البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyclizine hydrochloride
DE Pharmaceuticals
R06AE03
Cyclizine hydrochloride
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
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 Cyclizine Tablets are and what they are used for 2. What you need to know before you take Cyclizine Tablets 3. How to take Cyclizine Tablets 4. Possible side effects 5. How to store Cyclizine Tablets 6. Contents of the pack and other information 1. WHAT CYCLIZINE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Cyclizine Hydrochloride 50mg Tablets. Cyclizine Tablets contains the active ingredient cyclizine hydrochloride, which belongs to a group of medicines called antihistamines which can be used to help stop you feeling sick (nausea) or being sick (vomiting). Cyclizine Tablets may be used by adults and children aged 6 years and over. Cyclizine Tablets may be used if you suffer from travel or motion sickness; nausea caused by cancer treatment (radiography) or other medicines; or if you have had an operation, as general anaesthetics can sometimes cause sickness. Cyclizine Tablets can also be used to treat sickness caused by some inner ear problems such as Meniere's disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYCLIZINE TABLETS DO NOT TAKE CYCLIZINE TABLETS IF: ! you have ever had an allergic reaction to cyclizine or any of the other ingredients of this medicine (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing). ! you have been drinking alcohol. The anti-vomiting properties of cyclizi اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyclizine Hydrochloride 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of cyclizine hydrochloride. Excipients with known effect: Each tablet contains 37.00mg of Lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off white, circular shaped, flat bevelled uncoated tablets with central break line on one side and plain on other. The tablet can be divided into two halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cyclizine Tablets are indicated in adults and in children aged 6 years and over for the prevention and treatment of nausea and vomiting including:- • Motion sickness. • Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period. • Vomiting associated with radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels. Cyclizine Tablets may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology To prevent motion sickness Cyclizine Tablets should be taken about one to two hours before departure. ELDERLY There have been no specific studies of Cyclizine Tablets in the elderly. Experience has indicated that normal adult dosage is appropriate. PAEDIATRIC POPULATION Children less than 6 years of age: Cyclizine Tablets are not recommended for children less than 6 years of age. Children 6 to 12 years of age: 25 mg orally, which may be repeated up to three times a day. Children over 12 years of age: 50 mg orally, which may be repeated up to three times a day. Adults 50 mg orally, which may be repeated up to three times a day. Method of administration: Oral. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cyclizine is contraindicated in the presence of acute alcohol intoxication. T اقرأ الوثيقة كاملة