Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
fluoxetine hydrochloride
Eli Lilly Australia Pty Ltd
Registered
LOVAN _contains the active ingredient fluoxetine (hydrochloride)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LOVAN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking LOVAN against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT LOVAN IS USED FOR LOVAN is used to treat • depression • obsessive compulsive disorder (OCD) • premenstrual dysphoric disorder (PMDD). LOVAN 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LOVAN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed LOVAN for another reason. LOVAN is available only with a doctor's prescription. LOVAN is not recommended for use in children and adolescents under 18 years of age. BEFORE YOU TAKE LOVAN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE LOVAN IF YOU ARE ALLERGIC TO: • any medicines containing fluoxetine (such as Prozac and Zactin) • 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 LOVAN 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 LOVAN while you are taking a MAOI, you may experience shaking (tremor), shivering, muscle stiffness, fever, rapid pu Read the complete document
AUSTRALIAN PRODUCT INFORMATION LOVAN _Fluoxetine hydrochloride _ 1 NAME OF THE MEDICINE Fluoxetine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LOVAN CAPSULE Each Lovan capsule contains fluoxetine hydrochloride equivalent to 20 mg (64.7 moles) of fluoxetine. LOVAN TAB Each Lovan Tab contains fluoxetine hydrochloride equivalent to 20 mg (64.7 moles) of fluoxetine. Excipients with known effect: saccharin. LOVAN LIQUID Lovan Liquid contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 µmoles) of fluoxetine. Excipients with known effect: benzoates and sugars . For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Lovan 20 mg : Bright green capsules printed 20 in black ink on the cap. Lovan Tab 20 mg : White oval dispersible tablet marked 4400 on one side and scored on the reverse. Lovan Liquid 20 mg/5 mL : Clear, colourless, mint flavoured oral solution. Available in bottles of 35 mL, 70 mL or 140 mL. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lovan 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. 4.2 DOSE AND METHOD OF ADMINISTRATION Lovan – PRODUCT INFORMATION 2 Lovan capsules should be swallowed whole. Lovan Read the complete document