Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Dosulepin hydrochloride 75mg; Dosulepin hydrochloride 75mg; Dosulepin hydrochloride 75mg
Viatris Limited
Dosulepin hydrochloride 75 mg
75 mg
Film coated tablet
Active: Dosulepin hydrochloride 75mg Excipient: Carnauba wax Clear film coat 5544 + colour film coat 5553 Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Sodium starch glycolate Active: Dosulepin hydrochloride 75mg Excipient: Carnauba wax Diethyl phthalate Ethanol Hypromellose Lactose monohydrate Magnesium stearate Maize starch Opaspray red K-1F-4972 Povidone Purified talc Purified water Sodium starch glycolate Active: Dosulepin hydrochloride 75mg Excipient: Opadry Red OY-B-25005 Lactose monohydrate Magnesium stearate Maize starch Povidone Purified talc Sodium starch glycolate
Blister pack, 100 tablets
Prescription
Prescription
Dipharma Francis Srl
Depression of any aetiology and the anxiety frequently associated with depressive illness.
Package - Contents - Shelf Life: Blister pack, Al/PVC/PVdC - 30 tablets - 36 months from date of manufacture stored at or below 30°C. (The product manufactured at Alphapharm Pty Ltd) - Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 25°C
1989-09-22
NEW ZEALAND CONSUMER MEDICINE INFORMATION DOSULEPIN VIATRIS _DOSULEPIN (DOTHIEPIN) 75MG TABLETS_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dosulepin Viatris. It does not contain all the information available on this medicine. 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 Dosulepin Viatris against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this leaflet. You may want to read it again. WHAT DOSULEPIN VIATRIS IS USED FOR AND HOW IT WORKS Your Dosulepin Viatris tablets contain dosulepin hydrochloride. It belongs to a group of medicines known as tricyclic antidepressants (TCAs). Dosulepin Viatris is used to treat depression and the anxiety associated with depression. Depression may affect your whole body and may cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. Your doctor may, however, prescribe Dosulepin Viatris for another reason. Ask your doctor if you have any questions about why Dosulepin Viatris has been prescribed for you. DOSULEPIN VIATRIS IS NOT RECOMMENDED FOR USE IN CHILDREN 12 YEARS OF AGE AND UNDER. DOSULEPIN VIATRIS IS NOT RECOMMENDED FOR USE IN ADOLESCENTS (13-18 YEARS OF AGE) FOR THE TREATMENT OF DEPRESSION, UNLESS UNDER THE SUPERVISION OF A SPECIALIST. Dosulepin Viatris is available on prescription from your doctor. BEFORE YOU TAKE DOSULEPIN VIATRIS _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE DOSULEPIN VIATRIS IF: • you are allergic to dosulepin, other tricyclic antidepressants or any other ingredients listed at the end of this leaflet • you have liver problems • you are taking a medicine called a monoamine oxidase inhibitor (MAOI) or have been taking a MAOI Läs hela dokumentet
Page 1 of 11 NEW ZEALAND DATA SHEET DOSULEPIN VIATRIS 1. PRODUCT NAME DOSULEPIN VIATRIS, 75 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each DOSULEPIN VIATRIS 75 mg film-coated tablet contains 75 mg of dosulepin (dothiepin) hydrochloride. Excipient with known effect: sulfites, soya bean products and lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DOSULEPIN VIATRIS 75 mg tablets: 8.5 mm, normal, convex, red, film-coated tablet debossed “DT/75” on one side and “α” on the other. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Depression of any aetiology and the anxiety frequently associated with depressive illness. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE _ADULTS_ 75 mg daily in divided doses or as a single dose at night increasing to 150 mg daily. In certain circumstances, e.g. in hospital use, dosages up to 225 mg daily have been used. ELDERLY 50-75 mg daily initially. Half the normal adult dose may be sufficient to produce a satisfactory clinical response. _ADOLESCENTS_ Not recommended for use in adolescent patients 13-18 years of age for the treatment of depression, unless under the supervision of a specialist. _4.3_ _CONTRAINDICATIONS_ Dosulepin is contraindicated for the treatment of depression in patients 12 years of age and under. Dosulepin is contraindicated for the treatment of nocturnal enuresis. Epilepsy; seizure thresholds may be lowered by the medicine. Page 2 of 11 Tricyclic antidepressants should not be used concomitantly or within 14 days of treatment with MAOIs since the combination may cause cerebral excitation followed by coma and dangerous hyperthermia. Acute recovery phase following myocardial infarction; tricyclic antidepressants may produce conduction defects and arrhythmias. Hepatic failure. Hypersensitivity to dosulepin or to any of the excipients listed in section 6.1. _4.4_ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ Due to its toxicity in overdose, dosulepin should only be used in Läs hela dokumentet