ESCAPELLE Tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
ESCAPELLE tablet.
2. Qualitative and quantitative composition
Each tablet contains 1,50 mg of levonorgestrel. Contains sugar. Each tablet contains 142.5 mg lactose monohydrate. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Almost white, flat, rimmed tablet of about 8 mm diameter, with an impression mark of G00 on one side.
4.1. Therapeutic indications
Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.
4.2. Posology and method of administration
Posology The tablet should be taken, no later than 72 hours after unprotected intercourse. If the patient vomits within three to four hours of taking the tablet, another tablet should be taken immediately. ...
4.3. Contraindications
Hypersensitivity to the active substance levonorgestrel or to any of the excipients. Severe hepatic insufficiency. Pregnancy or suspected pregnancy (see section 4.6). Depression not well controlled with ...
4.4. Special warnings and precautions for use
Emergency contraception is an occasional method to be used in an emergency situation only. It should in no instance replace a regular contraceptive method. ESCAPELLE does not prevent a pregnancy in every ...
4.5. Interaction with other medicinal products and other forms of interaction
The metabolism of ESCAPELLE is enhanced by concomitant use of liver enzyme inducers. Medicines suspected of having the capacity to reduce the efficacy of levonorgestrel containing medication include barbiturates ...
4.6. Pregnancy and lactation
Pregnancy ESCAPELLE should not be given to pregnant women and will not interrupt the pregnancy. In case of failure of this emergency contraception with developing pregnancy, epidemiological studies indicate ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Nervous system disorders <u>Very common (>1/10):</u> Headache <u>Common (>1/100 ≤1/10):</u> Dizziness Gastrointestinal disorders <u>Very common (>1/10):</u> Nausea, lower abdominal pain <u>Common (>1/100 ...
4.9. 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 ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 21.8.2 2 Progesterones with or without oestrogen The precise mode of action of levonorgestrel is not known. Emergency hormonal contraception is thought to work ...
5.2. 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 one tablet of levonorgestrel, ...
6.1. List of excipients
Colloidal silica anhydrous Magnesium stearate Maize starch Potato starch Purified talc
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store at or below 25°C. Protect from light. Store in the original container until required for use.
6.5. Nature and contents of container
The folded carton of ESCAPELLE contains one aluminium/PVC blister of one tablet.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Litha Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686
8. Marketing authorization number(s)
41/21.8.2/0021
9. Date of first authorization / renewal of the authorization
Original date of registration: 08 February 2008
10. Date of revision of the text
28 March 2021
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