Pays: Malte
Langue: anglais
Source: Medicines Authority
CYCLIZINE HYDROCHLORIDE
Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
R06AE03
CYCLIZINE HYDROCHLORIDE 50 mg
TABLET
CYCLIZINE HYDROCHLORIDE 50 mg
POM
ANTIHISTAMINES FOR SYSTEMIC USE
Withdrawn
2015-01-02
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Cyclizine hydrochloride Cipla 50 mg tablets Cyclizine hydrochloride 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, pharmacist or nurse. - 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 hydrochloride tablets are and what they are used for 2. What you need to know before you take Cyclizine hydrochloride tablets 3. How to take Cyclizine hydrochloride tablets 4. Possible side effects 5. How to store Cyclizine hydrochloride tablets 6. Contents of the pack and other information 1. WHAT CYCLIZINE HYDROCHLORIDE TABLETS ARE AND WHAT IT IS USED FOR Cyclizine hydrochloride 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 hydrochloride 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 hydrochloride 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 HYDROCHLORIDE TABLETS DO NOT TAKE CYCLIZINE HYDROCHLORIDE TABLETS • If you are allergic to cyclizine or any other ingredients of this medicine (listed in section 6). 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 diffic Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cyclizine hydrochloride Cipla 50 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of cyclizine hydrochloride. Excipients with known effect: Each tablet contains 37 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off white, circular shaped, flat bevelled uncoated tablet with central break line on one side and plain on other. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Cyclizine hydrochloride is indicated 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 hydrochloride 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 _ _ _Route of administration_ : oral _Adults and Children over 12 Years_ : 50 mg orally, which may be repeated up to three times a day. _Children 6 – 12 Years_ : 25 mg orally, which may be repeated up to three times a day. _Children less than 6 years of age_ : Cyclizine Hydrochloride tablets are not recommended for children less than 6 years of age. _Use in the Elderly_ : There have been no specific studies of Cyclizine hydrochloride in the elderly. Experience has indicated that normal adult dosage is appropriate. To prevent motion sickness Cyclizine hydrochloride should be taken about one to two hours before departure. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other anticholinergic agents, Cyclizine hydrochloride may precipitate incipient gl Lire le document complet