País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
fluoxetine hydrochloride, Quantity: 22.35 mg (Equivalent: fluoxetine, Qty 20 mg)
Micro Labs 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
FLUOXETINE MLABS is indicated for the treatment of:,Major depression.,Obsessive Compulsive Disorder.,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 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2017-02-23
FLUOXETINE MLABS 1 FLUOXETINE MLABS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING FLUOXETINE MLABS? FLUOXETINE MLabs contains the active ingredient fluoxetine hydrochloride. FLUOXETINE MLabs is used to treat depression, obsessive compulsive disorder (OCD) and premenstrual dysphoric disorder (PMDD). For more information, see Section 1. Why am I using FLUOXETINE MLabs? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FLUOXETINE MLABS? Do not use if you have ever had an allergic reaction to fluoxetine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use FLUOXETINE MLabs? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FLUOXETINE MLabs and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE FLUOXETINE MLABS? Your doctor will tell you how much FLUOXETINE MLabs you need to take each day. More instructions can be found in Section 4. How do I use FLUOXETINE MLabs? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING FLUOXETINE MLABS? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are taking FLUOXETINE MLabs. Tell your doctor immediately if you become pregnant while taking FLUOXETINE MLabs. Tell your doctor immediately if you have thoughts about harming or killing yourself THINGS YOU SHOULD NOT DO Do not stop using this medicine suddenly or lower the dosage without checking with your doctor. Do not take the herbal remedy St. John’s Wort while you are being treated with FLUOXETINE MLabs. Do not give FLUOXETINE MLabs to anyone else, even if they have the same condition Leia o documento completo
FLUOXETINE MLABS 1 AUSTRALIAN PRODUCT INFORMATION FLUOXETINE MLABS 20 MG (FLUOXETINE HYDROCHLORIDE) CAPSULES 1. NAME OF THE MEDICINE Fluoxetine Hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FLUOXETINE MLABS capsules contains fluoxetine hydrochloride equivalent to 20 mg of fluoxetine. For a full list of excipients, See section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM 20 mg fluoxetine (present as the hydrochloride) 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 THERAPEUTIC INDICATIONS FLUOXETINE MLabs is indicated for 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. 4.2 DOSE AND METHOD OF ADMINISTRATION _*Fluoxetine MLabs 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. _ Fluoxetine MLabs capsules should be swallowed whole. FLUOXETINE MLABS 2 DEPRESSION: A dose of 20 mg/day, administered in the morning, is the usual recommended initial d Leia o documento completo