What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL16508/0045.


Mitomycin-C Kyowa 40 mg, powder for intravesical solution

Package leaflet: Information for the user

Mitomycin-C Kyowa® 40 mg powder for intravesical solution

Mitomycin-C

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
  • If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Mitomycin-C Kyowa 40 mg is and what it is used for
2. What you need to know before you use Mitomycin-C Kyowa 40 mg
3. How to use Mitomycin-C Kyowa 40 mg
4. Possible side effects
5. How to store Mitomycin-C Kyowa 40 mg
6. Contents of the pack and other information

1. What Mitomycin-C Kyowa 40 mg is and what it is used for

Mitomycin-C Kyowa 40 mg is an anticancer medicine used for the treatment of bladder cancer in adults. This medicine is introduced directly into the bladder after surgery to treat or reduce the chances of a recurrence of the condition.

2. What you need to know before you use Mitomycin-C Kyowa 40 mg

Do not use Mitomycin-C Kyowa 40 mg:

  • if you are allergic to Mitomycin C or any of the other ingredients of this medicine (listed in section 6).
  • if you have certain types of blood disorders (ask your doctor for advice).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Mitomycin-C Kyowa 40 mg.

Treatment with Mitomycin-C Kyowa 40 mg will be administered to you under the supervision of a medical doctor who is experienced in cancer chemotherapy. The doctor will therefore take all the necessary precautions for the safe administration of this product to you.

Take special care with Mitomycin-C Kyowa 40 mg if you:

  • have liver or kidney problems; side effects of Mitomycin C may be more noticeable
  • have been told that you have bone marrow depression (your bone marrow is not able to make the blood cells that you need); it may be made worse (especially in the elderly); infection (including chicken pox) may also be made worse due to effects on your bone marrow and may lead to life-threatening or fatal conditions.

Special attention will be paid if this product is administered to the elderly or to children due to the possible side effects in these age groups.

Other medicines and Mitomycin-C Kyowa 40 mg

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or been given other treatments (e.g. radiotherapy).

Mitomycin-C Kyowa 40 mg may interact with certain types of medicines:

  • when given together with certain other cancer treatment there have been some reports of problems related to bone marrow.
  • when taken together with vinca alkaloid agents (such as vincristine) that are used in cancer treatment, shortness of breath, coughing, wheezing and tightness in the chest may occur.

Pregnancy and breast-feeding

You should not be given Mitomycin-C Kyowa 40 mg if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Ask your doctor for advice before using this medicine.

Driving and using machines

A few people have reported that they feel tired or weak after the treatment. Do not drive or use any tools or machines if you are affected.

Mitomycin-C Kyowa 40 mg contains sodium

This medicine contains 378 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 19 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Mitomycin-C Kyowa 40 mg

Mitomycin-C Kyowa 40 mg should only be administered by healthcare professionals experienced in this kind of therapy.

Mitomycin-C Kyowa 40 mg is intended to be used for administration to the urinary bladder (intravesical use) after being dissolved. A solution of Mitomycin-C Kyowa 40 mg will be instilled directly into the bladder through a type of tube called a catheter.

The precise dosage, frequency of dosing and duration of treatment with Mitomycin-C Kyowa 40 mg will depend on your age, weight, medical condition and whether Mitomycin-C Kyowa 40 mg is being given in combination with other drug treatment.

The recommended dose is 20-40 mg administered into the bladder, weekly or three times a week for a total of 20 doses. The dosage may be decreased if side effects are a problem.

The dose of Mitomycin-C Kyowa 40 mg that you will receive will depend on whether it is being administered for prevention or cure. For prevention, the usual dose will be 4-10 mg. If you are receiving Mitomycin-C Kyowa 40 mg to treat bladder cancer, then the dose will be 10-40 mg. Your doctor will determine the appropriate dose to be administered.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following severe reactions tell your doctor immediately:

  • severe breathlessness
  • pneumonia – fever, chills, shortness of breath or a cough
  • severe allergic reaction (anaphylactic reaction) – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

Kidney or liver problems have also been reported. Your doctor will monitor your kidney (urine test) and liver (blood test) regularly.

Very common (may affect more than 1 in 10 people):

  • Blood in urine
  • Bladder irritation
  • Malaise

Common (may affect up to 1 in 10 people):

  • Allergy
  • Rash
  • Itching
  • Numbness, swelling and painful redness on palms of the hands and soles of feet (palmar-plantar erythrodysaesthesia (PPE)/hand-foot syndrome)
  • Cystitis (inflammation of the bladder causing lower abdominal pain or discomfort)
  • Bladder pain
  • Bladder spasm
  • Pain when passing urine
  • Frequently passing urine

Very rare (may affect up to 1 in 10,000 people):

  • Reduction in blood cells involved in clotting, known as platelets (thrombocytopenia)
  • Reduction in white blood cells (leucopenia) which helps the body to fight infections
  • Interstitial lung disease (lung tissue disease which can cause difficulty in breathing)
  • Nausea and vomiting
  • Diarrhoea
  • Hair loss
  • Kidney failure
  • Reduced kidney function
  • Bladder perforation
  • Bladder inflammation leading to loss of bladder tissue

Not known (frequency cannot be estimated from the available data):

  • Infections (bacterial, viral or fungal)
  • Sepsis and septic shock
  • Bone marrow suppression (decreased bone marrow function resulting in reduction of blood cells)
  • Reduction in red blood cells (anaemia)
  • Eosinophilia (an increase in a type of blood cells usually associated with allergic reactions)
  • Loss of appetite
  • Weight loss
  • Flushing
  • Raised blood pressure
  • Bleeding
  • Breathing problems
  • Scarring of lung tissue
  • Bronchospasm
  • Coughing
  • Lung oedema (fluid in the lungs)
  • Constipation
  • Liver problems including jaundice (yellowing of the skin and the whites of your eyes)
  • Redness and inflammation of the skin
  • Blisters
  • Contracted (small) bladder
  • Micturition urgency (sudden urge to pass urine)
  • Protein in urine due to abnormal kidney function
  • Penile necrosis
  • Fever
  • Oedema (swelling)
  • Calcinosis (formation of calcium deposits in the body)
  • Generalised weakness
  • Lethargy

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mitomycin-C Kyowa 40 mg

Keep out of the sight and reach of children.

Mitomycin-C Kyowa 40 mg should be kept in its original packaging.

Do not use this medicine after the expiry date which is stated on the label after “Exp Date”. The expiry date refers to the last day of that month.

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 to protect the environment.

6. Contents of the pack and other information

What Mitomycin-C Kyowa 40 mg contains

  • The active substance is mitomycin C
  • The other ingredient is sodium chloride

What Mitomycin-C Kyowa 40 mg looks like and contents of the pack

Mitomycin-C Kyowa 40 mg is a powder which is mixed before instillation into the bladder through a tube passed into the urinary passage (urethral catheter). Mitomycin-C Kyowa 40 mg is packaged in glass vials with a rubber stopper and aluminium seal.

Marketing Authorisation Holder

Kyowa Kirin Ltd
Galabank Business Park
Galashiels
TD1 1QH
UK

Manufacturer

Aesica Queenborough Limited
North Road
Queenborough
Kent
ME11 5EL
UK

This medicinal product is authorised in the Member States of the EEA under the following names:

Mitomycin-C Kyowa.

This leaflet was last revised in May 2019.