Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
betahistine dihydrochloride, Quantity: 16 mg
Arrotex Pharmaceuticals Pty Ltd
betahistine dihydrochloride
Tablet, uncoated
Excipient Ingredients: colloidal anhydrous silica; crospovidone; stearic acid; povidone; lactose monohydrate; microcrystalline cellulose
Oral
25
(S4) Prescription Only Medicine
Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting); hearing loss (hardness of hearing); tinnitus.
Visual Identification: White or almost white, round, flat bevelled edged tablets embossed "B16" on one side and scored on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-10-20
APO-Betahistine Tablet 1 APO-BETAHISTINE TABLETS _Betahistine dihydrochloride _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about betahistine. 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 using this medicine 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Betahistine is used to treat Meniere's Syndrome, a disorder of the inner ear. Meniere's Syndrome 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. _HOW IT WORKS _ Betahistine 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend using this medicine in children less than 18 years of age. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • 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, throat or other parts of the body • rash, Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION – APO-BETAHISTINE (BETAHISTINE DIHYDROCHLORIDE) 1 NAME OF THE MEDICINE Betahistine dihydrochloride. 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Each tablet contains 16mg of betahistine dihydrochloride as the active ingredient. List of excipients with known effect: contains sucrose as lactose monohydrate. Each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid. 16 MG TABLETS: White or almost white, round, flat bevelled edged tablets embossed B16 on one side and scored on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meniere’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 The recommended starting dose in adults is 8 to 16 mg three times a day. The maximum recommended daily dose is 48 mg. The tablets may be taken with or without food. However, if gastrointestinal upset occurs, it is recommended that the tablets be taken with meals. The dosage should be individually adapted according to the response. Improvement in symptoms may be observed in the first few days to weeks of treatment. 4.3 CONTRAINDICATIONS Betahistine is 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 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with bronchial asthma need to be carefully monitored during therapy. 2 Caution should be taken in the treatment of patients receiving antihistamines (See Section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). USE IN HEPATIC IMPAIRMENT No Прочитајте комплетан документ