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Emergency contraception (morning after pill) indicated to prevent unwanted pregnancies. It should be taken within 72 hours (3 days) after unprotected intercourse or after a fault occurred in the contraception.
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1. What it is Postinor (Levonelle) and what it is used
Postinor is an emergency contraceptive.
Postinor containing levonorgestrel as active ingredient, a synthetic hormone. Prevents about 85% of expected pregnancies when taken within 72 hours of having had unprotected sex. It will not always prevent pregnancy and is most effective if taken as soon as possible after unprotected intercourse. It is best taken in the first 12 hours delay decision until the third day (72 hours).
It is used in the following cases:
- If no contraceptives were used during sex.
- If contraception was not used in the right way, for example if the condom broke, slipped or was used in the wrong way, if the position of the diaphragm is altered or if drilled, broke or removed prematurely, or if failed disruption during coitus interruptus (p. eg., sperm are ejaculated into the vagina or external genitalia).
Postinor could work:
· Preventing the ovaries from releasing an egg;
· Preventing the sperm to fertilize any egg that may have been released; or
· Preventing a fertilized egg from attaching to the uterine wall.
Postinor can only prevent you from becoming pregnant if taken within 72 hours having had unprotected sex. It does not work if you are already pregnant. If you hold again unprotected sex after taking Postinor (also if this occurs during the same menstrual cycle), the medicine will not exert its contraceptive effect and there is again a risk of pregnancy.
2. What you need to know before taking Postinor (Levonelle)
Check with your doctor before taking Postinor if you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in Section 6.
Warnings and Precautions
If any of the following apply to you, tell your doctor before taking Postinor as emergency contraception may not be suitable for you. Your doctor may prescribe other emergency contraceptive.
· If you are pregnant or think you may be pregnant; because this medicine will not work if you are already pregnant. If you are already pregnant, Postinor can not terminate pregnancy, so Postinor is not an "abortion pill".
You may already be pregnant:
- Your period is delayed more than 5 days, or have had an abnormal bleeding when you have your next period correspond;
- After your last period has remained unprotected sex and have passed more than 72 hours .It is not advisable to use Postinor if:
- It has a small bowel disease (such as Crohn's disease) that inhibits the absorption of the medicine;
- Have severe liver problems;
- Have a history of ectopic pregnancy (when the fertilized egg implants outside the uterus);
- Have a history of salpingitis (inflammation of the fallopian tubes).
An ectopic pregnancy or an infection of the fallopian tubes previous increase the risk of a new ectopic pregnancy.
If you are worried about sexually transmitted diseases
If you have not used a condom (or has broken or slipped) during sex, you may have acquired a sexually transmitted disease or HIV virus.
This medicine will not protect you against sexually, since only the use of condoms can do transmission.
Consult your doctor or pharmacist or family planning center for advice if you are concerned about this.
Using Postinor (Levonelle) with other medicines
Tell your pharmacist if you are taking or have recently taken any other medicines. Some medicines may prevent Postinor work properly. These medications include:
- Barbiturates and other medicines used to treat epilepsy (eg primidone, phenytoin and carbamazepine)
- Medicines used to treat tuberculosis (eg, rifampin and rifabutin)
- A treatment for HIV infection (ritonavir)
- A medicine to treat fungal infections (griseofulvin)
- Herbal preparations containing St. John's wort (Hypericum perforatum)
- A medicine called cyclosporine (used to suppress the immune system).
If you take any of these medications, consult your doctor or pharmacist before taking Postinor.
How often you can use Postinor
You should only use Postinor in emergency situations and never as a regular contraceptive method. If you use Postinor more than once during the same menstrual cycle, its effectiveness is lower and you may see changes in your menstrual cycle (period).
Postinor not work as well as regular contraception. Your doctor can advise you about long-term contraceptive methods that are more effective in preventing pregnancy.
Pregnancy and lactation
If you are pregnant or breastfeeding, if you think you might be pregnant or are planning to have a baby, seek advice from your doctor or pharmacist before taking any medicine.
You should not take this medicine if you are pregnant. If you become pregnant after taking this medicine, it is important to seek medical attention. The data that are available indicate that Postinor can not damage the embryo if used as recommended. Anyway, your doctor may want to confirm that the pregnancy is not ectopic (where the fertilized egg implants outside the uterus). This is especially important if you notice severe abdominal pain after taking Postinor or if you have had an ectopic pregnancy, surgery of the fallopian tubes or pelvic inflammatory disease.
Small amounts of the active ingredient of this medicine may appear in breast milk, although not think this is harmful to the baby. However, if you are worried you can take your tablet immediately after breastfeeding and avoid giving breastfeeding after administration of levonorgestrel; then remove the milk with a breast pump during 6 hours after taking Postinor, dismissing it. This will reduce the amount of active ingredient that can receive your child with breast milk.
Driving and using machines
Postinor is unlikely to affect your ability to drive or use machines. However, if you are tired or dizzy do not drive or operate machinery.
In case of intolerance to milk sugar (lactose) should be noted that each tablet contains 142.5 mg Postinor lactose monohydrate.
If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Postinor
Follow exactly the instructions of medicine administration in this leaflet or as your pharmacist. If in doubt ask your doctor or pharmacist.
· Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected intercourse. You can take Postinor any time of the menstrual cycle unless you are already pregnant or think you may be pregnant. Take the tablet whole with a little water and do not chew. Do not delay taking the tablet, as this medication works best the sooner you take it after unprotected intercourse.
If you are already using a regular method of contraception such as oral contraceptives, you can continue to take it with the same regularity.
If you have another unprotected sexual relationship after taking Postinor (also if this occurs during the same menstrual cycle), the tablet will not exert its contraceptive effect and again no risk of pregnancy.
Use in children and adolescents
It is not recommended to use this medicine in children. The data available in women under 16 years old are very rare.
What to do in case of vomiting
If you vomit within three hours of taking the tablet, you should take another tablet.
After taking Postinor
If you want to have sex after taking Postinor, you should use condoms or a diaphragm spermicide until your next menstrual period, as Postinor will not work if you hold back unprotected sex before you have your next period.
After taking Postinor, it is advisable to make an appointment to see your doctor about three weeks later to confirm you are not pregnant. If your period is delayed more than 5 days or is exceptionally weak or intense, you should contact your doctor as soon as possible. If you become pregnant after taking this medicine, it is important to consult your doctor.
Your doctor will also advise you about long-term contraceptive methods that are more effective to avoid becoming pregnant.
If you continue to use regular hormonal contraception such as oral contraceptives and no bleeding during the period that does not take the contraceptive, contact your doctor to make sure you are not pregnant.
Your next period after taking Postinor
After using Postinor, the period is usually normal and will start at the usual day; however, sometimes it will take a few days earlier or later. If your period starts more than 5 days later than expected, if an "abnormal" at that time bleeding occurs or think you may be pregnant, a pregnancy test should be performed.
If you take more than you should Postinor
Although no serious adverse effects have been observed after taking several tablets at once, you may feel dizzy, vomit or have vaginal bleeding. You should consult your doctor or pharmacist or your family planning clinic for advice, especially if you have vomited, as the tablet may not have worked properly.
In case of overdose or accidental ingestion consult your doctor or poison control center, call +34 91 562 04 20.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Very common (may affect more than 1 user in 10): Nausea; Irregular bleeding until the next menstruation; Pain in the lower abdomen; Fatigue; Headache.
- Common (may affect up to 1 user in 10): vomiting. If you suffer vomiting, read the section "What to do in case of vomiting"; Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You may also have irregular bleeding or spotting until your next period. If your period is delayed more than 5 days or is unusually low or intense, you should contact your doctor as soon as possible; Increased breast tenderness, diarrhea, or dizziness after taking this medicine.
- Very rare (may affect up to 1 user in 10,000): rash, hives, itching, swelling of the face, pelvic pain, painful menstruation.
If you experience any adverse effects, tell your doctor or pharmacist. This includes possible side effects not listed in this leaflet.
5. Conservation postinor
Keep this medicine out of the sight and reach of children.
Do not use Postinor after the expiry date on the carton and blister after EXP. The expiry date is the last day of that month.
Store in the original package to protect from light.
6. Contents of the pack and other information
The active substance is levonorgestrel. Each tablet contains 1500 microgram levonorgestrel. The other ingredients are potato starch, maize starch, colloidal anhydrous silica, magnesium stearate, talc,
Postinor appearance and contents of container
Compressed: Compressed almost white, flat, with edge, about 8 mm in diameter, marked "G00" printed on one side.
Container: a tablet in a blister PVC // aluminum within a carton.
Holder of the marketing authorization
Medimpex UK Limited
127 Shirland Road
London W9 2EP United Kingdom
Local representative: Bayer Hispania, S.L.
Avd. Baix Llobregat, 3 and 5
08970 Sant Joan Despi
Responsible for manufacturing:
Bayer Weimar GmbH und Co.KG, Döbereiner Str. 20,
99427 Weimar, Germany
Gedeon Richter Plc. Gyömr? I út 19-21.
Source: Spanish Agency for Medicines and Health Products