Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluoxetine hydrochloride
DE Pharmaceuticals
N06AB03
Fluoxetine hydrochloride
10mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300
Eight important things you need to know about Fluoxetine capsules • Fluoxetine treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment. • Fluoxetine won’t work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better. See section 3,_ How to take Fluoxetine capsules_. • Fluoxetine is not for use in children and adolescents under 18. See Section 2,_ Children & adolescents aged 8 to_ _18 years_. • Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See Section 2,_ Thoughts of suicide_ _and worsening of your depression or anxiety disorder_. • Don’t stop taking Fluoxetine without talking to your doctor. If you stop taking Fluoxetine suddenly or miss a dose, you may get withdrawal effects. See Section 3,_ If you stop_ _taking Fluoxetine capsules_. • If you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing the dose of fluoxetine may make these feelings worse. See Section 4,_ Possible side-effects_. • Taking some other medicines with Fluoxetine can cause problems. You may need to talk to your doctor. See Section 2, _Other medicines and Fluoxetine capsules_. • If you are pregnant or planning to get pregnant, talk to your doctor. See section 2,_ Pregnancy, breast-feeding and fertility_. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribe Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluoxetine 10mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 10mg of fluoxetine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. The capsules are green opaque and printed ‘C28’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults: _ Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: Fluoxetine 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 Adults _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 undesirable effects at higher doses, in some patients, if after 2 weeks there is insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 60 m Belgenin tamamını okuyun