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MESNA TABLETS 400 MG

Active substance(s): SODIUM MERCAPTOETHANESULPHONATE / SODIUM MERCAPTOETHANESULPHONATE

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PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
Mesna 400 mg and
600 mg Tablets
Mesna
Read all of this leaflet carefully before
you are given 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, nurse 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 or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
Throughout this leaflet, Mesna 400 mg and 600 mg
Tablets will be called Mesna Tablets.
What is in this leaflet:
1. What Mesna Tablets are and what they are
used for
2. What you need to know before you are given
Mesna Tablets
3. How to take Mesna Tablets
4. Possible side effects

Discuss pregnancy with your doctor before having
this medicine.
Do not breast-feed while being treated with these
medicines.

Tests while you are taking Mesna
Tablets
Mesna does not prevent the damage to the lining of
the bladder in all patients. Your doctor or nurse will
want to check your urine regularly for blood with a
special ‘dipstick’ or look at it under a microscope.
Tell your doctor, nurse or pharmacist if you
are having any other urine tests because your
medicines can affect the results. ‘Dipstick’ and
other types of tests frequently used to monitor
diabetes can be used to detect ‘ketones’ or Vitamin
C levels in your urine. Mesna can interfere with
these types of urine tests.
Mesna can also interfere with the results
of laboratory blood tests for the creatine
phosphokinase (CPK) enzyme. Your doctor or
nurse are aware of this interference and different
test methods will be used while you are receiving
Mesna.

Mesna with food, drink and alcohol

5. How to store Mesna Tablets

Food does not affect the absorption and urinary
elimination of Mesna.

6. Contents of the pack and other information

Driving and using machines

1 What Mesna Tablets are and what
they are used for

Some of the side effects of treatment with Mesna
might affect your ability to drive and use machines
safely. Your doctor will decide if it is safe for you
to do so.

3 How to take Mesna Tablets
Taking this medicine
• Take this medicine by mouth.
• You can take the tablets with or without food.
• While you are taking Mesna Tablets you should
drink enough fluid every day to maintain a urine
output of 100 ml per hour.
• This helps to dilute your urine and keeps a good
flow of urine. It will help to protect your bladder.
You should pass urine (empty your bladder) as
normal when you need to. Do not try to change your
usual pattern.

The recommended usual dose

Mesna Tablets are taken with ifosfamide and
cyclophosphamide. They do not react with these
medicines, and are not known to react with any
others.
However, always tell your doctor, nurse or
pharmacist if you are taking or have recently taken
any other medicines. This includes medicines you
have obtained without a prescription.

Pregnancy, breast-feeding and fertility
Mesna Tablets are only taken with ifosfamide and
cyclophosphamide. If you are pregnant and your
doctor thinks that you need treatment with these
medicines, you will also need to have Mesna.
70037318-3414/917

If you take more Mesna Tablets than
you should
If you take too many tablets, or if a child has
swallowed any of your tablets, talk to a doctor or go
to a hospital straight away. Always take the labelled
medicine container with you whether or not there is
any medicine left.
Taking too much of Mesna can cause symptoms
such as nausea, vomiting, abdominal pain,
diarrhoea, headache, fatigue, limb and joint pains,
rash, flushing, low blood pressure, slow or irregular
heartbeat, feeling of pins and needles like tingling,
fever, and breathing difficulties.
GB HA-30-01-430 C 917

Date

Using other medicines

If you are not sure how to take your
tablets, ask your doctor, nurse or
pharmacist.

Signature

If any of these applies to you your doctor will only
give you Mesna following careful consideration of
the risks and benefits to you.

Name

• Your doctor will decide how much of the
medicine you will need and when you will need
to take it. Always take the medicine exactly as
Warnings and precautions
your doctor tells you.
Talk to your doctor, nurse or pharmacist before
• The dose will depend on:
using Mesna Tablets if:
– the dose and timing of your treatment
• you have any problems with your immune
with ifosfamide or cyclophosphamide
systems called ‘autoimmune’ disease, such
– if ifosfamide or cyclophosphamide is
as rheumatoid arthritis or lupus, where your
being given to you as tablets or injection
body’s immune system attacks itself. Patients
– if you suffer from water infections
with an autoimmune disease treated with
(urinary tract infections)
cyclophosphamide and Mesna could have an
– if you have ever had signs of
increased risk of allergic (hypersensitivity)
bladder damage from Ifosfamide or
reactions.
Cyclophosphamide before
• you have experienced any side effects in the past
– if you have had radiation therapy near
when given a thiol-containing compound as there
your bladder.
could be an increased risk of experiencing sideeffects with Mesna. Examples of thiol-containing Use in children
medicines are amifostine (used to reduce
Children generally urinate more frequently than
the toxicity of some chemotherapy products),
adults. For children your doctor may need to shorten
penicillamine (used to treat rheumatoid arthritis)
the interval between doses and/or increase the
and captopril (used to treat hypertension or heart
number of individual doses.
failure).

Country

• you are allergic (hypersensitive) to Mesna or any
of the other ingredients (listed in section 6). An
allergic reaction can include shortness of breath,
wheezing, rash, itching or swelling of the face
and lips. If you are not sure if you are allergic
talk to your doctor, nurse or pharmacist before
taking Mesna Tablets.

If you see any other doctor or have to go to hospital
for any reason, tell them what medicines you are
taking. Do not take any other medicines unless your
doctor knows you are taking Mesna.

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Do not take Mesna Tablets if:

What to do if you see a different doctor,
or have to go to hospital

DATE 24 Oct 2014

2 What you need to know before you
are given Mesna Tablets

This medicine contains lactose, which is a type of
sugar. If you have ever been told by a doctor that
you have an intolerance to some sugars, talk to your
doctor before taking this medicine.

RA TO APPROVE LAYOUT AND
FORMAT

The damage to your bladder may show up as blood
in your urine. Very small amounts of blood may not
be seen, so your doctor or nurse will test your urine
with a ‘dipstick’ or microscope to check for blood.
If a larger amount of blood is in your urine, you will
notice that it is red and very occasionally you may
be able to see blood clots in it.

Important information about some of
the ingredients of Mesna Tablets

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Mesna Tablets are used to help reduce and prevent
bleeding in the bladder (haemorrhagic cystitis)
caused by cyclophosphamide and ifosfamide.
Mesna Tablets help to protect the lining of the
bladder from damage caused by these two drugs.
The body breaks down these two drugs to form
products that can harm the bladder. Mesna Tablets
work by helping to make these breakdown products
less harmful. Mesna Tablets should only be taken
when you are also taking cyclophosphamide or
ifosfamide.

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Mesna Tablets contain a medicine called ‘mesna’.

A specific antidote treatment for Mesna overdose is
not known.

If you forget to take Mesna Tablets
It is very important to take Mesna Tablets at the
times your doctor has told you:
• these times will have been carefully worked out
to make sure that your bladder is fully protected
against damage.
If you do forget to take your tablets, take them as
soon as you remember, and talk to your doctor or go
to your nearest hospital immediately for advice.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Some of these side effects may be caused by
cyclophosphamide or ifosfamide rather than Mesna,
as they are always taken together.

Tell your doctor straight away, if you
notice any of the following side effects,
you may need urgent medical attention:
• The most severe adverse reactions associated
with use of Mesna are:
• Anaphylaxis. Signs of this would be
shortness of breath, wheezing, rash,
itching or swelling of the face and
lips (hypersensitivity). Severe allergic
reactions could lead to difficulty in
breathing or shock, with a possible
fatal outcome (anaphylactic shock,
anaphylactic/anaphylactoid reaction).
• Bullous skin reactions which are life
threatening conditions which cause:
– rash,
– ulcers,
– sore throat,
– fever,
– conjunctivitis,
– blistering of the skin.
• Drug rash with eosinophilia and
systemic symptoms (DRESS) which is a
life threatening hypersensitivity reaction
to drugs which can cause:
– rash,
– fever,
– pain and swelling of internal organs,
– swollen and tender lymph nodes,
– changes in blood cells (eosinophilia).
• The most frequently occurring adverse reactions
associated with use of Mesna, are:
• feeling sick, headache, diarrhoea,
• fever, flushing, rash,
• waves of sudden abdomen or stomach
pain (colic),
• light headedness, lack of energy,
tiredness,
• flu-like illness.
If you are actually sick (vomit) after taking Mesna
Tablets, you may need to have Mesna by injection
instead.

Other possible side effects include:
Blood and Lymphatic System
• swollen/enlarged lymph nodes
(lymphadenopathy).
Metabolism and Nutrition
• decreased appetite,
• feeling dehydrated.
Psychiatric
• insomnia,
• nightmares.






flatulence,
burning pain in the area of the stomach,
constipation,
bleeding gums.

Liver
• increased levels of certain proteins
produced by your liver called enzymes
(increased transaminases). Your doctor
will do blood tests to test for these.
Skin and Subcutaneous Tissue
• itching (pruritus),
• excessive sweating (hyperhidrosis),
• itchy, red rash which can develop in to
sores (erythema multiforme, erythema),
• ulceration or blistering,
• swelling of the deeper layers of the
skin, caused by a build-up of fluid
(angioedema),
• skin rash notable for pale red, raised,
itchy bumps (urticaria),
• burning sensation.
Musculoskeletal and Connective Tissue
• muscle or joint pain (myalgia,
arthralgia),
• back pain,
• pain in hands or feet (pain in extremity),
• jaw pain.
Renal and Urinary
• painful urination (dysuria),
• kidney failure (acute renal failure).
General Disorders and Administrative Site
Conditions
• chills (rigors),
• chest pain,
• swelling of the face ( face oedema),
• swelling of tissues, usually in the lower
limbs, due to the accumulation of fluids
(oedema peripheral),
• muscle weakness (Asthenia).
If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.

Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

UK
Yellow Card Scheme
www.mhra.gov.uk/yellowcard

5 How to store Mesna Tablets
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the label after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. If you have some tablets
left over, take them back to your hospital. These
measures will help protect the environment.

6 Contents of the pack and other
information
What Mesna Tablets contains

Nervous System
• dizziness,
• fainting (syncope),
• sensation of tickling, tingling, burning,
pricking (paresthesia),
• increased or abnormally painful
sensitivity to touch (hyperesthesia),
• reduced sensitivity to touch
(hypoesthesia),
• disturbance in paying attention.

• The active substance is mesna and each filmcoated tablet contains 400 mg or 600 mg.
• The other ingredients are: lactose
monohydrate, microcrystalline cellulose,
dibasic calcium phosphate dehydrate, corn
starch, povidone K25, magnesium stearate,
hydroxypropylmethylcellulose, polyethylene glycol
6000, titanium dioxide (E 171), simethicone.

Eyes
• blurred sight,
• sensitivity to light,
• inflammation of the eye (conjunctivitis).

The tablets are white and oblong with a notch on
one side and either M4 or M6 on the other. They are
available in blister strips in cartons containing 10,
20 and 50 tablets.

70037318-3414/917

Baxter is a trademark of Baxter International Inc.

GB HA-30-01-430 C 917

DATE 24 Oct 2014

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Date

For information about Mesna Tablets or
to request this leaflet in formats such
as audio or large print please contact
the Marketing Authorisation Holder: Tel:
01635 206345.

Signature

This leaflet was last revised in 07/2014.

Name

Mesna Tablets are manufactured by:
Temmler Pharma GmbH & Co. KG
Temmlerstrasse 2, 35039 Marburg
Germany

RA TO APPROVE LAYOUT AND
FORMAT

Send all enquiries to this address.

Country

Digestive system
• irritation of the lining of the mouth and
digestive system (mucosal irritation),

The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE
United Kingdom

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Lungs
• nasal congestion,
• cough,
• severe, sharp pain when breathing in
(pleuritic pain),
• dry mouth,
• difficulty in breathing or wheezing
(bronchospasm),
• shortness of breath (dyspnea),
• vocal cord discomfort (laryngeal
discomfort),
• nosebleeds (epistaxis),
• severe difficulty breathing (respiratory
distress),
• decrease levels of oxygen in your body
(hypoxia).

Marketing Authorisation Holder and
Manufacturer

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Heart and Circulation
• sensation that you have a “pounding”
heartbeat (palpitation),
• rapid heartbeat (tachycardia),
• low blood pressure (hypotension).

What Mesna Tablets looks like and
contents of the pack

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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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