Ermaft 0,75 mg Tablets

ERMAFT is used as an emergency birth control method. ERMAFT can be used to help prevent a pregnancy when taken within 72 hours (3 days) after having unprotected sex, or if your usual method of birth control has failed (e.g. a broken condom). ERMAFT is intended for occasional use only. You should not use it on a regular basis, or as a substitute for long-term contraception.

Do not take ERMAFT:

• If you are hypersensitive (allergic) to levonorgestrel or to any other ingredients of ERMAFT (see section 6.1).
• If you have severe liver problems.
• If you are pregnant or suspect that you are pregnant.
• If you suffer from bleeding between your regular menstrual cycles (periods) that has not been diagnosed by your doctor, or if you have a history of or current high risk of arterial disease.
• If you had already taken ERMAFT within the same monthly cycle.
• If you have depression, which is not well controlled with treatment.
• If you have had depression with previous use of hormonal contraceptives.

Warnings and precautions

Take special care with ERMAFT:

• ERMAFT is only intended for occasional use and should not be taken on a regular basis, or as a substitute for long-term birth control. Talk to your doctor or pharmacist about long-term birth control methods.
• If you still become pregnant after using ERMAFT, your doctor will closely evaluate you for an ectopic pregnancy especially if you have a history of an ectopic pregnancy, fallopian tube surgery or a pelvic inflammatory disease.
• A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy.
• If you have a disease of your small bowel (such as Crohn’s disease) that inhibits the absorption of ERMAFT.
• The use of ERMAFT does not protect you against sexually transmitted diseases (STDs). If you are worried about a sexual transmitted disease, talk to your doctor or pharmacist.

Tell your doctor before using ERMAFT:

• If you are on treatment for depression.
• If you have had depression with previous use of hormonal contraceptives.
• If you have a substance abuse problem.
• If you have underlying psychiatric disorder such as post-traumatic stress disorder or bipolar disorder.
• If you have a family history of mental disorders.
• If you have a history of physical or sexual abuse.

Hormonal contraceptives including ERMAFT, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behaviour (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes), and suicide. If you experience mood changes and depression contact your doctor for advice.

Do not share medicines prescribed for you with any other person. Always take ERMAFT exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take ERMAFT as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Do not delay taking ERMAFT. ERMAFT works best the sooner you take it after having unprotected sex. It can only prevent you becoming pregnant, if you take it within 72 hours of unprotected sex.

ERMAFT 0,75 mg: Take 2 tablets as soon as possible after unprotected sex.

ERMAFT 1,5 mg: Take 1 tablet as soon as possible after unprotected sex.

You should swallow ERMAFT whole with some liquid. It can be taken with or without food, according to your preference.

If you vomit within 3 to 4 hours after taking ERMAFT you should take another dose immediately.

If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

If you have the impression that the effect of ERMAFT is too strong or too weak, tell your doctor or pharmacist.

ERMAFT can have side effects. Not all side effects reported for ERMAFT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ERMAFT, please consult your healthcare provider for advice.

If any of the following happens, stop taking ERMAFT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to ERMAFT. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems,
• suicidal thoughts/behaviour and suicide.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headaches or dizziness,
• nausea (feeling sick), vomiting (being sick), lower abdominal pain, diarrhoea,
• changes in your menstrual cycle (period), irregular bleeding, vaginal bleeding not related to your menstrual cycle,
• breast tenderness,
• fever, feeling tired.

Less frequent side effects:

• Breast enlargement in men,
• changes in your libido (sex drive),
• changes in your liver enzyme results when blood tests are done,
• pain in your stomach area,
• hives (red, raised, itchy skin rash),
• painful menstruation with abdominal cramps, pelvic pain,
• swelling of your face.

Side effects with an unknown frequency

• Changes in your appetite or body mass,
• feeling depressed (depression), inability to sleep,
• drowsiness,
• stomach problems,
• acne (pimples),
• patchy, brown discolouration of your skin,
• hair loss (temporary) or abnormal hair growth in women,
• breast changes, premenstrual syndrome - like symptoms (mood swings, tender breasts, food cravings, tiredness, feeling irritable or depressed).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of ERMAFT.

Store all medicines out of reach of children. Store at or below 25 °C.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).