Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Citalopram hydrobromide 24.99mg equivalent to citalopram 20 mg; ;
PSM Healthcare Ltd trading as API Consumer Brands
Citalopram hydrobromide 24.99 mg (equivalent to citalopram 20 mg)
20 mg
Film coated tablet
Active: Citalopram hydrobromide 24.99mg equivalent to citalopram 20 mg Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Purified water Titanium dioxide
Blister pack, PVDC coated PVC/aluminium foil - 28 tablets, 28 tablets
Prescription
Prescription
Zhejiang Huahai Pharmaceutical Co Ltd
Treatment of depressive illness in the initial phase and as maintenance against potential relapse or recurrence.
Package - Contents - Shelf Life: Blister pack, PVDC coated PVC/aluminium foil - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC coated PVC/aluminium foil - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC coated PVC/aluminium foil - 84 tablets - 36 months from date of manufacture stored at or below 25°C
2004-09-27
NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI) 1 | P a g e CITALOPRAM, TABLETS, FILM-COATED, 20 MG _Citalopram hydrobromide _ _ _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Citalopram, tablets, film- coated, 20 mg. This leaflet answers some common questions about Citalopram, tablets, film-coated, 20 mg. It does not contain all the available information. 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 using Citalopram, tablets, film-coated, 20 mg 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 WITH THE MEDICINE. You may need to read it again. WHAT IT IS USED FOR Citalopram, tablets, film-coated, 20 mg is used to treat depression. It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are thought to work by their actions on brain chemicals called amines which are involved in controlling mood. Depression is longer lasting or more severe than the "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can 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. Citalopram, tablets, film-coated, 20 mg corrects this chemical imbalance and may help relieve the symptoms of depression. Your doctor may have prescribed Citalopram, tablets, film-coated, 20 mg for another reason. _ _ NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI) 2 | P a g e ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CITALOPRAM, TABLETS, FILM- COATED, 20 MG HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a Baca dokumen lengkap
NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 1 of 27 1. PRODUCT NAME Citalopram, tablets, film-coated, 20 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Each film-coated tablet contains 24.99 mg citalopram hydrobromide Ph. Eur. corresponding to 20 mg of citalopram base. Citalopram hydrobromide is a fine white to off-white, crystalline material. Sparingly soluble in water, soluble in ethanol (96%), freely soluble in chloroform and very slightly soluble in diethyl ether. No polymorphic forms have been detected. Excipient(s) with known effect For the full list of excipients, see section 6.1. The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not receive this medicine (also _refer Section 4.4 Special warnings and precautions_). 3. PHARMACEUTICAL FORM Oral, film-coated tablets Presentation White to off-white, oval, biconvex, film-coated tablets with break-line on one side & ‘20’ embossed on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications _Adults _ Treatment of depressive illness in the initial phase and as maintenance against potential relapse or recurrence. 4.2 Dose and method of administration The dose may be taken in the morning or evening without regard for food. As the treatment result in general can be evaluated only after 2-3 weeks' treatment, a possible dose increase in increments of 10mg should take place with intervals of 2-3 weeks. _Adults _ Should be administered as a single oral dose of 20mg daily. Dependent on individual patient response and severity of depression the dose may be increased to a maximum of 40mg NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 2 of 27 daily. The maximum daily dose of citalopram should not exceed 40mg/day as doses above 40mg/day are associated with an increased risk of QT prolongation. A maximum dose of 20mg/day is recommended for patients known to be CYP2C19 poor metabolisers o Baca dokumen lengkap