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THE UNITED REPUBLIC OF TANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY |
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Questions and Answers About Emergency Contraceptive Pills; Levonorgestrel
What is emergency contraception?
Emergency contraception refers to methods of contraception that can be used to prevent pregnancy after sexual intercourse. These are recommended for use within 3 days but are more effective the sooner they are used after the act of intercourse.
Emergency contraception are meant to offer women a second chance to prevent unplanned pregnancy when a regular method fails, no method was used, or when sex was forced.
What are emergency contraceptive pills?
Currently the most common emergency contraceptive medicines used, is a progestin hormone called Levonorgestrel in a tablet dosage form. These are marketed under many names and simply contain higher dosages of the same hormone found in many regular birth control pills.
Levonorgestrel as an emergency birth control is useful within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed. They commonly known as Morning After Pill.
There are various emergency oral contraceptive medicines registered in Tanzania that contains the active ingredient; Levonorgestrel under the following brand names; Microlut, Hyan, Pill 72, Revoke 1.5 and Revoke 72, Acelevo, Emerginor, Unosure 72, Trust Daisy 1 and Trusty Daisy 2, p2, Depregdina, Famy Pop e.t.c.
How does emergency oral contraceptive (Levonorgestrel) works?
Levonorgestrel works by stopping ovaries from releasing an egg and preventing sperms from fertilising any egg that may have already released. Emergency oral contraceptives can only prevent from becoming pregnant if is is taken within 72 hours of unprotected sex. It does not work if someone is already pregnant.
Does emergency oral contraceptives always work?
One-dose emergency contraception pills prevent pregnancy about 50-100% of the time. Some reasons emergency contraceptive pills can fail include ovulation timing, body mass index and drug interactions. Some medical conditions such diabetes may reduce the effectiveness of these medicines.
The morning-after pill (emergency oral contraception) can help to prevent pregnancy when you take it after having unprotected sex effectively within 72 hours. But, it won't prevent pregnancy for any sex you may have after taking it.
How long does it take for emergency oral contraceptives to work?
It can take up to seven days for the pill to become effective in preventing pregnancy
What is usually a normal dose for these medicines?
You should only use emergency oral contraceptives in real emergency situations and not as a regular method of contraception. If emergency oral contraceptives are used more than once in a menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period) and eventually results into menstruation irregularities.
When can someone take emergency oral contraceptives?
The emergency contraceptive pill is used to prevent a pregnancy that may occur because of:
- Forgotten contraception or a missed oral contraceptive or calendar mismatch,
- Failed contraception (for example, a condom broke, a diaphragm was dislodged, or the expulsion of an IUD or implant);
- Failed withdrawal; and
- Starting an oral contraceptive too late in your cycle.
- Forced sex intercourse
Note that, this is an emergency pill, should be used in an emergency situation and must not be taken as a routine contraceptive method.
How frequent can someone takes emergency oral contraceptives?
These medicines are supposed to be taken once in an emergency situation only in one menstrual cycle. If the medication is taken more than once (twice as much) in one menstrual cycle, its effectivess is not guaranteed and can result into pregnant if unprotected sex takes place.
What advice could be given to women who take these emergency oral contraceptives regularly?
Women who are frequently on such pills are advised to seek for an immediate healthcare providing facility to get awareness on the family planning and there will be provided with correct methods that will work for long term.
What are safety issues related to the use of these medicines?
The most commonly reported adverse effects are alterations of menstrual bleeding patterns, nausea, abdominal/pelvic pain, headache/migraine, dizziness, fatigue, amenorrhea, ovarian cysts, genital discharge, acne/seborrhea, breast tenderness, and vulvovaginitis.
Will these medicines prevent one from contracting HIV/AIDS and other Sexually Transmitted Infections?
These medicines will not stop you from getting sexual transmitted diseases such as HIV, Hepatitis B, Gonorrohoea, Syphillis, e.t.c if you come into contact with an infected person.
What are the roles of TMDA in ensuring safety of these medicines?
TMDA ensures quality, safety and efficacy of these medicines and other medicines by doing the following;
- Reviewing all documents (dossiers) submitted for Marketing Authorization for the purpose of establishing, quality, safety and efficacy of the products before registration.
- Conducting GMP inspection to Pharmaceutical Companies in which their products are applied to Tanzania for registration for establishment of cGMP compliance.
- Conducting Enforcement by controlling all imports with issuance of import permit certificates.
- Conducting Pharmacovigilance (PV) and Post Marketing Surveillance (PMS) for products follow up on quality, safety and safety profiles.
- Publications of Summary of the Product Characteristics (SmPC) and Product Labelling Information on the Website to create public awareness; and
- Providing public education on awareness on the use of medicines and other products regulated by TMDA e.g., the use of tobacco products, cigarettes.
Are there any concerns about the use of this medicine?
There has been an increasing trend of irrational use of this medicine on the market to most women recently without following proposer indications and instructions for use. The surge increase in consumption rate indicates that most women might be using irrationally this medicine. The TMDA is conducting research to identify consumption rates and irrational using practices across the country.
What should be done before taking an emergency contraceptive medicine?
You must obtain advice from a nearby Healthcare centre, Medical Doctor or Pharmacist before taking this medicine.
What the public needs to do?
The public is advised to refrain from using emergency contraceptive pills as a routine family planning method. Please consult the medical doctor or Pharmacist for advice on how to use emergency contraceptive pills
Medical professionals will assess your health condition and emergency situation before issuing this medicine.
What do other health professionals need to do?
Owners of premises including pharmacists, healthcare centres and other medical personnel serving in retail pharmacies must stop selling this medicine randomly to seekers without establishing an emergency situation that needs to be addressed.
Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
P. O. Box 1253, Dodoma
P.O. Box 77150, Dar es Salaam
Tell: +255-658 445222/777 700002
Hotline: 0800110084
Email: info@tmda.go.tz
Website: www.tmda.go.tz