Femilevo 0,75 mg Tablets

FEMILEVO is used as emergency contraception. FEMILEVO 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). FEMILEVO 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 FEMILEVO:

• If you are hypersensitive (allergic) to levonorgestrel or any of the other ingredients of FEMILEVO (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 FEMILEVO 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 FEMILEVO:

• FEMILEVO 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 FEMILEVO, 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 FEMILEVO.
• The use of FEMILEVO does not protect you against sexually transmitted diseases (STDs). If you are worried about a sexual transmitted disease, talk to your doctor or pharmacist.

Important information about some of the ingredients of FEMILEVO: FEMILEVO contains lactose. Patients with the rare hereditary conditions of lactose/fructose or galactose intolerance should not take FEMILEVO.

Tell your doctor before using FEMILEVO:

• 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 FEMILEVO, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behavior (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.

After you have taken FEMILEVO, you are advised to make an appointment to see your doctor about three weeks later, to make sure that FEMILEVO has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking FEMILEVO, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

After you have taken FEMILEVO, if you want to have sex, and are not using the contraceptive pill, you should use additional contraception methods (e.g. condoms or a cap plus spermicide) until your next menstrual period. This is because FEMILEVO will not work if you have unprotected sex again, before your next period is due.

If another unprotected intercourse takes place after the use of FEMILEVO (also if this is during the same menstrual cycle), FEMILEVO will not exert its contraceptive effect and there is again the risk of pregnancy.

There is some evidence that FEMILEVO may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, FEMILEVO is still recommended for all women regardless of their weight or BMI.

Children and adolescents

FEMILEVO is not recommended in children or adolescents under 16 years.

Other medicines and FEMILEVO:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist if you are currently using:

• medicines used for the treatment of the human immunodeficiency virus (HIV) (ritonavir, efavirenz);
• medicines used to treat epilepsy (phenobarbitone, phenytoin, primidone and carbamazepine);
• herbal remedies containing St. John’s wort ( Hypericum perforatum ) (used to treat depression);
• medicines used to treat tuberculosis (rifampicin, rifabutin);
• medicine used to treat fungal infections (griseofulvin);
• medicines used to treat bacterial infections (antibiotics, such as ampicillin);
• medicines used to prevent organ rejection after a transplant (ciclosporin).

Some medicines may prevent FEMILEVO from working effectively. If you have used any of the medicines above during the last 4 weeks, FEMILEVO may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD).

FEMILEVO with food and drink

There are no known interactions with food and/or drink (See section 3).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking FEMILEVO.

Pregnancy: Do not take FEMILEVO if you are pregnant. If you do become pregnant even after taking FEMILEVO, it is important that you see your doctor. There is no evidence that FEMILEVO will harm a baby that develops in your uterus/womb if you use FEMILEVO as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking FEMILEVO or if you have previously had an ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.

Breastfeeding: The active ingredient of FEMILEVO is excreted into your breast milk. Therefore, it is suggested that you take your tablet immediately after breastfeeding and avoid nursing at least 6 hours following FEMILEVO administration.

Fertility: FEMILEVO increases the possibility of changes in your menstruation cycle which can sometimes lead to you having an earlier or later ovulation date resulting in a modified fertility date. Although there are no fertility data in the long term, after treatment with FEMILEVO a rapid return to fertility is expected and therefore, you should initiate or continue with regular contraception as soon as possible after FEMILEVO use.

Always take FEMILEVO exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure.

Take FEMILEVO 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 FEMILEVO. FEMILEVO 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.

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

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

You should swallow FEMILEVO 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 FEMILEVO 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 FEMILEVO is too strong or too weak, tell your doctor or pharmacist.

If you take more FEMILEVO than you should Although there have been no reports of serious harmful effects from taking too much of FEMILEVO at once, you may feel sick or have vaginal bleeding. In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining FEMILEVO tablets with you so the doctor will know what you have taken.

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

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

• swelling of your 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 FEMILEVO. 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.

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:

• 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 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 experience side effects, talk to doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FEMILEVO.

• Store at or below 25 °C.

• Keep the blister strip in outer carton until required for use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the carton/blister.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).