ONCO KARBIDE 500 mg Hard capsule

Зміст інструкції

1. Onco Carbide 500 mg hard capsules
   1. What is Onco Carbide and what is it used for
   2. What you need to know before using Onco Carbide
   3. How to take Onco Carbide
   4. Possible side effects
   5. How to store Onco Carbide
   6. Contents of the pack and other information

Onco Carbide 500 mg hard capsules

Hydroxcarbamide (hydroxyurea)

Read this leaflet carefully before you start taking 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 Onco Carbide is and what it is used for
• 2. What you need to know before you use Onco Carbide
• 3. How to take Onco Carbide
• 4. Possible side effects
• 5. How to store Onco Carbide
• 6. Contents of the pack and other information

1. What is Onco Carbide and what is it used for

Onco Carbide contains the active substance hydroxycarbamide (also known as hydroxyurea), which
belongs to the group of medicines that interferes with the growth of a tumor (antineoplastic
medicinal product).
Onco Carbide is indicated in cases of:

• chronic myeloid leukemia (a blood disease due to a malfunction of the bone marrow, the organ that produces all blood cells);
• chronic myeloproliferative syndromes (blood diseases that determine excessive growth of some blood cells):
• essential thrombocythemia (a disease that generates too many platelets in the blood);
• polycythemia vera (a disease that generates too many red blood cells in the blood);
• idiopathic myelofibrosis (a chronic disease of the bone marrow with proliferation of immature cells and excessive deposition of fibrous tissue in the bone marrow);
• primary squamous cell carcinomas of the head and neck, excluding the lips (malignant tumors that affect the head and oral cavity) in combination with 5-Fluorouracil and radiotherapy
• homozygous sickle cell anemia (a blood disease in which red blood cells, a type of blood cell, take on an irregular shape resembling a crescent or sickle).

2. What you need to know before using Onco Carbide

Do not use Onco Carbide

• if you are allergic to hydroxycarbamide (hydroxyurea) or to any of the other ingredients of this medicine (listed in section 6);
• if you have a severe reduction in bone marrow function (severe bone marrow depression):
• leukopenia (severe reduction in the number of white blood cells in the blood that are less than
• 2,500/mm );
• thrombocytopenia (severe reduction in the number of platelets in the blood that are less than
• 100,000/mm );
• anemia (severe reduction in hemoglobin in the blood, a substance that carries oxygen in the blood);
• if you are pregnant and if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you have been given the yellow fever vaccine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Onco Carbide.
In particular, tell your doctor:

• if you have undergone radiotherapy as this may worsen radiation erythema (irritation and redness of the skin that can occur after radiotherapy) and reduce bone marrow function;
• if you have received antineoplastic therapy (treatment with medicines that fight tumors) because a reduction in bone marrow function may occur;
• if you have a severe reduction in kidney function;
• if you have severe liver disorders;
• if you have severe anemia. In this case, the doctor will subject you to blood transfusions before starting treatment with this medicine. During treatment with this medicine, the doctor will monitor your anemia;
• if you have diabetes and are using a continuous glucose monitoring (CGM) system to monitor blood glucose, hydroxycarbamide (also known as hydroxyurea) can cause falsely elevated glucose readings by some sensors. This could lead to using more insulin than necessary, resulting in hypoglycemia (low blood sugar). Talk to the doctor who prescribed the CGM to find out if it is safe to use it at the same time as Onco Carbide.

If you are a woman of childbearing potential, you must use an effective contraceptive method during the
treatment with Onco Carbide and for 6 months after the end of treatment (see section 2
“Pregnancy, breastfeeding and fertility”).
If you are a man of childbearing potential, you must use an effective contraceptive method during treatment
with Onco Carbide and for at least 3 months after the end of treatment. In addition, due to the risk of
reduced fertility, your doctor may suggest that you preserve your sperm before starting
treatment (see section 2 “Pregnancy, breastfeeding and fertility”).
During treatment with Onco Carbide, the doctor will monitor the levels of hemoglobin (a substance
that carries oxygen in the blood, present in red blood cells), leukocytes (white blood cells) and
platelets in your blood, through appropriate tests.
If, when checking the blood tests, hemolytic anemia (a disorder in which red blood cells are destroyed
faster than they can be produced) is detected, the doctor will stop
treatment with Onco Carbide.
In case of long-term treatment with hydroxycarbamide (hydroxyurea), you may experience adverse effects
affecting the skin and mouth (see section 4 “Possible side effects”).
Most of these, such as pigmentation (coloring) of the nails, skin and mouth, skin xerosis (dry skin), mouth ulcers and ichthyosis (a skin disease
that manifests with dry, thickened and scaly skin) do not require discontinuation of
treatment.
Skin ulcers may appear in cases of chronic myeloproliferative syndromes with
prolonged treatments at high doses and more frequently in the elderly or in women and require
temporary or permanent suspension of therapy (see section 4 “Possible side
effects”).
Skin cancer has been reported in patients treated with hydroxycarbamide (hydroxyurea) long-term.
You must protect your skin from the sun and check it regularly during treatment and
after stopping therapy with hydroxycarbamide (hydroxyurea). Your doctor will also
inspect your skin during routine check-up visits.

Other medicines and Onco Carbide
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor:

• if you are taking other myelosuppressivemedicines (to reduce the number of red blood cells and/or white blood cells or platelets);
• if you are undergoing radiotherapyas this may increase the risk of bone marrow depression or other side effects;
• if you are taking or have taken interferon(a medicine used for infections caused by certain viruses), because you may develop vasculitis (inflammation of blood vessels);
• in case of use of inactivated vaccines (for example, the one against poliomyelitis);
• in case of use of immunosuppressants (medicines that block the body's immune response);
• reverse transcriptase inhibitors (medicines used to treat HIV infections);
• in case of use of antiretroviral medicines (reverse transcriptase inhibitors, nucleoside analogs in case of HIV);
• cyclosporine and tacrolimus (medicines administered if you have undergone a transplant).

Pregnancy, breastfeeding and fertility

Contraception
If you are a man or a woman of childbearing potential, you must use an effective contraceptive method during
treatment with Onco Carbide and respectively for at least 3 and 6 months after discontinuation of
treatment.

Pregnancy
Hydroxycarbamide (hydroxyurea) crosses the placenta, therefore do nottake this medicine if
you are pregnant (see section “Do not use Onco Carbide”) because it may harm the
fetus. However, if necessary, your doctor may prescribe it after informing you of the possible
risks to the fetus.
If you are pregnant and assist a person taking Onco Carbide, you must not come into
contact with the powder contained in the capsule (see section “How to take Onco
Carbide”).

Breastfeeding
Hydroxycarbamide (hydroxyurea) passes into breast milk, therefore you must not breastfeed while
taking this medicine (see section “Do not use Onco Carbide”).
If you are a man who wishes to have children, you should be informed of the risk of a reduction in
your fertility.

Driving and using machines
No studies have been conducted on the ability to drive and use machines.
It is not known whether this medicine can alter attention and reaction times.

Onco Carbide contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

Onco Carbide contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per single dose (1 capsule), i.e.
essentially “sodium-free” and about 1.5 mmol (approximately 34.9 mg) of sodium (the main component
of table salt) per dose of 2000 mg (4 capsules) equivalent to 1.7% of the maximum recommended daily intake with the diet of an adult.

3. How to take Onco Carbide

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
The dose of Onco Carbide will be established by the doctor based on your health conditions. The doctor will perform regular blood tests, if necessary, may interrupt the treatment and may eventually reduce the dose of Onco Carbide.
The doctor may prescribe you to take the medicine both daily and irregularly to reduce the toxic effects that may occur during treatment with Onco Carbide or in association with radiotherapy.

• In chronic myeloid leukemiaand in chronic myeloproliferative syndromes,the recommended dose is 20-30 mg/Kg orally in one or two daily administrations. The duration of treatment is at least six weeks. If the doctor deems it appropriate, he may continue the therapy.
• In sickle cell anemia,the recommended dose is 15-30 mg/Kg orally in one or two daily administrations. The duration of treatment is at least 6-8 months. In primary head and neck cancers, excluding the lips, the recommended dose varies from 1000 to 2000 mg per day orally generally divided into two daily administrations.

In solid tumors, the doctor may implement a therapy of 80 mg/Kg orally in a single daily administration.

Instructions for those who must handle this medicine, but must not take it.
If you have to handle the capsules, you must wear disposable gloves and wash your hands before and after touching the capsules.
In case of opening the capsule, excess powder must be removed with absorbent paper to be resealed in a closed plastic bag.
If you are pregnant and are assisting a person taking Onco Carbide, you must not come into contact with the powder contained in the capsule.

Elderly
If you are elderly you may be more sensitive to Onco Carbide and, therefore, the doctor may prescribe a lower dose.

Duration of treatment
You must continue to take Onco Carbide for as long as your doctor tells you.

If you take more Onco Carbide than you should
In case of accidental ingestion/administration of an excessive dose of Onco Carbide, immediately notify your doctor or go to the nearest hospital.
If you have taken an excessive dose of this medicine, the doctor may temporarily interrupt the treatment, perform checks and administer appropriate therapy.

If you forget to use Onco Carbide
Do not take a double dose to compensate for the forgotten capsule.

If you stop the treatment with Onco Carbide
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects during treatment with Onco Carbide, your
doctor WILL STOPthe treatment:

• skin lesions(skin ulcers), located near the malleoli (ankle bones) or in the legs. Discontinuation of Onco Carbide generally leads to complete healing and disappearance of pain (see section “Warnings and precautions”);
• effects affecting the blood:severe bone marrow depression (reduction of white blood cells, platelets and red blood cells). You may also experience the following side effects:

Other effects affecting the blood

• secondary leukemia (blood cancer that can occur after long-term treatment);
• hemolytic anemia (frequency unknown).

Effects affecting mouth, stomach and intestines

• stomatitis (inflammation of the mouth);
• anorexia (loss of appetite);
• nausea;
• vomiting;
• diarrhea;
• constipation.

Effects affecting kidneys, bladder and genital organs

• reduced kidney function (resulting in increased uric acid, nitrogen and creatinine in the blood);
• dysuria (difficulty urinating);
• amenorrhea (cessation of menstruation);
• azospermia (absence of spermatozoa in the seminal fluid in men), oligospermia (presence of modest amounts of spermatozoa in the seminal fluid in men). Azoospermia and

oligospermia are usually reversible, i.e. sperm counts return to
normal.

Effects affecting the skin and mucous membranes

• maculopapular rash (skin eruptions with the formation of red spots and small bumps on the skin);
• facial erythema (irritation and redness of the face);
• pruritus;
• hyperpigmentation (alteration of skin color);
• alopecia (hair loss);
• melanonychia (damage affecting the nails which take on a dark coloration);
• dry skin;
• dermo-ungual atrophy (thinning of the skin and nails);
• skin desquamation (loss of the superficial layer of the skin);
• skin lesions similar to dermatomyositis: skin lesions of an erythematous type (red skin) or erythematous-desquamative type (red skin that scales);
• cancer affecting certain types of skin cells (basal cell carcinoma and squamous cell carcinoma);
• inflammation of the skin causing red and scaly patches, sometimes accompanied by joint pain.

Effects affecting the nervous system

• headache;
• dizziness;
• disorientation;
• hallucinations (perception of things that do not exist in reality);
• convulsions (uncontrolled body movements).

Effects affecting the liver

• alteration of liver parameters (alteration of some blood values that may indicate liver damage).

Effects affecting the lungs and respiratory tract

• fever, cough or breathing problems, which may be a sign of a serious lung disease (frequency unknown).

Other effects

• Fever.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at 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 Onco Carbide

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Onco Carbide contains

• the active ingredient is: hydroxycarbamide (hydroxyurea) 500 mg
• the other ingredients are :lactose (see paragraph “Onco Carbide contains lactose”); calcium citrate; trisodium citrate; magnesium stearate. The components of the capsule shell are: gelatin; titanium dioxide (E171); iron oxide (E172).

Description of the appearance of Onco Carbide and contents of the pack
Onco Carbide is presented in 500 mg hard capsules, packaged in blisters in a carton containing 20
capsules.

Marketing Authorisation Holder
TEOFARMA S.r.l. Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV).

Manufacturer
Teofarma S.r.l. Viale Certosa, 8/A – 27100 Pavia.