Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluoxetine hydrochloride
Relonchem Ltd
N06AB03
Fluoxetine hydrochloride
20mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300; GTIN: 5055144200644
FLUOXETINE 20 MG CAPSULES Fluoxetine Hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER Medicines like Fluoxetine Capsules (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. THOUGHTS OF SUICIDE AND WORSENING OF YOUR DEPRESSION OR ANXIETY DISORDER If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting anti-depressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: • If you have previously had thoughts about killing or harming yourself. • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an anti-depressant. If you have thoughts of harming or killing yourself at any time, CONTACT YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY. YOU MAY FIND IT HELPFUL TO TELL A RELATIVE OR CLOSE FRIEND that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse or if they are worried about changes in your behaviour. Use in children and adolescents aged 8 to 18 years: Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Fluoxetine Capsules should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychological therapy) and it should not be used to treat other conditions. Additionally, only limited information concerning the long-term safety of Fluoxetine Capsules on growth, puberty, mental, emotional and behavioural development in th Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluoxetine 20mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Fluoxetine 20 mg as Fluoxetine Hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Size 3. Capsule cap is light green opaque. Capsule body is standard yellow opaque. Markings are "F20". 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS: _Depression: _Fluoxetine is indicated for the treatment of the symptoms of Major depressive episodes, with or without associated anxiety symptoms, especially where sedation is not required. _Obsessive-compulsive disorder. _ _Bulimia nervosa: _Fluoxetine is indicated for the reduction of binge-eating and purging activity. _ _ CHILDREN AND ADOLESCENTS AGED 8 YEARS AND ABOVE: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Fluoxetine capsules are meant for oral administration in adults only. The capsules should be swallowed whole with a glass of water. _ _ _Adults _ _ _ _Major depressive disorders/episodes _ _Adults and the elderly_: A dose of 20 mg/day is recommended. Dosage should be reviewed and adjusted if necessary, within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg (see section 5.1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. _ _ Soma hati kamili