Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zolmitriptan
Torrent Pharma (UK) Ltd
N02CC03
Zolmitriptan
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 5060623371920
COLOUR BLACK Reviewed By ACTIVITIES DEPARTMENT NAME SIGNATURE DATE Prepared By PKG.DEV PKG.DEV LOCATION : SUPERSEDES A/W NO.: - COUNTRY : UK QUALITY Approved By REMARK : SIZE : 175 X 380 MM_FRONT/BACK SIDE CODE : 8068214-7803 FONT TYPE: HELVETICA CONDENSED_FONT SIZE: 9PT 8068214-7803 DATE : 05-06-2020 SUBSTRATE : THIS COLOUR PROOF IS NOT COLOUR BINDING. FOLLOW PANTONE SHADE REFERENCE FOR ACTUAL COLOUR MATCHING. PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLMITRIPTAN 2.5 MG AND 5 MG ORODISPERSIBLE TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Zolmitriptan tablets are and what they are used for 2. Before you take Zolmitriptan tablets 3. How to take Zolmitriptan tablets 4. Possible side effects 5. How to store Zolmitriptan tablets 6. Further information 1. WHAT ZOLMITRIPTAN TABLETS ARE AND WHAT THEY ARE USED FOR Zolmitriptan orodispersible tablets contain zolmitriptan and belong to a group of medicines called triptans. Zolmitriptan is used to treat migraine headache. • Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound. • Zolmitriptan works only when a migraine attack has started. It will not stop you from getting an attack. 2. BEFORE YOU TAKE ZOLMITRIPTAN TABLETS DO NOT TAKE ZOLMITRIPTAN - if you are allergic (hypersensitive) to Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zolmitriptan 2.5 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg orodispersible tablet contains 2.5 mg zolmitriptan. Excipient(s) with known effect: aspartame (4 mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. White, 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 The recommended dose of zolmitriptan to treat a migraine attack is 2.5 mg. If symptoms persist or return within 24 hours, a second dose of zolmitriptan has been shown to be effective. If a second dose if required, it should not be taken within 2 hours of the initial dose. If a patient does not achieve satisfactory relief with 2.5mg doses, subsequent attacks can be treated with 5mg doses of zolmitriptan. Zolmitriptan is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that zolmitriptan is taken as early as possible after the onset of migraine headache. In the event of recurrent attacks, it is recommended that the total intake of zolmitriptan in a 24-hour period should not exceed 10 mg. Zolmitriptan is not indicated for prophylaxis of migraine._ _ _ _ _Paediatric population (_Children below the age of 12 years) The safety and efficacy of zolmitriptan in children aged 0-12 years has not yet been established. No data are available. Use of zolmitriptan in children is therefore not recommended. Adolescents (12 - 17 years of age) The efficacy of zolmitriptan was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of zolmitriptan in adolescents is therefore not recommended. _Elderly _ The safety and efficacy of zolmitriptan in individuals aged over 65 years have not been established. Use of zolmitriptan in the elderly is therefore not recommended. _Hepatic impairmen Прочитайте повний документ