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ULIPRISTAL ACETATE

Brand Name(s) : ellaOne, Esmya
Warnings
Uses
Side Effects
Precautions
Interactions
Overdose

ULIPRISTAL ACETATE WARNINGS

Ulipristal should be used with caution in

  • People with severe asthma
  • People with liver or kidney problems
  • Women taking hormonal contraception, such as the birth control pill

For emergency contraception, it should not be used in:

  • People with allergy to ulipristal or to any other ingredients contained in the medicine
  • Pregnancy

For uterine fibroids, it should not be used in:

  • People with allergy to ulipristal or to any other ingredients contained in the medicine
  • Pregnancy or breastfeeding
  • People with abnormal bleeding from the vagina not caused by uterine fibroids
  • People with cancer of the womb (uterus), neck of the womb (cervix), ovary or breast
  • Women who have already received treatment with ulipristal for three months
  • Also see list of precautions and interactions

    STORAGE

    Store in original container.

    ULIPRISTAL ACETATE USES

    What is it used for?

    • Ulipristal is used as an oral emergency contraceptive to prevent pregnancy after unprotected sex or failure of a contraceptive method. It is thought to work by preventing the ovaries from releasing an egg and by changing the lining of the womb so that it is not thick enough for a fertilised egg to grow in it. It is used for up to 5 days after unprotected sex. It is important to note ulipristal is not suitable as a regular method of contraception.
    • Ulipristal is also used to treat moderate to severe symptoms of uterine fibroids in adult women of reproductive age who need an operation. It is used for a maximum of three months to reduce the size of fibroids or reduce bleeding before the operation.
    • It is a synthetic hormone which works by changing the activity of progesterone, a naturally occurring hormone in the body.
    • In general this drug is used as an emergency contraceptive after unprotected sex or where a contraceptive method has failed. It is also used to treat symptoms of uterine fibroids in women who need an operation.
    • Benefits of being on this drug can include prevention of pregnancy and relief from uterine fibroids symptoms.

    Listed below are the typical uses of ulipristal.

    • Emergency oral contraception
    • Treatment of moderate to severe symptoms of uterine fibroids in adult women who need an operation, for a maximum of three months.

    On occasion your doctor may prescribe this medicine to treat a condition not on the above list.

    HOW TO USE/TAKE

    How often do I take it?

    • If you are taking ulipristal for emergency contraception then take the tablet as soon as possible and no later than 120 hours (5 days) after you have had unprotected sex. You should use a reliable barrier method of contraception such as a condom until your next period.
    • For uterine fibroids, take this medication by mouth, usually once daily for up to three months.
    • Remember to use it at the same time each day - unless specifically told otherwise by your doctor.
    • Certain medical conditions may require different dosage instructions as directed by your doctor.

    What dose?

    • Dosage is based on your age, medical condition, response to therapy, and use of certain interacting medicines.

    Do I need to avoid anything?

    • Ulipristal is not known to affect ability to drive or operate machinery. Consult your doctor or pharmacist for more details.

    When can I stop?

    • Ulipristal is not a suitable method of regular contraception. It is indicated for emergency contraception, hence should only be used occasionally.
    • Ulipristal is used for up to three months when used for the treatment of uterine fibroids. It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.

    ULIPRISTAL ACETATE SIDE EFFECTS

    If any of these persist or you consider them severe then inform your doctor or pharmacist.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

    ULIPRISTAL ACETATE PRECAUTIONS

    Before taking ulipristal, tell your doctor or pharmacist if you are allergic to it; or to other progestogens; or if you have any other allergies.

    This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of: an allergy to ulipristal or to any other ingredients contained in the medicine, pregnancy, intolerance to certain sugars, cancer of the womb, neck of the womb, ovary or breast, abnormal bleeding from the vagina of unknown cause.

    Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: severe asthma, liver or kidney problems.

    Before having surgery, tell your doctor or dentist that you are taking this medication.

    Does alcohol intake affect this drug?

    • Alcohol intake is not known to affect ulipristal.

    The elderly: ulipristal is not indicated for use in the elderly.

    Pregnancy and breastfeeding - please ensure you read the detailed information below

    PREGNANCY

    Ulipristal is not safe to take if you are, or are planning to become, pregnant.

    It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

    If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

    BREAST FEEDING

    Ulipristal is not recommended if you are breastfeeding.

    It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

    If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

    ULIPRISTAL ACETATE INTERACTIONS

    Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

    Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

    This information does not contain all possible interactions. Therefore, before using ulipristal, tell your doctor or pharmacist of all the products you use.

    ULIPRISTAL ACETATE OVERDOSE

    Experience with ulipristal overdose is limited.

    If you think you, or someone you care for, might have accidentally taken more than the recommended dose of ulipristal or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

    MISSED DOSE

    For emergency contraception: One tablet should be taken as soon as possible and no later than 120 hours (5 days) after unprotected sex or contraceptive failure. Taking the tablet should not be delayed.

    For Uterine fibroids: If you miss a dose by less than 12 hours, take it as soon as you remember. If you miss a dose by more than 12 hours, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse events, nor should it be construed to indicate that use of a particular medicine is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any medicine, changing any diet, or discontinuing any course of treatment.

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