ORGOVYX 120 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Orgovyx 120 mg film-coated tablets

Relugolix

This medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Orgovyx and what is it used for

Orgovyx contains the active substance relugolix. It is used for the treatment of adult patients with advanced prostate cancer who respond to hormonal therapy.

Relugolix works by blocking a step in the process that tells the testicles to produce testosterone (the male sex hormone). Since testosterone can stimulate the growth of prostate cancer, by lowering it to very low levels, relugolix prevents prostate cancer cells from growing and dividing.

2. What you need to know before you take Orgovyx

Do not take Orgovyx

• if you are allergic to relugolix or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Orgovyx if you have any of the following:

• Heart circulation problems, such as heart rhythm problems (arrhythmia). The risk of heart rhythm problems may increase with the use of Orgovyx. During treatment with Orgovyx, your doctor may check the salts in your body (electrolytes) and the electrical activity of your heart.
• Tell your doctor immediately if you experience signs or symptoms such as dizziness, fainting, feeling that your heart is beating hard or fast (palpitations) or chest pain. These may be symptoms of serious heart rhythm problems.
• Liver disease. It may be necessary to check your liver function. The use of Orgovyx has not been investigated in patients with severe liver disease.
• Kidney disease.
• Osteoporosis or any disease that affects bone strength. Low testosterone levels can cause bones to thin.
• Monitoring of your disease with a blood test for prostate-specific antigen (PSA).

Children and adolescents

Orgovyx should not be used in children and adolescents under 18 years of age.

Other medicines and Orgovyx

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Orgovyx may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm problems if used with other medicines, such as methadone (used to relieve pain and as part of detoxification treatment for addiction), moxifloxacin (an antibiotic) and antipsychotics (used to treat serious mental illnesses).

Other medicines may interfere with the absorption of relugolix and increase blood levels, which could increase side effects, or reduce them, which would reduce the effectiveness of Orgovyx. Medicines that may interfere with Orgovyx include:

• Some medicines used to treat epilepsy(e.g. carbamazepine, phenytoin, phenobarbital).
• Some medicines used to treat bacterial infections(e.g. rifampicin, azithromycin, erythromycin, clarithromycin, gentamicin, tetracycline).
• Some medicines used to treat fungal infections(e.g. ketoconazole, itraconazole).
• Some medicines used to treat prostate cancer(e.g. apalutamide).
• Herbal medicines containing St. John's Wort(Hypericum perforatum).
• Some medicines used to treat high blood pressure(e.g. carvedilol, verapamil).
• Some medicines used to treat arrhythmia(e.g. amiodarone, dronedarone, propafenone, quinidine).
• Some medicines used to treat angina(e.g. ranolazine).
• Some medicines used as immunosuppressants(e.g. cyclosporin).
• Some medicines used to treat HIV infection(e.g. ritonavir [or combinations containing ritonavir], efavirenz).
• Some medicines used to treat hepatitis C virus (HCV)(e.g. telaprevir).

Therefore, your doctor may change your medicines, change the time you take certain medicines, the dose of them or increase the dose of Orgovyx.

Pregnancy, breastfeeding and fertility

Orgovyx is indicated for use in men with prostate cancer. This medicine may have an effect on male fertility.

This medicine is not indicated in women who may become pregnant. It is not used in women who are or may be pregnant or breastfeeding.

• Information for males:

Driving and using machines

Fatigue and dizziness are very common (fatigue) and common (dizziness) side effects that may affect your ability to drive and use machines. These side effects may be due to treatment or the effects of the underlying disease.

Orgovyx contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

3. How to take Orgovyx

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is:

• Three tablets on the first day of treatment.
• Afterwards, one tablet once a day, taken at approximately the same time each day.

Your doctor may change your dose if necessary.

The tablet should be swallowed whole. The tablets can be taken with or without food and with a little liquid.

If you take more Orgovyx than you should

There are no reports of serious harm caused by taking several doses of this medicine at the same time. If you have taken too many Orgovyx tablets, or if a child has taken some, talk to your doctor as soon as possible. Take the medicine with you to show the doctor.

If you forget to take Orgovyx

If you remember that you have missed a dose less than 12 hours after the time you would normally have taken it, take it as soon as you remember and then take the next doses as usual. If you miss a dose for more than 12 hours, do not take it. Simply take the next dose at the usual time the next day.

If you stop taking Orgovyx

If you want to stop taking this medicine, talk to your doctor first. Your doctor will explain the effects of stopping treatment and will discuss other options with you.

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

4. Possible side effects

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

Some side effects may be serious.

Seek medical attention immediately if you develop:

• Rapid swelling of the face, mouth, lips, tongue, throat, abdomen or arms and legs (angioedema) (uncommon: may affect up to 1 in 100 people).

The following side effects have been reported with Orgovyx:

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

• hot flushes
• diarrhoea
• constipation
• muscle and joint pain
• fatigue

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

• low red blood cell count (anaemia)
• breast enlargement in men (gynaecomastia)
• sleeplessness
• depression
• dizziness
• headache
• high blood pressure
• stomach upset, including feeling sick (nausea)
• increased sweating
• rash
• decreased interest in sex
• weight gain
• increased blood sugar levels
• increased blood fat levels (triglycerides)
• increased blood cholesterol levels

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

• thinning of the bones (osteoporosis)
• increased liver enzymes
• hives
• heart attack

Frequency not known(frequency cannot be estimated from the available data):

• changes in the electrocardiogram (prolongation of the QT interval)

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.

5. Storage of Orgovyx

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 outer carton and on the label of the bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

What Orgovyx contains

• The active substance is relugolix.
• The other ingredients are: mannitol (E421), sodium carboxymethylcellulose (E468), hydroxypropylcellulose (E463), magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), red iron oxide (E172) and carnauba wax (E903).

For more information, see “Orgovyx contains sodium” in section 2.

Appearance of Orgovyx and contents of the pack

Orgovyx film-coated tablets are light red, almond-shaped (11 mm [length] x 8 mm [width]), with an “R” on one side and “120” on the other. Orgovyx is supplied in a white plastic bottle containing 30 or 90 film-coated tablets, in pack sizes of 30 film-coated tablets and 90 film-coated tablets (in 3 bottles of 30 film-coated tablets or 1 bottle of 90 film-coated tablets). Each bottle also contains a desiccant to help keep the medicine dry (to protect it from moisture), do not remove the desiccant from the bottle. Each bottle is closed with an induction-sealed and child-resistant cap.

Orgovyx film-coated tablets are also supplied in Alu/Alu blisters containing 30 and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

You can request more information about this medicine from the local representative of the marketing authorisation holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Τηλ: +30 210 74 88 821

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.