Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Betahistine dihydrochloride 16mg;
Viatris Limited
Betahistine dihydrochloride 16 mg
16 mg
Tablet
Active: Betahistine dihydrochloride 16mg Excipient: Citric acid monohydrate Colloidal silicon dioxide Mannitol Microcrystalline cellulose Purified talc
Blister pack, physician sample pack, 10 tablets
Prescription
Prescription
Finorga SA
Package - Contents - Shelf Life: Blister pack, physician sample pack - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 25 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 30°C
1998-08-03
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION SERC ® _BETAHISTINE DIHYDROCHLORIDE 16 MG TABLET_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Serc. This leaflet answers some common questions about Serc. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Serc against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SERC IS USED FOR Serc is used to treat a disorder of your inner ear. This disorder may include one or more of the following symptoms, in one or both ears: ringing in the ears (tinnitus) loss of clear hearing problems with balance (vertigo) These symptoms may also be associated with nausea, vomiting and headache. Often these symptoms together are referred to as Meniere's Syndrome. Serc contains the active ingredient betahistine dihydrochloride. It belongs to a group of medicines to help treat vertigo. Serc works by improving the blood flow of the inner ear and restoring it to normal. It also acts on the nerve endings in the inner ear to normalise the way in which the nerves respond to outside influences. Your doctor may have prescribed this medicine for another reason. This medicine is not addictive. Ask your doctor if you have any questions about why this medicine has been prescribed for you. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE SERC _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE SERC IF YOU HAVE AN ALLERGY TO: any medicine containing betahistine dihydrochloride any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash Izlasiet visu dokumentu
Page 1 of 6 NEW ZEALAND DATA SHEET SERC ® 1. PRODUCT NAME SERC, 8 mg, 16 mg tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8 mg tablet contains 8 mg betahistine dihydrochloride corresponding to 5.21mg betahistine, Each 16 mg tablet contains 16 mg betahistine dihydrochloride corresponding to 10.42 mg betahistine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 8 mg tablet: round, flat, white to almost white tablet with bevelled edges, one side inscribed with ‘256’. 16 mg: round, biconvex, scored, white to almost white tablet with bevelled edges, one side inscribed ‘267’ on either side of the score. SERC 16 mg tablets can be divided into equal doses. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Ménière’s Syndrome as defined by the following core symptoms: Vertigo (with nausea/vomiting) Hearing loss (hardness of hearing) Tinnitus _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE The recommended starting dose is 8 to 16 mg taken three times a day. The maximum recommended daily dose is 48 mg. The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. _SPECIAL POPULATIONS_ PAEDIATRIC Due to lack of clinical experience, betahistine dihydrochloride should not be used in children less than 18 years (see section 4.3). Page 2 of 6 METHOD OF ADMINISTRATION The tablets may be taken with or without food. However, if gastrointestinal upset occurs, it is recommended that the tablets be taken with meals. _4.3_ _CONTRAINDICATIONS_ Serc (betahistine dihydrochloride) Tablets are contraindicated as follows: During pregnancy and lactation In children less than 18 years In patients suffering from phaeochromocytoma In patients with active peptic ulcer or a history of this condition In patients with hypersensitivity to any component to the product (see Section 6.1) _4.4_ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ Patients with bronchial asthma need to be carefu Izlasiet visu dokumentu