DEXAMED Tablet (2017)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Dexamed 0.5 mg tablets. Dexamed 1.5mg tablets.

2. Qualitative and quantitative composition

Dexamed 0.5mg: Each tablet contains 0.5mg of dexamethasone Dexamed 1.5mg: Each tablet contains 1.5mg of dexamethasone Excipients with known effect: lactose monohydrate. Each 0.5mg tablet contains ...

3. Pharmaceutical form

Dexamed 0.5mg tablets: Pink, round flat, scored embossed MC tablets with diameter 7.0mm. Dexamed 1.5mg tablets: White, round flat, scored tablets, 7mm diameter.

4.1. Therapeutic indications

Dexamed is indicated as a treatment for certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema and for diagnostic testing of adrenocortical hyperfunction. Endocrine disorders: ...

4.2. Posology and method of administration

General considerations: dosage must be individualized on the basis of the disease and the response of the patient. In order to minimize side effects, the lowest possible dosage adequate to control the ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Systemic fungal infections; Systemic infection unless specific anti-infective therapy is employed; Administration ...

4.4. Special warnings and precautions for use

Undesirable effects can be minimised by use of the lowest effective dose for minimum period, and when appropriate by administration of daily dose as a single morning dose, or, if possible, as a morning ...

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

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the ...

4.6. Fertility, pregnancy and lactation

Pregnancy In animals there is evidence of harmful effects in pregnancy, intra-uterine growth retardation, small increased risk of cleft palate and affects on brain growth and development have been reported. ...

4.7. Effects on ability to drive and use machines

Not relevant.

4.8. Undesirable effects

The following adverse effects with dexamethasone are listed below by system organ class; the frequency is not known (cannot be estimated from available data). The frequency of predictable undesirable effects, ...

4.9. Overdose

Definition of overdose is difficult as therapeutic dose varies widely according to indication and patient response. In overdose it would be anticipated that corticosteroid adverse effects would be severe ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids for systemic use, plain, Glucocorticoids ATC Code: H02AB02 Dexamethasone is a synthetic glucocorticoid with an anti-inflammatory potency about seven ...

5.2. Pharmacokinetic properties

Generally corticosteroids are well absorbed from the gastro-intestinal tract. Following administration of dexamethasone sodium phosphate, it is rapidly hydrolysed to dexamethasone. Reported plasma half ...

5.3. Preclinical safety data

Not applicable.

6.1. List of excipients

Dexamed tablets 1.5 mg: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate. Dexamed tablets 0.5 mg: Lactose monohydrate, microcrystalline cellulose, ...

6.2. Incompatibilities

None known.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Dexamed 0.5mg: Packs of 100 tablets. Dexamed 1.5mg: Packs of 50 and 100 tablets.

6.6. Special precautions for disposal and other handling

For oral administration only.

7. Marketing authorization holder

Medochemie Ltd, 1-10 Constantinoupoleos street, 3011, Limassol, Cyprus

8. Marketing authorization number(s)

Dexamed 0.5mg: 19974 Dexamed 1.5mg: 19973

9. Date of first authorization / renewal of the authorization

Dexamed 0.5mg: Date of first authorisation: 20.12.2005 Date of latest renewal: 15.06.2011 Dexamed 1.5mg: Date of first authorization: 20.12.2005 Date of latest renewal: 14.11.2013

10. Date of revision of the text

09/2017

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