Medication Information Leaflet
What is this medication for?
Fibroids are the most common form of non-cancerous, benign (not harmful) growth in women of reproductive age that grow in the muscles of the uterus (womb). Most of them are very small and do not cause symptoms at all. However, when they become very large, they can cause heavy menstrual bleeding, pelvic pain and discomfort. The causes of uterine fibroids are not yet fully understood, however, they seem to be stimulated by the female hormones.
Esmya® (ulipristal acetate) is used to treat moderate to severe symptoms of uterine fibroids by changing the activity of progesterone.
A single course of Esmya® can be used in women who are about to have surgery for their fibroids. It can be used for more than one course only in women who should not have surgery.
How should I take/use this medication?
- Do not stop taking your medication without checking with your healthcare professional
- You may take this medication with or without food.
- You should stop taking other hormonal treatments before starting this medication.
- You should start taking this medication during the first week of your menses (if this is your first time taking Esmya®).
- You should take one tablet (5mg) daily, preferably at the same time every day, for a treatment course of up to 3 months continuously.
- If you have been prescribed several treatment courses of Esmya® (i.e. 3 months per course), you should start each course at the earliest during the first week of the second menstrual bleeding following the previous treatment completion. Menstrual bleed will generally return within 4 weeks after the end of the treatment course.
Example: Your 1st course begin in first week of your menstrual bleed in February and last for 3 months (February-April). Break and wait for your next menstrual bleed to occur sometime in May. Your 2nd course will begin on the first week of your menstrual bleed in June. This course will last for up to 3 months. (June-August)
What should I do if I forget to take/use this medication?
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 tablet. Do not take a double dose to make up for a forgotten tablet.
What precautions should I take?
Inform your healthcare professional if:
- You are allergic to this medication or any of the other ingredients of this medication
- You are pregnant, planning to become pregnant, or breastfeeding
- You are taking any other medications, including supplements, traditional medications and herbal remedies.
- You have a history of or current medical conditions such as liver problems or cancer
What are some side-effects that I need to seek medical advice immediately?
Esmya® has very rarely been reported to cause liver injury. In order to prevent rare but serious liver injury:
- Blood tests will be done to find out how well your liver is working. Depending on the result of these tests, your doctor will decide if Esmya® is suitable for you.
- You will also have blood tests to check your liver function during treatment with Esmya®. Another check will be done after stopping treatment.
The symptoms of liver injury include one or more of the following:
- Tiredness
- Yellowing of the skin
- Darkening of the urine
- Nausea and vomiting
- Right stomach pain
The symptoms of a drug allergy include one or more of the following:
- Swollen face/eyes/lips/tongue
- Difficulty in breathing
- Itchy skin rashes over your whole body
If you experience any of these symptoms, you should stop your medication and see your healthcare professional immediately.
What are some other side-effects of this medication?
- Reduced or absence of menstrual bleeding and thickening of the lining of the womb
- Esmya® leads to a significant reduction in menstrual blood loss and may even stop your menstrual bleeding within the first 10 days of treatment. You should inform your doctor if you continue to have heavy menstrual bleeding. Menstrual bleeding will generally return within 4 weeks after the end of the treatment course.
- Dizziness
- Hot flushes, fatigue
- Headache, muscle pain
- You may take Paracetamol to manage headaches and muscle pain.
- Stomach discomfort such as nausea, vomiting, abdominal pain
- Take the medication after food to reduce these side effects.
- Breast tenderness
- Acne
- Use gentle, fragrance-free facial cleansers. Avoid picking or squeezing pimples.
Consult your doctor about any symptoms that becomes bothersome.
What food or medication should I avoid when I take this medication?
Esmya® is likely to make some hormonal contraceptives less effective. Women taking Esmya® a treatment for uterine fibroids are advised to use non-hormonal contraception (e.g barrier-method such as a condom) as a precaution to prevent pregnancy.
Avoid taking grapefruit,or grapefruit juice as they may interact with your medication and
increase the risk of side-effects.
How should I store this medication?
Store in a cool and dry place, away from direct sunlight. Keep this medication away from children.
How should I throw away this medication safely?
Pack this medication into a black trash bag and seal it tightly before throwing into the rubbish chute or bin.
Disclaimers
If you take more than the recommended dose, please seek medical advice immediately. The information provided on this page does not replace information from your healthcare professional. Please consult your healthcare professional for more information.
This article is jointly developed by members of the National Medication Information workgroup. The workgroup consists of cluster partners (National Healthcare Group, National University Health System and SingHealth), community pharmacies (Guardian, Unity and Watsons) and Pharmaceutical Society of Singapore.
Last reviewed on June 2019
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Copyright © Ministry of Health Singapore. All rights reserved.
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