Mesna Tablets 600 mg

• 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.

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
5. How to store Mesna Tablets
6. Contents of the pack and other information

• 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.

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

• you have any problems with your immune systems called ‘autoimmune’ disease, such as rheumatoid arthritis or lupus, where your body’s immune system attacks itself. Patients with an autoimmune disease treated with cyclophosphamide and 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.

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.

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. Discuss pregnancy with your doctor before having this medicine.

Do not breast-feed while being treated with these medicines.

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.

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

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.

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.

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.

• 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.

• 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 signs of bladder damage from Ifosfamide or Cyclophosphamide before
  • if you have had radiation therapy near your bladder.

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 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.

A specific antidote treatment for Mesna overdose is not known.

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.

• 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.

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 and digestive system (mucosal irritation),
• 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.

UK

• The active substance is mesna and each film-coated 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.

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.

The Marketing Authorisation holder is:

Send all enquiries to this address.

Mesna Tablets are manufactured by: