Dicynene 500 Tablets

1. Name Of The Medicinal Product

Dicynene 500 Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 500mg etamsylate as the active ingredient.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

White capsule-shaped tablet imprinted “D500" on one face, with a break-mark on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Dicynene is used clinically for the short term treatment of blood loss in primary and IUCD-induced menorrhagia.

4.2 Posology And Method Of Administration

Adults only

The usual dosage is 500mg four times daily from the start of bleeding until menstruation ceases.

Route of administration: oral

4.3 Contraindications

Treatment should only be undertaken following exclusion of other pelvic pathology, in particular the presence of fibroids. Use in patients with a known hypersensitivity to etamsylate or to any of the excipients. Use in patients with porphyria.

4.4 Special Warnings And Precautions For Use

The drug contains:

• Sulfites which may cause anaphylactic reactions (see 4.8 Undesirable effects).

• Wheat starch which may contain gluten but only in trace amounts and is therefore considered safe for patients with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine.

If the patient develops a fever then treatment should be discontinued.

In patients receiving Dicynene for menorrhagia the use of the product before onset of bleeding is not recommended.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Clinical use in pregnancy is not relevant for this indication. Studies in animals have revealed no teratogenic effect of etamsylate however there is inadequate evidence of safety in human pregnancy.

Etamsylate is secreted in breast milk and administration to nursing mothers is not recommended.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Fever may occur.

Occasional headaches or skin rashes may also occur but usually disappear on reduced dosage. A few patients may experience gastrointestinal disturbances such as nausea, vomiting or diarrhoea; however this may be overcome by administering the dose after food.

Due to the presence of sulfites, allergic reactions may occur including anaphylactic symptoms ranging from rash to anaphylactic shock (see 4.4 Special warnings and precautions for use).

4.9 Overdose

There is no experience of overdosage with Dicynene 500 tablets.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Vitamin K and Other Hemostatics, Other systemic hemostatics. ATC code B02BX01.

Dicynene is a non-hormonal agent which reduces capillary exudation and blood loss. Dicynene does not affect the normal coagulation mechanism since administration is without effect on prothrombin times, fibrinolysis, platelet count or function.

Dicynene is thought to act by increasing capillary vascular wall resistance and platelet adhesiveness; in the presence of a vascular lesion, it inhibits the biosynthesis and action of those prostaglandins which cause platelet disaggregation, vasodilation and increased capillary permeability. Dicynene does not have a vasoconstricting action.

5.2 Pharmacokinetic Properties

Dicynene is fully absorbed when given orally and is excreted unchanged, largely by the urinary route.

5.3 Preclinical Safety Data

No further information is available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium sulphite anhydrous

Sodium dihydrogen citrate

Microcrystalline cellulose

Povidone

Wheat starch

Stearic acid

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25^oC. Securitainer - Keep the bottle in the outer carton.

6.5 Nature And Contents Of Container

Securitainer with lid and foam wad or moulded pack insert (jayfilla) containing 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0206

9. Date Of First Authorisation/Renewal Of The Authorisation

20 February 2009

10. Date Of Revision Of The Text

February 2009

Legal category: POM