EMERRES Tablet (2020)
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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
<u>For oral administration:</u> 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 ...
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, <u>mainly CYP3A4 enzyme inducers</u>. Concomitant administration of efavirenz has been found to reduce plasma levels ...
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. System Organ Class Frequency of adverse reactions Very common (≥1/10) Common (≥1/100 to <1/10) <b>Nervous system disorders</b> Headache Dizziness ...
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
Absorption Orally administered levonorgestrel is rapidly and almost completely absorbed. The absolute bioavailability of levonorgestrel was determined to be almost 100% of the dose administered. The results ...
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
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
05/05/2020
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