Baxter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Mesna 400 mg and 600 mg Tablets

Mesna

1 What Mesna Tablets are and what they are used for

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

Do not take Mesna Tablets if:

•    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.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using Mesna Tablets if:

•    you have any problems with your immune systems called ‘autoimmune’ cfisease, such as rheumatoid arthritis or lupus, where your body’s immune system attacks itself. Patients with an autoimmune disease treated with cyclophosphamide aid Mesna could have an increased risk of allergic (hypersensitivity) reactions.

•    you have experienced any side effects in the past when given a thiol-containing compound as there could be an increased risk of experiencing side-effects with Mesna. Examples of thiol-containing medicines are amifostine (used to reduce

the toxicity of some chemotherapy products), penicillamine (used to treat rheumatoid arthritis) and captopril (used to treat hypertension or heart failure).

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

Using other medicines

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 mecficines 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.

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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

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

Driving and using machines

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.

Important information about some of the ingredients of 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.

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

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.

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

•    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 your doctor tells you.

•    The dose will depend on:

-    the dose and timing of your treatment with ifosfamide or cyclophosphamide

-    if ifosfamide or cyclophosphamide is being given to you as tablets or injection

-    if you suffer from water infections (urinary tract infections)

-    if you have ever had sips of bladder damage from Ifosfamide or Cyclophosphamide before

-    if you have had radiation therapy near your bladder.

Use in children

Children generally urinate more frequently than adults. For children your doctor may need to shorten the interval between doses and/or increase the number of individual doses.

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

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 pans, rash, flushing, low blood pressure, slow or irregular heartbeat, feeling of pins and needles like tingling, fever, and breathing difficulties.

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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.

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.

Eyes

•    blurred sight,

•    sensitivity to light,

•    inflammation of the eye (conjunctivitis).

Heart and Circulation

•    sensation that you have a “pounding'’ heartbeat (palpitation),

•    rapid heartbeat (tachycardia),

•    low blood pressure (hypotension).

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).

Digestive system

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

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•    flatulence,

•    burning pain in the area of the stomach,

•    constipation,

•    bleeding gums.

Liver

•    increased levels of certain protans 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 cfirectly (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 GZR-1368 Gzira

Website: www.medicinesauthority.gov.mt e-mail: post!icensing.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 dale 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

•    The active substance is mesna aid each film-coated tablet contains 400 mg or 600 mg.

•    The other ingredients are: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate dehydrate, com starch, povidone K25, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol 6000, titanium dioxide (E171), simethicone.

What Mesna Tablets looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is:

Baxter Healthcare Ltd

Caxton Way, Thetford, Norfolk, IP24 3SE

United Kingdom

Send all enquiries to this address.

Mesna Tablets are manufactured by:

Baxter Oncology GmbH Kantstrasse 2 33790 Halle/Westfalen Germany

This leaflet was last revised in 03/2015.

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.

Baxter is a trademark of Baxter International Inc.

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