ZOLMITRIPTAN Orodispersible tablets (2019)
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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
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