Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zolmitriptan
Zentiva Pharma UK Ltd
N02CC03
Zolmitriptan
2.5mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 5000283655084
IB-CSP-approved 17/10/14 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLMITRIPTAN 2.5MG ORODISPERSIBLE TABLETS ZOLMITRIPTAN 5MG ORODISPERSIBLE TABLETS 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 symptoms 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 The name of your medicine is Zolmitriptan 2.5mg orodispersible tablets or Zolmitriptan 5mg orodispersible tablets (called Zolmitriptan throughout this leaflet). Zolmitriptan orodispersible tablets contains the active substance zolmitriptan and belongs to a group of medicines called triptans. Zolmitriptan is used to TREAT MIGRAINE ATTACKS (headaches and nausea). Migraine symptoms may be caused by swollen blood vessels in the head. Zolmitriptan 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 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 (hypersensitive) to zolmitriptan or any of the other ingredients of this medicine (listed in section 6). have high blood pressure. have ever had heart problems, including a heart atta Pročitajte cijeli dokument
OBJECT 1 ZOLMITRIPTAN 2.5MG ORODISPERSIBLE TABLETS Summary of Product Characteristics Updated 06-Nov-2014 | Zentiva 1. Name of the medicinal product ZOLMITRIPTAN 2.5 MG orodispersible tablets 2. Qualitative and quantitative composition Zolmitriptan 2.5 mg: Each tablet contains 2.5 mg of zolmitriptan. Excipient: Each tablet contains also 2.5 mg of aspartame. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Orodispersible tablet Zolmitriptan 2.5 mg orodispersible tablets: White to off-white, round, flat faced beveled edge uncoated tablet with '2.5' debossed on one side and plain on other side. 4. Clinical particulars 4.1 Therapeutic indications Zolmitriptan is indicated for the 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 should recur within 24 hours following an initial response, a second dose of zolmitriptan 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. Caution is advised due to an increased incidence of undesirable effects. A controlled clinical study failed to demonstrate superiority of the 5mg dose over the 2.5 mg dose. Nevertheless a 5 mg dose may be of benefit in some patients. 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. Special populations: _PATIENTS AGED OVER 65 YEARS_ Safety and efficacy of Zolmitriptan in individuals aged over 65 ye Pročitajte cijeli dokument