HYDROXYCARBAMIDE MEDAC 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Hydroxycarbamide medac 500mg Hard Capsules

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

1. What is Hydroxycarbamide medac and what is it used for

Hydroxycarbamide medac contains the active substance hydroxycarbamide, which belongs to a group of medicines used in certain blood disorders and interferes with the growth of cancer cells.

This medicine has been prescribed for you by your doctor for the treatment of blood disorders (bone marrow tumors: chronic myeloid leukemia, essential thrombocythemia, and polycythemia vera).

2. What you need to know before you take Hydroxycarbamide medac

Do not take Hydroxycarbamide medac

• if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6).
• if you have a low blood cell count.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine.

Treatment with hydroxycarbamide requires close monitoring. You will have blood tests before and during treatment to check that you have enough blood cells and adequate kidney and liver function to receive this medicine. Blood tests are usually done once a week.

Tell your doctor if you have ever had gout. Tell your doctor if you have a folic acid deficiency.

In case you have a decrease in red blood cell count (anemia) before or during treatment, red blood cells can be replaced when necessary. If laboratory tests determine that there is hemolytic anemia (a blood disorder in which red blood cells are destroyed faster than they are produced), your doctor will stop treatment with this medicine.

You should drink plenty of fluids during treatment.

If you have kidney and/or liver problems, tell your doctor before starting treatment with this medicine.

If you receive prolonged treatment with hydroxycarbamide, you may develop secondary leukemia. It is currently unknown to what extent this is due to the pre-existing disease or treatment with hydroxycarbamide.

Cases of skin cancer have been reported in patients who received hydroxycarbamide for a prolonged period. You should protect your skin from the sun and check your skin frequently during treatment with hydroxycarbamide and after treatment. Your doctor will also check your skin during routine check-ups.

You may have ulcers on your legs. In this case, your doctor will decide whether you should continue taking this medicine. Ulcers usually heal slowly over several weeks if you stop taking this medicine.

Consult your doctor or pharmacist before starting treatment with Hydroxycarbamide medac if you have diabetes and are using a continuous glucose monitor (CGM) to check your blood glucose levels. Hydroxycarbamide (also known as hydroxyurea) may cause falsely elevated glucose readings in certain sensors. This could lead to the use of more insulin than necessary, resulting in low blood sugar (hypoglycemia). Talk to the doctor who prescribed the CGM about whether it is safe to use while taking Hydroxycarbamide medac.

Other medicines and Hydroxycarbamide medac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you have previously received or are currently receiving similar medicines or radiation therapy, side effects may occur more frequently and with greater intensity. These effects include mainly a decrease in blood cell count (bone marrow depression), inflammation of the stomach mucous membrane, and skin inflammation.

Previous or concurrent radiation therapy may cause redness and skin irritation.

Hydroxycarbamide may increase the activity of NRTIs (nucleoside reverse transcriptase inhibitors), which are medicines used to treat HIV (e.g., didanosine, stavudine). It has been shown that hydroxycarbamide in combination with didanosine, stavudine, and indinavir causes a decrease in white blood cell count (reduced CD4 lymphocytes). The combination of hydroxycarbamide and NRTIs may increase the risk of side effects caused by NRTIs.

Tell your doctor if you have recently received a vaccine or are scheduled to be vaccinated.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is a risk of harmful effects on the unborn baby. Therefore, you should not take this medicine during pregnancy, unless your doctor has specifically prescribed it for you.

You must use an effective method of contraception before starting treatment with this medicine, during treatment, and for six months after treatment. If you become pregnant while taking or after taking this medicine, you should consult your doctor.

Breastfeeding

Hydroxycarbamide should not be taken during breastfeeding. The active substance of this medicine is excreted in breast milk. Consult your doctor for advice.

Fertility

During treatment and for three months after treatment, it is recommended that men use effective contraceptive methods. Consult your doctor about the possibility of sperm preservation before starting treatment.

Genetic counseling is recommended for patients who wish to have children after treatment.

Driving and using machines

Your reaction time may be affected during treatment with this medicine. Take this into account if you are going to perform activities that require greater attention, such as driving and using machines.

Hydroxycarbamide medac contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Hydroxycarbamide medac contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Hydroxycarbamide medac

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults

In chronic myeloid leukemia, the usual initial dose is 40 mg/kg body weight per day. The dose is then adjusted individually based on the white blood cell count.

In polycythemia vera, the usual initial dose is between 15 and 20 mg/kg body weight per day. The dose is then adjusted individually to 1 or 2 capsules (500-1000 mg) depending on the blood cell count.

In essential thrombocythemia, the usual initial dose is 15 mg/kg body weight per day, with individual dose adjustment based on the blood cell count.

Elderly patients

Elderly patients may be more sensitive to hydroxycarbamide and may require a lower dose.

The capsules should be swallowed whole and not broken in the mouth. The capsules should be handled with care. You should wear gloves or wash your hands well after handling them. Although the risks to the fetus are minimal, pregnant women should avoid handling the capsules.

If you take more Hydroxycarbamide medac than you should

If you have taken a higher dose of this medicine than prescribed, always contact a doctor or go to a hospital. You may experience symptoms that affect the mucous membranes and skin.

If you forget to take Hydroxycarbamide medac

It is important to follow the course of medication exactly as prescribed by your doctor.

Do not take a double dose to make up for forgotten doses. If you have forgotten a single dose, continue treatment as prescribed. If you have forgotten several doses, continue treatment as prescribed, but contact your doctor for further information.

If you have any other questions 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.

Contact your doctor immediately if you experience symptoms such as:

• Fever, cough, or respiratory problems, as this could be a sign of severe lung disease (frequency not known).
• High fever (>39°C) with stomach problems, lung problems, muscle problems, liver problems, skin problems, and heart problems in the 6 weeks following administration of this medicine (rare).

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

• Absence or low amount of sperm in the semen (azoospermia or oligospermia).
• Decrease in blood cell count (bone marrow depression), especially white blood cells (leukopenia), including the type of white blood cell that helps the body fight disease (reduced CD4 lymphocytes), red blood cells (anemia), and platelets (thrombocytopenia).
• Feeling sick (nausea), vomiting, loss of appetite, mouth sores (stomatitis), diarrhea, constipation, abdominal pain, mucous membrane inflammation (mucositis), digestive problems (dyspepsia).
• Black tarry stools or blood in the stool.
• In combination with certain HIV treatments: pancreas inflammation (pancreatitis) with stomach or abdominal pain.
• Medicine-induced fever, chills, feeling unwell (malaise), weakness, loss of energy.
• Skin ulcers, especially leg ulcers.
• Skin rash with spots and blisters (maculopapular rash), redness of the face, redness of hands and feet (hand-foot syndrome).
• Skin changes such as purple spots and skin thinning; darkening and shedding of nails and skin, itching, small purple bumps on the skin; skin peeling, blackening, and death of skin.
• Hair loss (alopecia).
• Temporary kidney problems with elevated blood parameters such as uric acid, urea, and creatinine.
• Difficulty urinating.

Common (may affect up to 1 in 10 people)

• Large immature red blood cells (megaloblastosis).
• Skin cancer.
• Increased liver enzymes.
• Liver inflammation (hepatitis) that causes flu-like symptoms, such as fatigue, loss of appetite, fever, pain, and nausea, pressure or pain under the right ribs and may also include yellowing of the skin or eyes.
• Bile flow problems (cholestasis). The bile produced by the liver to help digest food may not flow properly. A buildup of bile can cause itching, yellow skin, dark urine, and pale stools.
• Nervous system disorders, including headache, dizziness, drowsiness, disorientation, hallucinations, and seizures.
• Acute and chronic lung reactions with changes in lung tissue observed on X-rays and difficulty breathing, as well as fever in acute reactions and dry cough in chronic reactions.
• In combination with certain HIV treatments: numbness and tingling or pain in arms and legs (peripheral neuropathy) and abdominal pain, nausea, or vomiting, or yellow skin (hepatotoxicity).

Uncommon (may affect up to 1 in 100 people)

• Thick and scaly skin patches (actinic keratosis).
• High levels of red blood cell breakdown product (bilirubin) in the blood.

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions.
• Metabolic complications due to cancer cell breakdown products (tumor lysis syndrome).
• Skin ulcers with severe infection.

Very rare (may affect up to 1 in 10,000 people)

• Skin inflammation that causes red and scaly patches and may occur with joint pain.
• Reduced kidney function.

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

• High levels of potassium in the blood that can cause an abnormal heart rhythm.
• Fever, cough, or respiratory problems, this could be a sign of severe lung disease; allergic inflammation of the air sacs.
• Hemolytic anemia.
• Dry skin.

In post-marketing surveillance, cases of low sodium levels in the blood have been observed, which can cause fatigue and confusion, muscle spasms, seizures, or coma.

If you receive prolonged treatment with hydroxycarbamide, you may develop secondary leukemia (blood cancer). It is currently unknown to what extent this is due to the pre-existing disease or treatment with hydroxycarbamide.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydroxycarbamide medac

Do not store above 25°C.

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 after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Deposit the containers and the medicines that you no longer need in the SIGRE collection point of the pharmacy.

6. Contents of the pack and other information

Composition of Hydroxycarbamide medac

• The active substance is hydroxycarbamide. Each capsule contains 500 mg of hydroxycarbamide.
• The other ingredients are: lactose monohydrate, calcium citrate, disodium citrate, magnesium stearate, gelatin, and titanium dioxide (colorant E171).

Appearance and packaging

Hard white capsules.

Available pack sizes: 50 or 100 (clinical pack) hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

medac

Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Phone: +49 4103 8006 0

Fax: +49 4103 8006 100

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

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo n° 29

08022 Barcelona

Spain

Phone: +34 93 205 86 86

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Denmark, Finland, Iceland, Norway, Netherlands, Portugal, Sweden: Hydroxyurea medac

Germany: Syrea

Slovakia: Hydroxykarbamid medac

Spain: Hidroxicarbamida medac

United Kingdom (Northern Ireland): Hydroxycarbamide

Date of last revision of this leaflet:11/2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)