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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Almogran 12.5 mg Film-coated tablet (2012)

Εκδότης

Εκδότης Almirall Limited
Διεύθυνση 1 The Square, Stockley Park, Uxbridge, UB11 1TD, UK
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Περιεχόμενα

Name of the medicinal product

Almogran/Amignul/Almotrex 12.5 mg Film-coated tablet.

Qualitative and quantitative composition

Each tablet contains almotriptan 12.5 mg as almotriptan D,L-hydrogen malate. For the full list of excipients, ...

Pharmaceutical form

Film-coated tablet. White, circular, biconvex film-coated tablet with a blue A printed on one side. ...

Therapeutic indications

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

Posology and method of administration

Almogran/Amignul/Almotrex should be taken with liquids as early as possible after the onset of migraine-associated ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. As with other ...

Special warnings and precautions for use

.Almotriptan should only be used where there is a clear diagnosis of migraine. It should not be used ...

Interaction with other medicinal products and other forms of interaction

Interaction studies were performed with monoamine oxidase A inhibitors, beta-blockers, selective serotonin ...

Fertility, pregnancy and lactation

Pregnancy For almotriptan, very limited data on pregnant patients are available. Animal studies do not ...

Effects on ability to drive and use machines

There are no studies on the effect of almotriptan on the ability to drive or operate machinery. However, ...

Undesirable effects

Almogran/Amignul was evaluated in over 2700 patients for up to one year in clinical trials. The most ...

Overdose

No case of overdose has been reported. The most frequently reported adverse event in patients receiving ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimigraine. Selective 5-HT1 receptor agonist ATC code: N02CC05 Mechanism ...

Pharmacokinetic properties

Almotriptan is well absorbed, with an oral bioavailability of about 70%. Maximum plasma concentrations ...

Preclinical safety data

In safety pharmacology, repeated dose toxicity and reproduction toxicity studies, adverse effects were ...

List of excipients

Tablet core: Mannitol Microcrystalline cellulose Povidone Sodium starch glycolate Sodium stearyl fumarate ...

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Boxes containing aluminium foil blisters with 2, 3, 4, 6, 7, 9, 12, 14 or 18 tablets. Not all pack sizes ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Almirall, S.A. General Mitre, 151 08022 Barcelona Spain

Marketing authorization number(s)

PL 16973/0005

Date of first authorization / renewal of the authorization

Date of first authorisation: October 2000 Date of last renewal: December 2009

Date of revision of the text

February 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.