País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
citalopram hydrobromide, Quantity: 24.99 mg (Equivalent: citalopram, Qty 20 mg)
AVALLON PHARMACEUTICALS PTY LTD
Tablet, film coated
Excipient Ingredients: maize starch; microcrystalline cellulose; glycerol; hypromellose; titanium dioxide; lactose monohydrate; sodium starch glycollate; magnesium stearate; copovidone; purified talc; macrogol 6000
Oral
28 tablets
(S4) Prescription Only Medicine
Treatment of major depression.
Visual Identification: White, oblong, biconvex, film-coated tablets, scored on one side and embossed 'C20'; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2018-02-26
NOUMED CITALOPRAM 1 NOUMED CITALOPRAM _citalopram hydrobromide tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Noumed Citalopram. 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 NOUMED CITALOPRAM IS USED FOR This medicine is used for the treatment of depression. It contains the active ingredient citalopram hydrobromide. Citalopram hydrobromide 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 sexual drive, lack of energy and feeling guilty over nothing. Noumed 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 it for another reason. This medicine is available only with a doctor's prescription. Noumed Citalopram is not addictive. However, if you suddenly stop taking it, you may get side effects. TELL YOUR DOCTOR IF YOU GET ANY SIDE EFFECTS AFTER STOPPING NOUMED CITALOPRAM. BEFORE YOU TAKE NOUMED CITALOPRAM _ Llegiu el document complet
Product Information - Australia Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION – NOUMED CITALOPRAM (CITALOPRAM) 1. NAME OF THE MEDICINE Citalopram hydrobromide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Noumed Citalopram tablet contain 20 mg or 40 mg citalopram (as hydrobromide). Excipients with known effect: lactose monohydrate For the full list of excipients, see _section 6.1 List of excipients_. 3. PHARMACEUTICAL FORM Noumed Citalopram 20 mg tablets - oval, white, biconvex film-coated tablets with a score notch on one side, and embossed C 20. Noumed Citalopram 40 mg tablets - oval, white, biconvex film-coated tablets with a one-sided notch and embossment C 40. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depression. 4.2 DOSE AND METHOD OF ADMINISTRATION Noumed 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 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 safety and efficacy of citalopram for the treatment of major depressive disorder have not been established in this population. Citalopram should not be used in children and adolescents under the age of 18 years. REDUCED HEPATIC FUNCTION The maximum recommended dose is 20 mg/day. REDUCED RENAL FUNCTION Dosage adjustment is not necessary in patients with mild or moderate renal impairment. No information is available on treatment of patients with severely reduced Llegiu el document complet