Package leaflet: Information for the patient

Hydrea 500 mg Hard Capsules

Hydroxycarbamide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Hydrea (Capsules) is and what it is used for

2.    What you need to know before you take Hydrea _3. How to take Hydrea

4.    Possible side effects

5.    How to store Hydrea

S 6. Contents of the pack and other information

1. What Hydrea is and what it is used for

™ The name of your medicine is Hydrea. Each capsule contains hydroxycarbamide as the active ingredient. ~ Hydroxycarbamide belongs to a group of medicines called anti-neoplastic medicines. These medicines interfere with the growth of cancer cells.

Hydrea 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 Hydrea is best discussed with your doctor.

2. What you need to know before you take Hydrea Do not take Hydrea Capsules:

•    if you are allergic to hydroxycarbamide 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 Hydrea.

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

Take special care with Hydrea Capsules 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 Hydrea, secondary leukaemia has been reported. Skin cancer has also been reported in patient receiving long term hydrocarbamide. 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 Hydrea

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 Hydrea. Hydrea with food, drink or 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 safe contraceptive measure before and during treatment with Hydrea.

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.

Hydrea contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Hydrea

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

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

The recommended dose is 20-30mg of Hydrea 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 Hydrea 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. 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 Hydrea 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 Hydrea in this age group.

If you take more Hydrea 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 Hydrea

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.

4.    Possible side effects

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

If you notice any of the following symptoms: swelling of the face, lips, tongue or throat; itching or skin rashes; difficulty breathing, unexplained fever, chills or sore throat, breathing difficulties, wasting of muscles and peeling of the skin and nails, you should stop taking the tablets and tell your doctor immediately as these may be signs of an allergic reaction.

If you notice any of these symptoms you should see your doctor immediately.

•    unexplained shortness of breath or cough with fever, skin ulceration, especially with severe infection

•    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

•    numbness or tingling of hands or feet

The following side effects have been seen in some people:

•    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).

•    absence or low amount of sperm in the semen (azoospermia or oligospermia).

•    loss of appetite

•    weakness, loss of energy

•    sickness, diarrhoea, constipation, abdominal pain

•    sores on the lips or mouth

•    difficulty or pain passing urine

•    skin problems may occur including rashes, 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

•    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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Hydrea

Do not store your tablets above 25°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 blister or carton after EXP. The expiry date refers to the last day of that month.

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

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.

6.    Contents of the pack and other information What Hydrea contains

-    Each Hydrea capsule contains 500 mg of the active ingredient hydroxycarbamide.

-    The other ingredients are citric acid anhydrous, erythrosine (E127), gelatin, indigotine (E132), lactose

monohydrate, magnesium stearate, sodium laurilsulfate, sodium phosphate, titanium dioxide (E171), yellow iron oxide (E172) and opacode S-1-8100.

What Hydrea looks like and contents of the pack

Hydrea capsules are pink, opaque capsules with green, opaque caps, and ‘BMS 303’ printed on them in black.

Hydrea capsules are packed in blister packs of 100 capsules.

People who are not taking Hydrea should not be exposed to it. To decrease the risk of exposure, wear disposable gloves when handling Hydrea. Anyone handling Hydrea should wash their hands before and after contact with the capsules. Pregnant women should not handle Hydrea.

For any information about this medicine, please contact the Marketing Authorisation Holder.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder E R Squibb & Sons Ltd.,

Uxbridge Business Park,

Sanderson Road,

Uxbridge, Middlesex UB8 1DH,

England.

Tel: 0800 7311736 Manufacturer

Corden Pharma Latina S.p.A.

Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy.

This leaflet was last revised in March 2015

3000648A1