Negara: Australia
Bahasa: Inggris
Sumber: 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
1 FLUOTEX 20MG CAPSULES _fluoxetine hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fluotex. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Fluotex against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT FLUOTEX IS USED FOR Fluotex is used to treat: • depression • obsessive compulsive disorder (OCD) • premenstrual dysphoric disorder (PMDD) ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FLUOTEX HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Fluotex for another reason. Fluotex 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. Fluotex is available only with a doctor's prescription. Fluotex is not recommended for use in children and adolescents under 18 years of age. BEFORE YOU TAKE FLUOTEX _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE FLUOTEX IF YOU ARE ALLERGIC TO • ANY MEDICINES CONTAINING FLUOXETINE • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE FLUOTEX IF YOU ARE TAKING ANOTHER MEDICINE FOR DEPRESSION CALLED A MONOAMINE OXIDASE INHIBITOR (MAOI) OR HAVE BEEN TAKING A MAOI WITHIN THE LAST 14 DAYS. CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU ARE UNSURE AS TO WHETHER OR NOT YOU ARE TAKING A MAOI. If you do take Fluotex while you are taking a MAOI, you may experience shaking (tremor), shivering, muscle stiffness, fever, rap Baca dokumen lengkapnya
1 AUSTRALIAN PRODUCT INFORMATION – FLUOTEX (FLUOXETINE HYDROCHLORIDE) CAPSULES 1 NAME OF THE MEDICINE Fluoxetine Hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each FLUOTEX capsule contains fluoxetine hydrochloride equivalent to 20 mg of fluoxetine. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM FLUOTEX 20MG CAPSULES: 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. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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. 2 4.2 D OSE AND METHOD OF ADMINISTRATION _*FLUOTEX is only available as a 20 mg capsule and therefore only appropriate for use in patients _ _prescribed ≥ 20 mg of fluoxetine. For patients requiring treatment with lower strengths of fluoxetine, _ _fluoxetine dispersible tablets are available from other brands. FLUOTEX 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/day s Baca dokumen lengkapnya