DICYNONE 500 Tablet

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

DICYNONE 500.

2. Qualitative and quantitative composition

Active principle: etamsylate 500 mg. Excipient with known effect: sodium sulfite (E221). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablets.

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., ...

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 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Acute porphyria. Bronchial asthma, proven hypersensitivity to sulphites.

4.4. Special warnings and precautions for use

Parenteral administration of Dicynone may induce a drop in blood pressure, but no data have been reported on such a risk during oral administration. If Dicynone 500 is administered for a reduction of excessive ...

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

No interaction with other medicinal products is known. At therapeutic doses, etamsylate may interfere with creatinine enzymatic assay by giving lower values than expected. During the course of etamsylate ...

4.6. Pregnancy and lactation

There are limited amount of data from the use of etamsylate in pregnant women. Animal experiments have not revealed any direct or indirect toxicity affecting pregnancy, embryonic development, foetal development ...

4.7. Effects on ability to drive and use machines

Dicynone 500 has no effect upon driving capacity and managing of machines.

4.8. Undesirable effects

The side effects are classified according to the MedDRA convention by system organ class and by frequency as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare ...

4.9. Overdose

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

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other systemic hemostatics ATC code: B02BX01 Etamsylate is a synthetic antihaemorrhagic and angioprotective drug acting on the first step of haemostasis (endothelium-platelet ...

5.2. Pharmacokinetic properties

When given p.o., etamsylate is slowly absorbed from the gastrointestinal tract. After oral administration of 500 mg etamsylate maximum plasma level, i.e. 15 µg/ml, is reached at 4 h, but bioavailability ...

5.3. Preclinical safety data

Toxicity studies have not revealed any toxic effect.

6.1. List of excipients

Maize starch Microcrystalline cellulose Polyvinylpyrrolidone Stearic acid Sodium dihydrogen citrate Anhydrous sodium sulfite

6.2. Incompatibilities

No known up to now.

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.

7. Marketing authorization holder

OM PHARMA S.A., R. da Indústria, 2 – Quinta Grande, 2610-088 Аmadora Portugal

8. Marketing authorization number(s)

14836

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 5 July 1994

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