PROZAC Hard capsules / Oral solution (2018)
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Περιεχόμενα
Name of the medicinal product
PROZAC 20mg hard capsules. PROZAC 20mg per 5ml oral solution.
Qualitative and quantitative composition
Each capsule contains 20 mg of fluoxetine (as fluoxetine hydrochloride). Each 5 ml of oral solution contains 20 mg of fluoxetine (as fluoxetine hydrochloride). Excipients with known effect: contains 3 ...
Pharmaceutical form
Hard capsules. The capsules are green and yellow, printed Lilly 3105. Oral solution. The solution is clear, colourless, mint odoured.
Therapeutic indications
Adults Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: PROZAC is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. Children and ...
Posology and method of administration
Posology Adults Major depressive episodes Adults and the elderly: The recommended dose is 20mg daily. Dosage should be reviewed and adjusted if necessary, within 3 to 4 weeks of initiation of therapy and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Fluoxetine is contra-indicated in combination with irreversible, non-selective monoamine oxidase inhibitors (e.g. ...
Special warnings and precautions for use
Paediatric population Children and adolescents under 18 years of age Suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour ...
Interaction with other medicinal products and other forms of interaction
Half-life: The long elimination half-lives of both fluoxetine and norfluoxetine should be borne in mind (see section 5.2) when considering pharmacodynamic or pharmacokinetic drug interactions (e.g. when ...
Fertility, pregnancy and lactation
Pregnancy Some epidemiological studies suggest an increased risk of cardiovascular defects associated with the use of fluoxetine during the first trimester. The mechanism is unknown. Overall the data suggest ...
Effects on ability to drive and use machines
Prozac has no or negligible influence on the ability to drive and use machines. Although fluoxetine has been shown not to affect psychomotor performance in healthy volunteers, any psychoactive drug may ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions in patients treated with fluoxetine were headache, nausea, insomnia, fatigue and diarrhoea. Undesirable effects may decrease in ...
Overdose
Symptoms Cases of overdose of fluoxetine alone usually have a mild course. Symptoms of overdose have included nausea, vomiting, seizures, cardiovascular dysfunction ranging from asymptomatic arrhythmias ...
Pharmacodynamic properties
Pharmacotherapeutic group: Selective serotonin reuptake inhibitors ATC code: N06AB03 Mechanism of action Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism ...
Pharmacokinetic properties
Absorption Fluoxetine is well absorbed from the gastro-intestinal tract after oral administration. The bioavailability is not affected by food intake. Distribution Fluoxetine is extensively bound to plasma ...
Preclinical safety data
There is no evidence of carcinogenicity or mutagenicity from in vitro or animal studies. Adult animal studies In a 2-generation rat reproduction study, fluoxetine did not produce adverse effects on the ...
List of excipients
The oral solution contains: Benzoic acid Sucrose Glycerine Mint flavour (containing 0.23% ethanol (alcohol)) Purified water The capsules contain: Maize starch flowable Dimeticone Capsule components: Patent ...
Incompatibilities
Not applicable.
Shelf life
<u>Capsules:</u> 3 years. <u>Oral solution:</u> 2 years.
Special precautions for storage
Do not store above 30°C. Oral solution: Store in the original bottle to protect from light.
Nature and contents of container
Capsules: PVC/aluminium blister packs of 2, 7, 12, 14, 20, 28, 30, 50, 56, 70, 98, 100 and 500 capsules. Oral solution: Brown glass bottles containing 60 ml, 70 ml or 140 ml oral solution. The pack may ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom
Marketing authorization number(s)
Capsules: PL 00006/0195 Oral solution: PL 00006/0272
Date of first authorization / renewal of the authorization
Capsules: Date of first authorisation: 25 November 1988 Date of latest renewal: 01 April 2013 Oral solution: Date of first authorisation: 28 October 1992 Date of latest renewal: 01 April 2013
Date of revision of the text
08 March 2018
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