Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cinnarizine
Johnson & Johnson Ltd
N07CA02
Cinnarizine
15mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5012674061381
– 1 – PACKAGE LEAFL ET: INFORMATION FOR THE PATIENT 15 MG TABLETS Cinnarizine Stugeron is a registered trademark READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. 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 signs of illness are the same as yours. • If you get any side eff ects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leafl et. See section 4. WHAT IS IN THIS LEAFL ET 1 WHAT STUGERON TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE STUGERON TABLETS 3 HOW TO TAKE STUGERON TABLETS 4 POSSIBLE SIDE EFF ECTS 5 HOW TO STORE STUGERON TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT STUGERON TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Stugeron 15 mg tablets. It is called Stugeron tablets in this leafl et. The tablets contain a medicine called cinnarizine that helps symptoms caused by balance or movement problems. Stugeron tablets are used: • to control travel sickness • for problems with balance (such as Ménières disease) to treat symptoms of: - feeling dizzy or lightheaded - ringing in the ears - feeling sick (nausea) and being sick (vomiting) This medicine is for use in adults and children aged over 5 years. HOW TO HELP STOP TRAVEL SICKNESS The following tips may help you avoid travel sickness: • At sea - Stay on deck and keep your eyes on the horizon - Keep away from diesel and galley smells - Do not eat rich and fatty foods while travelling • On the road - Keep looking ahead into the distance - Travel in daylight with a window open - Make sure children can see out of the windscreen - Do not read - Do not eat rich and fatty foods while travelling 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE STUGERON TABLETS DO NOT TAKE STUGERON TA Pročitajte cijeli dokument
1 NAME OF THE MEDICINAL PRODUCT Stugeron 15 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg cinnarizine. Excipients with known effect: Each tablet contains 160 mg lactose monohydrate and 15 mg sucrose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM White circular tablet with S/15 on one side and JANSSEN on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Disorders of balance - maintenance therapy for symptoms of labyrinthine disorders, including vertigo, tinnitus, nystagmus, nausea and vomiting such as is seen in Meniere’s Disease. Prophylaxis of motion sickness 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Oral. The tablets may be chewed, sucked or swallowed whole. Posology Stugeron should preferably be taken after meals. Vestibular symptoms Adults, elderly and children over 12 years: 2 tablets three times a day. Children 5 to 12 years: One half the adult dose. These doses should not be exceeded. Motion sickness Adults, elderly and children over 12 years: 2 tablets 2 hours before you travel and 1 tablet every 8 hours during your journey. Children 5 to 12 years: One half the adult dose. 4.3. CONTRA-INDICATIONS Stugeron should not be given to patients with known hypersensitivity to cinnarizine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other antihistamines, Stugeron may cause epigastric discomfort; taking it after meals may diminish the gastric irritation. In patients with Parkinson’s Disease, Stugeron should only be given if the advantages outweigh the possible risk of aggravating this disease. Because of its antihistamine effect, Stugeron may prevent an otherwise positive reaction to dermal reactivity indicators if used within 4 days prior to testing. Use of cinnarizine should be avoided in porphyria. There have been no specific studies in hepatic or renal dysfunction. Stugeron should be used with care in patients with hepatic or renal insufficiency. Patients with rare hereditary problems of fructose Pročitajte cijeli dokument