The name of your medicine is Cureaml. Each capsule contains hydroxyurea as the active ingredient. Hydroxyurea belongs to a group of medicines called anti-neoplastic medicines.

These medicines interfere with the growth of cancer cells.

Cureaml is used to treat some types of cancer such as cervical cancer and a type of leukaemia called chronic myeloid leukaemia (CML). The precise reason why you are being given Cureaml is best discussed with your doctor.

Do not take Cureaml:

• If you are allergic to hydroxyurea or any of the other ingredients of this medicine (listed in section 6).
• If you have history of any blood problems.
• If you have severe anaemia.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cureaml.

Your doctor will do regular blood tests before and whilst you are taking Cureaml. You may need to control or treat the source conditions before starting treatment with Cureaml.

Take special care with Cureaml if:

• You have any kidney or liver problems
• You are pregnant, planning to become pregnant or are breast feeding
• You have ever suffered from gout
• You have leg ulcers
• You have previously received radiotherapy or chemotherapy, or are currently taking any other medicines for cancer treatment, especially interferon therapy
• You have folic acid deficiency

In long term use of hydroxyurea, secondary leukaemia has been reported. Skin cancer has also been reported in patient receiving long term hydroxyurea. You should protect your skin from the sun, regularly inspect your skin yourself and be screened by your doctor for secondary malignancies during routine follow-up visits.

Other medicines and Cureaml

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

• Antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e.g., didanosine, stavudine and indinavir
• Myelosuppressive medicines (including chemotherapies) and radiation therapy
• Some vaccines, if you recently had a vaccination or are planning to have one, tell your doctor.

Always tell your doctor about other medicines you may be taking or have recently taken including those obtained without a prescription as some medicines can affect each others actions.

It may be necessary to adjust the dose of some medicines if they are taken at the same time as Cureaml.

Cureaml with alcohol

You should check with your doctor before drinking alcohol to find out if it is advisable for you.

Pregnancy, breast-feeding and fertility

You should not take this medicine if you are pregnant, planning to become pregnant or are breastfeeding, unless your doctor recommends it.

When appropriate both male and female patients should discuss effective safe contraceptive measure before, during and for at least 12 months and 6 months respectively after treatment with Cureaml.

For male patients only, this medicine can affect the production of sperm so you might want to discuss the possibility of conservation (by storage of sperm) with your doctor.

In addition, if you are pregnant, planning to be or breastfeeding you should not handle the capsules.

Driving and using machines

 You may feel drowsy. You should not drive or operate any machinery unless it has been shown not to affect you and have discussed it with your doctor.

Cureaml contains lactose monohydrate and sodium

Cureaml contains lactose monohydrate. Each hard capsule of Cureaml 500 mg Hard Capsules contains 41 mg lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Cureaml contains sodium. Each hard capsule of Cureaml 500 mg Hard Capsules contains 11.66 mg sodium. This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or physician experienced in antineoplastic agents if you are not sure.

Cureaml is a cytotoxic drug. Caution is needed when handling Cureaml to minimize risk of exposure.

People who are not taking Cureaml should not be exposed to it.

You may be instructed to take your medicine on either a daily basis or an irregular basis.

The recommended dose is 20-30 mg of Cureaml per kg of your bodyweight once a day or 80 mg per kg of your body weight once every third day.

Elderly patients may be more sensitive to the effects of Cureaml and may be given a lower dose.

You can take this medicine at any time of the day, before or after meals. The capsules should be swallowed whole with a glass of water. However, if you find it difficult to swallow them, the contents of the capsule can be emptied into a glass of water and taken immediately. If some of the powder floats on the surface of the water, do not worry this is just filler from the capsule.

The capsules should be swallowed whole and should not be opened or crushed.

Do not inhale the contents of the capsules and if you spill any on the skin wipe it immediately.

While you are being treated with Cureaml it is important that you drink plenty of fluids. This will help your kidneys work well.

If you are going to have radiation therapy, this medicine will usually be started 7 days before starting radiation treatment.

You should keep taking your capsules until your doctor tells you to stop.

Children

There is limited experience with the use of hydroxyurea in this age group.

If you take more Cureaml than you should

If you take too many capsules you should go to your nearest hospital Casualty Department immediately and take the medicine carton with you. The symptoms of overdose include; soreness, swelling of hands and feet and redness of skin.

If you forget to take Cureaml

If you forget to take a dose of this medicine do not take the missed dose at all. Take your next dose when it is due; do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following symptoms, you should stop taking the capsules and tell your doctor immediately as these may be signs of an allergic reaction:

• Swelling of the face, lips, tongue or throat
• Itching or skin rashes
• Difficulty breathing
• Unexplained fever, chills or sore throat
• Wasting of muscles
• Peeling of the skin and nails

Tell your doctor immediately if you have a high fever (>39°C) with stomach, lung, muscle, liver, skin or heart problems within 6 weeks of taking Cureaml.

The following side effects have been seen in some people:

Very common: may affect more than 1 in 10 people

• Blood disorders (reduction in white blood cells, red blood cells and platelets)
• Lower back pain or pain in your side
• Black tarry stools or blood in the stools
• Unusual bleeding or bruising
• Skin changes and muscle weakness (dermatomyositis)
  - you may experience symptoms such as muscle tenderness, muscle weakness or tiredness (especially when climbing stairs, walking or rising from a chair etc), a rash on the face, hands or other parts of the body (which in some cases maybe scaly, purple and raised).
• Sores on the lips or mouth
• Difficulty or pain passing urine
• Absence or low amount of sperm in the semen (azoospermia or oligospermia).
• Loss of appetite
• Weakness, loss of energy
• Sickness, diarrhoea, constipation, abdominal pain
• Skin problems may occur including darkening of the skin, peeling of the skin, purple raised patches of skin and redness. There may be a worsening of existing redness or discomfort in the skin or mucous membranes if you have had radiation treatment in the past
• Temporary hair loss
• Kidney problems

Common: may affect up to 1 in 10 people:

• Unexplained shortness of breath or cough with fever
• Numbness or tingling of hands or feet
• Skin cancer
• 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
• Drowsiness, dizziness, fits, confusion or hallucinations (seeing hearing or feeling things that are not there)
• Headache

Rare: may affect up to 1 in 1000 people

• Skin ulceration with severe infection
• Tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)

Not known: frequency cannot be estimated from available data

• Changes in the colour of the nails

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

The capsule should not be opened, broken or crushed.

For medication administration, use gloves and wash hands thoroughly before and after. If gloves are not worn, tip tablets and from their container/blister pack directly into a disposable medicine cup.

Caution should be observed in handling, opened or crushed capsules. Avoid direct contact of the Cureaml with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with sterile water, or plain water if sterile water is unavailable.

Pregnant should avoid handling Cureaml capsules.

Family members should use gloves when handling laundry or cleaning within or around toilets.

Close the lid before flushing the toilet and flush twice after each use by patient, for 48 hours after receiving chemotherapy. If available, use separate bathroom from family members.

Conduct double washing of linens and wash them separately from other family laundry.

Only keep the medicine if your doctor tells you to.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.