5 mg tablets 
Ulipristal acetate

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Esmya is and what it is used for 
2. What you need to know before taking Esmya 
3. How to take Esmya 
4. Possible side effects 
5. How to store Esmya 
6. Contents of the packaging and other information 

1. What Esmya is and what it is used for

Esmya contains the active substance ulipristal acetate. It is used to treat moderate to severe symptoms of uterine fibroids in the uterus (also known as fibroids) which tumor you (not cancer) in the womb ( uterus ).

Esmya is used in adult women (over 18 years of age) who have not reached menopause ( menopause ).

In some women, fibroids in the uterus can cause heavy menstrual bleeding, pelvic pain (discomfort in the belly), and create pressure on other organs.

This drug works by affecting the activity of progesterone, which is a naturally occurring hormone in the body. It is used for the long-term treatment of fibroids to reduce their size, stop or reduce bleeding and increase the number of red blood cells.

2. What you need to know before taking Esmya

You should be aware that most women do not have any menstrual bleeding during treatment and for a few weeks afterward.

Do not take Esmya

  • if you are allergic to ulipristal acetate or any of the other ingredients of Esmya (listed in section 6)
  • if you have liver disease.
  • if you are pregnant or breast-feeding
  • if you have vaginal bleeding not caused by uterine fibroids in the uterus
  • if you have cancer of the uterus ( uterus ), cervix, ovaries, or breasts.

Warnings and cautions

  • Before starting treatment with Esmya, blood tests will be taken to find out how well your liver is working. Based on the results of the tests, your doctor will decide if you can be treated with Esmya. These blood tests will be repeated every month during the first two courses of treatment. For more treatment regimens, the liver is checked once before starting the treatment regimen and if you experience any of the symptoms listed below. Also, an additional check-up of your liver is performed 2-4 weeks after the end of treatment. If you experience any symptoms from the liver during treatment such as nausea or vomiting, fatigue, severe fatigue, jaundice (yellow eyes or yellow skin), dark urine, itching, or pain in the upper abdomen, discontinue treatment and seek medical attention immediately. Your doctor will check how your liver is working and determine if you can continue treatment.
  • If you are currently taking hormone contraceptives (eg birth control pills ) (see “Other medicines and Esmya”), you should use another reliable barrier contraceptive method (eg condoms) when taking Esmya.
  • If you have liver or kidney disease, consult your doctor or pharmacist before taking Esmya.
  • If you suffer from severe asthma, treatment with Esmya may not be suitable for you. You should discuss this with your doctor.

Treatment with Esmya usually leads to a sharp reduction or complete cessation of menstrual bleeding during the first 10 days of treatment. If you continue to bleed profusely, talk to your doctor.

Your period generally returns within 4 weeks of stopping treatment with Esmya. The lining of the uterus may become thicker or change as a result of treatment with Esmya. These changes stop when the treatment is stopped and your period returns.

Children and teenagers

Esmya should not be taken by children under 18 years of age as the safety and efficacy of ulipristal acetate have not been established in this age group.

Other medicines and Esmya

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines may affect Esmya or may be affected by Esmya:

  • certain medicines used to treat the heart (eg digoxin )
  • certain medicines used to prevent strokes and blood clots (eg dabigatran etexilate)
  • certain medicines used to treat epilepsy (eg phenytoin, fosphenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone)
  • certain drugs used to treat HIV – infection (ritonavir, efavirenz, nevirapine)
  • medicines used to treat certain bacterial infections (eg rifampicin, telithromycin, clarithromycin, erythromycin, rifabutin)
  • certain medicines used to treat fungal infections (eg ketoconazole [other than shampoo], itraconazole)
  • herbal herbal remedies containing St. John’s wort ( Hypericum perforatum ) and used for depression or anxiety
  • certain medicines used to treat depression (eg nefazodone)
  • certain medicines used to treat high blood pressure (eg verapamil).

Esmya is likely to make some hormone contraceptives less effective. Also, hormonal contraceptives and progestogens (eg norethindrone or levonorgestrel) are likely to make Esmya less effective. Therefore, hormone contraceptives are not recommended and you should use another reliable barrier contraceptive method, e.g. condom, under treatment with Esmya.

Esmya with food and drink

Avoid drinking grapefruit juice while you are being treated with Esmya.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Esmya if you are pregnant. Treatment during pregnancy can affect the pregnancy (it is not known if Esmya could harm your baby or cause a miscarriage). If you become pregnant during treatment with Esmya, stop taking Esmya immediately and contact your doctor or pharmacist.

Esmya is likely to make some hormone contraceptives less effective (see “Other medicines and Esmya”).

Esmya is excreted in human milk, so you should not breast-feed while taking Esmya.

Driving and using machines

Esmya may cause mild dizziness (see section 4 “Possible side effects”). Do not drive or use machines if you get these symptoms.

3. How to take Esmya

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one 5 mg tablet a day for treatment regimens of up to 3 months each. If you have been prescribed several courses of treatment for 3 months with Esmya, you should start each period at the earliest during the second menstrual period after the end of the previous treatment.

You should always start taking Esmya during the first week of your period.

The tablet should be swallowed with water and can be taken with or without food.

If you take more Esmya then you should

Experience with Esmya when several doses are taken at the same time is limited. There have been no reports of serious side effects after taking several doses of this medicine at the same time. You should still consult a doctor or pharmacist if you have taken too much Esmya.

If you forget to take Esmya

If you miss a dose of fewer than 12 hours, take it as soon as you remember. If you miss a dose of more than 12 hours, skip the forgotten tablet and only take one tablet as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Esmya

Esmya should be taken daily during treatment courses of up to 3 months in a row. During each course of treatment, do not stop taking the tablets without first consulting a doctor even if you feel better, as symptoms may return later.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Esmya and contact a doctor immediately, if you experience any of the following symptoms:

  • swelling of the face, tongue, or throat, difficulty swallowing, hives, or difficulty breathing. This may be a symptom of angioedema (no known frequency).
  • nausea or vomiting, severe fatigue, jaundice (yellow eyes or yellow skin), dark urine, itching, or pain in the upper abdomen. These symptoms may be signs of liver damage (no known frequency), which is a few cases that have led to liver transplantation. See also section 2 Warnings and Precautions.

Very common (may affect more than 1 in 10 people) side effects:

  • reduction or cessation of menstrual bleeding ( amenorrhea )
  • thickening of the lining of the uterus (endometrial thickening).

Common (may affect up to 1 in 10 people) side effects:

  • headache
  • dizziness ( vertigo )
  • abdominal pain, malaise (nausea)
  • acne
  • muscle and bone pain (musculoskeletal pain)
  • bladder fluid (ovarian cyst), tenderness/pain in the breast, lower abdominal pain (pelvis), hot flashes
  • fatigue (exhaustion)
  • weight gain

Uncommon (may affect up to 1 in 100 people) side effects:

  • drug allergy
  • anxiety
  • Mood swings
  • dizziness
  • dry mouth, constipation
  • hair loss, dry skin, increased sweating
  • back pain
  • urine leakage
  • uterine bleeding (uterine bleeding), vaginal discharge, abnormal vaginal bleeding
  • chest pleasure
  • swelling due to fluid retention ( edema )
  • extreme fatigue ( asthenia )
  • increased blood cholesterol levels detected in blood tests, increased fat levels ( triglycerides ) in the blood detected in blood tests.

Rare (may affect up to 1 in 1,000 people) side effects:

  • nosebleeds
  • poor digestion, flatulence
  • rupture of the fluid bladder in the ovaries (ruptured ovarian cyst)
  • breast swelling.

5. How to store Esmya

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Store the blister pack in the outer carton. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ulipristal acetate. One tablet contains 5 mg of ulipristal acetate.
  • The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc, and magnesium stearate.

What the medicine looks like and the contents of the pack

Esmya is a white to off-white, round and biconvex tablet of 7 mm with “ES5” printed on one side.

It is available in Al / PVC / PE / PVDC blister packs in cartons of 28, 30, and 84 tablets or Al / PVC / PVDC blister packs in cartons of 28 and 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Gedeon Richter Plc.

Gyömrői out 19-21.

1103 Budapest

Hungary

Manufacturer

Cenexi

17, rue de Pontoise

F-95520 Osny

France

Gedeon Richter Plc.

Gyömrői out 19-21.

1103 Budapest

Hungary

Muhammad Nadeem

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