国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Sumatriptan
GlaxoSmithKline (Ireland) Limited
N02CC; N02CC01
Sumatriptan
10 milligram(s)
Nasal spray, solution
Product subject to prescription which may be renewed (B)
Selective serotonin (5HT1) agonists; sumatriptan
Marketed
1999-07-07
PACKAGE LEAFLET: INFORMATION FOR THE USER IMIGRAN 10 MG NASAL SPRAY, SOLUTION IMIGRAN 20 MG NASAL SPRAY, SOLUTION SUMATRIPTAN 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 IMIGRAN IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN NASAL SPRAY 3. HOW TO USE IMIGRAN NASAL SPRAY 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE IMIGRAN NASAL SPRAY 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT IMIGRAN IS AND WHAT IT IS USED FOR IMIGRAN CONTAINS THE ACTIVE SUBSTANCE SUMATRIPTAN which belongs to a group of medicines called triptans _(also known as 5-HT1 receptor agonists)._ Each pre-filled Imigran 10 mg/ Imigran 20 mg Nasal Spray device contains 10 mg/ 20 mg sumatriptan respectively in 0.1 ml of aqueous solution. IMIGRAN NASAL SPRAY IS USED TO TREAT MIGRAINE HEADACHES WITH OR WITHOUT WARNING SIGNS (AURA) . Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Imigran Nasal Spray is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN NASAL SPRAY DO NOT USE IMIGRAN: IF YOU ARE ALLERGIC to sumatriptan, or any of the other ingredients (listed in Section 6). IF YOU HAVE A HEART PROBLEM such as narrowing of the arteries _(Ischaemic heart disease)_ or chest pains _(angina)_ , or have already had a heart at 阅读完整的文件
Health Products Regulatory Authority 25 November 2021 CRN00CHWN Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Imigran 10 mg Nasal Spray, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each nasal applicator contains 10 mg of sumatriptan in 0.1 ml of solution. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution. A clear, pale to dark yellow, buffered solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imigran Nasal Spray is indicated for the acute treatment of migraine attacks with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Imigran Nasal Spray should not be used prophylactically. The recommended dose of Imigran Nasal Spray should not be exceeded. Imigran Nasal Spray is recommended as monotherapy for the acute treatment of a migraine attack and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide) (see section 4.3). It is advisable that Imigran Nasal Spray be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered. ADULTS (18 YEARS OF AGE AND OVER): The optimal dose of Imigran Nasal Spray is 20 mg for administration into one nostril. However, due to inter/intra patient variability of both the migraine attacks and the absorption of sumatriptan, 10 mg may be effective in some patients. If a patient does not respond to the first dose of Imigran Nasal Spray, a second dose should not be taken for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Imigran Nasal Spray may be taken for subsequent attacks. If the patient has responded to the first dose, but the symptoms recur a second dose may be given in the next 24 hours, provided that there is a minimum interval of 2 hours between the two doses. No more than two doses of Imigran 20 mg Nasal Spray (four doses of Imigran 10 mg Nasal Spray (taken in 2 阅读完整的文件