Prospect: information for the user

Orgovyx 120 mg film-coated tablets

Relugolix

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Orgovyx contains the active ingredient relugolix. It is used for the treatment of adult patients with advanced prostate cancer that responds to hormone therapy.

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

Do not take Orgovyx

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Orgovyx if you have any of the following:

• Heart circulation disorders, 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 monitor the salts in your body (electrolytes) and the electrical activity of your heart.
• Inform your doctor immediately if you experience symptoms such as dizziness, fainting, a sensation that your heart is beating strongly or rapidly (palpitations), or chest pain. These may be symptoms of serious heart rhythm problems.
• Liver disease. It may be necessary to monitor your liver function. Orgovyx has not been investigated in patients with severe liver disease.
• Kidney disease (kidney).
• Osteoporosis or any disease that affects bone strength. Low levels of testosterone can cause bone thinning.
• 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 old.

Other medications and Orgovyx

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Orgovyx may interact with some medications 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 medications, for example, methadone (used to relieve pain and as part of detoxification treatment for addiction), moxifloxacine (an antibiotic), and antipsychotics (used to treat severe mental illnesses).

Other medications may interact with Orgovyx and increase its levels in the blood, which could increase side effects, or decrease them, which would reduce the effectiveness of Orgovyx. Among the medications that may interact with Orgovyx are:

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

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

Pregnancy, breastfeeding, and fertility

Orgovyx is indicated for use in men with prostate cancer. This medication may affect male fertility.

Orgovyx 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 men:
• if you have sex with a woman who may become pregnant, use a condom and another effective contraceptive method used by your partner during treatment and for 2 weeks after treatment with this medication to prevent pregnancy.
• if you have sex with a pregnant woman, use a condom to protect the fetus.

Driving and operating machinery

Dizziness and drowsiness are very common (drowsiness) and common (dizziness) side effects that may affect your ability to drive and operate machinery. These side effects may be due to treatment or the effects resulting from the underlying disease.

Orgovyx contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per coated tablet, that is, it is practically sodium-free.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Your doctor may change your dose if necessary.

The tablet should be swallowed whole. 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 severe adverse effects caused by taking multiple doses of this medication at the same time. If you have taken too many Orgovyx tablets, or if you discover that a child has taken some, consult your doctor as soon as possible. Bring the medication to show the doctor.

If you forgot to take Orgovyx

If you remember to have forgotten a dose less than 12 hours after the usual time you would have taken it, take it as soon as you remember and continue taking the next tablets as usual. If you forget a dose more than 12 hours after the usual time, do not take it. Simply take the next dose the following day as usual.

If you interrupt treatment with Orgovyx

If you want to interrupt treatment with this medication, speak first with your doctor. Your doctor will explain the effects of interrupting treatment and analyze other possibilities with you.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be serious.

Seek urgent medical attention if you develop:

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

The following side effects have been reported with Orgovyx based on the frequency with which they occur.

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

-Hot flashes

-Diarrhea

-Constipation

-Muscle and joint pain

-Fatigue

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

-Low red blood cell count (anemia)

-Enlargement of the breasts in men (gynecomastia)

-Insomnia

-Depression

-Dizziness

-Headache

-High blood pressure

-Unpleasant stomach, including nausea

-Increased sweating

-Rash

-Decreased interest in sex

-Weight gain

-Increased blood sugar levels

-Increased blood fat levels (triglycerides)

-Increased blood cholesterol levels

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

-Bone thinning (osteoporosis)

-Increased liver enzymes

-Hives

-Heart attack

Unknown frequency(the frequency cannot be estimated from the available data):

-Changes in the electrocardiogram (prolongation of the QT interval)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the outer box and the bottle label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Orgovyx

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

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

Appearance of Orgovyx and contents of the container

The film-coated tablets of Orgovyx are light red in color, almond-shaped (11 mm [length] × 8 mm [width]), with an “R” on one side and “120” on the other. Orgovyx is supplied in a white plastic bottle that contains 30 film-coated tablets. Each bottle also contains a desiccant to help keep the medication 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.

The film-coated tablets of Orgovyx are also supplied in Alu/Alu blisters that contain 30 and 90 film-coated tablets.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Accord Healthcare S.L.U.

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

Edifici Est 6th floor,

08039 Barcelona,

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization 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 / UK (NI)

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win MedicaA.E.

Tel: +30 210 74 88 821

Last review date of this leaflet: November 2023

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu.