Hydrea 500 mg Capsules

Each HYDREA capsule contains 500 mg hydroxyurea. HYDREA (hydroxyurea) is a prescription medicine intended for use in the treatment of a type of blood cancer (chronic myeloid leukaemia) and skin cancer (squamous cell carcinoma) of the head and neck (excluding the lip).

Do not take HYDREA:

• If you are hypersensitive (allergic) to hydroxyurea or any of the other ingredients of HYDREA (listed in section 6).
• If you have bone marrow depression, i.e. leukopenia, thrombocytopenia or severe anaemia.
• If you are taking anti-HIV medicine such as didanosine or stavudine. Tell your doctor if you are taking these anti-HIV medicines.
• If you are pregnant or breastfeeding (see Pregnancy and breastfeeding and fertility).

Warnings and precautions

Talk to your doctor if you are using a continuous glucose monitor (CGM) to test your blood glucose. Hydroxyurea (i.e., HYDREA) may affect your sensor glucose results and may lead to low blood sugar (hypoglycaemia). Talk to the healthcare provider that prescribed your CGM about whether it is safe to use while you are taking HYDREA.

If haemolytic anaemia (disorder in which red blood cells are destroyed faster than they can be made) is detected when the blood tests are checked, your doctor will stop treatment with HYDREA.

Take special care with HYDREA:

• If you have fever, severe chills, sore throat or mouth ulcers, and unexpected bleeding (signs of bone marrow depression).
• If you have previously received irradiation or cytotoxic therapy. Tell your doctor if you are receiving these therapies.
• If you are anaemic (low blood count). Severe anaemia must be corrected with whole blood replacement before initiating therapy with HYDREA.
• If you have any kidney dysfunction.
• If you have numbness or weakness of the arms and legs (signs of peripheral neuropathy).
• If you have signs and symptoms of pancreatitis (pain and tenderness of the abdomen, abdominal distention and vomiting) and hepatotoxicity (toxicity of the liver).
• If you have any vasculitic ulcerations (inflammation of the blood vessels in the skin).
• If you are on interferon therapy.
• If you need to take any live vaccinations. It should be avoided during your treatment with HYDREA and for at least 6 months after your treatment has finished. Vaccination with a live vaccine may result in severe infection. Your antibody response to vaccines may be decreased.
• If you develop fever, cough, difficulty in breathing or other lung or breathing symptoms.

Children and adolescents

Paediatric Use: Safety and effectiveness in children have not been established. Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually treated with topical anaesthetics and orally administered analgesics, (pain medicines). Nausea, vomiting, and anorexia, resulting from combined therapy may usually be controlled by interruption of HYDREA administration. If any of the above effects affects you, please inform your doctor immediately. Elderly patients may be more sensitive to the effects of HYDREA and may require a lower dose regimen. It is very important to maintain an adequate fluid intake. Tell your doctor if you are taking HYDREA and are having blood tests done to test for urea, uric acid or lactic acid, as HYDREA may influence the blood test results.

Do not share medicines prescribed for you with any other person. Always take HYDREA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is: All HYDREA dosage regimens are based on the patient's actual or ideal weight, whichever is less. Your doctor will calculate the dosage of HYDREA that you should be taking based on your weight. Depending on your age (elderly patients) and your response to treatment and any side effects that you may experience, your doctor may adjust your dose of HYDREA upward or downward or may temporarily discontinue HYDREA.

Handling HYDREA: Swallow HYDREA capsules whole with water. If you prefer, or are unable to swallow capsules, empty the contents of the capsules into a glass of water and take immediately. Some particles in the capsule may not dissolve and float on the surface. If you take HYDREA by emptying the contents of the capsule into water, please beware that this is a potent medicine and must be handled with care. As far as possible avoid the powder coming into contact with the skin and mucous membranes (lining of the mouth, nose airways), as well as avoid inhaling the powder when opening the capsules. People who are not taking HYDREA should not be exposed to it. To decrease the risk of skin exposure, wear disposable gloves when handling HYDREA or bottles containing HYDREA and wash your hands before and after contact with the bottle or capsules (the same applies to anyone else that may handle your medicine). If the powder is spilled, it should be immediately wiped up with a damp disposable towel and discarded in a closed container, such as a plastic bag, as should the empty capsules. HYDREA should be kept away from children and pets. Your doctor will tell you how long your treatment with HYDREA will last. Do not stop treatment early. If you have the impression that the effect of HYDREA is too strong or too weak, tell your doctor or pharmacist.

HYDREA can have side effects. Not all side effects reported for HYDREA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking HYDREA, please consult your health care provider for advice.

If any of the following happens, stop taking HYDREA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• redness of the skin (rash), skin ulcerations or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to HYDREA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Side effect reported frequently:

• yellowing of the skin and eyes, also called jaundice,
• inflammation of the pancreas usually characterised by severe upper stomach pain, often with nausea and vomiting (pancreatitis),
• liver damage (hepatotoxicity) usually characterised by flu-like symptoms, including tiredness, loss of appetite, fever, aching, and feeling sick/being sick, pressure or pain below the right ribs and might also include yellowing of the skin or eyes,
• unexplained difficulty breathing (shortness of breath),
• signs of recurrent infections such as fever,
• kidney problems like less urine than is normal for you (instances of painful or difficult urination),
• skin cancer,
• low blood counts and blood disorders (reduction in the white blood cells, red blood cells and platelets),
• systemic lupus erythematosus (an autoimmune disease where the immune system of your body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain or other organs),
• cutaneous lupus erythematosus (symptoms can include butterfly rash over the cheeks, rash on arms, sometimes forming large plaques and spreading widely, a rash on all recently sun-exposed skin, inflammation of the lips and mouth ulcers, blisters and erosions).

Side effects reported less frequently:

• tissue death (gangrene) which is characterised by darkening of the skin, severe pain, numbness and tingling of the hands or feet, and a foul discharge.

Side effects reported with unknown frequency:

• fever, cough or breathing problems, this could be a sign of serious lung disease,
• a high fever (> 39 °C) with stomach, lung, muscle, liver, skin and heart problems within 6 weeks of taking HYDREA.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• sores on the lips or mouth (inflammation of the mucous membranes in the mouth),
• loss of appetite for food,
• nausea (feeling sick),
• vomiting,
• diarrhoea,
• constipation,
• abdominal cramps or stomach pains,
• hair loss,
• headache,
• dizziness,
• drowsiness,
• disorientation,
• hallucinations,
• convulsion,
• chills,
• weakness, tiredness or loss of energy,
• problems with the flow of the bile (cholestasis), the bile which is made by the liver to aid in digestion of food may not flow properly. A build-up of bile can cause itchiness, yellow skin, very dark urine and very pale stools,
• inflammation of the liver (hepatitis) which cause flu-like symptoms, including tiredness, loss of appetite, fever, aching, and feeling sick/being sick, pressure or pain below the right ribs and might also include yellowing of the skin or eyes.
• absence or low amount of sperm in the semen (azoospermia or oligospermia).

The following side effects have been reported less frequently:

• tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood).

The following side effects have been reported with unknown frequency:

• change in the colour of the nails,
• haemolytic anaemia (your body doesn't have enough healthy red blood cells to carry oxygen around, which can make you feel tired and weak), blood tests may likely be done.

Combined HYDREA and irradiation therapy: Nearly all patients receiving an adequate course of combined HYDREA and irradiation therapy will develop leukopenia (low white blood cell count). HYDREA may potentiate (increase) some adverse reactions usually seen with radiation alone, such as gastric distress and mucositis. (See Take special care with HYDREA.) If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of HYDREA.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Avoid excessive heat.
• Keep the container tightly closed.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).