País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zolmitriptan
Lupin Healthcare (UK) Ltd
N02CC03
Zolmitriptan
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 8902805500162
2 1 Artwork No. Barcode mind when you drive or use any tools or machines. Zolmitriptan Tablets is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zolmitriptan Tablets affects you before you try these activities. ZOLMITRIPTAN TABLETS CONTAIN ASPARTAME (E951) Zolmitriptan 2.5mg orodispersible tablets contains 0.250mg of aspartame in each tablet. Zolmitriptan 5mg orodispersible tablets contains 0.500mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. 3. HOW TO TAKE ZOLMITRIPTAN TABLETS Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You can take Zolmitriptan Tablets as soon as a migraine headache starts. You can also take it once an attack is underway. Ÿ The usual dose is one tablet (either 2.5mg or 5mg). Ÿ You can take another tablet if the migraine is still present after two hours or if it returns within 24 hours. If the tablets did not give you enough help with your migraine, tell your doctor. Your doctor may raise the dose to 5mg or change your treatment. You are more likely to get side effects with the higher dose (5mg). DO NOT use more than the dose prescribed for you. DO NOT use more than two doses in one day. If you have been prescribed the 2.5mg tablet, the maximum daily dose is 5mg. If you have been prescribed the 5mg tablet, the maximum daily dose is 10mg. _Instruction for use_ 1. Peel the blister pack open. Do not push the tablet through the foil. 2. Place the tablet on your tongue, where it will dissolve and be swallowed with the saliva. You do not have to take a drink of water in order to swallow your tablet. IF YOU TAKE MORE ZOLMITRIPTAN TABLETS THAN YOU SHOULD If you have taken more Zolmitriptan Tablets than prescribed by your doctor, tell your doctor or go to the nearest hospital STRAIGHT AWAY. Take Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zolmitriptan 2.5mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5mg orodispersible tablet contains 2.5mg zolmitriptan. Excipient with know effect: Each 2.5mg orodispersible tablet contains 4mg aspartame. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Zolmitriptan 2.5mg Orodispersible Tablets are white and round flat tablets with the diameter 7.5 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute treatment of migraine headache with or without aura. 4.2 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 advisable that zolmitriptan is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not respond to the first dose, it is unlikely that a second dose will be of benefit in the same attack. If a patient does not achieve satisfactory relief with 2.5mg doses, for subsequent attacks 5mg doses of zolmitriptan could be considered. The total daily intake should not exceed 10mg. Not more than 2 doses of zolmitriptan should be taken in any 24-hour period. Zolmitriptan is not indicated for prophylaxis of migraine. _Children (below 12 years of age) _ Safety and efficacy of zolmitriptan tablets in paediatric patients have not been evaluated. Use of zolmitriptan in children is therefore not recommended. _Adolescents (12 - 17 years of age) _ The efficacy of zolmitriptan tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of zolmitriptan in adolescents is therefore n Leer el documento completo