Ermaft 0,75 mg/1,5 mg Tablets

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. ERMAFT is intended for emergencies only and is completely unsuitable for regular contraception. Its reliability is not as high as that of the familiar u201cpillu201d, which is taken for at least 21 days of the menstrual cycle.

Posology

Adults

ERMAFT 0,75 mg: Take 2 tablets in a single administration as soon as possible, preferably within 12 hours, but not later than 72 hours after unprotected sexual intercourse.

ERMAFT 1,5 mg: Take 1 tablet as soon as possible in a single administration. The tablet should be taken no later than 72 hours after unprotected sexual intercourse. If the patient vomits within three to four hours of taking ERMAFT, another dose should be taken immediately. The earlier ERMAFT is used, the more effective it is. Even extremely high doses of hormone can no longer prevent pregnancy once a fertilised ovum has become implanted in the uterine mucosa.

ERMAFT 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, foam, pessary) until the next menstrual period starts. The use of ERMAFT does not contraindicate the continuation of regular hormonal contraception.

Paediatric population

ERMAFT is not recommended in children. Very limited data are available in women under 16 years of age.

Method of administration

For oral administration.

ERMAFT is contraindicated in:

• Hypersensitivity to levonorgestrel or to any of the excipients listed in section 6.1.
• Severe hepatic insufficiency.
• Pregnancy or suspected pregnancy (see section 4.6).
• Patients with undiagnosed vaginal bleeding, or those with a history of or current high risk of arterial disease.
• Depression, which is not well controlled with treatment.
• A history of depression with the use of hormonal contraceptives.

The repeated use of ERMAFT within a monthly cycle is to be avoided, since it constitutes undesirable hormonal stress and may result in severe cycle disturbances.

Pregnancy

ERMAFT 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 foetus but there are no clinical data on the potential consequences if doses greater than 1,5 mg of levonorgestrel are taken. In case of unprotected coitus more than 72 hours earlier, the patient may be pregnant. In these cases, pregnancy should be investigated.

Breastfeeding

About 0,1 % of the maternal ERMAFT dose can be transferred via breast milk to the nursed infant. Potential exposure of an infant to ERMAFT can be reduced if the breastfeeding woman takes the tablet immediately after feeding and avoids nursing at least 6 hours following ERMAFT administration.

Fertility

Levonorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in the long term, after treatment with ERMAFT a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after ERMAFT use.

ERMAFT can cause side effects, such as dizziness and can affect the ability to drive a vehicle and use machines. Caution is advised when driving a vehicle or operating machinery until the effects of ERMAFT are known.

a) Tabulated list of adverse reactions

System organ class

Frequent

Less frequent

Frequency unknown (cannot be estimated from the available data)

Metabolism and nutrition disorders

Changes in appetite or weight, fluid retention, oedema

Immune system disorders

Anaphylaxis, anaphylactoid reactions

Psychiatric disorders

Mental depression

Nervous system disorders

Headache, dizziness

Drowsiness, insomnia

Gastrointestinal disorders

Nausea, lower abdominal pain, diarrhoea, vomiting

Gastrointestinal disturbances

Hepato-biliary disorders

Alterations in liver function tests, jaundice

Skin and subcutaneous tissue disorders

Acne, melasma or chloasma, allergic skin reactions, hair loss or hirsutism

Reproductive system and breast disorders

Bleeding not related to menses*, delay of menses more than 7 days **, irregular menstruation or spotting, breast tenderness

Gynaecomastia, changes in libido

Breast changes, premenstrual syndrome like symptoms

General disorders and administrative site conditions

Fatigue, fever

*Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 7 days of the expected time (see section 4.4).

**If the next menstrual period is more than 5 days overdue, pregnancy should be excluded (see section 4.4).

Symptoms

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.

Treatment

There are no specific antidotes and treatment should be symptomatic and supportive.