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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

EMERRES Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Emerres 1.5 mg tablet.

Qualitative and quantitative composition

Each tablet contains 1.5 mg of levonorgestrel. Excipients with known effects: each tablet contains 154 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. Each tablet is round, white to off-white, uncoated flat tablets debossed 145 on one side and plain on the other side.

Therapeutic indications

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.

Posology and method of administration

For oral administration: One tablet should be taken, as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse (see section 5.1). If vomiting occurs within ...

Contraindications

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

Special warnings and precautions for use

Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method. Emergency contraception does not prevent a pregnancy in every instance. If there is uncertainty ...

Interaction with other medicinal products and other forms of interaction

The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of ...

Fertility, pregnancy and lactation

Pregnancy Levonorgestrel should not be given to pregnant women. It will not interrupt a pregnancy. In the case of continued pregnancy, limited epidemiological data indicate no adverse effects on the fetus ...

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects

The most commonly reported undesirable effect was nausea. Very common (>10%) Common (>1% to <10%) Nervous system disorders Very common: Headache Common: Dizziness Gastrointestinal disorders Very common: ...

Overdose

Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes ...

Pharmacodynamic properties

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives ATC code: G03AD01 The precise mode of action of levonorgestrel as an emergency contraceptive is not ...

Pharmacokinetic properties

Orally administered levonorgestrel is rapidly and almost completely absorbed. The results of a pharmacokinetic study carried out with 16 healthy women showed that following ingestion of single dose of ...

Preclinical safety data

Animal experiments with levonorgestrel have shown virilisation of female fetuses at high doses. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

List of excipients

Lactose monohydrate Maize starch Povidone (E1201) Silica colloidal anhydrous (E551) Magnesium stearate (E572)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Blister composed of PVC film coated with PVDC and aluminium foil. Pack size: 1 tablet.

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Morningside Healthcare Ltd., Unit C, Harcourt Way, Leicester, LE19 1WP, United Kingdom

Marketing authorization number(s)

PL 20117/0138

Date of first authorization / renewal of the authorization

10/11/2014

Date of revision of the text

01/02/2019

Πηγαίο έγγραφο

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