POM: Prescription only medicine
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 are: PL16508/0042 , PL16508/0043 , PL16508/0044 .
Mitomycin-C Kyowa 2 mg, 10 mg, or 20 mg, Powder for solution for injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
MITOMYCIN-C KYOWA® 2, 10 or 20 mg Powder for solution for injection
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
In this leaflet:
1. What Mitomycin-C Kyowa is and what it is used for
2. What you need to know before you use Mitomycin-C Kyowa
3. How to use Mitomycin-C Kyowa
4. Possible side effects
5. How to store Mitomycin-C Kyowa
6. Contents of the pack and other information
1. WHAT MITOMYCIN-C KYOWA IS AND WHAT IT IS USED FOR
As a single medicine or in a combination with other medicines, Mitomycin-C Kyowa can be used to treat different types of cancers in many different parts of the body as described below:-
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MITOMYCIN-C KYOWA
Do not use Mitomycin-C Kyowa if you:
Take special care with Mitomycin-C Kyowa if you:
Special attention will be paid if this product is given to the elderly or to children due to the possible side effects in these age groups.
You will be given the treatment under the supervision of a healthcare professional who is experienced in this particular branch of medicine to minimise any unwanted side effects in the injection site.
Other medicines and Mitomycin-C Kyowa
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or been given other treatments (e.g. radiotherapy).
When given together with certain other cancer treatment there have been some reports of problems related to bone marrow and the occurrence of cancer involving various types of blood cells.
Pregnancy and breast-feeding
You should not be given Mitomycin-C Kyowa if you are pregnant, may be pregnant or if you are breast-feeding. Ask your doctor for advice before taking any 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.
3. HOW TO USE MITOMYCIN-C KYOWA
Always use the medicine as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Mitomycin-C Kyowa is usually given by injection or as an infusion (with a drip). However in the treatment or the prevention of the recurrence of bladder cancer, a solution of 'Mitomycin-C' Kyowa will be given 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 will depend on your age, weight, medical condition and whether Mitomycin-C Kyowa is being given in combination with other drug treatment.
For example, when given by injection the recommended dose is in the range of 4-10 mg given at 1-6 weekly intervals. A course ranging from 40-80 mg is often required for a satisfactory result when used alone or in combination with other treatments. Thus, the period of treatment could last from just a few weeks up to a number of months, depending on the condition being treated.
In the treatment of bladder cancer, the recommended dose is 20-40mg 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.
If during treatment you develop a dry cough, breathlessness, rapid breathing or anything else which suggests your lungs might be affected, you may require to be monitored by X-rays of your chest that could continue up to 4 weeks after the end of treatment.
If you are given more Mitomycin-C Kyowa than you should
If you have been accidentally given a higher dose you may experience symptoms such as fever, nausea, vomiting and blood disorders. Your doctor may give you supportive treatment for any symptoms that may occur.
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:
If you experience any of the following tell your doctor as soon as possible:
Kidney or liver problems have also been reported. Your doctor will monitor your kidney (urine test) and liver (blood test) regularly.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MITOMYCIN-C KYOWA
Keep out of the sight and reach of children.
Mitomycin-C Kyowa 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 medicinces you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mitomycin-C Kyowa contains
What Mitomycin-C Kyowa looks like and contents of the pack
Mitomycin-C Kyowa is a powder which is mixed before injection. It is packaged in glass vials with a rubber stopper and aluminium seal.
Marketing Authorisation Holder
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in May 2019.
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