ANARGIL Capsule, hard (2015)

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Περιεχόμενα

1. Name of the medicinal product

Anargil 100mg capsules, hard. Anargil 200mg capsules, hard.

2. Qualitative and quantitative composition

Each capsule contains 100mg or 200mg danazol. Excipient with known effect: lactose. Each 100mg capsule contains 123mg of lactose. Each 200mg capsule contains 35mg of lactose. For the full list of ...

3. Pharmaceutical form

Capsule, hard. Anargil 100mg capsules hard: yellow capsules. Anargil 200mg capsules hard: orange capsules. For oral administration.

4.1. Therapeutic indications

Anargil 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 ...

4.2. Posology and method of administration

Posology Adults Anargil 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 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy Breast feeding Markedly impaired hepatic, renal or cardiac function Porphyria Active thrombosis or ...

4.4. Special warnings and precautions for use

Special warnings In the event of virilisation, danazol should be withdrawn.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

4.5. Interaction with other medicinal products and other forms of interaction

Anti-convulsant therapy: Danazol 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 ...

4.6. Pregnancy and lactation

Pregnancy 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 ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

The undesirable effects are displayed by system organ class and frequency using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to ...

4.9. Overdose

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

5.1. 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, ...

5.2. 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 ...

5.3. 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.

6.1. List of excipients

Anargil capsules contain maize starch, povidone, lactose, croscarmellose sodium, sodium lauryl sulphate and magnesium stearate. Anargil 100mg capsules' shell contain gelatin, quinolone yellow (E104), iron ...

6.2. Incompatibilities

None.

6.3. Shelf life

5 years.

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

Combination polyvinylchloride-aluminium blisters of ten capsules. Five or ten such blisters (50 capsules or 100 capsules) are contained in a card carton. Also, PVC securitainers with 50,100 and 500 capsules ...

6.6. Special precautions for disposal and other handling

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)

Anargil 100mg capsules, hard: 19832 Anargil 200mg capsules, hard: 19833

9. Date of first authorization / renewal of the authorization

Anargil 100mg capsules, hard: 16.12.2005/07.05.2014 Anargil 200mg capsules, hard: 16.12.2005/07.05.2014

10. Date of revision of the text

April 2015

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