...

Overdose

Rizatriptan 40 mg (administered as either a single dose or as two doses with a two-hour interdose interval) was generally well tolerated in over 300 adult patients; dizziness and somnolence were the most ...

Pharmacodynamic properties

Pharmacotherapeutic group: antimigraine preparations, selective serotonin (5HT<sub>1</sub>) agonist ATC-code: N02CC04 Mechanism of action: Selective Serotonin (5-HT<sub>1B/1D</sub>) agonists Rizatriptan ...

Pharmacokinetic properties

Absorption Rizatriptan is rapidly and completely absorbed following oral administration. The mean oral bioavailability of the tablet is approximately 40-45%, and mean peak plasma concentrations (C<sub> ...

Preclinical safety data

Preclinical data indicate no risk for humans based on conventional studies of repeat dose toxicity, genotoxicity, carcinogenic potential, reproductive and developmental toxicity, safety pharmacology, and ...

List of excipients

Lactose monohydrate Microcrystalline cellulose (E460a) Starch, pregelatinised Iron oxide red (E172) Magnesium stearate (E572)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

All aluminium blister push through, packs of 2, 3, 6, 12 or 18 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization number(s)

Tablet 5 mg: PL 00025/0369 Tablet 10 mg: PL 00025/0370

Date of first authorization / renewal of the authorization

Date of first authorisation: June 1998 Date of latest renewal: 12 May 2014

Date of revision of the text

06 July 2018

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