देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pizotifen hydrogen malate
Rivopharm (UK) Ltd
N02CX01
Pizotifen hydrogen malate
500microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070402; GTIN: 5060388650377
Pizotifen 0.5 mg & 1.5 mg tablets – PL 14682/0001-0002 Edmond Pharma Version October 2015 PACKAPA FLET: PACKAGE LEAFLET: INFORMATION FOR THE USER PIZOTIFEN 0.5 MG TABLETS PIZOTIFEN 1.5 MG TABLETS Pizotifen READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Please 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Pizotifen 0.5mg & 1.5mg Tablets are and what they are used for 2. Before you take Pizotifen 0.5mg & 1.5mg Tablets 3. How to take Pizotifen 0.5mg & 1.5mg Tablets 4. Possible side effects 5. How to store Pizotifen 0.5mg & 1.5mg Tablets 6. Further information 1. WHAT PIZOTIFEN 0.5MG & 1.5MG TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Pizotifen 0.5mg or 1.5mg Tablets. The active ingredient is pizotifen hydrogen malate. Pizotifen belongs to a group of medicines called anti-migraines. Pizotifen is used to help block the actions of certain chemicals in the blood such as serotonin, histamine and tryptamine. These chemicals act on the blood vessels in the brain and are involved in causing types of headache, such as migraine. If Pizotifen 0.5mg or 1.5mg Tablets are taken regularly, they can help reduce the number and severity of headaches including the pain of cluster headaches and both common and classical migraine. Pizotifen can also prevent some migraine attacks starting and helps make other attacks less severe. Pizotifen does not help to relieve a migraine attack once it has started 2. BEFORE YOU TAKE PIZOTIFEN 0.5MG & 1.5MG TABLETS DO NOT TAKE THIS MEDICINE IF: • you have ever had an allergic reaction to any of the ingredients of Pizotifen Tablets or any other medicines that you may पूरा दस्तावेज़ पढ़ें
OBJECT 1 PIZOTIFEN 0.5 MG TABLETS Summary of Product Characteristics Updated 19-Apr-2017 | Rivopharm UK Ltd 1. Name of the medicinal product Pizotifen 0.5 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 0.725 mg pizotifen hydrogen malate BP, equivalent to 0.5 mg of pizotifen base. Each film-coated tablet contains lactose monohydrate 32.14 mg, as excipient For a full list of excipients, see section 6.1. 3. Pharmaceutical form Film coated tablet. The tablets are white, marked P on one side and plain on the reverse. 4. Clinical particulars 4.1 Therapeutic indications Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia). It is not effective in relieving migraine attacks once in progress 4.2 Posology and method of administration _Adults: _Usually 1.5 mg daily, This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted according to individual patient requirements, up to a maximum of 4.5 mg daily. Up to 3 mg can be given as a single dose. _Children _(aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night. _Elderly_: As for adults. Method of administration: oral 4.3 Contraindications Hypersensitivity to the drug or to any of the other tablet ingredients. Pizotifen should not be given to children under 2 years of age 4.4 Special warnings and precautions for use Although the anticholinergic activity of Pizotifen is relatively weak, caution is required in the presence of closed-angle glaucoma and in patients with a predisposition to urinary retention. Dosage adjustment may be required in patients with renal insufficiency. Pizotifen should be used with caution in patients with a history of epilepsy. Pizotifen tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-glactose malabsorption should not take Pizotifen tablet पूरा दस्तावेज़ पढ़ें