Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
citalopram hydrobromide, Quantity: 49.98 mg (Equivalent: citalopram, Qty 40 mg)
Arrotex Pharmaceuticals Pty Ltd
citalopram hydrobromide
Tablet, film coated
Excipient Ingredients: titanium dioxide; croscarmellose sodium; purified water; maize starch; magnesium stearate; macrogol 400; hypromellose; lactose monohydrate; pregelatinised maize starch; purified talc; microcrystalline cellulose
Oral
56, 28, 14, 7, 84
(S4) Prescription Only Medicine
Treatment of major depression
Visual Identification: White to off white, oval, biconvex, film coated tablets with BL embossed on one side, & '40' on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-05-07
TALAM – Consumer Medicine Information Page 1 of 8 Talam citalopram hydrobromide CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Talam. 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 taking Talam against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT TALAM IS USED FOR Talam contains the active ingredient citalopram (as citalopram hydrobromide) and is used to treat depression. It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). SSRIs are thought to work by their action on brain chemicals called amines which are involved in controlling mood. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TALAM HAS BEEN PRESCRIBED FOR YOU. Depression is longer lasting and/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 corrects this chemical imbalance and may help relieve the symptoms of depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. There is no evidence that this medicine is addictive. However, if you suddenly stop taking it, you may get side effects. This medicine is available only with a doctor's prescription. DO NOT GIVE THIS MEDICINE TO A CHILD OR AD Lees het volledige document
1 AUSTRALIAN PRODUCT INFORMATION TALAM (CITALOPRAM HYDROBROMIDE) TABLET 1 NAME OF THE MEDICINE Citalopram hydrobromide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Talam tablets contain 10 mg, 20 mg or 40mg of citalopram (as hydrobromide). Excipient with known effect: sugars as lactose monohydrate. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM _TALAM 10MG: _White to off-white, round, plain film-coated tablets containing 10mg citalopram (as hydrobromide). _TALAM 20MG_: White oval film-coated tablet containing 20 mg citalopram (as hydrobromide), marked C, scoreline, A on one side and blank on the other. _TALAM 40MG: _White to off-white, oval, biconvex film-coated tablets containing 40mg citalopram (as hydrobromide), with ‘BL’ embossed on one side and ‘40’ on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of major depression. 4.2 D OSE AND METHOD OF ADMINISTRATION Citalopram should be administered as a single daily dose. The dose may be taken in the morning or evening without regard for food. ADULTS: The starting dose is 20 mg/day. The dose can be increased in increments of 10 mg until satisfactory clinical response is achieved. The maximum dose is 40 mg/day. As the treatment result in general can be evaluated only after two to three weeks' treatment, possible dose increases should take place at intervals of two to three weeks. 2 ELDERLY PATIENTS: The starting dose is 10 mg/day. The dose can be increased by 10 mg to a maximum of 20 mg/day. As the treatment result in general can be evaluated only after 2-3 weeks’ treatment, a possible dose increase should take place after an interval of 2-3 weeks. REDUCED HEPATIC FUNCTION: An initial dose of 10 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. The maximum recommended dosage is 20 mg/day. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function. REDUCED RENAL FUNCTION: Dosage adjus Lees het volledige document