Levonorgestrel 1.5MG Mylan: Emergency contraception to be taken within 72 hours after unprotected intercourse or in case of failure of a contraceptive method.
A forgotten pill, a condom that slips or tears, an incorrectly placed vaginal ring...: there are many risky situations that can lead to an unplanned pregnancy. However, there are remedial methods, to be taken as soon as possible after unprotected (or poorly) protected intercourse: this is called emergency contraception.
Levonorgestrel is a medicine used as an oral contraceptive (pill). Levonorgestrel belongs to the class of medications called progestins . Progestins are female sex hormones that are used in oral contraceptives (often in combination with another hormone, estrogen).
Emergency contraception to be taken within 72 hours after unprotected intercourse or if a contraceptive method fails .
Levonorgestrel 1500 micrograms
For one tablet.
Excipient : lactose.
The tablet is white and round, with G00 engraved on one side.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 26/01/2017
LEVONORGESTREL BIOGARAN 1500 micrograms, tablet
levonorgestrel
Read all of this leaflet carefully before you start taking this medicine.
· Keep this leaflet, you may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you. Never give it to anyone else, even if the symptoms are the same, it could be harmful.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this notice :
1. WHAT IS LEVONORGESTREL BIOGARAN 1500 micrograms, tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE LEVONORGESTREL BIOGARAN 1500 micrograms, tablet?
3. HOW TO TAKE LEVONORGESTREL BIOGARAN 1500 micrograms, tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LEVONORGESTREL BIOGARAN 1500 micrograms, tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS LEVONORGESTREL BIOGARAN 1500 micrograms, tablet AND WHAT IT IS USED FOR?
These are:
· no contraceptives were used during sexual intercourse.
· the contraceptive method has not been used correctly, for example if a condom has broken, slipped or has been misused, if a vaginal pessary or diaphragm has moved, broken, torn or was removed too soon, in the event of failure of the method of interrupted coitus (ejaculation of the sperm in the vagina or on the external genitals).
Levonorgestrel Biogaran 1500 contains an active substance, namely a synthetic hormone called levonorgestrel. It prevents about 85% of pregnancies if you take it within 72 hours of unprotected intercourse. It does not prevent pregnancy in all cases and it is most effective if you take it as soon as possible after unprotected intercourse. It is best to take it within 12 hours than wait until the third day.
LEVONORGESTREL BIOGARAN 1500 acts:
· by preventing the ovaries from releasing an egg;
· by preventing a sperm from fertilizing an already released egg.
Levonorgestrel Biogaran can only prevent you from becoming pregnant if you take it within 72 hours after unprotected intercourse. It is ineffective if you are already pregnant. If you have other sexual intercourse after taking LEVONORGESTREL BIOGARAN 1500 (or if it occurs during the same menstrual cycle), the tablet will not have a contraceptive effect and the risk of pregnancy will be present again.
2. BEFORE YOU TAKE LEVONORGESTREL BIOGARAN 1500 micrograms, tablet?
List of information needed before taking the medication
Not applicable.
Never take LEVONORGESTREL BIOGARAN 1500 micrograms, tablet in the following case:
· If you are allergic to levonorgestrel or to any of the other ingredients of this medication mentioned in section 6.
Precautions for use; special warnings
If any of the following apply to you, tell your doctor before taking LEVONORGESTREL BIOGARAN 1500 because emergency contraception may not be appropriate for you. Your doctor may prescribe another type of emergency contraception.
· if you are pregnant or suspect that you may already be pregnant. This drug will be ineffective if you are already pregnant. If you are already pregnant, LEVONORGESTREL BIOGARAN 1500 can not interrupt the pregnancy. LEVONORGESTREL BIOGARAN 1500 is therefore not an "abortive pill".
You may already be pregnant if:
· your periods are more than 5 days late or you have had unusual bleeding at the time your next periods were to occur.
· you had unprotected sex over 72 hours ago and since your last menstrual period.
The use of LEVONORGESTREL BIOGARAN 1500 is not recommended if:
· you have a small bowel disease (Crohn's disease for example) that inhibits the absorption of the drug
· you have severe liver problems
· you have a history of ectopic pregnancy (when the baby develops out of the uterus)
· you have a history of salpingitis (inflammation of the fallopian tubes).
A previous ectopic pregnancy or previous infection of the fallopian tubes increases the risk of a new ectopic pregnancy.
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. Some data suggest that LEVONORGESTREL BIOGARAN 1500 may be less effective with an increase in body weight or body mass index (BMI), but these data are limited and inconclusive. The LEVONORGESTREL BIOGARAN 1500 is therefore always recommended for all women regardless of weight or BMI.
It is recommended that you contact a health professional if you are concerned about problems associated with taking an emergency contraceptive .
Children and Youth
The use of this medication is not recommended in children. Available data are very limited for women under 16 years of age.
If you are concerned about sexually transmitted diseases
If you have not used a condom (or if it has torn or slipped) during sexual intercourse, it may be possible that you have caught a sexually transmitted disease or the HIV virus.
This medication will not protect you against sexually transmitted diseases, only condoms can do it. Seek advice from your doctor, nurse, family planning center or pharmacist if you have any concerns.
Interaction with other medicines
Other medicines and LEVONORGESTREL BIOGARAN
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Some medications may prevent LEVONORGESTREL BIOGARAN 1500 from working properly, including:
· barbiturates and other drugs used to treat epilepsy (eg primidone, phenytoin and carbamazepine)
· medicines used to treat tuberculosis (rifampicin, rifabutin, for example)
· a treatment against HIV infection (ritonavir)
· a drug used to treat fungal infections (griseofulvin)
· medicinal plant preparations containing St. John's wort (Hypericum perforatum)
· a drug called ciclosporin (it depresses the immune system)
If you are taking any of the medicines listed above, talk to your doctor or pharmacist before taking LEVONORGESTREL BIOGARAN 1500.
Frequency of use of LEVONORGESTREL BIOGARAN
You should only use LEVONORGESTREL BIOGARAN 1500 in an emergency and not as a regular contraceptive method. If LEVONORGESTREL BIOGARAN 1500 is used more than once during a menstrual cycle, it is less reliable and more likely to disrupt your cycle (rules).
LEVONORGESTREL BIOGARAN 1500 is not as effective as regular contraceptive methods. Your doctor, the nurse in the practice or the family planning center can tell you about more effective long-term contraceptive methods that will prevent you from starting a pregnancy.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy, breast-feeding and fertility
If you are pregnant, breast-feeding, thinking to become pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
You should not take this medication if you are already pregnant. If you become pregnant although you have taken this medication, it is important to consult your doctor. No adverse effects of LEVONORGESTREL BIOGARAN 1500 on children developing in the uterus have been demonstrated when LEVONORGESTREL BIOGARAN 1500 is used as directed but your doctor will want to check that the pregnancy is not ectopic (when the baby develops out of the uterus). This is especially important if you have severe abdominal pain after taking LEVONORGESTREL BIOGARAN 1500 or if you have a history of ectopic pregnancy, surgery in the fallopian tubes or inflammatory pelvic disease.
The active substance of this drug is excreted in breast milk. Therefore, it is advisable to take the tablet immediately after breast-feeding and to avoid breast-feeding for at least 8 hours after taking levonorgestrel, and to aspirate the milk with a pump- milk for 8 hours after taking the tablet. This way, you take your tablet well before the next feeding and you decrease the amount of active substance that the baby absorbs with the milk.
LEVONORGESTREL BIOGARAN 1500 increases the possible occurrence of menstrual disorders which can sometimes lead to an early or late ovulation date and thus modify the date of fertility. Although data on long-term fertility are not available after treatment with LEVONORGESTREL BIOGARAN 1500, fertility is expected to return rapidly and regular contraception should be continued or instituted as soon as possible after the end- use of LEVONORGESTREL BIOGARAN 1500.
Not applicable.
Effects on ability to drive or use machines
The LEVONORGESTREL BIOGARAN 1500 tablet is unlikely to affect your ability to drive or use machines. However, if you feel tired or dizzy, do not drive or use machines.
List of excipients with known effect
LEVONORGESTREL BIOGARAN contains lactose
In case of intolerance to a carbohydrate present in milk (lactose), account should be taken of the fact that each LEVONORGESTREL BIOGARAN 1500 tablet contains 142.5 mg of lactose.
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
3. HOW TO TAKE LEVONORGESTREL BIOGARAN 1500 micrograms, tablet?
Emergency contraception is all the more effective when used quickly. Indeed, its effectiveness decreases by about half between 24 and 72 hours. |
Dosage
The treatment is one tablet.
The tablet should be taken as soon as possible, if possible within 12 hours after unprotected intercourse and within 72 hours (3 days) after the report.
This treatment requires taking one tablet at one time.
If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.
This medication can be taken at any time of the cycle.
If you have used this medication due to a forgetful birth control pill, you should continue taking the current pamphlet until the end. If you do not have your period at the end of the leaflet, make sure that you are not pregnant.
After using this emergency contraception and until your next menstrual period, it is strongly recommended to use a local contraceptive method (condom, cervical cap, spermicide) during the following sexual intercourse.
Method and route of administration
Oral use.
The tablet should be swallowed with a glass of water.
Symptoms and Instructions for Overdose
If you take more LEVONORGESTREL BIOGARAN 1500 micrograms, tablet than you should:
Acute toxicity has not been demonstrated with multiple doses.
Instructions for omission of one or more doses
If you forget to take LEVONORGESTREL BIOGARAN 1500 micrograms, tablet:
The effectiveness of this medication is not ensured if the tablet has not been taken under the recommended conditions. In this case, make sure you are not pregnant, if you do not have your period on schedule.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, LEVONORGESTREL BIOGARAN 1500 micrograms, tablet is likely to have undesirable effects, although not everyone is subject to it.
The undesired effects that have been observed are:
· nausea, vomiting, diarrhea,
· dizziness, fatigue, headache,
· low abdominal pain,
· a feeling of tension of the breasts,
· a delay of rules.
· Regular bleeding may occur after taking this medication.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE LEVONORGESTREL BIOGARAN 1500 micrograms, tablet?
Keep out of the reach and sight of children.
Do not use LEVONORGESTREL BIOGARAN 1500 micrograms, tablet after the expiry date stated on the carton.
Keep the blister packs in the outer carton, protected from light.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Full list of active substances and excipients
What does LEVONORGESTREL BIOGARAN contain 1500 micrograms, tablet?
The active substance is:
Levonorgestrel ................................................. .................................................. ............ 1500 micrograms
For a tablet.
The other components are:
Potato starch, corn starch, anhydrous colloidal silica, magnesium stearate, talc, lactose monohydrate.
Pharmaceutical form and content
What is LEVONORGESTREL BIOGARAN 1500 micrograms, tablet and contents of the pack?
This medicine comes in tablet form. Box of 1 tablet.
GYÖMRŐI ÚT 19-21.
1103 BUDAPEST
HUNGARY
BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
GEDEON RICHTER SA
GYOMROI UT 19-21
1013 BUDAPEST
HUNGARY
Names of the medicinal product in the Member States of the European Economic Area
[to be completed by the holder]
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
a) Some notions on:
· periods
The menstrual cycle is the time elapsed between two episodes of menstruation. Most often, the cycle lasts 28 days, it begins on the first day of the rules and ends on the first day of the following rules. But the length of a cycle may vary from one woman to another.
The rules arise when a woman is not pregnant.
· fertilization
In the middle of the cycle, an ovule is expelled by one of the 2 ovaries (this time is called "ovulation"). In general, ovulation occurs in the middle of the cycle but can occur at any point in the cycle.
If spermatozoa are found in the vicinity of the ovum, "fertilization" (ie the encounter of the ovum and a spermatozoon to create an embryo) can take place.
After a few days, the fertilized egg will settle (or "implant") in the uterus, and the pregnancy begins.
· contraception
Contraceptive methods are designed to prevent:
o ovulation: this is the case of the birth control pill,
o fertilization (encounter of spermatozoa and ovum): this is the case of condoms,
o or implantation if the egg is fertilized: this is the case of the IUD.
· emergency contraception
Emergency contraception is meant to block ovulation or prevent fertilization during a cycle.
On the other hand, it is ineffective once the implantation has started.
In the absence of contraception, a woman can never rule out the possibility of becoming pregnant after intercourse.
If you have used this medication and do not usually have contraception, it is strongly recommended that you consult your doctor to discuss a regular contraceptive method that is appropriate for you.
b) Recall of risks following sexual intercourse without a condom and advice
If you are concerned about pregnancy, it may mean that you have not used a condom (or misused it) during intercourse. You may have contracted a sexually transmitted disease or the AIDS virus if you are unfamiliar with your partner's health status or if you have multiple partners. You should consult your doctor as soon as possible so that he can offer you a screening and possibly an early treatment.
During your next sexual intercourse, the most appropriate measures should be taken to prevent unwanted pregnancy or sexually transmitted disease and to prevent contamination by the AIDS virus.
Consult your doctor or family planning center or call one of the following numbers:
Young Health Filters: 0 800 235 236
AIDS info service: 0 800 840 800
GLOSSARY
· Ectopic pregnancy:
pregnancy that develops outside the uterus most often in a fallopian tube. Warning signs are persistent abdominal pain, delayed menstruation, vaginal bleeding, signs of pregnancy (nausea, tightness of the breasts). These symptoms should prompt a doctor to consult.
· PID:
infection of the fallopian tubes, often responsible for abdominal pain, fever and vaginal discharge.
IN SUMMARY
The important points | To behave |
The use of LEVONORGESTREL BIOGARAN 1500 micrograms, tablet must remain exceptional. | |
LEVONORGESTREL BIOGARAN 1500 micrograms, tablet can be used at any time of the cycle. | |
Take LEVONORGESTREL BIOGARAN 1500 micrograms, tablet is not recommended if you have had an extra-uterine pregnancy or if you have had salpingitis in the past. | In case of doubt, or if your periods are abnormal, or if your periods do not arrive, or if you have abdominal pain, consult your doctor. |
The tablet should be taken as soon as possible after unprotected intercourse. | |
Treatment requires a single tablet. | If you have vomited within 3 hours of taking the tablet, another tablet should be taken immediately. |
LEVONORGESTREL BIOGARAN 1500 micrograms, tablet is effective only 7 to 9 times out of 10. | 1500 If you have a delay of more than 5 bears in relation to the expected date, take a pregnancy test to make sure you are not pregnant. |
After taking LEVONORGESTREL BIOGARAN 1500 micrograms, compressed, local contraception should be used until the following rules. | If you do not have your period at the end of the next blister, make sure that you are not pregnant. |
If you have used this medication due to a forgetful birth control pill, you should continue taking the current pamphlet until the end. | |
Taking LEVONORGESTREL BIOGARAN 1500 micrograms, tablet does not avoid the risk of sexually transmitted disease (especially AIDS). | If in doubt, consult your doctor or call one of the following: |
Emergency Contraceptive
. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Undesirable effects . Lexicon
LÉVONORGESTREL BIOGARAN 1500 μg: tablet; box of 1.
Refunded at 65%. - price: 5,01 euro (s).
Biogaran Laboratory
| p cp | |
| levonorgestrel | 1.5 mg |
| Lactose | + |
