ELLAONE 30MG emergency contraception

For warnings, precautions and contraindications, please refer to the package insert.

ELLAONE 30MG emergency contraception

EllaOne 30 mg tablet is an oral emergency contraceptive, which means it can be used to prevent pregnancy after unprotected sexual intercourse or if your contraceptive method fails, for example:
If your condom, or your partner's, has torn, slipped or come off, or if you've forgotten to use one,
If you have forgotten to take your pill on time (consult the leaflet accompanying your pack of contraceptive pills).

Description of ELLAONE 30MG emergency contraception

EllaOne can be used up to 120 hours (5 days) after unprotected sexual intercourse if a contraceptive method has failed.

EllaOne works by modifying the activity of progesterone, a natural hormone. EllaOne is supposed to work by preventing your ovaries from releasing an egg. EllaOne is not effective in all cases: out of 100 women receiving EllaOne less than 5 days after unprotected sexual intercourse, around 2 will become pregnant.

EllaOne cannot be used as a regular contraceptive method.

Directions for use ELLAONE 30MG Emergency contraceptive

How to use EllaOne

Always follow the dosage instructions given by your doctor, healthcare professional or pharmacist. If in doubt, ask your doctor, healthcare professional or pharmacist.

Take an oral tablet as soon as possible and within 120 hours (5 days) of unprotected sexual intercourse or after the failure of your contraceptive method. Do not wait to take the tablet.

• You can take EllaOne before, during or after a meal.
• You can take EllaOne at any time during your menstrual cycle.
• If you vomit within 3 hours of taking an EllaOne tablet, you should consult your doctor or healthcare professional about taking another tablet.
• If you find that you are pregnant after taking EllaOne, it is important to contact your doctor, healthcare professional or pharmacist.
• If you have any further questions about the use of this medicine, ask your doctor, the healthcare professional who is following you or your pharmacist.

Never take EllaOne

• if you think you might be pregnant,
• if you are allergic to ulipristal acetate or any of the other ingredients of this medicine.

Composition of ELLAONE 30MG emergency contraception

What EllaOne contains

The active substance isulipristal acetate. One tablet contains 30 milligrams of ulipristal acetate.

Other ingredients include lactose, povidone k30, croscarmellose sodium and magnesium stearate.

Precautions for use

Warnings and Precautions :

Emergency contraception is a back-up method to avoid pregnancy and should only be used occasionally. Only limited information is available on the safety and efficacy of repeated use of EllaOne; it is therefore advisable not to use EllaOne more than once during the same menstrual cycle. Your doctor or other healthcare professional can advise you on the most appropriate methods of regular long-term contraception for you.

Tell your doctor, healthcare professional or pharmacist if you have liver disease. The use of EllaOne is not recommended in cases of severe liver disease.

Inform your doctor, healthcare professional or pharmacist if you suffer from severe asthma.

After taking EllaOne, if you wish to have sexual intercourse, you must use a reliable barrier contraceptive method, such as a condom. EllaOne will be ineffective if you have unprotected sexual intercourse again.

After using EllaOne, if you wish to start a hormonal contraceptive method such as the contraceptive pill immediately during the same cycle, you may do so, but you must always continue to use a reliable barrier contraceptive method such as condoms until your next period.

If you are currently taking hormonal contraception (such as a birth control pill), you can continue the current pack immediately after taking EllaOne, but you must use a reliable barrier contraceptive method, such as a condom, until your next period.

After taking EllaOne, most women menstruate on schedule, but some may menstruate earlier or later than expected. For all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that EllaOne may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. So EllaOne is still recommended for all women, whatever their weight or BMI.

It is recommended that you speak to a healthcare professional if you are concerned about any problems associated with taking emergency contraception. If your period is more than 7 days late, or if it is less or more abundant than usual, or if you experience symptoms such as abdominal pain, nausea, vomiting or breast pain, or if you have the slightest doubt that you could be pregnant, you should take a pregnancy test to make sure you are not pregnant.

Presentation of ELLAONE 30MG emergency contraception

Box of 1 tablet

Our expert advice at the pharmacy

If you find yourself pregnant after taking EllaOne, it's important to contact your doctor. Your doctor may want to check that your pregnancy is not ectopic (where the baby develops outside the uterus). This is particularly important if, after taking EllaOne, you experience severe abdominal pain or bleeding, or if you have ever had an ectopic pregnancy, fallopian tube surgery or a long-term (chronic) genital infection (upper genital infection).

If you have concerns about sexually transmitted diseases, EllaOne will not protect you from HIV infection (AIDS) or any other sexually transmitted disease (such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B or syphilis). Only condoms can protect you from these diseases. Consult your doctor or healthcare professional if you have any concerns.

Emergency Contraceptive

ulipristal acetate

. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS ^(summary)

ELLAONE 30 mg: tablet (white); box of 1.
Refunded at 65%. - price: 18,60 euro (s).

Laboratory

COMPOSITION ^(summary)

	p cp
Ulipristal acetate	30 mg
Lactose	+

INDICATIONS ^(summary)

This drug contains a substance that belongs to the family of progesterone receptor modulators. It prevents progesterone from acting on its receptors. It thus inhibits ovulation and interferes with the processes that predate the fixation of the fertilized egg in the uterus. This is not a method of terminating pregnancy.
It is used for emergency contraception, in particular in the following cases:

• forgetting or breaking a condom,
  
• delay in taking the usual contraceptive tablet beyond the acceptable time limit (see this time limit in your contraceptive pill form),
  
• loss of an IUD spontaneously expelled from the uterus,
  
• displacement or early withdrawal of a vaginal diaphragm or a contraceptive cape,
  
• doubt about the good practice of the method of interrupted coitus,
  
• error of date when using periodic abstinence method (temperature method),
  
• sexual relationship resulting from rape.
  

WARNING ^(Contents)

Treatment is possible within 5 days of the potentially fertile relationship. It has no action on the transmission of sexually transmitted infections.
This medicinal product is for exceptional use and can not constitute a regular method of contraception. It does not have a preventive effect for subsequent intercourse and may disrupt current hormonal contraception. Local contraception (preservative, spermicide) should be used until the end of the current cycle.
This emergency contraception is not totally effective: a pregnancy can occur despite the treatment. In case of delayed periods of more than 7 days, a pregnancy test will show whether this delay is due to a progressive pregnancy or hormonal disruption.
In case of abdominal pain or abnormal bleeding around the expected date of menstruation, also perform a pregnancy test and consult your doctor if your test is positive. A diagnosis of ectopic pregnancy should be made by ultrasound.
Repeated use of this medication during the same cycle should be avoided.
Precautions are necessary in cases of severe asthma.
Due to its potential adverse effects, this medication may not be compatible with driving or handling dangerous machinery. Be sure to take the first few times that you are taking this medicine before you drive or use a machine.

DRUG INTERACTIONS ^(summary)

Contraceptive efficacy of this drug may be impaired if you are taking an enzyme inducer .

PREGNANCY AND BREAST-FEEDING ^(summary)

Pregnancy :
The use of this medication during pregnancy is contraindicated.

Breastfeeding:
The punctual use of this medication does not contraindicate the continuation of the breast-feeding. It is recommended to breastfeed just before taking the medication and to avoid breastfeeding for the next 36 hours.

DIRECTIONS FOR USE AND DOSAGE ^(summary)

This medicine may be taken with or without food.

Usual dosage:

• Female over 18: take 1 tablet as soon as possible after unprotected intercourse, and at the latest within 5 days of the report.
  

TIPS ^(summary)

If vomiting occurs within 3 hours of taking, get another can and take another tablet.
This medication can be taken at any time during the cycle.

POSSIBLE ADVERSE EFFECTS ^(summary)

Transient hormonal dysregulation: early or delayed menstruation, intermittent bleeding outside menstruation, breast tension.
Nausea, vomiting, abdominal pain.
Dizziness , headache, tiredness, mood disorders.

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GLOSSARY ^(summary)

ectopic pregnancy
Pregnancy developing outside the uterus: during a normal pregnancy, the egg is fertilized in the fallopian tube by a spermatozoon; it should normally progress to the uterus where it is attached to the endometrium. In some cases, this progression is stopped and the egg develops in the proboscis, which is likely to rupture. This is an ectopic pregnancy diagnosed by ultrasound and requires surgery. The signs suggestive of ectopic pregnancy are lower abdominal pain and intermittent bleeding in a woman who has a positive pregnancy test.


enzymatic inducer
The liver, a true chemical plant in the body, ensures the elimination or destruction of many drugs.
Some substances stimulate the hepatic enzymes that provide this elimination function. These substances are enzymatic inducers, and their consumption can reduce the blood concentration of drugs sensitive to their action, diminishing or even canceling their effect. An increase in the dosage of the drug often makes it possible to compensate for the effect of the joint use of an enzyme inducer, but the risk of inefficiency sometimes leads to discouragement of their association. This is the case for oral contraceptives ("pills"), which may lose their effectiveness if they are combined with the regular intake of an enzyme inducer.
The risk is mentioned in the section Drug Interactions when a drug is likely to be significantly modified by the use of an enzyme inducer.
The main enzymatic inducers are usually themselves medicines:

• anti-epileptic drugs (anticonvulsants): carbamazepine, phenobarbital, phenytoin, primidone;
  
• antituberculosis drug: rifabutin, rifampicin;
  
• antifungal: griseofulvin.
  

Other substances may have an enzymatic inducing effect:

• St. John's wort, a plant contained in certain preparations;
  
• tobacco and alcohol.
  

Dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).