Држава: Шведска
Језик: Шведски
Извор: Läkemedelsverket (Medical Products Agency)
zolmitriptan
Orifarm AB
N02CC03
zolmitriptan
2,5 mg
Munsönderfallande tablett
zolmitriptan 2,5 mg Aktiv substans; aspartam Hjälpämne; mannitol Hjälpämne
Receptbelagt
Zolmitriptan
Avregistrerad
2006-04-19
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOMIG RAPIMELT 2.5 MG AND 5 MG ORODISPERSIBLE TABLETS zolmitriptan 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 only. 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 Zomig Rapimelt is and what it is used for 2. What you need to know before you take Zomig Rapimelt 3. How to take Zomig Rapimelt 4. Possible side effects 5. How to store Zomig Rapimelt 6. Contents of the pack and other information 1. WHAT ZOMIG RAPIMELT IS AND WHAT IT IS USED FOR Zomig Rapimelt contains zolmitriptan and belongs to a group of medicines called triptans. ZOMIG RAPIMELT IS USED TO TREAT MIGRAINE HEADACHE IN ADULTS AGED 18 YEARS AND OLDER . Migraine symptoms may be caused by the widening of blood vessels in the head. Zomig Rapimelt 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. Zomig Rapimelt works only when a migraine attack has started. It will not stop you from getting an attack. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOMIG RAPIMELT DO NOT TAKE ZOMIG RAPIMELT: - if you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6). - if you have high blood pressure - if you have ever had heart problems, including a heart attack, angina (chest pain caused by exercise or effort), Prinzmetal’s angina (chest pain which happens at rest) or have experienced heart related symptoms such as shortness Прочитајте комплетан документ
Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Zomig Rapimelt 2.5 mg orodispersible tablet Zomig Rapimelt 5 mg orodispersible tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg orodispersible tablet contains 2.5 mg zolmitriptan. Each 5 mg orodispersible tablet contains 5 mg zolmitriptan. Excipients with known effect Each 2.5 mg orodispersible tablet contains 5 mg aspartame. Each 5 mg orodispersible tablet contains 10 mg aspartame. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet The 2.5 mg tablet is a white, flat-faced, round, bevelled edge orodispersible tablet, intagliated with ‘Z’ on one side. The 5 mg tablet is a white, flat-faced, round, bevelled edge orodispersible tablet, intagliated with ‘Z 5’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zomig Rapimelt is indicated in adults aged 18 years and older for acute treatment of migraine headache with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of 'Zomig Rapimelt' to treat a migraine attack is 2.5 mg. It is advisable that ‘Zomig Rapimelt’ 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 2.5 mg doses, for subsequent attacks 5 mg doses of 'Zomig Rapimelt' could be considered. The total daily intake should not exceed 10 mg. Not more than 2 doses of ‘Zomig Rapimelt’ should be taken in any 24-hour period. Page 2 of 10 ´Zomig Rapimelt´ is not indicated for prophylaxis of migraine. _Paediatric population_ _Use in Children (under 12 years of age)_ The safety and efficacy of zolmitriptan tablets Прочитајте комплетан документ