Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Hydroxycarbamide
CHEPLAPHARM Arzneimittel GmbH
L01XX; L01XX05
Hydroxycarbamide
Capsule, hard
Other antineoplastic agents; hydroxycarbamide
Marketed
1979-04-01
1 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 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. 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 sta Baca dokumen lengkap
Health Products Regulatory Authority 26 June 2023 CRN00D63V Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrea 500 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg of Hydroxycarbamide. Excipients with known effect: Contains Lactose Monohydrate 42.2 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. Size 0 hard gelatin capsule with an opaque pink body and an opaque green cap, containing a white homogeneous powder. Printed with 'CHP 500' in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of malignant neoplastic disease including chronic myeloid leukaemia (pretreatment phase and palliative care). It is also indicated for treatment of cancer of the cervix and other solid type tumours in conjunction with radiotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Treatment regimens can be continuous or intermittent. The continuous regimen is particularly suitable for chronic myeloid leukaemia, while the intermittent regimen, with its diminished effect on the bone marrow, is more satisfactory for the management of solid type tumours. Hydrea should be started 7 days before concurrent irradiation therapy. If Hydrea is used concomitantly with radiotherapy, adjustment of radiation dosage is not usually necessary. An adequate trial period for determining the antineoplastic effect of Hydrea is six weeks. Where there is a significant clinical response therapy may be continued indefinitely, provided that the patient is kept under adequate observation and shows no unusual or severe reactions. Therapy should be interrupted if the white cell count drops below 2.5x10 9 /L or the platelet count below 100x10 9 /L (see section 4.4). In these cases, the counts should be re-evaluated after three days and therapy resumed when the counts return to acceptable levels. Hematopoietic rebound is usually rapid. If rapid rebound has not occurred during combined Hydrea and irradiation th Baca dokumen lengkap