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DANOL 100mg Capsule, hard (2019)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης SANOFI
Διεύθυνση 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Περιεχόμενα

Name of the medicinal product

Danol 100mg Capsules.

Qualitative and quantitative composition

Each capsule contains 100mg of danazol. Also contains 62 mg of lactose monohydrate. For a full list of excipients, see section 6.1.

Pharmaceutical form

Capsule, hard. Capsule with a grey cap and opaque white body containing a white or almost white powder, with D100 printed in black ink.

Therapeutic indications

Danol capsules are recommended for the treatment of: Endometriosis: treatment of endometriosis-associated symptoms or/and to reduce the extent of endometriosis foci. Danazol may be used either in conjunction ...

Posology and method of administration

Adults Danol capsules should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patients response. A reduction in dosage once a satisfactory response ...

Contraindications

Pregnancy Breast feeding Markedly impaired hepatic, renal or cardiac function Porphyria Active thrombosis or thromboembolic disease and a history of such events Androgen dependent tumour Undiagnosed abnormal ...

Special warnings and precautions for use

Special warnings In the event of virilisation, Danol should be withdrawn. Androgenic reactions generally prove reversible, but continued use of Danol after evidence of androgenic virilisation increases ...

Interaction with other medicinal products and other forms of interaction

__Anti-convulsant therapy: __Danol may affect the plasma level of carbamazepine and possibly the patients response to this agent and to phenytoin. With phenobarbital it is likely that similar interaction ...

Fertility, pregnancy and lactation

There is epidemiological and toxicological evidence of hazard in human pregnancy. Danazol is known to be associated with the risk of virilisation to the female foetus if administered during human pregnancy. ...

Effects on ability to drive and use machines

Danol has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Blood and lymphatic system disorders: Increase in red cell and platelet count. Reversible polycythaemia, leucopoenia, thrombocytopenia, eosinophilia and splenic peliosis. Endocrine disorders: Androgenic ...

Overdose

Available evidence suggests that acute overdosage would be unlikely to give rise to immediate serious reaction. In the case of acute overdose consideration should be given to reducing the absorption of ...

Pharmacodynamic properties

Pharmacotherapeutic group: sex hormones and modulators of the genital system, antigonadotropins and similar agents ATC code: G03XA01 Danazol, 17a-pregna-2,4-dien-20-yno(2,3-d)-isoxazol-17-ol, is a synthetic ...

Pharmacokinetic properties

Danazol is absorbed from the gastrointestinal tract, peak plasma concentrations of 50-80ng/ml being reached approximately 2-3 hours after dosing. Compared to the fasting state, the bioavailability has ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

List of excipients

Capsule: Maize starch Lactose monohydrate Purified talc Magnesium stearate Cap: Titanium dioxide (E171) Gelatin Black iron oxide Capsule Shell Body (size 3): Titanium dioxide (E171) Gelatin Black Ink: ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

None.

Nature and contents of container

PVC blister pack compound of polyvinyl chloride (thickness 250µm) sealed to aluminium foil (thickness 20µm). The blisters are then packed in a cardboard carton. Pack sizes: 50, 60 and 100 capsules. Not ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization number(s)

PL 04425/0194

Date of first authorization / renewal of the authorization

Date of First Authorisation: 10 June 1974 Date of Latest Renewal: 2 April 2002

Date of revision of the text

14 August 2019

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