ESCAPELLE Tablet Ref.[50444] Active ingredients: Levonorgestrel

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Litha Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686

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.

ESCAPELLE can be used at any time during the menstrual cycle unless menstrual bleeding is overdue.

After using emergency contraception it is recommended to use a local barrier method (e.g. condom) until the next menstrual period starts. The use of ESCAPELLE does not contraindicate the continuation of regular hormonal contraception.

Children: ESCAPELLE is not recommended in children.

Very limited data are available in women under 16 years of age.

Method of administration

For oral administration.

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 and treatment should be symptomatic and supportive.

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.

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