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Rx 1.WHAT CHLORAMBUCIL TABLETS

ARE AND WHAT THEY ARE USED
FOR
Chlorambucil Tablets 2mg
USP Taj Pharma Chlorambucil contains a medicine called
chlorambucil. This belongs to a group of
Package leaflet: medicines called cytotoxics (also called
chemotherapy). Chlorambucil is used to
Information for the patient treat some types of cancer and certain blood
Chlorambucil tablets 2mg, 5 mg tablet problems. It works by reducing the number
of abnormal cells your body makes.
Read all of this leaflet carefully before Chlorambucil is used for:
you start taking this medicine because it - Hodgkin's disease and Non-Hodgkin’s
contains important information for you. Lymphoma. Together, these form a group
- Keep this leaflet. You may need to read it of diseases called lymphomas. They are
again. cancers formed from cells of the lymphatic
- If you have any further questions, ask your
system.
doctor or pharmacist.
- This medicine has been prescribed for you - Chronic lymphocytic leukaemia. A type
only. Do not pass it on to others. It may of white blood cell cancer where the bone
harm them, even if their signs of illness are marrow produces a large number of
the same as yours. abnormal white cells.
- If you get any side effects, talk to your - Waldenstrom's macroglobulinaemia A
doctor or pharmacist. This includes any
rare lymphoma associated with an
possible side effects not listed in this leaflet
(see section 4). uncontrolled increase of B-cells, a type of
-The full name of the product is white blood cell, resulting in the release of
Chlorambucil 2 mg Film-coated Tablets but an abnormal protein into the blood. Ask
within the leaflet it will be referred to as your doctor if you would like more
Chlorambucil tablets. explanation about these diseases.
You must talk to a doctor if you do not feel
What is in this leaflet
better or if you feel worse.
1. What Chlorambucil tablets are and
what they are used for
2. What you need to know before you take 2. WHAT YOU NEED TO KNOW
Chlorambucil tablets BEFORE YOU TAKE
3. How to take Chlorambucil tablets CHLORAMBUCIL TABLETS
4. Possible side effects
5. How to store Chlorambucil tablets Do not take Chlorambucil :
6. Contents of the pack and other - If you are allergic (hypersensitive) to
information chlorambucil or any of the other ingredients
of Chlorambucil tablets (See section 6).
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If you are not sure, talk to your doctor or (such as oral polio vaccine, measles,
nurse before taking Chlorambucil. mumps, rubella). - Phenylbutazone (a
medicine used to treat fever, pain, and
Warnings and precautions
inflammation in the body) - you may require
Before you take Chlorambucil, tell your
a lower dose of Chlorambucil.
doctor or nurse if:
- Fludarabine, Pentostatin or Cladribine,
- you have been recently vaccinated, or
which are other chemotherapy medicines
planning to be vaccinated with a live
that may be used for the treatment of
vaccine (see Other medicines and
haematological malignancies (types of
Chlorambucil). Chlorambucil can make your
cancer that affect blood, bone marrow and
body less able to fight infections.
lymph nodes).
- you are a potential candidate for bone
marrow transplantation (autologous stem
Chlorambucil with food
cell transplantation) as the long term use of
Chlorambucil should be taken on an empty
Chlorambucil may reduce the amount of
stomach..
stem cells.
- you have had radiotherapy or
Pregnancy, breast-feeding and fertility
chemotherapy, now or recently
Pregnancy and breast-feeding
- you have a liver or kidney problems
If you are pregnant or breast-feeding, think
- you have a kidney problem (nephrotic
you may be pregnant or are planning to have
syndrome) , had high pulse dosing regimen
a baby, ask your doctor for advice before
or ever had a fit or convulsion. If you had
taking this medicine. Do not take
ever had fits or convulsions, you might be
Chlorambucil if you are planning to have a
more at risk of having fits or convulsions
baby. This applies to both men and women.
when taking Chlorambucil.
Treatment with Chlorambucil is not
It is possible that the use of Chlorambucil,
recommended during pregnancy because it
particularly long term use, may increase the
may cause permanent damage to a foetus.
risk of developing a secondary blood cancer.
Your doctor will consider the risks and
In many cases, patients who develop this
benefits to you and your baby of taking
have also received another type of
Chlorambucil. Do not breast-feed while
chemotherapy or some form of radiation
taking Chlorambucil. There have been
therapy. Symptoms of a secondary blood
reports indicating that Chlorambucil and its
cancer include tiredness, fever, infection and
ingredients can be passed into breast-milk.
bruising. Tell your doctor as soon as
Ask your doctor or midwife for advice.
possible if you have any of these symptoms.
Other medicines and Chlorambucil Fertility
Please tell your doctor if you are taking, Chlorambucil can affect ovaries or sperm,
have recently taken or might take any other which may cause infertility (inability to have
medicines, including medicines obtained a baby). In woman menstruation can stop
without a prescription. This includes herbal (amenorrhoea) and in men, a complete lack
medicines. In particular, tell your doctor if of sperm can be observed (azoospermia).
you are taking or have recently taken any of Use a reliable form of contraception to avoid
the following: pregnancy if either you or your partner is
- Vaccines which contain live organisms taking Chlorambucil. Ask your doctor for
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advice.
Hodgkin’s Disease
Driving and using machines - The usual dose is 0.2 mg per kilogram of
No information on the effects of your body weight each day for adults and
Chlorambucil on the ability to drive and use children.
machines is available. Non-Hodgkin’s Lymphoma
- The usual dose is 0.1 to 0.2 mg per
Chlorambucil contains lactose kilogram of your body weight each day for
Chlorambucil tablets contain lactose. If you adults and children.
have been told by your doctor that you have Chronic Lymphocytic Leukaemia
an intolerance to some sugars, contact your - The usual starting dose is 0.15 mg per
doctor before you take Chlorambucil tablets. kilogram of your body weight each day.
Waldenstrom's macroglobulinaemia
3. HOW TO TAKE CHLORAMBUCIL - The usual starting dose is 6 to 12 mg each
TABLETS day. Some people have to take Chlorambucil
long term. If you have to take it long term,
Always take this medicine exactly as your the usual dose is 2 to 8 mg each day. Follow
doctor has told you. Check with your doctor your doctor’s instructions carefully.
if you are not sure. Chlorambucil should
only be given to you by a specialist doctor If you take more Chlorambucil than you
who is experienced in treating cancer. The should
duration of the treatment will be decided by Tell your doctor immediately or go to a
your doctor based on your disease. hospital straight away. Ensure to take the
- Chlorambucil is administrated orally and medicine pack with you.
should be taken daily on an empty stomach
If you forget to take Chlorambucil
(at least one hour before meals or three
Tell your doctor. Do not take a double dose
hours after meals).
to make up for a forgotten dose.
- Swallow your tablets whole with a glass of
water.
If you stop taking Chlorambucil
- Do not break, crush or chew the tablets.
If you have any further questions on the use
of this medicine, ask your doctor or nurse.
The dose of Chlorambucil depends on the
type of your blood problem or cancer .
- Your doctor may change your dose during 4. POSSIBLE SIDE EFFECTS
your treatment depending on your needs.
The dose can sometimes be changed if you
are an older person or have liver problems. Like all medicines, Chlorambucil can cause
Your kidney or liver functions may be side effects, although not everybody
monitored during treatment, if you are an experiences them.
elderly person.
- When you take Chlorambucil your doctor If you experience any of the following,
will take regular blood tests to check the talk to your specialist doctor or go to
number of cells in your blood and your drug
dose may be adjusted as a result. hospital straight away:
- any signs of fever or infection (sore throat,
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sore mouth or urinary problems), hives (urticaria) or swelling of the tissues

- any unexpected bruising or bleeding, as (oedema),
this could mean that too few blood cells of a - skin rash has been reported to progress to
particular type are being produced, serious conditions including Stevens-
- if you suddenly feel unwell (even with a Johnson syndrome and toxic epidermal
normal temperature), 5 necrolysis. These two forms of the same
- if you start feeling extremely tired, serious skin disease cause rash, skin peeling
- if you notice numbness or weakness of and stores on the mucous membranes,
your muscles, - fever,
- if you experience skin rashes, blisters on - fit or convulsion.
the skin, sore mouth or eyes and have a high - liver damage/injury (hepatotoxicity).
temperature.
Talk to your doctor if you have any of the Very rare (affects less than 1 in 10,000
following side effects, which may also people)
happen with this medicine: - abnormal and repetitive shaking movement
of the body or twitching, without fits or
Very Common (affects more than 1 in 10 convulsions,
people) - inflammation of the bladder called cystitis,
- a drop in the number of blood cells, or - irreversible bone marrow failure - your
bone marrow suppression. body may stop producing blood cells
transiently,
Common (affects less than 1 in 10 people) - scarring and thickening in the lungs with
- feeling sick (nausea), being sick shortness of breath,
(vomiting), diarrhoea or mouth ulcers - lung disease,
(sores), - secondary blood cancers (acute - condition affecting nerves leading to
secondary haematologic malignancies), - fits impairment of sensation, movement and
(convulsions) in children with a kidney organ function (peripheral neuropathy).
problem known as nephrotic syndrome, - a
drop on red blood cells or anaemia which Not known: frequency cannot be
may make you feel tired or weak or estimated from the available data
breathless. - absence of menstruation (amenorrhoea),
- absence of sperm (azoospermia).
Uncommon (affects less than 1 in 100
people) - rash. If any of the side effects get serious, or if
you notice any side effects not listed in this
Rare (affects less than 1 in 1,000 people) leaflet, please tell your doctor.
- yellowing of the whites of the eyes or skin Reporting of side effects
(jaundice), If you get any side effects, talk to your
- allergy symptoms such as skin lumps, doctor or nurse. This includes any possible
 Chloram bucil Tablets 2mg U SP Taj Phar ma: U s es , Side Effects , Interacti ons , Pictures , W arni ngs , Chloram bucil Tablets 2mg U SP T aj Phar ma Dos age & Rx Inf o | Chlora mbucil Tablets 2mg U SP Taj Pha rma U s es , Side Effects , Chlora mbucil Tablets 2mg U SP Taj Pha rma : Indica tions , Side Effects , W arni ngs , Chloram bucil Tablets 2mg U SP Taj Phar ma - D rug Inf orma tion - Taj Phar ma, Chlora mbucil Tablets 2mg U SP Taj Pha rma dos e Taj pha rmaceu ticals Chloramb ucil Tablets 2mg U SP Taj Phar ma inte ractions , Taj Phar maceutical Chlo rambucil Table ts 2mg U SP Taj Pharma con train dications , Chlo rambucil Table ts 2m g U SP Taj Pharma price, Chl oram bucil Tablets 2mg U SP Taj Phar maTajPhar ma Chlo rambucil Table ts 2mg U SP Taj Pharma P IL- TajPhar ma Stay connecte d to all upda ted on Chlora mbucil Tablets 2mg U SP Taj Pha rmaTaj Pha rmaceuticals Taj pha rmaceuticals . Patien t Info rma tion Leaflets , PIL.

side effects not listed in this leaflet. You can Chloroambucil USP 5mg
also report side effects directly via the Excipients q.s
national reporting system: the Yellow Card
Colours: Titanium Dioxide USP
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help What Chlorambucil looks like and
provide more information on the safety of contents of the pack
this medicine. Tablets are packed in Bottle.

5.HOW TO STORE Pack Size of: 7, 14, 28, 30, 50, 90, 100 or
CHLOMBUCILTABLETS 200 tablets.

-Keep this medicine out of the sight and Not all pack sizes may be marketed.
reach of children.
- Do not use this medicine after the expiry
date which is stated on the pack after ‘Exp’. 7. Manufactured by:
- Store in a refrigerator (2 and 8°C). Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
- If your doctor tells you to stop taking the
at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
tablets, it is important to return any which
ATHIYAWAD, DABHEL, DAMAN- 396210
are left over to your pharmacist, who will (INDIA)
destroy them according to disposal of
dangerous substance guidelines. Only keep
the tablets if your doctor tells you to.
- 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

FURTHER INFORMATION

What Chlorambucil contains

a) Chlorambucil Tablets 2mg USP
Each film-coated tablet contains:
Chloroambucil USP 2mg
Excipients q.s
Colours: Titanium Dioxide USP

b) Chlorambucil Tablets 5mg USP

Each film-coated tablet contains: