Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - esmya

Document Subject

Generated Narrative: MedicinalProductDefinition mpa5f47c93f2a2eb5b88e9129e2aa9f3b9

identifier: http://ema.europa.eu/identifier/EU/1/12/750/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Esmya 5 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a5f47c93f2a2eb5b88e9129e2aa9f3b9

identifier: http://ema.europa.eu/identifier/EU/1/12/750/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - esmya

Attesters

What is in this leaflet

1. What Esmya is and what it is used for
2. What you need to know before you take Esmya
3. How to take Esmya
4. Possible side effects
5. How to store Esmya
6. Contents of the pack and other information

Esmya contains the active substance ulipristal acetate. It is used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb).
Esmya is used in adult women (over 18 years of age) before they reach the menopause.

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

This medicine acts by modifying the activity of progesterone, a naturally occuring hormone in the body. It is used for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.

You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards.

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 an underlying hepatic disorder.
• if you are pregnant or if you are breastfeeding.
• if you have vaginal bleeding not caused by uterine fibroids.
• if you have cancer of the uterus (womb), cervix (the neck of the womb), ovary or breast.

Warnings and precautions

• Before you start treatment with Esmya blood tests will be undertaken to find out how well your liver is working. Depending on the result of these tests your doctor will decide if treatment with Esmya is suitable for you. These tests will be repeated monthly for the first 2 treatment courses. For further treatment courses, your liver will be checked once before each new treatment course and if you experience any of the symptoms described below. In addition, an additional check of your liver 2-4 weeks after your treatment has stopped should be done.
  If during the treatment you experience any liver related signs such as feeling of being sick (nausea or vomiting), fatigue, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache, you should stop treatment and immediately contact a doctor, who will check the functioning of your liver and decide if you can continue the treatment.
• If you are currently taking hormonal contraception (for example birth control pills) (see Other medicines and Esmya ) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Esmya.
• If you have liver or kidney disease tell 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 significant reduction or may even stop your menstrual bleeding (your period ) within the first 10 days of treatment. However, if you continue to experience excessive bleeding tell your doctor.

Your period should generally return within 4 weeks after treatment with Esmya is stopped. The lining of the uterus may thicken or change as a result of taking Esmya. These changes return to normal after treatment is stopped and your periods restart.

Children and adolescents Esmya should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has 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 can affect Esmya or be affected by Esmya:

• Certain medicines which are used to treat the heart (e.g. digoxin).
• Certain medicines used to prevent strokes and blood clots (e.g. dabigatran etexilate).
• Certain medicines used to treat epilepsy (e.g. phenytoin, fosphenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone).
• Certain medicines used to treat HIV infection (e.g. ritonavir, efavirenz, nevirapine).
• Medicines used to treat certain bacterial infections (e.g. rifampicin, telithromycin, clarithromycin, erythromycin, rifabutin).
• Certain medicines to treat fungal infections (e.g. ketoconazole (except shampoo), itraconazole).
• Herbal remedies containing St John s wort (Hypericum perforatum) used for depression or anxiety.
• Certain medicines used to treat depression (e.g. nefazodone).
• Certain medicines used to treat hypertension (e.g. verapamil).

Esmya is likely to make some hormonal contraceptives less effective. In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Esmya less effective. Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Esmya treatment.

Esmya with food and drink You should avoid drinking grapefruit juice while on treatment with Esmya.

Pregnancy and breastfeeding If you are pregnant or breastfeeding, 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 whilst pregnant might affect your pregnancy (it is not known if Esmya might harm your baby or whether can cause miscarriage). If you do become pregnant during Esmya treatment, you should stop taking Esmya immediately and contact your doctor or pharmacist.

Esmya is likely to make some hormonal contraceptives less effective (see Other medicines and Esmya ). Esmya passes into the breast milk. Therefore, do not breast-feed your baby 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 experience these symptoms.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one 5 mg tablet per day, for treatment courses of up to 3 months each. If you have been prescribed several courses of Esmya 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion. You should always start taking Esmya within the first week of your menstrual period. The tablet should be swallowed with water and may be taken with or without food.

If you take more Esmya than you should Experience with Esmya when several doses are taken at once is limited. There have been no reports of serious harmful effects from taking several doses of this medicine at once. You should nonetheless ask your doctor or pharmacist for advice if you take more Esmya than you should.

If you forget to take Esmya 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 and take only a single tablet as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Esmya Esmya is to be taken daily during treatment courses of up to 3 months continuously. During each course of treatment, do not stop taking your tablets without the advice of your doctor even if you feel better, as symptoms may re-occur later.

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

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

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

• swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties. These are possible symptoms of angioedema (frequency not known).
• nausea or vomiting, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache. These symptoms may be signs of liver injury (frequency not known), which in a small number of cases 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 absence of menstrual bleeding (amenorrhea)
• thickening of the lining of the womb (endometrial thickening).

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

• headache
• spinning sensation (vertigo)
• stomach ache, feeling sick (nausea)
• acne
• muscle and bone (musculoskeletal) pain
• sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic) pain, hot flushes
• tiredness (fatigue)
• weight increase.

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
• leakage of urine
• bleeding from the womb (uterine bleeding), vaginal discharge, abnormal vaginal bleeding, breast discomfort
• swelling due to fluid retention (oedema)
• extreme tiredness (asthenia)
• increase in blood cholesterol seen in blood tests, increase in blood fats (triglycerides) seen in blood tests.

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

• nosebleed
• indigestion, bloating
• break of sac of fluid within the ovaries (ovarian cyst ruptured)
• breast swelling.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 on the blister after EXP. The expiry date refers to the last day of that month.

Keep the blister in the outer carton in order to protect from light.

Do not throw away via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Esmya contains

• 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 Esmya looks like and contents of the pack Esmya is white to off-white, round curved tablet of 7 mm engraved with code ES5 on one face. It is available in Alu/PVC/PE/PVDC blisters in cartons containing 28, 30 and 84 tablets or Alu/PVC/PVDC blisters in cartons containing 28 and 84 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder Gedeon Richter Plc. Gy mr i t 19-21. 1103 Budapest Hungary

Manufacturer Cenexi 17 rue de Pontoise F-95520 Osny France

Gedeon Richter Plc. Gy mr i t 19-21. 1103 Budapest Hungary

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: