देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
ZOLMITRIPTAN
ASTRAZENECA (ISRAEL) LTD
N02CC03
FILM COATED TABLETS
ZOLMITRIPTAN 2.5 MG
PER OS
Required
ASTRA ZENECA UK LIMITED
ZOLMITRIPTAN
ZOLMITRIPTAN
Acute treatment of migraine with or without aura.
2022-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Zomig ® 2.5 mg Film-coated Tablets Composition: Each film-coated tablet contains: Zolmitriptan 2.5 mg For inactive ingredients, please see section 6 - "Further Information". Please also see section 2 – "Important information about some of the ingredients of the medicine ". Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. This medicine is not recommended for children and adolescents under 18 years of age and for adults over 65 years of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Treatment of migraine with or without aura. Therapeutic group: Triptans, selective serotonergic 5HT 1 agonist (5HT 1 agonists). Migraine symptoms may be caused by swollen blood vessels in the head. Zomig is reducing the widening of these blood vessels. This helps to reduce the headache and other symptoms of a migraine attack, such as nausea or vomiting and being sensitive to light and sound. Zomig works only when a migraine attack has started. It will not stop you from getting an attack. 2. BEFORE USING THE MEDICINE X Do not use the medicine if: • you are sensitive (allergic) to the active ingredient Zolmitriptan or to any of the other ingredients contained in the medicine (please see section 6). • you suffer from high blood pressure. • you suffer or have suffered in the past from heart problems, including myocardial infarction (heart attack), angina pectoris (chest pain caused by exercise or effort), Prinzmetal's angina (chest pain which happens at rest) or you have experienced heart-related symptoms such as shortness of breath or pressure over the chest. • you suffer from a पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zomig 2.5 mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of zolmitriptan. Excipient(s) with known effect Each tablet contains 100 mg lactose anhydrous. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film Coated Tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ‘Zomig’ is indicated for the acute treatment of migraine with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Zomig to treat a migraine attack is 2.5 mg. If symptoms persist or return within 24 hours, a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not achieve satisfactory relief with 2.5 mg doses, subsequent attacks can be treated with 5 mg doses of Zomig. In those patients who respond, significant efficacy is apparent within 1 hour of dosing. Zomig is equally effective whenever the tablets are taken during a migraine attack; although it is advisable that Zomig 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 Zomig in a 24 hour period should not exceed 10 mg. Zomig is not indicated for prophylaxis of migraine. _Paediatric population (under 12 years of age) _ The safety and efficacy of Zomig tablets in children aged 0-12 years has not yet been established. No data are available. Use of Zomig in children is therefore not recommended. _Adolescents (12 - 17 years of age)_ _ _ The efficacy of Zomig tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of Zomig tablets in adolescents is therefore not recommended. _Elderly _ Safety and efficacy of Zomig in individuals aged over 65 years have not been systematically evaluated. _Hepatic impairment _ Metabolism is reduced in patients with hepatic impairment (see Section 5.2 पूरा दस्तावेज़ पढ़ें