מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
ZOLMITRIPTAN
Sanofi-Aventis Ireland Limited T/A SANOFI
ZOLMITRIPTAN
2.5 Milligram
Orodispersible Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Reference: 5603 1.3.1.3 - Leaflet Text - PIL - 2.5mg - 2012-12-03 0.2 PACKAGE LEAFLET: INFORMATION FOR THE USER Zolmitriptan Sanofi 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 Sanofi is and what it is used for 2. What you need to know before you take Zolmitriptan Sanofi 3. How to take Zolmitriptan Sanofi 4. Possible side effects 5. How to store Zolmitriptan Sanofi 6. Contents of the pack and other information 1. WHAT ZOLMITRIPTAN SANOFI IS AND WHAT IT IS USED FOR Zolmitriptan Sanofi contains active substance zolmitriptan and belongs to a group of medicines called triptans. Zolmitriptan Sanofi is used to TREAT MIGRAINE ATTACKS (headache and nausea). Migraine symptoms may be caused by swollen blood vessels in the head. Zolmitriptan Sanofi reduces 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 Sanofi 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 S קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zolmitriptan Sanofi 2.5mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 2.5 mg of zolmitriptan. Excipient with known effect: Each tablet contains also 2.5 mg of aspartame (E951). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet White to off-white, round, flat faced beveled edge uncoated tablet of 6.4 ± 0.3 mm diameter and with ‘2.5’ debossed on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zolmitriptan Sanofi is indicated for the acute treatment of migraine headache with or without aura. Zolmitriptan Sanofi is not indicated for prophylaxis of migraine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: The recommended dose is 2.5 mg zolmitriptan. It is advisable that Zolmitriptan Sanofi 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 zolmitriptan, for subsequent attacks doses of 5 mg zolmitriptan could be considered. The total daily intake should not exceed 10 mg. Not more than 2 doses should be taken in any 24 hour period. Special populations: _Patients aged over 65 years_ Safety and efficacy of Zolmitriptan Sanofi in patients קרא את המסמך השלם