MEDOVIR Tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Medovir, 200 mg, tablets. Medovir, 400 mg, tablets. Medovir, 800 mg, tablets.

2. Qualitative and quantitative composition

Each Medovir 200 mg, tablet contains 200 mg of aciclovir. Each Medovir 400 mg tablet contains 400 mg of aciclovir. Each Medovir 800 mg tablet contains 800 mg of aciclovir. Excipient with known effect ...

3. Pharmaceutical form

Tablet. Medovir 200 mg: white, flat, round scored tablets. Medovir 400 mg: marble pink, flat, round, scored on one side tablets. Medovir 800 mg: marble light blue capsule-shaped, ...

4.1. Therapeutic indications

Medovir is indicated for: The treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections ...

4.2. Posology and method of administration

Posology Adults Treatment of herpes simplex infections 200 mg of aciclovir should be taken five times daily, at approximately four hour intervals, omitting the night time dose. Treatment should continue ...

4.3. Contraindications

Hypersensitivity to the active substance, valaciclovir or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Use in patients with renal impairment and in elderly patients Aciclovir is eliminated by renal clearance; therefore the dose must be adjusted in patients with renal impairment (see section 4.2). Elderly ...

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

Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. ...

4.6. Pregnancy and lactation

Pregnancy The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks. A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes ...

4.7. Effects on ability to drive and use machines

There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery. A detrimental effect on such activities cannot be predicted from the pharmacology ...

4.8. Undesirable effects

The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their ...

4.9. Overdose

Symptoms Aciclovir is only partly absorbed in the gastrointestinal tract. Patients have ingested overdoses of up to 20g aciclovir on a single occasion, usually without toxic effects. Accidental, repeated ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use ATC code: J05AB01 Aciclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity ...

5.2. Pharmacokinetic properties

Aciclovir is only partially absorbed from the gut. Mean steady state peak plasma concentrations (Cssmax) following doses of 200 mg administered four-hourly were 3.1 microMol (0.7 micrograms/ml) ...

5.3. Preclinical safety data

Mutagenicity The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir is unlikely to pose a genetic risk to man. Carcinogenicity Aciclovir was not found to be carcinogenic ...

6.1. List of excipients

Medovir 200 mg tablets: lactose monohydrate, pregelatinised starch, sodium croscaramellose, magnesium stearate. Medovir 400 mg tablets: lactose monohydrate, cellulose microcrystalline, sodium ...

6.2. Incompatibilities

No known incompatibilities.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

This medicine does not require any special storage conditions.

6.5. Nature and contents of container

Combination of polyvinylchloride and aluminium blisters in a carton with the patient information leaflet. Cartons of 10, 30, 35, 40 100, 500 and 1000 tablets are available. Medovir 400 mg tablets have ...

6.6. Special precautions for disposal and other handling

For oral administration, swallow whole with a little water if required. No special requirements for disposal.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

Aciclovir 200 mg: 12781 Aciclovir 400 mg: 14927 Aciclovir 800 mg: 14928

9. Date of first authorization / renewal of the authorization

Date of first authorisation: Aciclovir 200 mg: 06/06/1990 Aciclovir 400 mg: 13/02/1994 Aciclovir 800 mg: 13/02/1994 Date of latest renewal: Aciclovir 200 mg: 26/09/2012 Aciclovir 400 mg: 05/07/2013 Aciclovir ...

10. Date of revision of the text

26/06/2020

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