País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Zolmitriptan
Actavis Group PTC ehf
N02CC; N02CC03
Zolmitriptan
2.5 milligram(s)
Orodispersible tablet
Product subject to prescription which may be renewed (B)
Selective serotonin (5HT1) agonists; zolmitriptan
Marketed
2009-08-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZOLMITRIPTAN 2.5 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 Zolmitriptan is and what it is used for 2. What you need to know before you take Zolmitriptan 3. How to take Zolmitriptan 4. Possible side effects 5. How to store Zolmitriptan 6. Contents of the pack and other information 1. WHAT ZOLMITRIPTAN IS AND WHAT IT IS USED FOR Zolmitriptan contains zolmitriptan and belongs 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOLMITRIPTAN DO NOT TAKE ZOLMITRIPTAN - 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 of breath or pressure over the chest - if you have circulatory problems (restricted b Leer el documento completo
Health Products Regulatory Authority 28 May 2019 CRN008YP3 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zolmitriptan 2.5 mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 2.5 mg zolmitriptan. Excipient with known effect: Each orodispersible tablet contains 4 mg aspartame. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Zolmitriptan 2.5 mg 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 The recommended dose of zolmitriptan to treat a migraine attack is 2.5 mg. 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 2.5 mg doses, for subsequent attacks 5 mg doses of zolmitriptan could be considered. The total daily intake should not exceed 10 mg. Not more than 2 doses of zolmitriptan should be taken in any 24-hour period. Zolmitriptan is not indicated for prophylaxis of migraine. _Paediatric population _ 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 not recommended. _Use i Leer el documento completo