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SPC, UK: Anafranil Capsules (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Novartis Pharmaceuticals UK Ltd
Διεύθυνση :
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
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Name of the medicinal product

Anafranil 10mg, 25mg and 50mg capsules.

Qualitative and quantitative composition

Chemical name: 3-chloro-5-[3-(dimethylamino)propyl] 10, 11 dihydro-5H-dibenz [b,f] azepine hydrochloride (= clomipramine hydrochloric). Anafranil 10mg capsules: Each capsule contains 10mg clomipramine ...

Pharmaceutical form

Capsule.

Therapeutic indications

Adults Symptoms of depressive illness especially where sedation is required. Obsessional and phobic states. Adjunctive treatment of cataplexy associated with narcolepsy. Children and Adolescents In children ...

Posology and method of administration

Before initiating treatment with Anafranil, hypokalemia should be treated (see 4.4. Special warnings and precautions for use). After a response has been obtained, maintenance therapy should be continued ...

Contraindications

Known hypersensitivity to clomipramine, or any of the excipients or cross-sensitivity to tricyclic antidepressants of the dibenzazepine group. Recent myocardial infarction. Any degree of heart block or ...

Special warnings and precautions for use

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 ...

Interaction with other medicinal products and other forms of interaction

Interactions resulting in a contraindication MAO inhibitors Do not give Anafranil for at least 3 weeks after discontinuation of treatment with MAO inhibitors (there is a risk of severe symptoms consistent ...

Pregnancy and lactation

There is inadequate evidence of safety of Anafranil in human pregnancy. Do not use unless there are compelling reasons, especially during the first and last trimesters. Animal work has not shown clomipramine ...

Effects on ability to drive and use machines

Patients receiving Anafranil should be warned that blurred vision, drowsiness and other nervous system and psychiatric related disorders such as somnolence, disturbance in attention, confusion, disorientation, ...

Undesirable effects

Unwanted effects are usually mild and transient, disappearing under continued treatment or with a reduction in the dosage. They do not always correlate with plasma drug levels or dose. It is often difficult ...

Overdose

The signs and symptoms of overdose with Anafranil are similar to those reported with other tricyclic antidepressants. Cardiac abnormalities and neurological disturbances are the main complications. In ...

Pharmacodynamic properties

Pharmacotherapeutic group: Tricyclic antidepressant. Noradrenaline and preferential serotonin- reuptake inhibitor (non selective monoamine reuptake inhibitors) ATC code: N06AA04 Mechanism of action The ...

Pharmacokinetic properties

Absorption The active substance is completely absorbed following oral administration and intramuscular injection. The systemic bioavailability of unchanged clomipramine is reduced by 50% by first-pass ...

Preclinical safety data

None stated.

List of excipients

Lactose Gelatin (220 Bloom) Magnesium stearate Yellow iron oxide (E172) Black iron oxide (E172) Red iron oxide (E172) Titanium dioxide Brown printing ink

Incompatibilities

Not applicable.

Shelf life

60 months.

Special precautions for storage

Protect from moisture. Store below 30°C.

Nature and contents of container

10mg Capsules The capsules are two tone brownish-caramel cap/greyish yellow body, hard gelatin size 4, imprinted Geigy and come in PVC/PVDC/aluminium blister packs in pack sizes of 84 and 100. 25mg Capsules ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Novartis Pharmaceuticals UK Limited Trading as: Geigy Pharmaceuticals Frimley Business Park Frimley Camberley Surrey GU16 7SR

Marketing authorization number(s)

10mg: PL 00101/0438 25mg: PL 00101/0439 50mg: PL 00101/0440

Date of first authorization / renewal of the authorization

04 July 1997 / 26 February 2009

Date of revision of the text

10 July 2012