MAGRILAN Hard capsule (2021)

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Περιεχόμενα

1. Name of the medicinal product

Magrilan 20mg capsules.

2. Qualitative and quantitative composition

Each Magrilan 20mg capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine base. Excipients with known effect: lactose monohydrate, sunset yellow. Each 20 mg capsule contains ...

3. Pharmaceutical form

Hard capsule. Yellow-violet hard gelatine capsules, size 4.

4.1. Therapeutic indications

Adults Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: Magrilan is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. Children ...

4.2. Posology and method of administration

Posology Major depressive episodes Adults and 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 thereafter ...

4.3. 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. ...

4.4. 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 ...

4.5. 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., ...

4.6. 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 ...

4.7. Effects on ability to drive and use machines

Fluoxetine 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 ...

4.8. Undesirable effects

a. 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 ...

4.9. 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 ...

5.1. 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 ...

5.2. 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 ...

5.3. 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 ...

6.1. List of excipients

Violet/Yellow capsules: Lactose monohydrate Cellulose microcrystalline Magnesium stearate Capsule shell consisting of sunset yellow FCF (E110), titanium dioxide (E171), iron oxide yellow (E172), ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store below 25°C in the original package in order to protect from light and moisture

6.5. Nature and contents of container

PVC Al blisters. Boxes of 10, and 30 capsules. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

19891

9. Date of first authorization / renewal of the authorization

Date of first authorization: 28/12/2005 Date of Renewal of the Authorisation: 14/09/2011

10. Date of revision of the text

1/2021

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