Hydroxyurea Capsules

Do not take Hydroxyurea

• If you are hypersensitive (allergic) to hydroxycarbamide or any of the other ingredients of Hydroxyurea. Therapy should be discontinued if hypersensitivity to Hydroxyurea occurs.
• If the function of the bone marrow is considerably reduced, such as
— reduced number of white blood cells (less than 2.5 x 109 leukocytes/l)
— deficiency of blood platelets (less than 100 x 109 thrombocytes/l)
— severe anaemia.
• If you are breastfeeding.
• If you are concomitantly treated with yellow fever vaccine.

Take special care with Hydroxyurea
• If you suffer from impaired liver and/or kidney function.
— Only little experience is available regarding this.
— Special caution is therefore required during treatment with Hydroxyurea, particularly at the beginning of therapy.
— The blood values as well as liver and kidney function are to be monitored by a doctor during treatment with Hydroxyurea.
• If you suffer from anaemia or if it occurs.
— Red blood cells can be replaced, if necessary.
— Their formation from abnormally large precursors is often to be observed only when treatment is started and it resembles the anaemia due to vitamin B12 deficiency.
— However, this is not attributable to too little vitamin B12 or folic acid.
• If you notice skin changes.
— These require further observation, as certain types of skin cancer can occur in isolated cases.
• If you notice painful ulcers on the lower legs.
— These are usually difficult to treat and can require interruption of treatment.
— Discontinuation of hydroxycarbamide usually enables the ulcers to slowly heal after some weeks.
• If you receive long-term treatment in cases of excessive formation of blood cells such as polycythaemia vera and thrombocythaemia.
— Another white blood cell cancer can develop.
— The extent to which this relates to the underlying disease or treatment with hydroxycarbamide is unknown to date.
• If you experience impaired blood formation in the bone marrow.
— A considerable reduction in white blood cells is the first and most common sign.
— A considerable reduction in blood platelets and anaemia occur less frequently and rarely without preceding leukopenia.
• If you are given other anticancer drugs or radiotherapy treatment.
• If you are concomitantly treated with live attenuated vaccines (expected yellow fever vaccines see “Do not take Hydroxyurea”).

• The control interval must be individualised, but is normally once a week.
• It is important to monitor uric acid levels regularly.
• You should always drink sufficient liquid during treatment with Hydroxyurea.
• Appropriate contraceptive measures are to be taken if one partner is treated with Hydroxyurea.
• Men undergoing treatment with Hydroxyurea should not father a child during treatment and up to 1 year afterwards.
• Seek advice on sperm conservation before beginning therapy as hydroxycarbamide therapy can cause transient infertility.
• If pregnancy is desired, specialized counselling is recommended even after therapy.

Taking other medicines

• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• Other medicines against tumour diseases or radiotherapy
• Side effects can be more intense and more common than after administration of Hydroxyurea alone.
• These side effects include the suppression of blood formation in the bone marrow, stomach and bowel complaints and inflammation in the mouth cavity.

Possible Side Effects

• Like all medicines, Hydroxyurea can cause side effects, although not everybody gets them.
• The strength of suppressed blood formation of the bone marrow determines the dosage or whether therapy must be interrupted in rare cases.
• Side effects affecting the stomach or the intestine only rarely require dose reduction or cessation of treatment.

Side effects can occur with the following frequencies:
Common, occurs in 1 to 10 per 100 users
• Suppressed blood formation in the bone marrow
• Reduced number of white blood cells (you are more prone to catch infections)
• Changes in the red blood count (megaloblastosis)

• Possible changes in the red blood count which do not respond to treatment with folic acid or vitamin B12 subside when therapy is discontinued.

• Diarrhoea
• Constipation

Uncommon, occurs in 1 to 10 per 1,000 users
• reduced number of blood platelets (you are more prone to bruising, bleeding)
• anaemia (feeling tired)
• nausea, vomiting, loss of appetite
• inflammation of oral mucosa
• drug fever
• chills
• feeling unwell
• flaky, knotty inflamed skin, skin rash
• inflammatory reddening affecting face, arms and legs
• elevated liver enzymes
• elevated bilirubin
• transient disorders of tubular kidney function with increase in uric acid, urea and creatinine in blood

Rare, occurs in 1 to 10 per 10,000 users
• allergic reactions
• hair loss
• rare disorders of nerve function including headache, dizziness, disorientation, hallucinations and fits
• development of an acute lung reaction with accumulation of liquid in the lung, fever, shortness of breath
• allergic reactions in the lungs
• difficult or painful urination (dysuria)
• Potentially life-threatening metabolic complications that can occur after treatment of cancer leading to increased uric acid level in the blood, which may result in gout or acute renal failure (tumour lysis syndrome)

Very rare, occurs in fewer than 1 per 10,000 users
In isolated cases after maintenance therapy for several years with daily intake of hydroxycarbamide:
• variable skin changes such as reddening and swelling
• excessive pigmentation on skin and nails
• thinning of skin and nails
• ulcers of the lower legs
• itching
• small, rough reddish patches on the skin, which may become skin cancer if not removed (actinic keratosis)
• skin cancer
• violet nodules
• skin scaling
• impaired kidney function
• cutaneous ulcers (especially ulcers of the lower legs)

How To Store

Keep out of the reach and sight of children.
Do not store above 30 °C.
Do not use the medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
The medicine 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.