Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
betahistine dihydrochloride, Quantity: 16 mg
Viatris Pty Ltd
betahistine dihydrochloride
Tablet, uncoated
Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; mannitol; citric acid monohydrate; purified talc
Oral
25 tablets
(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: Round, biconvex, scored, white to almost white, uncoated tablet with bevelled edges, one side inscribed with "267" on either side of the score.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-08-29
BETAHISTINE MYLAN B e t a h i s t i n e M y l a n CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BETAHISTINE MYLAN? BETAHISTINE MYLAN contains the active ingredient betahistine dihydrochloride. BETAHISTINE MYLAN 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 and 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. For more information, see Section 1. Why am I using BETAHISTINE MYLAN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BETAHISTINE MYLAN? Do not use if you have ever had an allergic reaction to betahistine dihydrochloride or any of the ingredients listed at the end of the CMI. DO NOT TAKE THIS MEDICINE IF YOU HAVE PEPTIC ULCER OR A RARE ABNORMALITY OF THE ADRENAL GLAND KNOWN AS PHAEOCHROMOCYTOMA. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS (E.G. PEPTIC ULCER, ASTHMA OR A HISTORY OF SKIN CONDITIONS), TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use BETAHISTINE MYLAN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BETAHISTINE MYLAN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BETAHISTINE MYLAN? • The usual adult starting dose is half to one tablet taken three times a day. • Take BETAHISTINE MYLAN at about the same time each day during or immediately after a meal. More instructions can be found in Section 4. How do I use BETAHISTINE MYLAN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BETAHISTINE MYLAN? THINGS YOU SHOULD DO • Remin Perskaitykite visą dokumentą
AUSTRALIAN PRODUCT INFORMATION BETAHISTINE MYLAN _Betahistine dihydrochloride tablets _ 1 NAME OF THE MEDICINE Betahistine dihydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient is betahistine dihydrochloride. Each tablet contains 16 mg of betahistine dihydrochloride. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM BETAHISTINE MYLAN (betahistine dihydrochloride) 16 mg tablets: round, biconvex, scored, white to almost white uncoated tablet, one side inscribed with ‘267’ on either side of the score. 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 MYLAN (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 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AND SECTION 6 PHARMACEUTICAL PARTICULARS, 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 ). BETAHISTINE MYLAN – PRODUCT INFORMAT Perskaitykite visą dokumentą