500 mg capsule, hard
hydroxycarbamide
What Hydroxyurea medac is and what it is used for
Hydroxyurea medac contains the active substance hydroxycarbamide, which belongs to a group of medicines used in certain blood diseases and prevents the growth of cancer cells.
This medicine has been prescribed by your doctor for the treatment of blood diseases ( tumors in the bone marrow: chronic myeloid leukemia, essential thrombocytemia, and polycythemia vera ).
Hydroxyurea contained in Hydroxyurea medac may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Hydroxyurea medac
Do not take Hydroxyurea medac
- if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6).
- if you have too low a blood cell count .
Warnings and cautions
Talk to your doctor or pharmacist before taking Hydroxyurea medac.
Treatment with hydroxycarbamide requires extensive monitoring. Before and during treatment with this medicine, your blood levels will be tested to check that you have enough blood cells, as well as tests of kidney and liver function to check that they are adequate. The tests of the blood values are normally done once a week.
If you have reduced red blood cell count, anemia ( anemia ), before, or develop during, treatment, if necessary, red blood cells can be added.
You should drink plenty of fluids during the treatment.
If you have kidney or liver problems, tell your doctor before starting treatment with this medicine.
If you receive long-term treatment with hydroxycarbamide, secondary leukemia may develop. To what extent this is due to the underlying disease or due to the treatment with hydroxycarbamide is currently unknown.
Skin cancer has been reported in patients receiving long-term treatment with hydroxycarbamide. You must protect your skin from sunlight and examine your skin regularly during and after treatment with hydroxycarbamide. Your doctor will also examine your skin in connection with recurring follow-up visits.
You can get leg ulcers. If so, your doctor will decide if you should continue to take this medicine. Leg ulcers usually heal slowly after a few weeks if you stop taking this medicine.
Other medicines and Hydroxyurea medac
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
If you have previously received or are still receiving similar medications or radiation therapy, side effects may occur more often and be more severe. Such side effects mainly include a decrease in the number of blood cells (suppressed bone marrow function), inflammation of the lining of the stomach, and inflammation of the skin.
Previous or concurrent radiation therapy may cause redness and irritation of the skin.
Hydroxycarbamide may increase the activity of NRTI (reverse transcriptase nucleoside analogue inhibitors), which are medicines used to treat HIV (eg didanosine, stavudine). Hydroxycarbamide in combination with NRTIs may increase the risk of side effects of NRTIs.
If you have recently been vaccinated or are planning a vaccination, tell your doctor.
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 fetus. Therefore, do not take this medicine during pregnancy except on explicit prescription from a doctor.
You must use effective contraception before and during treatment with this medicine. If you become pregnant while taking or after taking this medicine, you should contact your doctor.
Breast-feeding
Hydroxyurea medac must not be used during breastfeeding. Therefore, you must stop breastfeeding before taking this medicine for the first time.
Fertility
Men should use effective contraception during treatment and for at least 3 months after stopping treatment. Ask your doctor about the possibility of preserving sperm before starting treatment.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
The reactivity may be impaired during treatment with Hydroxyurea medac. This should be remembered when sharper attention is needed, e.g. when driving and using machines.
Hydroxyurea medac contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Hydroxyurea medac contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free.
How to take Hydroxyurea medac
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
In chronic myeloid leukemia, the usual starting dose is 40 mg per kg body weight daily. Dose one is then adjusted individually depending on the number of white blood cells in the blood.
In polycythemia vera, the usual initial dose is 15 – 20 mg per kg body weight daily. Dose one is then adjusted individually to 1 – 2 capsules (500 – 1,000 mg) depending on the blood value.
In the case of essential thrombocytemia, the usual initial dose is 15 mg per kg body weight daily with individual dose adjustment depending on the blood level.
Elderly patients
Elderly patients may be more sensitive to hydroxycarbamide and may need a lower dose.
The capsules should be swallowed whole and must not be dissolved in the mouth. The capsules should be handled with care. You should use gloves or wash your hands thoroughly after handling them. Although the risk to the fetus is minimal, pregnant women should avoid handling the capsules.
If you take more Hydroxyurea medac than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. You may have symptoms related to the mucous membranes and skin.
If you forget to take Hydroxyurea medac
It is important to complete the medication exactly as your doctor has prescribed it.
Do not take a double dose to make up for a forgotten dose . If you miss a single dose , continue treatment as prescribed . If you miss several doses , continue treatment as prescribed, but contact your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Contact a doctor immediately if you get symptoms such as:
- Fever, cough or difficulty breathing. This may be a sign of severe lung disease (has been reported).
Very common (may affect more than 1 user in 10)
- No or a low number of sperm in the semen ( azoospermia or oligospermia)
Common ( may affect up to 1 in 10 people)
- Decreased number of blood cells (suppressed bone marrow function), especially white blood cells ( leukopenia ), large immature red blood cells (megaloblasts)
- Diarrhea, constipation
- Skin ulcers (especially leg ulcers)
Uncommon ( may affect up to 1 in 100 people)
- Decreased number of red blood cells ( anemia ) and platelets ( thrombocytopenia )
- Nausea, vomiting, loss of appetite, mouth ulcers ( stomatitis )
- Fever caused by the drug, chills, malaise (feeling sick)
- Skin rash in the form of spots and blisters (maculopapular rash), redness of the face, redness of the hands and feet (hand-foot syndrome)
- Thick and scaly skin spots ( actinic keratosis ), skin cancer
- Elevated levels of liver enzymes and bilirubin (degradation product of the red blood dye)
- Temporary kidney problems with elevation of certain blood parameters such as uric acid , urea and creatinine
- In combination with certain HIV treatments: inflammation of the pancreas ( pancreatitis ) with pain in the abdomen or abdomen; abdominal pain, nausea or vomiting or yellow skin (hepatotoxicity); numbness and tingling in the arms and legs ( peripheral neuropathy )
Rare ( may affect up to 1 in 1,000 people)
- Allergic reactions
- Hair loss ( alopecia )
- Acute lung reactions with changes in lung tissue which can be seen on X-ray, fever and shortness of breath, and allergic inflammation in the air sacs
- Difficulty urinating
- Neurological disorders such as headache, dizziness, confusion, hallucinations and seizures
- Metabolic complications due to degradation products of cancer cells (tumor lysis syndrome)
Very rare ( may affect up to 1 in 10,000 people)
- Skin changes such as purple rash and thinning, inflammation of the skin that causes red, scaly patches and which can occur simultaneously with pain in the joints, darkening and fading of nails and skin, itching , small, violet bumps, scaly skin, blackening skin and dead skin
- Impaired renal function
- Chronic lung reactions with changes in the lung tissue seen on X-rays, shortness of breath and dry cough
Has been reported (occurs in an unknown number of users)
- High blood levels of potassium which can cause abnormal heart rhythms
Cases of low levels of sodium which can cause fatigue and confusion, muscle twitching, seizures or coma have been observed after the market introduction.
High doses can cause moderate drowsiness.
If you receive long-term treatment with hydroxycarbamide, secondary leukemia (blood cancer) may develop. To what extent this is due to the underlying disease or due to the treatment with hydroxycarbamide is currently unknown.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Hydroxyurea 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 expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- 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 (dye E171).
What the medicine looks like and contents of the pack
White capsules, hard (capsules).
Available pack sizes: 50 or 100 capsules.
Marketing Authorization Holder and Manufacturer
medac
Society for Clinical Specialties mbH
Theaterstr. 6
22880 Wedel
Germany
| Tel: | +49 4103 8006 0 (Germany)+46 340 64 54 70 (Sweden) |
| Fax: | +49 4103 8006-100 |
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Finland, Greece, Iceland, Netherlands, Norway, Austria, Portugal, Sweden:
Hydroxyurea medac
United Kingdom: Hydroxycarbamide
Germany: Syria