Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
fluoxetine hydrochloride, Quantity: 22.36 mg (Equivalent: fluoxetine, Qty 20 mg)
Eli Lilly Australia Pty Ltd
Capsule, hard
Excipient Ingredients: iron oxide yellow; titanium dioxide; pregelatinised maize starch; Gelatin; dimeticone 350; patent blue V; indigo carmine; butan-1-ol; Shellac; iron oxide black
Oral
28, 7 sample
(S4) Prescription Only Medicine
Prozac is indicated for the treatment of: Major depression. Obsessive Complusive Disorder. Premenstrual Dysphoric Disorder (PMDD) as defined by DMV-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: A size 3 capsule with an opaque green cap and an opaque yellow body. Imprinted with "LILLY 3105".; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-05
PROZAC ® v4.0 1 PROZAC ® _fluoxetine hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PROZAC. 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 PROZAC 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 PROZAC IS USED FOR PROZAC is used to treat: • depression • obsessive compulsive disorder (OCD) • premenstrual dysphoric disorder (PMDD) ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PROZAC HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed PROZAC for another reason. PROZAC 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. PROZAC is available only with a doctor's prescription. PROZAC is not recommended for use in children and adolescents under 18 years of age. BEFORE YOU TAKE PROZAC _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PROZAC 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 PROZAC 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 PROZAC while you are taking a MAOI, you may experience shaking (tremor), shivering, muscle stiffness, fever, rapid pulse, rap Lees het volledige document
AUSTRALIAN PRODUCT INFORMATION vA13-18Jun21 SUPERSEDES: vA12-6May20 Page 1 of 23 PROZAC (FLUOXETINE HYDROCHLORIDE) TABLETS, CAPSULES AND ORAL LIQUIDS 1. NAME OF THE MEDICINE Fluoxetine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PROZAC TABLETS (_NOT AVAILABLE IN AUSTRALIA_) Fluoxetine 20 mg (present as the hydrochloride). Excipients with known effect: Prozac tablets contain saccharin. PROZAC CAPSULES Fluoxetine 20 mg fluoxetine (present as the hydrochloride). PROZAC LIQUID (_NOT AVAILABLE IN AUSTRALIA_) Fluoxetine 20 mg/5 mL (present as the hydrochloride). Excipients with known effect: Prozac liquid contains sugars (as sucrose) and benzoate. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM TABLETS PROZAC 20 mg tablets are white, elongated, scored dispersible tablets embossed with “4400”. CAPSULES PROZAC 20 mg capsules have an opaque green cap and opaque yellow body. Imprinted with “Lilly 3105”. LIQUID (_NOT AVAILABLE IN AUSTRALIA_) PROZAC Liquid is a clear, colourless, mint flavoured oral solution (M-5120). vA13-18Jun21 SUPERSEDES: vA12-6May20 Page 2 of 23 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PROZAC 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 Lees het volledige document