Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Generics (UK) Limited
N06AB03
FLUOXETINE HYDROCHLORIDE
20 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
fluoxetine
Marketed
1999-02-19
1. What Gerozac is and what it is used for 2. What you need to know before you take Gerozac 3. How to take Gerozac 4. Possible side effects 5. How to store Gerozac 6. Contents of the pack and other information. Gerozac 20 mg Capsules, Hard What is in this leaflet 1. What Gerozac is and what it is used for The name of your medicine is Gerozac 20 mg Capsules, hard. It contains the active substance fluoxetine. Gerozac belongs to a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants. Gerozac can be given to treat the following conditions: Adults: • Major depressive episodes • The symptoms of a condition called obsessive-compulsive disorder (OCD) • The eating disorder bulimia nervosa. This medicine is used alongside psychotherapy for the reduction of binge-eating and purging. Children and adolescents aged 8 years and above: • Moderate to severe major depressive disorder, if the depression does not respond to psychological therapy after 4-6 sessions. Gerozac should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy. 2. What you need to know before you take Gerozac Do not take Gerozac: • if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately. • if you are taking the medicine metoprolol, used to treat heart failure • if you are taking medicines known specifically as irreversible, non-selective monoamine oxidase inhibitors (MAOIs) since serious or even fatal reactions can occur. An example of such a medicine is ipronazid, which is used to treat depression. Treatment with fluoxetine should only be started two weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). Do not take any MAOIs for at least 5 weeks after stopping fluoxetine Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gerozac 20 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg fluoxetine as fluoxetine hydrochloride. Excipient with known effect Each capsule contains 139.64 mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard A hard gelatin capsule with a light green opaque body and a purple opaque cap; printed “FL20” on the body and “ ” on the cap in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults:_ Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: Gerozac is indicated as a complement of psychotherapy 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 _Major depressive episodes:_ Adults and the elderly: The recommended dose is 20 mg daily. 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 20 mg, the dose may be increased gradually up to a maximum of 60 mg (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. _Obsessive-compulsive disorder:_ Adults and the elderly: The recommended dose is 20 mg daily. Although there may be an increased potential for H E A L T H P R O D U C T S R E G U L A Aqra d-dokument sħiħ