Prospect: Patient Information

Metopirone 250 mg capsulesSoft

metirapona

Read this prospect carefully before starting to take this medication, as 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 nurse.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

Metopirone contains 250 mg of metirapone. Metirapone belongs to a group of medicationsusedas tests for the evaluation of pituitary function. Metirapone is used as a diagnostic test to identify if you have an insufficient level of ACTH, a hormone secreted by the pituitary gland (hypophysis), which controls the secretion of cortisol, or it may be used to help diagnose a specific type of Cushing syndrome.

The medication may also be used to treat the signs and symptoms of endogenous Cushing syndrome, by reducing elevated levels of cortisol (a hormone produced by the adrenal glands). Cushing syndrome is a set of symptoms caused by elevated levels ofcortisol, which are produced by the adrenal glands.

Do not take Metopirone as a diagnostic test for ACTH deficiency:

• if you have a condition in which the adrenal glands do not produce enough steroid hormones, cortisol or aldosterone, known as Addison's disease.

Do not take Metopirone:

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

Warnings and precautions

Consult your doctor before taking Metopirone for a diagnostic test

• if you have, or think you may have, a condition in which your hormone levels are low (for example, reduced cortisol production in the adrenal glands or severe hypopituitarism). Your doctor will need to perform a test to verify that Metopirone is suitable for you,
• if you have liver disease or liver damage, as this may cause the medication to act more slowly,
• if you are taking medications such as glucocorticoids; your doctor may decide that you should not undergo the test with Metopirone, as you should stop taking them.

During treatment with Metopirone

Metopirone may temporarily reduce the amount of hormones produced by the adrenal glands (cortisol), but your doctor will correct this with an appropriate hormone replacement medication.

If you have Cushing's syndrome, your doctor may also give you medications to prevent the development of infections. But if you experience shortness of breath and fever for hours or days, contact your doctor immediately, as you may be developing a severe lung infection.

Tests before and during treatment with Metopirone

Your doctor will perform a blood test before starting treatment and regularly during treatment. This is to detect any possible abnormalities in your potassium levels and also to measure your cortisol levels. Depending on the results, your doctor may be able to adjust the dose and/or prescribe corrective treatment.

Depending on your cardiac risk factors, your doctor may decide to perform an ECG before starting or during treatment with Metopirone.

Consult your doctor if you experience any of the following symptoms: weakness, fatigue, dizziness, loss of appetite, nausea, vomiting, diarrhea, or abdominal pain. These symptoms, as well as low blood pressure, high potassium levels, low sodium levels, or low blood glucose, may be signs of hypocortisolism (insufficient cortisol levels in the blood).

As a result, your doctor will monitor your blood pressure and perform a blood test. If you are diagnosed with hypocortisolism, your doctor may decide to administer temporary steroid replacement therapy (glucocorticoids), and/or reduce the dose or discontinue Metopirone treatment.

If you take Metopirone for a prolonged period

Your blood pressure may rise when taking this medication.

Other medications and Metopirone

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, as they may affect the results of the test with this medication. The following medications may affect the results of the test with Metopirone:

• Anticonvulsants used to control epilepsy (for example, phenytoin, barbiturates).
• Antidepressants and neuroleptics used to treat anxiety, depression, or psychiatric problems (for example, amitriptyline, chlorpromazine, alprazolam).
• Hormones that affect the hypothalamic-pituitary axis that regulates many bodily processes such as stress, emotions, energy levels, digestion, and the immune system (for example, cortisol, hydrocortisone, ACTH, tetracosactide).
• Corticosteroids.
• Antithyroid medications used to treat thyroid gland diseases (for example, thyroxine, levothyroxine, carbimazole).
• Ciproheptadine, used to treat allergies (for example, Periactin).

You should not take Metopirone with paracetamol without consulting your doctor.

Pregnancy, breastfeeding, and fertility

Use during pregnancy

Metopirone is not recommended for women of childbearing age who are not using contraceptive methods.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor as soon as possible to find out if you should stop or continue taking Metopirone.

If you take the medication during pregnancy, your doctor will need to monitor your baby's cortisol levels during the first week of life if necessary.

Use during breastfeeding

You will need to stop breastfeeding during Metopirone treatment, as there is a possibility that metyrapone may pass into breast milk.

Driving and operating machinery

If you feel dizzy or disoriented after taking this medication, do not drive or operate machinery until these effects have disappeared.

Metopirone contains parahydroxybenzoate sodium (E215) and propylparahydroxybenzoate sodium (E217), which may cause allergic reactions (possibly delayed).Metopirone contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially "sodium-free".

Monitoring and supervision

When used as a diagnostic test, this medication should only be administered in the presence of a healthcare professional, as they will need to monitor your body's response to the medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. If you are to be administered Metopirone to diagnose Cushing's syndrome, you will need to go to the hospital for some tests.

Use in adults

If you are to undergo a short test with a single dose (to evaluate pituitary function):

You will be asked to take the (capsule(s) with yogurt or milk around midnight. Then a blood sample will be taken in the morning, which will be reviewed by your doctor. The recommended dose is 30mg/kg. In children, the same dose is used.

If you are to undergo a test with multiple doses(to evaluate pituitary function and to help diagnose a specific type of Cushing's syndrome):

Your doctor will start taking urine samples 24 hours before you are administered this medication. Then 2-3 capsules (500 – 750 mg) will be administered every 4 hours for the next 24 hours. You should take the capsules with milk or after a meal. Your doctor will then take more urine samples over the next 24 hours.

If you receive treatment for the symptoms and signs of endogenous Cushing's syndrome

The dose you will be administered will be specific to you, and can range from 1 capsule (250 mg) to 24 capsules (6g) per day, in three or four divided doses. Your doctor may adjust the dose of Metopironeperiodicallyto restore normal cortisol levels.

You must always follow your doctor's instructions scrupulously, and never modify the dose unless your doctor tells you to.

Use in children

For the multiple-dose test, children should be administered 15mg/kg, with a minimum dose of 250mg every 4 hours.

For the management of Cushing's syndrome, the dose should be adjusted individually based on cortisol levels and tolerability.

If you take more Metopirone than you should

If you take too many capsules, inform your doctor or nurse immediately or go toemergency. You may experience nausea and stomach pain and/or diarrhea. You may also feel dizzy, tired, have a headache, start sweating, and have high blood pressure. You may need to take activated charcoal and administer hydrocortisone.

If you forget to take Metopirone

If you accidentally forget to take a dose of capsules, take it as soon as you remember. If it is almost time for your next dose, do not take a double dose to make up for the missed dose, but continue taking the capsules in the usual manner.

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

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

Some side effects can be serious:

• Inform your doctor immediately if you have two or more of these symptoms: weakness, dizziness, fatigue, loss of appetite, nausea, vomiting, abdominal pain, diarrhea. This may indicate that you have adrenal insufficiency (low cortisol levels). Adrenal insufficiency occurs when metirapona decreases cortisol levels too much. It is more likely to occur during periods of metirapona dose increase or greater stress. Your doctor will correct it by using a hormone medication to compensate for the lack of cortisol and/or adjusting the metirapona dose.
• Inform your doctor immediatelyif you have bleeding or bruising that lasts longer than usual, if you notice bleeding in the gums, nose, or skin, and if you feel tired most of the time. This may indicate that you have a decrease in the number of red blood cells and/or white blood cells and/or platelets.

See also in Section 2 “During Metopirone treatment”.

Side effects by frequency:

Side effects very common (may affect more than 1 in 10 people)

• Adrenal insufficiency (low cortisol levels)
• Loss of appetite
• Headache
• Dizziness (drowsiness)
• High blood pressure (hypertension)
• Nausea (urge to vomit)
• Abdominal pain (stomach pain)
• Diarrhea
• Allergic reactions on the skin (urticaria, rash, itching)
• Joint pain
• Swelling of extremities, hands, or feet
• Asthenic disorders (fatigue, tiredness)

Side effects common (may affect up to 1 in 10 people):

• Low potassium levels (hypokalemia)
• Sensation of tiredness or drowsiness
• Low blood pressure (hypotension)
• Vomiting
• Acne
• Excessive hair growth in unusual areas (hirsutism)
• Muscle pain

Of unknown frequency (cannot be estimated from available data):

• Abnormal liver function (elevated liver enzymes)
• Leucopenia, anemia, thrombocytopenia (decrease in the number of red blood cells, white blood cells, or platelets in the blood)
• Alopecia (hair loss)
• Pulmonary infection

Reporting side effects

If you experience any type of side effect, consult your doctor orpharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish Medicines Adverse Event Reporting System: 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 bottle and on the box after the letters CAD. The expiration date is the last day of the month indicated. Use within a period of two months after its first opening.

Keep the bottle perfectly closed to protect it from moisture.

Store below 25°C.

Medications should not be disposed of through drains or trash.Deposit containers and medications that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of containers and medications that you no longer need. By doing so, you will help protect the environment.

Metopirone Composition

• The active ingredient is metirapona. Each capsule contains 250 mg of metirapona.
• The other components are: ethyl vanillin, gelatin, glycerol, macrogol 400, macrogol 4000, P-methoxyacetophenone, sodium ethyl parahydroxybenzoate (E215), propyl parahydroxybenzoate sodium (E217), titanium dioxide (E171) and purified water. The printing ink (red) of the capsules contains carmine acid (E120), aluminum chloride hexahydrate, sodium hydroxide, hypromellose and propylene glycol.

Product appearance and container contents

Soft gelatin capsule, oblong, opaque, white to light yellow in color, with "HRA" engraved in red ink, with a slightly yellowish viscous to gelatinous content. Capsule size: 18.5 mm in length, 7.5 mm in diameter.

Each plastic bottle contains 50 capsules.

This medicine is authorized in the member states of the European Economic Area with the following names:

Metopirone: Ireland, Croatia, Czech Republic, Latvia, Denmark, Finland, Netherlands, Portugal, Poland, Spain, Sweden

Metycor: Slovenia, Austria, Norway

Metyrapone Esteve: France

Metopiron: Germany

Cormeto: Italy, Estonia, Hungary

Last review date of this leaflet:11/2024.

Detailed and updated information about this medicine is available on the website of the Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.