Prozac - Summary of Product Characteristics (SPC) by Eli Lilly and Company (Ireland) Limited. Fluoxetine 20 mg Hard Capsules - Summary of Product Characteristics (SPC) by Wockhardt UK Ltd.
Fluoxetine 2. 0 mg Capsules - Summary of Product Characteristics (SPC)Fluoxetine 2. Capsules. Each capsule contains Fluoxetine 2. Fluoxetine Hydrochloride. For the full list of excipients, see section 6. Hard Capsule. Light green opaque / standard yellow opaque, size `3', hard gelatin capsules with imprinting “BJ” on cap and “F2.
Adults: Major Depressive Episodes: Fluoxetine is indicated for the treatment of the symptoms of major depressive illness, with or without associated anxiety symptoms, especially where sedation is not required. 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. Posology. Adults. Major Depressive Episodes– Adults and the elderly: A dose of 2. 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 2.
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: A dose of 2.
Although there may be an increase in the potential of side- effects at higher doses, in some patients, if after two weeks there is insufficient response to 2. If no improvement is observed within 1.
Identification; Name: Cholecalciferol: Accession Number: DB00169 (NUTR00008, APRD00506) Type: Small Molecule: Groups: Approved, Nutraceutical: Description: Derivative. Fluoxetine 20 mg Capsules - Summary of Product Characteristics (SPC) by Accord Healthcare Limited.
Thoraxruimte als blaasbalg. De thoraxruimte of borstholte is de ruimte tussen de wervelzuil, de ribben, het sternum of borstbeen en onderaan het diafragma.
If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. While there are no systematic studies to answer the question of how long to continue fluoxetine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 1. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose.
The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioural psychotherapy for patients who have done well on pharmacotherapy. Long- term efficacy (more than 2. OCD. Bulimia nervosa: Adults and the elderly: A dose of 6. Long- term efficacy (more than 3 months) has not been demonstrated in bulimia nervosa.
All indications: The recommended dose may be increased or decreased. Doses above 8. 0mg/day have not been systematically evaluated. Paediatric population - Children and adolescents aged 8 years and above (moderate to severe major depressive episode): Treatment should be initiated and monitored under specialist supervision. The starting dose is 1. Fluoxetine oral solution. Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose. After one to two weeks, the dose may be increased to 2.
Clinical trial experience with daily doses greater than 2. There is only limited data on treatment beyond 9 weeks. Lower- weight children: Due to higher plasma levels in lower- weight children, the therapeutic effect may be achieved with lower doses (see section 5. For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed. If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered. Elderly patients: Caution is recommended when increasing the dose, and the daily dose should generally not exceed 4. Maximum recommended dose is 6.
Patients with hepatic impairment. A lower or less frequent dose (eg, 2.
Withdrawal symptoms seen on discontinuation of fluoxetine: Abrupt discontinuation should be avoided. When stopping treatment with fluoxetine the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section 4. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. Method of administration. For oral administration.
Fluoxetine may be administered as a single or divided dose, during or between meals. When dosing is stopped, active drug substances will persist in the body for weeks.
The capsule and oral solution forms are bioequivalent. Hypersensitivity to the active substance or to any of the excipients listed in section 6.
Fluoxetine is contra- indicated in combination with metoprolol used in cardiac failure (see section 4. Fluoxetine is contra- indicated in combination with irreversible, non- selective monoamine oxidase inhibitors (e. Paediatric population - Children and adolescents under 1. Suicide- related behaviours (suicidal attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. Fluoxetine should only be used in children and adolescents aged 8 to 1.
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, only limited evidence is available concerning long- term effect on safety in children and adolescents, including effects on growth, sexual maturation and cognitive, emotional and behavioural developments (see section 5. In a 1. 9- week clinical trial, decreased height and weight gain was observed in children and adolescents treated with fluoxetine (see section 5. It has not been established whether there is an effect on achieving normal adult height. The possibility of a delay in puberty cannot be ruled out (see sections 5.
Growth and pubertal development (height, weight, and TANNER staging) should therefore be monitored during and after treatment with fluoxetine. If either is slowed, referral to a paediatrician should be considered. In paediatric trials, mania and hypomania were commonly reported (see section 4. Therefore, regular monitoring for the occurrence of mania/hypomania is recommended. Fluoxetine should be discontinued in any patient entering a manic phase.
It is important that the prescriber discusses carefully the risks and benefits of treatment with the child/young person and/or their parents. Suicide/suicidal thoughts or clinical worsening. Depression is associated with an increased risk of suicidal thoughts, self- harm and suicide (suicide- related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which fluoxetine is prescribed can also be associated with an increased risk of suicide- related events.
Upon the appearance of rash or of other allergic phenomena for which an alternative aetiology cannot be identified, fluoxetine should be discontinued. Seizures: Seizures are a potential risk with antidepressant drugs. Therefore, as with other antidepressants, fluoxetine should be introduced cautiously in patients who have a history of seizures. Treatment should be discontinued in any patient who develops seizures or where there is an increase in seizure frequency.
Fluoxetine should be avoided in patients with unstable seizure disorders/epilepsy and patients with controlled epilepsy should be carefully monitored (see section 4. Mania: Antidepressants should be used with caution in patients with a history of mania/hypomania.
As with all antidepressants, fluoxetine should be discontinued in any patient entering a manic phase. Hepatic/Renal function: Fluoxetine is extensively metabolised by the liver and excreted by the kidneys. A lower dose, e. g., alternate day dosing, is recommended in patients with significant hepatic dysfunction. When given fluoxetine 2. GFR < 1. 0ml/min) requiring dialysis showed no difference in plasma levels of fluoxetine or norfluoxetine compared to controls with normal renal function. Tamoxifen: Fluoxetine, a potent inhibitor of CYP2. D6, may lead to reduced concentrations of endoxifen, one of the most important active metabolites of tamoxifen.
Therefore, fluoxetine should whenever possible be avoided during tamoxifen treatment (see section 4. Cardiovascular Effects: Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post- marketing period (see sections 4. Fluoxetine should be used with caution in patients with conditions such as congenital long QT syndrome, a family history of QT prolongation or other clinical conditions that predispose to arrhythmias (e. QT prolongation and/or torsade de points (see section 4. If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started.
If signs of cardiac arrhythmia occur during treatment with fluoxetine, the treatment should be withdrawn and an ECG should be performed. Weight loss: Weight loss may occur in patients taking fluoxetine, but it is usually proportional to baseline body weight.
Diabetes: In patients with diabetes, treatment with an SSRI may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.