Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
citalopram hydrobromide, Quantity: 24.99 mg (Equivalent: citalopram, Qty 20 mg)
Arrotex Pharmaceuticals Pty Ltd
citalopram hydrobromide
Tablet, film coated
Excipient Ingredients: purified water; macrogol 400; microcrystalline cellulose; purified talc; croscarmellose sodium; lactose monohydrate; hypromellose; titanium dioxide; magnesium stearate; maize starch; pregelatinised maize starch
Oral
500, 28
(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, & '20' on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-03-05
APO-CITALOPRAM TABLETS 1 APO-CITALOPRAM TABLETS _Contains the active ingredient citalopram (as citalopram hydrobromide) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR APO-Citalopram contains the active ingredient citalopram (as citalopram hydrobromide). It is used to treat depression. Citalopram belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Citalopram and other SSRIs are thought to help by increasing the amount of serotonin in your brain. 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. D Izlasiet visu dokumentu
1 AUSTRALIAN PRODUCT INFORMATION APO- CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLETS 1 NAME OF THE MEDICINE Citalopram hydrobromide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION APO-CITALOPRAM 20 MG: Each tablet contains 20 mg of citalopram, as the active ingredient. APO-CITALOPRAM 40 MG: Each tablet contains 40 mg of citalopram, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM APO-CITALOPRAM 20 MG: White to off-white, oval, biconvex, film-coated tablets, with BL embossed on one side and '20' on the other. APO-CITALOPRAM 40 MG: White to off-white, oval, biconvex, film coated tablets with '40' embossed on one and 'BL' embossed on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depression. 4.2 DOSE AND METHOD OF ADMINISTRATION Citalopram tablets are intended for oral administration. DOSAGE 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 2 result in general can be evaluated only after 2–3 weeks' treatment, a possible dose increase should take place with intervals of 2–3 weeks. 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. CHILDREN AND ADOLESCENTS (< 18 YEARS OF AGE) The efficacy and safety of citalopram for the treatment of major depressive disorder have not been established in children and adolescents under the age of 18 years. Consequently, citalopram should not be used in children and adolescents less than 18 years of age. HEPATIC IMPAIRMENT An initial dose of 10 mg daily for Izlasiet visu dokumentu