Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
fluoxetine hydrochloride, Quantity: 22.35 mg (Equivalent: fluoxetine, Qty 20 mg)
Arrotex Pharmaceuticals Pty Ltd
Fluoxetine hydrochloride
Capsule, hard
Excipient Ingredients: pregelatinised maize starch; Shellac; ethanol absolute; iron oxide black; butan-1-ol; isopropyl alcohol; propylene glycol; purified water; titanium dioxide; brilliant blue FCF; iron oxide yellow; Gelatin; sodium lauryl sulfate
Oral
PVC/PVdC/Aluminium blister pack of 28 (14'sx2) capsules in carton
(S4) Prescription Only Medicine
Treatment of Major depression. Treatment of Obsessive Compulsive Disorder. Treatment of Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria.,The essential features of PMDD, according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others.
Visual Identification: Green/Off-white hard gelatin self locked capsules of size '2' imprinted with 'FLX' and 'MIL' on cap/body in black edible ink containing white powder.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 42 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-02-23
FLUOXETINE APOTEX CAPSULES 1 FLUOXETINE APOTEX CAPSULES _Fluoxetine (as fluoxetine hydrochloride) _ 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 fluoxetine. 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 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 your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Fluoxetine APOTEX. It contains the active ingredient fluoxetine (as fluoxetine hydrochloride). Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Serotonin is one of the chemicals in your brain which helps control your mood. Fluoxetine and other SSRIs are thought to help by increasing the amount of serotonin in your brain. Fluoxetine is used to treat: • depression • obsessive compulsive disorder (OCD) • premenstrual dysphoric disorder (PDD) 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. Fluoxetine corrects this chemical imbalance and may help relieve the symptoms of depression. Check with your doctor if you need more information about obsessive compulsive disorder (OCD). The symptoms of OCD vary from patient to patient. This medicine is not expected Lue koko asiakirja
AUSTRALIAN PRODUCT INFORMATION FLUOXETINE APOTEX (FLUOXETINE HYDROCHLORIDE) 1 NAME OF THE MEDICINE Fluoxetine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg fluoxetine (as hydrochloride). For a full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Green/off-white hard gelatin, self-locked, size 2 capsule imprinted with 'FLX' and 'MIL' on cap/body in black edible ink, containing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluoxetine is indicated for treatment of – • major depression • Obsessive Compulsive Disorder (OCD) • Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria. The essential features of PMDD, according to the Diagnostic and Statistical Manual – 4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. 4.2 DOSE AND METHOD OF ADMINISTRATION _* This medicine is only available as a 20 mg capsule and therefore only appropriate for use in _ _patients prescribed ≥ 20 mg fluoxetine. For patients requiring treatment with lower doses of _ _fluoxetine, fluoxetine dispersible tablets are available in other brands. _ This medicine is an antidepressant for oral administration; capsules should be swallowed whole. DEPRESSION A dose of 20 mg/day, administered in the morning, is the usual recommended initial dose. If no clinical improvement is observed, a dose increase may be considered after several weeks. Doses above 20 mg/da Lue koko asiakirja