Hydrea 500 mg Hard Capsules

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Hydroxycarbamide

Tilgjengelig fra:

Bristol-Myers Squibb Pharmaceuticals uc

ATC-kode:

L01XX; L01XX05

INN (International Name):

Hydroxycarbamide

Dosering :

500 milligram(s)

Legemiddelform:

Capsule, hard

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Other antineoplastic agents; hydroxycarbamide

Autorisasjon status:

Marketed

Autorisasjon dato:

1979-04-01

Informasjon til brukeren

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.
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

Preparatomtale

Health Products Regulatory Authority
06 December 2021
CRN00CJZC
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 'BMS 303' 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 irradiatio