Package leaflet: Information for the patient
Hydrea 500 mg Hard Capsules
Hydroxycarbamide
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
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
Talk to your doctor or pharmacist before taking Hydrea.
If hemolytic anemia (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.
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.
In long term use of Hydrea, secondary leukaemia has been reported. Skin cancer has been reported in patients receiving long term hydroxycarbamide. You should protect your skin from the sun and regularly inspect your skin yourself during the treatment and after discontinuation of the therapy with hydroxycarbamide. Your doctor will also inspect your skin during routine follow-up visits.
Children
There is limited experience with the use of Hydrea in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:
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.
You should check with your doctor before drinking alcohol to find out if it is advisable for you.
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 contraceptive measure before and during treatment with Hydrea. 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.
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 Hydrea.
In addition, if you are pregnant, planning to be or breastfeeding you should not handle the capsules.
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.
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.
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 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.
Tell your doctor immediately if you have a high fever (>39°C) with stomach, lung, muscle, liver, skin and heart problems within 6 weeks of taking Hydrea.
The following side effects have been seen in some people:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Rare: may affect up to 1 in 1000 people
Very rare: may affect up to 1 in 10000 people
Not known: frequency cannot be estimated from available data
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
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 or pets.
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
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
Bristol-Myers Squibb Pharmaceuticals uc
Plaza 254
Blanchardstown Corporate Park 2
Ballycoolin
Dublin 15
D15 T867
Ireland
Tel: 01 483 3625
Manufacturer
Corden Pharma Latina S.P.A.
Via Murillo, 7,
04013 Sermoneta (LT)
Italy
This leaflet was last revised in June 2022.