DICYNONE 500 Tablet Ref.[11039] Active ingredients: Etamsylate

Source: Υπουργείο Υγείας (CY)  Publisher: OM PHARMA S.A., R. da Indústria, 2 – Quinta Grande, 2610-088 Аmadora Portugal

4.1. Therapeutic indications

Dicynone 500 is indicated in adults.

In surgery

Prevention and treatment of pre- or postsurgical capillary haemorrhages in all delicate operations and in those affecting highly vascularised tissues: E.N.T., gynecology, obstetrics, urology, odontostomatology, ophthalmology, plastic and reconstructive surgery.

In internal medicine

Prevention and treatment of capillary haemorrhages of whatever origin or localisation: haematuria, haematemesis, melaena, epistaxis, gingivorrhagia.

In gynecology

Metrorrhagia, primary or IUD-related menorrhagia in the absence of organic pathology.

4.2. Posology and method of administration

Adults

Presurgical: 1 tablet (500 mg) 1 hour before surgery.

Postsurgical: 1 tablet (500 mg) every 4-6 hours as long as the risk of bleeding persists.

Internal medicine: generally 1 tablet 2-3 times a day (1000-1500 mg) to be taken with meals with a little water; treatment duration depends on the results obtained.

Gynecology, meno-metrorrhagia: 1 tablet 3 times a day (1500 mg) to be taken with meals with a little water. Treatment lasts 10 days and starts 5 days before the expected onset of menses.

Children

Because of its high concentration of active principle, Dicynone 500 is not appropriate for children.

Special population

Clinical studies have not been performed in patients presenting hepatic or renal impairment. Consequently, caution is required when administering Dicynone 500 to these patients.

4.9. Overdose

Signs of overdosage are unknown. In case of overdosage, a symptomatic treatment should be initiated.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Dicynone 500 should not be administered after the expiration date indicated on the package (EXP).

6.5. Nature and contents of container

Blister-packs of 10 tablets:

  • Aluminium foil lacquered with PVDC
  • PVC/PVDC foil

Box of 20 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special instructions.

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