Norlevo (levonorgestrel) 1500 mcg 1 comprimido
'Morning After Pill'.
Emergency contraceptive indicated for preventing pregnancy after unprotected sexual intercourse or failure of a contraceptive method. It must be taken as soon as possible preferably within 12 hours and never later than 72 hours (3 days).
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1. WHAT IS NorLevo AND WHAT IT IS USED
NorLevo is an emergency contraceptive.
Emergency contraception is indicated for preventing pregnancy after having had unprotected sex or failure of a contraceptive method (eg if you forgot to take the pill at the time; if the condom partner has broken or slipped, if you suspect has expelled the IUD, if your vaginal diaphragm or cervical cap has moved or if he has withdrawn prematurely; if you are concerned that the method of coitus interruptus or the rhythm method had failed ...).
Levonorgestrel belongs to a group of medicines called progestins.
This contraceptive method should be used as soon as possible, preferably within 12 hours and never later than 72 hours (3 days) after unprotected intercourse or when the contraceptive method failed. It is more effective if you take it as soon as possible after having had unprotected sex. NorLevo can only prevent pregnancy if taken within 72 hours of having had unprotected sex. It is not effective if you are already pregnant. If you hold unprotected sex after taking NorLevo, the medicine does not prevent you from getting pregnant.
It is believed that NorLevo acts:
- Preventing the ovaries from releasing an egg
- Preventing a fertilized egg from attaching to the uterine wall
NorLevo is not a regular contraceptive, and is only indicated as an emergency contraceptive.
2. BEFORE YOU TAKE NorLevo
Do not take NorLevo if you are allergic (hypersensitive) to levonorgestrel or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Take special care with NorLevo:
- If you have had on occasion an ectopic pregnancy (when the fertilized egg implants outside the uterus, fallopian tubes),
- If you have had an infection in the fallopian tubes (salpingitis)
- If you have a serious digestive problem that prevents the absorption of food or medicines, such as Crohn's disease,
- If you have severe liver problems.
Emergency contraception is a method that should be used only occasionally. In no case should replace a regular contraceptive method because:
Not always prevents pregnancy;
In the case of regular consumption there is a risk of overload and hormonal problems arise during the cycle are not recommended.
Emergency contraception does not interrupt the pregnancy.
If unprotected sex occurred more than 72 hours ago within the same menstrual cycle, you should consider the possibility of pregnancy. NorLevo can not be effective if you hold a second intercourse during treatment.
NorLevo repeated administration within the same menstrual cycle is not advisable because of the possibility of changes in the cycle.
NorLevo is not as effective as a conventional method of contraception. See your doctor for the adoption of any of the conventional contraceptive methods that are more effective in preventing pregnancy.
NorLevo contains lactose. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.
After taking this medicine:
It is mandatory to exclude the possibility of pregnancy by performing a pregnancy test:
- If your next menstrual period is delayed more than five days,
- If abnormal bleeding occurs at the expected date of your next period.
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. Emergency contraception does not protect you against sexually, since only the use of condoms can do transmission.
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medications, such as those listed below, can reduce or prevent NorLevo work properly.
- Some medicines used to treat epilepsy (such as phenobarbital, phenytoin, primidone and carbamazepine)
- Some medicines used to treat HIV infection (ritonavir)
- Some medications for treating certain bacterial infections
(Rifabutin, rifampicin, griseofulvin)
- Medicinal plants containing St. John's wort (Hypericum perforatum).
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
This medicine does not interrupt an established pregnancy.
If he takes this medicine and nevertheless are becoming pregnant, the results of epidemiological studies indicate no risk of malformation for the developing fetus. In any case, this medicine should not be administered to pregnant women.
If you become pregnant after taking NorLevo should contact your doctor. Your doctor may want to confirm that the pregnancy is not ectopic. This is especially important if you experience severe pain in her abdomen after taking NorLevo or if you have had an ectopic pregnancy, surgery of the fallopian tubes or pelvic inflammatory disease.
Breastfeeding is possible. However, taking into account that levonorgestrel passes into breast milk, it is recommended to breastfeed immediately before taking NorLevo, and avoid breastfeeding for at least 8 hours after administration of NorLevo.
Driving and using machines
After taking NorLevo, some women feel fatigue and dizziness (see section 4 of this leaflet); do not drive or use machines if you experience these symptoms.
There have been no studies on the effects on the ability to drive and use machines.
3. HOW TO TAKE NorLevo
Follow these instructions NorLevo administration unless your doctor has given you different. Ask your doctor or pharmacist if you have doubts.
NorLevo is administered orally. The tablet should be taken with a glass of water and must not be chewed.
The tablet should be taken as soon as possible, preferably within the first 12 hours, and no later than 72 hours (3 days) after unprotected intercourse.
NorLevo can be taken at any time during the menstrual cycle.
If you vomit within three hours since taking NorLevo tablet, you take another tablet immediately.
After using this emergency contraceptive method it is recommended to use a barrier method of contraception (condoms, spermicide, cervical cap) until the start of the next menstrual cycle. If you hold unprotected sex after taking NorLevo (during the same menstrual cycle), becomes at risk of pregnancy. Use of NorLevo is not a contraindication to continue with regular hormonal contraception.
If you have taken this medicine while using an oral contraceptive (birth control pill) should continue taking the tablets until the end of treatment, as usual. In case of not having menstrual bleeding in the rest period of taking the pill, a pregnancy test should be performed to exclude potential pregnancy.
Your doctor can inform long-term contraceptive methods because they are more effective in preventing pregnancy.
If you continue to use regular hormonal contraception such as the pill, and no bleeding during their break from the pill, ask your doctor to confirm you are not pregnant.
After using NorLevo, your cycle is usually normal and will start the usual day; however sometimes it can be advanced or delayed some days.
If your period is delayed more than 5 days or is unusually scarce or plentiful, if for any reason or think you may be pregnant, you should confirm whether you are pregnant by performing a pregnancy test. If you become pregnant despite taking this medicine, contact your doctor.
If you take more than you should NorLevo
After ingestion of several tablets of this medicine has not been observed acute toxicity or serious harmful effects. However, you may feel dizzy, nauseated (vomiting) or appearing vaginal bleeding. Consult your doctor or pharmacist for advice.
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, NorLevo can cause side effects, although not everybody gets them.
Possible side effects are listed below according to their frequency: Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100) Very rare (affects less than 1 in 10,000 users)
Not known (can not be estimated from available data)
They have observed the following side effects:
+ Very common side effects:
- Dizziness, headache.
- Nausea, pain in the lower abdomen.
- Increased breast tenderness, delayed menstruation exceptionally heavy menstruation, bleeding.
+ Common side effects:
- Diarrhea, vomiting.
+ Adverse effects of unknown frequency:
- Hypersensitivity skin reactions may include rash, hives, itching, swelling of the face.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE NorLevo
Keep out of reach and sight of children.
Keep the blister pack in the outer carton to protect from light.
Do not use NorLevo after the expiration date on the carton after EXP. The expiry date is the last day of that month.
Do not use NorLevo if you notice visible signs of deterioration; It must be returned to your pharmacist.
6. FURTHER INFORMATION
- The active substance is levonorgestrel.
- The other ingredients are lactose monohydrate, maize starch, povidone, colloidal anhydrous silica and magnesium stearate.
Looks like and contents of the pack
NorLevo is a white tablet with round and convex shape and engraved with code NL 1.5 on one side.
Each package contains a compressed NorLevo 1,500 micrograms of levonorgestrel.
Holder of the marketing authorization
Chiesi Spain, S.A.
Placa d'Europa, 41-43, Floor 10
08908 L'Hospitalet de Llobregat - Barcelona (Spain)
Responsible for manufacturing
Osny Pharma S.A.S
17, rue de Pontoise
95520 Osny (France)
Delpharm Lille S.A.S.
Z.I. Roubaix Est
Rue de Toufflers
59390 Lys-lez-Lannoy (France)
Source: Spanish Agency for Medicines and Health Products