Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
betahistine dihydrochloride, Quantity: 16 mg
Generic Health Pty Ltd
betahistine dihydrochloride
Tablet, uncoated
Excipient Ingredients: citric acid; microcrystalline cellulose; mannitol; colloidal anhydrous silica; purified talc
Oral
60 tablets, 30 tablets, 10 tablets, 25 tablets, 100 tablets
(S4) Prescription Only Medicine
Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting), hearing loss (hardness of hearing) and tinnitus.
Visual Identification: Uncoated, round, biconvex, white to light creamy tablets, with a groove on one surface.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-08-14
CONSUMER MEDICINE INFORMATION BETAHISTINE GH (BETAHISTINE DIHYDROCHLORIDE) UNCOATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about Betahistine GH. It does not contain all the information that is known about Betahistine GH. 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 Betahistine GH 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 BETAHISTINE GH IS USED FOR Betahistine GH 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 your 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. Betahistine GH tablets contain the active ingredient betahistine dihydrochloride. 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. Your doctor will have explained why you are being treated with Betahistine GH and told you what dose to take. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR CAREFULLY. They may differ from the information contained in this leaflet. This medicine is only available with a doctor’s prescription. Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information. Betahistine GH is not addictive. BEFORE YOU TAKE BETAHISTINE GH _WHEN YOU MUST NOT TAKE IT _ DO NOT USE BETAHISTINE GH IF YOU HAVE AN ALLERGY TO: • ANY MEDICINE CONTAINING BETAHISTINE DIHYDROCHLORIDE; • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symp Soma hati kamili
AUSTRALIAN PRODUCT INFORMATION – BETAHISTINE GH (BETAHISTINE DIHYDROCHLORIDE) UNCOATED TABLET 1 NAME OF THE MEDICINE Betahistine dihydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betahistine GH tablets are available as uncoated tablets containing 16 mg betahistine dihydrochloride. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Betahistine GH 16 mg tablets_:_ Uncoated, round, biconvex, white to light creamy tablets, with a groove on one surface. 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 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 GH 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; Betahistine GH v4.0 Page 2 of 7 (betahistine dihydrochloride) uncoated tablet • in patients with hypersensitivity to any component in the product (see SECTION 6.1 LIST OF EXCIPIENTS). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with bronchial asthma need to be carefully monitored during therapy. 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 THE ELDERLY No data available. PAEDIATRIC USE Due to lack of clinical experience, betahistine dihydrochloride should not be used i Soma hati kamili