ULIPRISTAL ACETATE 5 MG TABLETS - patient leaflet, side effects, dosage

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Package leaflet: Information for the patient

Ulipristal Acetate 5mg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Ulipristal Acetate 5mg Tablets, but within this leaflet it will be referred to as Ulipristal Tablets.

What is in this leaflet

jl What Ulipristal Tablets are and what they are used for J

What you need to know before you take Ulipristal Tablets 3 How to take Ulipristal Tablets

4 possible side effects

How to store Ulipristal Tablets

6| Contents of the pack and other information

J What Ulipristal Tablets are and what they are used for

Ulipristal Tablets contain the active substance ulipristal acetate. They are used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb).

Ulipristal Tablets are 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 either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.

3 what you need to know before you take ulipristal tablets

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

DO NOT take Ulipristal Tablets:

• if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6)
• if you have an underlying hepatic disorder
• if you are pregnant or if you are breast-feeding
• 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.
• before you start treatment with Ulipristal Tablets, 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 Ulipristal Tablets 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. Moreover, an additional check of your liver 3–4 weeks after your treatment has stopped should be done. If during the treatment you experience any liver related signs such as feeling or 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 your 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 Ulipristal Tablets ”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Ulipristal Tablets.
• if you have liver or kidney disease tell your doctor or pharmacist before taking Ulipristal Tablets.
• if you suffer from severe asthma, treatment with Ulipristal Tablets may not be suitable for you. You should discuss this with your doctor.

Treatment with Ulipristal Tablets 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 Ulipristal Tablets is stopped. The lining of the uterus may thicken or change as a result of taking Ulipristal Tablets. These changes return to normal after treatment is stopped and your periods restart.

Children and adolescents

Ulipristal Tablets 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 Ulipristal Tablets

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 Ulipristal Tablets or be affected by Ulipristal Tablets:

• 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).

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

Ulipristal Tablets with food and drink

You should avoid drinking grapefruit juice while on treatment with Ulipristal Tablets.

Pregnancy and breast-feeding

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

Ulipristal Tablets are likely to make some hormonal contraceptives less effective (see “Other medicines and Ulipristal Tablets”).

Ulipristal Tablets pass into the breast milk. Therefore, do not breast-feed your baby while taking Ulipristal Tablets.

Driving and using machines

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

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Patient card

Ulipristal Acetate 5mg Tablets

What you need to know before use

Ulipristal Tablets can cause side effects although not everybody gets them. One possible side effect is serious damage to your liver.

This card provides information on blood tests you will need throughout treatment and on what you should do if liver side effects occur.

Do not take Ulipristal Tablets if you have liver problems. Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver.

What to do before, during and after your treatment

Have regular blood tests

You need blood tests before starting each treatment course to find out how your liver is working. Depending on the result of these tests, the doctor will decide if treatment with Ulipristal Tablets is suitable for you.

During treatment with Ulipristal Tablets, your doctor will carry out regular blood tests to check your liver function. These tests need to happen every month, including a few weeks after you finish a course of treatment (see schedule overleaf). These blood tests will inform the doctor of the functioning of your liver and are vital when monitoring your treatment.

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Ulipristal Tablets contain lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially “sodium free”.

How to take Ulipristal Tablets

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 5mg tablet per day, for treatment courses of up to 3 months each. If you have been prescribed several courses of Ulipristal Tablets 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 Ulipristal Tablets 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 Ulipristal Tablets than you should

Experience with ulipristal acetate 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 ask your doctor or pharmacist for advice if you take more Ulipristal Tablets than you should.

If you forget to take Ulipristal Tablets

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 Ulipristal Tablets

Ulipristal Tablets are 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.

Possible side effects

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

Stop using Ulipristal Tablets 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). 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.

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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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Ulipristal Tablets

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.

This medicinal product does not require any special temperature storage conditions.

Store the blister in the original package in order to protect from light.

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

6| Contents of the pack and other information

What Ulipristal Tablets contain

• The active substance is ulipristal acetate. One tablet contains 5mg of ulipristal acetate.
• The other ingredients are povidone (K29/32), sodium starch glycolate (Type A), cellulose, microcrystalline, lactose monohydrate (see section 2) and magnesium stearate.

What Ulipristal Tablets look like and contents of the pack

Ulipristal Tablets are white or almost white, round biconvex tablet of 7 mm, engraved with “149” on one side and “LP” on the other side.

They are available in PVC/PVDC-Aluminium blisters of 14 tablets each, in cartons containing

28 tablets.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer

Cyndea Pharma S.L

Poligono Industrial Emiliano Revilla Sanz

Av. Agreda

31, 42110 Olvega

Soria

Spain

This leaflet was last revised in October 2019

If you would like a leaflet with larger text, please contact 01271 385257.

The table below helps you to track your blood tests:

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Signs and symptoms of possible liver problems

Stop treatment and contact a doctor right away if you observe any of the following signs or symptoms:

• – fatigue, severe tiredness

• – yellow skin/eyes

• – darkening of the urine

• – pain in the upper right stomach

• – itching

• – nausea (feeling sick)

• – vomiting.