CORMETO 250 mg Софт Капсула

Содержание инструкции

1. Cormeto 250 mg soft capsules
   1. What is Cormeto and what is it used for
   2. What you need to know before taking Cormeto
   3. How to take Cormeto
   4. Possible side effects
   5. How to store Cormeto
   6. Contents of the pack and other information

Cormeto 250 mg soft capsules

metirapone

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Cormeto and what is it used for

Cormeto contains 250 mg of metirapone. Metirapone belongs to a group of drugs used as a
test for the evaluation of pituitary function. Metirapone is used as a diagnostic test for
the identification of insufficient levels of ACTH, a hormone secreted by the pituitary gland, which controls
the secretion of cortisol, or it may be used for the diagnosis of a specific type of Cushing's syndrome.
This medicine can also be used in the treatment of signs and symptoms of endogenous Cushing's syndrome
to lower elevated levels of cortisol (a hormone produced by the adrenal glands). Cushing's syndrome is a
constellation of symptoms that manifest due to the high levels of the hormone cortisol produced in the body
by the adrenal glands.

2. What you need to know before taking Cormeto

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

• if you suffer from a disease known as Addison's disease, where your adrenal glands do not produce enough steroid hormones, cortisol or aldosterone.

Do not take Cormeto:

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

Warnings and precautions
Talk to your doctor before taking Cormeto for a diagnostic test if:

• you suffer from or think you may suffer from a disease that manifests with low hormone levels (e.g. reduced adrenal secretion of cortisol or severe hypopituitarism). The doctor will need to perform a test to verify if Cormeto is the right therapy for you.
• you have a liver disease or dysfunction that could slow down the action of the medicine.
• you are taking medicines such as glucocorticoids as the doctor may decide not to perform the test with Cormeto because you will first need to stop taking these medicines.

During treatment with Cormeto
Cormeto may temporarily induce a reduction in the levels of hormones produced by the adrenal gland (cortisol), but the doctor will correct this imbalance with appropriate hormone therapy.
If you suffer from Cushing's syndrome, the doctor may also prescribe you medicines to prevent the onset of infections. However, if you develop shortness of breath and fever within a few hours or days, contact your doctor as soon as possible as you may have a serious lung infection.

Tests before and during treatment with Cormeto
The doctor will examine your blood before starting treatment and regularly during treatment.
This is to detect any abnormalities in potassium levels and also to measure cortisol levels. Depending on the results, the doctor may adjust the dosage and/or prescribe corrective treatment.
Depending on cardiac risk factors, the doctor may decide to perform an ECG before starting or during treatment with Cormeto.
Talk to your doctor if you experience any of the following symptoms: weakness, fatigue, dizziness, loss of appetite, nausea, vomiting, diarrhea, abdominal pain. These symptoms, together with hypotension, high potassium levels, low sodium levels or low blood sugar, may be signs of hypocortisolism (insufficient levels of cortisol in the blood).
Therefore, the doctor will check your blood pressure and perform blood tests. If diagnosed with hypocortisolism, the doctor may decide to temporarily administer steroid-based replacement therapy (glucocorticoids) and/or reduce the dose or stop treatment with Cormeto.

If you take Cormeto for a long period of time
Your blood pressure may increase with the use of this medicine.

Other medicines and Cormeto
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines as the latter could influence the results of the test conducted with this medicine. The results of the test with Cormeto can be altered by the following medicines:

• anticonvulsants used to control epilepsy (e.g. phenytoin, barbiturates)
• antidepressants and antipsychotics for the treatment of anxiety, depression or psychiatric problems (e.g. amitriptyline, chlorpromazine, alprazolam)
• hormones that act on the hypothalamus-pituitary axis which regulates numerous processes in the body such as stress, emotions, energy levels, digestion and the immune system (e.g. cortisol, hydrocortisone, ACTH, tetracosactide)
• corticosteroids
• antithyroid agents used in the treatment of thyroid disorders (e.g. thyroxine, liothyronine, carbimazole)
• cyproheptadine used in the treatment of allergies (e.g. Periactin)

Cormeto should not be taken with paracetamol without consulting your doctor.

Pregnancy, breastfeeding and fertility
Use in pregnancy
Cormeto is not recommended in women of childbearing potential who are not using contraceptives.
If you are pregnant, suspect or are planning a pregnancy, ask your doctor for advice as soon as possible to know if you should stop or continue therapy with Cormeto.
If you need to take the medicine during pregnancy, your doctor will need to monitor your baby's cortisol levels for the first week of life.

Use during breastfeeding
Breastfeeding must be stopped during treatment with Cormeto as there is a possibility that metirapone passes into breast milk.

Driving and operating machinery
If you develop dizziness or drowsiness after taking the medicine, you should not drive vehicles or operate machinery until these effects have disappeared.

Cormeto contains ethyl parahydroxybenzoate sodium (E215) and propyl parahydroxybenzoate sodium (E217)
which may cause allergic reactions (which may be delayed reactions).

Cormeto contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

Monitoring and supervision
If used as a diagnostic test, this medicine must only be administered to you in the presence of a healthcare professional, who will monitor your body's response to the medicine.

3. How to take Cormeto

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. If Cormeto is administered to you for the diagnosis of Cushing's syndrome,
you must go to the hospital to undergo some tests.

Use in adults
If you are to undergo a single-dose rapid test (to evaluate pituitary function)
You will have to swallow the capsule(s) with yogurt or milk around midnight. Then, the next morning, a
blood sample will be taken from you and examined by the doctor. The recommended dose is 30 mg/kg. The
same dose is used in children.

If you are to undergo a multiple-dose test (to evaluate pituitary function and for the diagnosis of
a specific type of Cushing's syndrome):
The doctor will begin collecting samples of your urine 24 hours before you are administered this
medicine. Then you will receive 2-3 capsules (500-750 mg) to be taken at intervals of 4 hours over the next 24
hours. The capsules must be taken with milk or after a meal. The doctor will then collect
further urine samples over the next 24 hours.

If you are being treated for signs and symptoms of endogenous Cushing's syndrome:
The dose that will be administered to you will be calculated specifically for you and may vary from 1 capsule
(250 mg) to 24 capsules (6 g) per day in three or four separate doses. The dose of Cormeto may be
adjusted periodically by the doctor in order to restore normal cortisol levels.
You should always carefully follow the doctor's instructions and never change the dose unless
told to do so by the doctor.

Use in children
For the multiple-dose test, children must receive 15 mg/kg with a minimum dose of 250 mg every 4 hours.
For the management of Cushing's syndrome, the dose must be adjusted on an individual basis according to
cortisol levels and product tolerability.

If you take more Cormeto than you should
If you take an excessive number of capsules, inform your doctor or nurse immediately or go to the
nearest Emergency Room. You may develop nausea and stomach pain and/or diarrhea. You may also feel
dizzy, tired, have a headache, start sweating, and have an increase in blood pressure. It may be
necessary to administer you activated charcoal and hydrocortisone.

If you forget to take Cormeto
If you accidentally forget to take a dose of capsules, you should take it as soon as you remember.
If it is almost time to take the next dose, do not double the dose to make up for the missed one,
but continue taking the capsules as usual.
If you have any doubts about 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 can be serious:

• Tell your doctor immediately if you experience two or more of these symptoms: weakness, mild confusion, fatigue, loss of appetite, nausea, vomiting, abdominal pain, diarrhea. This could indicate that you have adrenal insufficiency (low levels of cortisol). Adrenal insufficiency occurs when metirapone lowers the amount of cortisol too much. It is more likely to occur during periods of increased metirapone dosage or increased stress. The doctor will correct this by using a hormonal medicine to compensate for the lack of cortisol and/or adjusting the dose of metirapone.
• Tell your doctor immediately if you have bleeding or bruising that lasts longer than normal, blood in your gums, nose or skin and feeling tired most of the time. This may indicate a decrease in the amount of red blood cells and/or white blood cells and/or platelets in the blood.

See also paragraph 2 “During treatment with Cormeto”.

Side effects by frequency:
Very common side effects (may affect more than 1 in 10 people)

• Adrenal insufficiency (low levels of cortisol)
• Loss of appetite
• Headache
• Dizziness (mild confusion)
• High blood pressure (hypertension)
• Nausea (feeling sick)
• Abdominal pain (stomach ache)
• Diarrhea
• Allergic skin reaction [urticaria, rash (redness of the skin), itching]
• Joint pain
• Swelling of the limbs, hands or feet
• Asthenic conditions (fatigue, tiredness)

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

• Low levels of potassium (hypokalaemia)
• Feeling tired or sleepy
• Low blood pressure (hypotension)
• Vomiting
• Acne
• Excessive hair growth in unusual areas (hirsutism)
• Muscle pain

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

• Abnormal liver function (increased liver enzymes)
• Leukopenia, anemia, thrombocytopenia (decrease in the amount of red blood cells, white blood cells or platelets in the blood)
• Alopecia (hair loss)
• Lung infection

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the system
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cormeto

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 bottle and the packaging after
“Exp.”. The expiry date refers to the last day of that month. Use the medicine within two months
of opening.
Keep the bottle tightly closed to protect the medicine from moisture.
Store at a temperature below 25°C
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cormeto contains
The active ingredient is metirapone. Each capsule contains 250 mg of metirapone.

• The other ingredients are: ethyl vanillin, gelatin, glycerol, macrogol 400, macrogol 4000, P-methoxyacetophenone, sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217), titanium dioxide (E171) and purified water. The printing ink (red in colour) on the capsules contains: carminic acid (E120), aluminium chloride hexahydrate, sodium hydroxide, hypromellose and propylene glycol.

Description of the appearance of Cormeto and contents of the pack
Soft gelatin capsule, with an opaque appearance, oblong in shape, from white to yellowish-white in colour, with
the inscription “HRA” printed in red ink and with a content ranging from viscous to gelatinous in consistency, of a
slightly yellowish colour. Capsule dimensions: length 18.5 mm, diameter 7.5 mm.
Each plastic bottle contains 50 capsules.

Marketing Authorisation Holder
Esteve Pharmaceuticals S.A.
Passeig de la Zona Franca 109 Planta 4
08038 Barcelona
Spain
+34 93 446 60 00

Manufacturer
DELPHARM LILLE S.A.S
Parc d’activités Roubaix-Est
22 Rue de Toufflers CS 50070
LYS LEZ LANNOY 59452
France

This medicinal product is authorised 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