Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
betahistine dihydrochloride
Southern Cross Pharma Pty Ltd
betahistine dihydrochloride
Registered
SENIERE 1 SENIERE _ _ _Betahistine dihydrochloride tablets_ _ _ CONSUMER MEDICINE INFORMATION _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Seniere tablets. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Seniere tablets against the benefits this medicine is expected to have for you. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT SENIERE IS USED FOR Seniere is used to treat a disorder of the working 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 Méniere's Syndrome. Seniere tablets contain the active ingredient betahistine dihydrochloride, which work 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 normalize the way in which the nerves respond to outside influences. Your doctor may have prescribed Seniere for another reason. Ask your doctor if you have any questions about why Seniere has been prescribed for you. There is no evidence that Seniere is addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE SENIERE _WHEN YOU MUST NOT _ _TAKE IT_ _ _ DO NOT TAKE SENIERE IF: • you are pregnant or intend to become pregnant. Seniere may affect your developing baby if taken during pregnancy. • you are breast-feeding or plan to breast-feed. Seniere may pass into breast milk and therefore there is possibility that the breast-fed baby may be affected. • you are allergic to betahistine dihydrochloride or any of the ingredients l Olvassa el a teljes dokumentumot
AUSTRALIAN PRODUCT INFORMATION SENIERE (BETAHISTINE DIHYDROCHLORIDE) TABLETS _ _ 1. NAME OF THE MEDICINE Betahistine dihydrochloride. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Seniere tablets contain 16 mg of the active ingredient betahistine dihydrochloride. Excipient with known effect: sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Seniere tablets are white flat tablets with bevelled edges and a break-line on one 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 one-half to one tablet (8 to 16 mg) taken three times a day. The maximum recommended daily dosage 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 • 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 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. Seniere – AUSTRALIAN PRODUCT INFORMATION 2 PAEDIATRIC USE Due to lack of clinical experience, betahistine dihydrochloride should not be used in children less than 18 years (see Section 4.3 CONTRAINDICATIONS). EFFECTS ON Olvassa el a teljes dokumentumot