IMIGRAN Tablet (2021)
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
Imigran 50mg Tablets.
Qualitative and quantitative composition
50mg sumatriptan base as the succinate salt. <u>Excipient with known effect:</u> 70 mg lactose monohydrate/tablet. 140 mg lactose/tablet. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. <u>50 mg tablet:</u> Pink, film-coated, capsule-shaped, biconvex tablet (of nominal dimensions: 12 mm x 6.5 mm), engraved 50 on one face and plain on the other face.
Therapeutic indications
Imigran tablets are indicated for the acute relief of migraine attacks, with or without aura. Imigran should only be used where there is a clear diagnosis of migraine.
Posology and method of administration
Adults Imigran is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically. The recommended dose of Imigran should not be exceeded. It is advisable that Imigran ...
Contraindications
Hypersensitivity to sumatriptan or to any of the excipients listed in section 6.1. Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary ...
Special warnings and precautions for use
Imigran should only be used where there is a clear diagnosis of migraine. Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Before treating with ...
Interaction with other medicinal products and other forms of interaction
Studies in healthy subjects show that sumatriptan does not interact with propranolol, flunarizine, pizotifen or alcohol. There are limited data on an interaction with preparations containing ergotamine ...
Pregnancy and lactation
Pregnancy Post-marketing data from the use of sumatriptan during the first trimester in over 1,000 women are available. Although these data contain insufficient information to draw definitive conclusions, ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Drowsiness may occur as a result of migraine or treatment with sumatriptan. This may influence the ability to drive ...
Undesirable effects
Adverse events are listed below by system organ class and frequency 4. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), ...
Overdose
Doses in excess of 400mg orally were not associated with side effects other than those mentioned. If overdosage occurs, the patient should be monitored for at least ten hours and standard supportive treatment ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Analgesics: Selective 5-HT<sub>1</sub> receptor agonists. <b>ATC code:</b> N02CC01 Sumatriptan has been demonstrated to be a specific and selective 5-Hydroxytryptamine ...
Pharmacokinetic properties
Following oral administration, sumatriptan is rapidly absorbed, 70% of maximum concentration occurring at 45 minutes. After 100mg dose, the maximum plasma concentration is 54ng/ml. Mean absolute oral bioavailability ...
Preclinical safety data
Sumatriptan was devoid of genotoxic and carcinogenic activity in in-vitro systems and animal studies. In a rat fertility study oral doses of sumatriptan resulting in plasma levels approximately 200 times ...
List of excipients
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Methylhydroxypropylcellulose Titanium dioxide Triacetin Iron oxide
Incompatibilities
None stated.
Shelf life
36 months.
Special precautions for storage
Store below 30°C.
Nature and contents of container
Aluminium double foil blister pack or child-resistant foil blister pack in a cardboard carton, containing either 2, 3, 6, 12, 18 or 24 tablets.
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Glaxo Wellcome UK Ltd. trading as GlaxoSmithKline UK., 980 Great West Road, Brentford, Middlesex, TW8 9GS
Marketing authorization number(s)
PL 10949/0222
Date of first authorization / renewal of the authorization
29/12/2005
Date of revision of the text
09 September 2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
