NARAMIG Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Naramig 2.5 mg film-coated tablets.
Qualitative and quantitative composition
Tablets containing 2.5 mg of naratriptan as naratriptan hydrochloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets.
Therapeutic indications
Naramig Tablets are indicated for the acute treatment of migraine attacks with or without aura.
Posology and method of administration
Naramig tablets should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage. Naramig Tablets are recommended as monotherapy for the acute ...
Contraindications
Hypersensitivity to naratriptan or to any of the excipients listed in section 6.1. As with other 5-hydroxytryptamine1 (5-HT<sub>1</sub>) receptor agonists naratriptan should not be used in patients who ...
Special warnings and precautions for use
Naratriptan should only be used where there is a clear diagnosis of migraine. Naratriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. As with other acute ...
Interaction with other medicinal products and other forms of interaction
Serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) has been reported following concomitant treatment with triptans and SSRIs/SNRIs (see Section ...
Pregnancy and lactation
Pregnancy Evaluation of experimental animal studies does not indicate any direct teratogenic effects or harmful effects on peri- and postnatal development. However, delays in foetal ossification and possible ...
Effects on ability to drive and use machines
Drowsiness may occur as a result of migraine or its treatment with naratriptan. Caution is recommended when skilled tasks are to be performed (e.g. driving or operating machinery).
Undesirable effects
At therapeutic doses of naratriptan the incidence of side effects reported in clinical trials was similar to placebo. Some of the symptoms may be part of the migraine attack. Undesirable effects are ranked ...
Overdose
Administration of a high dose of 25 mg naratriptan in one healthy male subject increased blood pressure by up to 71 mmHg and resulted in adverse events including light-headedness, tension in the neck, ...
Pharmacodynamic properties
Mechanism of action Naratriptan has been shown to be a selective agonist for 5 hydroxytryptamine<sub>1</sub> (5-HT<sub>1</sub>) receptors mediating vascular contraction. This receptor is found predominantly ...
Pharmacokinetic properties
Absorption Following oral administration, naratriptan is rapidly absorbed with maximum plasma concentrations observed at 2-3 hours. After administration of a 2.5mg naratriptan tablet C<sub>max</sub> is ...
Preclinical safety data
No clinically relevant findings were observed in preclinical studies.
List of excipients
Tablet core: Microcrystalline cellulose Anhydrous lactose Croscarmellose sodium Magnesium stearate Film-coat: Methylhydroxypropylcellulose Titanium dioxide (E171) Triacetin Iron oxide yellow (E172) Indigo ...
Incompatibilities
None reported.
Shelf life
36 months.
Special precautions for storage
Store below 30°C.
Nature and contents of container
2, 4, 6 or 12 tablets in a double foil blister pack or child-resistant foil blister pack. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Marketing authorization number(s)
PL 10949/0273
Date of first authorization / renewal of the authorization
28 April 2002
Date of revision of the text
14 October 2019
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