Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
betahistine dihydrochloride, Quantity: 24 mg
Southern XP IP Pty Ltd
betahistine dihydrochloride
Tablet
Excipient Ingredients: lactose monohydrate; maize starch; microcrystalline cellulose; citric acid; povidone; crospovidone; hydrogenated vegetable oil
Oral
60, 15, 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 flat tablets with bevelled edges and a break line on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-03-02
Setear 1 SETEAR 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 SETEAR? Setear contains 24 mg of the active ingredient betahistine dihydrochloride. Setear is used to treat an inner ear disorder called Meniere’s syndrome, which may cause ringing in the ears, hearing loss or balance problems and sometimes nausea, vomiting and headache. For more information, see Section 1. Why am I using Setear? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE SETEAR? Do not use if you have ever had an allergic reaction to Setear or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL 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 Setear? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Setear 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 SETEAR? • The usual adult starting dose is half to one 24 mg tablet taken twice a day. Your doctor may however prescribe a different dose. The maximum recommended daily dosage is 48 mg. • Swallow Setear with a glass of water following food, and at about the same time each day. More instructions can be found in Section 4. How do I use Setear? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING SETEAR? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Setear. • Tell your doctor if you have or have had a peptic ulcer, suffer from asthma, have a history of allergic skin conditions or tumours of the adrenal gland, have or have had any other medical conditions including pregnancy or breastfeeding, or have any allergies to any other medicines or substances. THINGS YOU SHOULD NOT DO • Do not give Setear to Olvassa el a teljes dokumentumot
AUSTRALIAN PRODUCT INFORMATION SETEAR 24 MG (BETAHISTINE HYDROCHLORIDE) TABLET _ _ 1. NAME OF THE MEDICINE Betahistine dihydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SETEAR tablets contain the active ingredient betahistine dihydrochloride. Each SETEAR tablet contains 24 mg of 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 SETEAR 24 mg 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 24 mg taken two times a day. The maximum recommended daily dosage is 48 mg, which may be taken as 16 mg three times daily or 24 mg twice daily. Refer to separate Product Information for Betahistine 16 mg tablets. 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 . SETEAR – AUSTRALIAN PRODUCT INFORMATION 2 PAEDI Olvassa el a teljes dokumentumot