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PROCARBAZINE 50MG CAPSULES

Active substance(s): PROCARBAZINE HYDROCHLORIDE

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14-139 Procarbazine PIL 02-07-14_Layout 1 02/07/2014 10:49 Page 1

Artwork Information

Product Title:

Procarbazine PIL

Date:

02-07-14

Product Size:

148 x 210mm

Label Number:

14-139

Colours Used:

Black

Fonts Used:

Bosis Light, Medium and Semibold

Font size:

7pt

Artwork by:

Kevin Raddy

14-139 Procarbazine PIL 02-07-14_Layout 1 02/07/2014 10:49 Page 2

Package leaflet: Information for the patient

Procarbazine 50mg Capsules
Procarbazine hydrochloride
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. See section 4.

What is in this leaflet
1. What Procarbazine 50mg Capsules are and what they are used for
2. What you need to know before you take Procarbazine 50mg
Capsules
3. How to take Procarbazine 50mg Capsules
4. Possible side effects
5. How to store Procarbazine 50mg Capsules
6. Contents of the pack and other information
1. What Procarbazine 50mg Capsules are and what they
are used for
Procarbazine is one of the group of medicines known as alkylating
agents, which interfere with the growth of certain types of cells in the
body.
Procarbazine is used as one of the chemotherapy drugs in the
treatment of some cancers.
In adults, Procarbazine is used on its own or in combination with
other drugs in the treatment of cancers such as Hodgkin’s disease (a
cancer of the lymph glands).
In children (aged 2-18 years), Procarbazine is used in combination with
other drugs in the treatment of Hodgkin’s disease.
2. What you need to know before you take Procarbazine 50mg
Capsules
Do not take Procarbazine 50mg Capsules:


if you are allergic to procarbazine or any of the other ingredients
of this medicine (listed in section 6)
• if you have anything wrong with your blood, in particular, too few
white cells or platelets (your doctor will be able to advise you).
• if you suffer from any severe kidney or liver disorder
• if you have a non-cancerous tumour
• if you are in the first trimester of pregnancy
• if you are breast-feeding
Make sure your doctor knows if any of the above applies to you.
Warnings and precautions
Talk to your doctor before taking Procarbazine 50mg Capsules:
• if you suffer from any kidney or liver disorder
• if you have any disorder of the heart or circulation
• if you are, or could be, pregnant or may want to become pregnant
in the future (for further information refer to the following
sections of this leaflet: ‘Do not take Procarbazine 50mg Capsules’
and ‘Pregnancy, breast-feeding and fertility’)





if you have a tumour on the adrenal gland (near the kidney),
causing high blood pressure
if you suffer from epilepsy
if you have had a stroke

Some types of vaccinations should not be given to you during or
within at least six months of treatment with chemotherapy drugs such
as procarbazine. Your doctor will be able to advise you on this. If you
need any other medical treatment or surgery whilst taking
Procarbazine 50mg Capsules, remember to tell the doctor or dentist
treating you that you are taking this medicine.
Try to avoid people with infections whilst taking procarbazine. Check
with your doctor immediately if you get a cough, cold, or any
other infection.
Other medicines and Procarbazine 50mg Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
In particular, check with your doctor or pharmacist if you are taking
any of the following:
• strong painkillers (especially Pethidine)
• medicines for anxiety or difficulty in sleeping
• anticholinergic medicines, these include some medicines used for
irritable bowel syndrome, asthma or incontinence
• medicines for depression
• medicines for high blood pressure or for your heart
• anaesthetic products
• medicines for epilepsy
• clozapine (an anti-psychotic medication)
It is safe to use plain Paracetamol or Aspirin without speaking to your
pharmacist.
Procarbazine 50mg Capsules with food, drink and alcohol
Certain foods, drinks and medicines may cause an unpleasant reaction if
taken whilst you are being treated with Procarbazine 50mg Capsules or
during the two weeks after the course of treatment is completed. The
most important foods and drinks that might cause such an effect are:
Mature cheeses (including processed cheeses), yeast or meat extracts
(such as Marmite, Oxo and Bovril), broad bean pods, pickled herring,
salami sausage, pepperoni sausage, bologna sausage, overripe fruit,
alcoholic drinks (especially heavy red wines such as Chianti), nonalcoholic beers, lagers and wines and other foods which are not fresh,
particularly if they have been fermented, pickled, smoked, ‘hung’ or
‘matured’.
These reactions are extremely rare and if you want to eat or drink
anything on the list you could try a little at a time, until you are sure
that it does not upset you. However, it is best to avoid alcohol
altogether.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to
become pregnant or are breast-feeding, you should tell your doctor.
Pregnancy
Procarbazine should not be taken during the first trimester of
pregnancy. Its use should also be avoided throughout the remainder
of the pregnancy period.

14-139 Procarbazine PIL 02-07-14_Layout 1 02/07/2014 10:49 Page 3

Breast-feeding
Do not take Procarbazine if you are breast-feeding.



Liver disorder. If you (or your child) develop signs of liver disorder
which include persistent vomiting, feeling sick, feeling tired and
yellowing of the skin or the whites of the eyes (jaundice) you should
stop treatment and contact your doctor immediately

Ask your doctor or pharmacist for advice before taking any medicine.



Loss of appetite, especially at the start of treatment. This usually
improves after a few days

Driving and using machines



Procarbazine can cause drowsiness. If affected you should not drive or
use machinery.

Lowering of your white blood cell count. Common symptoms
include infections, lack of energy, headache, fever and irritability



Drowsiness and a lack of enthusiasm

3. How to take Procarbazine 50mg Capsules



Inflammation of lung tissue. Symptoms include shortness of breath,
cough, and a burning sensation in the chest.

Fertility
Procarbazine may cause infertility which might mean that you are not
able to have children.

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Procarbazine is usually given in combination with other drugs and it is
important that you (or your child) take each medicine
at the right time. Sometimes treatment starts with a small dose (1
capsule per day) and is increased each day up to a maximum of six
capsules per day.
If you take more Procarbazine 50mg Capsules than
you should
If you swallow too many capsules or someone else accidentally takes
your medicine, contact your doctor, pharmacist or nearest hospital
straight away.

Procarbazine in combination with other chemotherapy drugs has been
associated with an increased occurrence of a rare cancer of the blood
cells.
It is very important that you keep all hospital appointments whilst
taking procarbazine so that your progress can be checked.
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 internet at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

Overdose can cause severe vomiting and feeling sick, dizziness,
imagining sensations (hallucinations), depression, fits, low blood
pressure and increased pulse rate.

5. How to store Procarbazine 50mg Capsules

If you forget to take Procarbazine 50mg Capsules

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

If you miss a dose, take it as soon as you remember unless your next
dose is due within a couple of hours. In this case you should skip the
missed dose, go back to your regular dosing schedule and check with
your doctor. Do not take a double dose to make up for a forgotten
capsule. The same applies if you forget to give a dose to your child at
the right time.

In order that Procarbazine 50mg Capsules are always clearly identified
they should not be removed from their blister packaging until you are
ready to take them. Do not mix loose Procarbazine 50mg Capsules
with other loose capsules or tablets. Store in the original container in
order to protect from moisture. Do not store above 25˚C.

After taking Procarbazine 50mg Capsules

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.

Patients and carers should use gloves when handling urine or vomit
produced for up to 48 hours after a dose of procarbazine has been
taken.
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.
All medicines can cause allergic reactions although serious allergic
reactions are very rare. Any sudden wheeziness, difficulty in
breathing, swelling in any part of the body, rash or itching
(especially affecting your whole body) should be reported to a doctor
immediately.
Procarbazine may cause the following side effects:


Infertility, which might mean that you are not able to have
children



Skin rash or any unusual bleeding or bruising. If you (or your child)
develop these side effects, check with your doctor as soon as
possible



Nausea and vomiting. Do not stop taking procarbazine if it makes
you (or your child) sick in the first few days, as this side effect should
disappear. However if it is very bad, or if vomiting occurs shortly
after taking a dose, check with the hospital or your own doctor who
will tell you what to do. It may be possible to reduce this unpleasant
effect

Keep this medicine out of the sight and reach of children – preferably
in a locked cupboard or medicine cabinet.

6. Contents of the pack and other information
What Procarbazine 50mg Capsules contain
The active substance is procarbazine hydrochloride. There is 50mg of
procarbazine in each capsule. The other ingredients are mannitol,
maize starch, talc and magnesium stearate. The capsule shells are
made from gelatin, and also titanium dioxide (E171), shellac,
propylene glycol, ammonium hydroxide and black iron oxide (E172).
What Procarbazine 50mg Capsules look like and contents
of pack
Procarbazine 50mg Capsules are white, with ‘CL50’ on one half. They
are produced in blister strips, each pack contains 50 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Alliance Pharmaceuticals Limited,
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.
Manufacturer: EirGen Pharma Ltd., Westside Business Park, Old
Kilmeaden Road, Waterford, Ireland.
This leaflet was last revised in December 2013.
Alliance, Alliance Pharmaceuticals and associated devices are
registered trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited, 2013

PCO855

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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