Active ingredient
- bacillus calmette-guerin
Legal Category
POM: Prescription only medicine
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 is: PL 00025/0639 .
OncoTICE
OncoTICE® powder for suspension
2-8 X 108 CFU Tice® BCG
Information for the patient
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Oncotice is and what it is used for
2. Before you are given Oncotice
3. How Oncotice is given
4. Possible side effects
5. How to store Oncotice
6. Further information
1. What Oncotice is and what it is used for
Oncotice contains something called ‘BCG’ (‘Bacillus Calmette-Guérin’). This is a bacteria which has been specially altered, so that it can be used as a medicine.
Oncotice is used to:
It comes as a powder which is mixed with saline (salt water). It is then run into your bladder through a tube. BCG is also used as a vaccine for TB (tuberculosis). Oncotice is a much stronger sort of BCG that can’t be used as a vaccine.
2. Before you are given Oncotice
Oncotice should not be given if:
Tell your doctor if any of the following apply to you:
Take special care with Oncotice
Check with your doctor or pharmacist before being given the medicine if:
If you are not sure if any of the above apply to you talk to your doctor or pharmacist before being given Oncotice.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine. This includes medicines obtained without a prescription, including herbal medicines.
Do not have Oncotice and talk to your doctor straight away if:
The following can lower the effect of Oncotice:
If you are having any of these medicines or are having radiation treatment, your doctor will probably delay giving you Oncotice.
Using Oncotice with food and drink
Pregnancy and breast-feeding
Do not have Oncotice if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Oncotice will not affect your being able to drive or use any tools or machines.
Important information about some of the ingredients of Oncotice
3. How Oncotice is given
You will always be given Oncotice by a doctor or nurse.
Before it is given
Being given your medicine
After it has been given
During the next 6 hours
How often Oncotice is given
Oncotice is usually given once a week for 6 weeks. After this some people have ‘maintenance therapy’, where you may be given more doses. Your doctor will talk to you about this.
Having sex in the week after having Oncotice
If you have sexual intercourse during the week after being given the medicine, you must use a condom. This will lower the chance of the BCG bacteria being passed to your partner.
If you have more Oncotice than you should
Oncotice is made up from a standard bottle by your doctor, pharmacist or nurse. It is unlikely that you will receive too much Oncotice. If you do have too much, your doctor will check carefully to see whether you have BCG infection. If necessary you will need to have treatment for TB.
4. Possible side effects
Like all medicines, Oncotice can cause side effects, although not everybody gets them.
If you notice the following side effects, see your doctor straight away:
See your doctor straight away if you notice any of these side effects.
The following side effects have been reported but the frequency cannot be estimated from the available information (frequency not known):
Other side effects include:
Very common
(affects more than 1 in 10 people)
Common
(affects less than 1 in 10 people)
Uncommon
(affects less than 1 in 100 people)
Rare
(affects less than 1 in every 1,000 people)
Very Rare
(affects less than 1 in every 10,000 people)
Tell your doctor if any side effect is severe or lasts longer than 48 hours. If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
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 at: 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 Oncotice
Keep Oncotice out of the reach and sight of children. Oncotice will be stored in the hospital according to the instructions given by the manufacturer on the packaging. Store at 2 °C to 8 °C (in a refrigerator). Do not use Oncotice after the expiry date which is stated on the carton and label.
6. Further information
What Oncotice contains
What Oncotice looks like and contents of the pack
Oncotice is a freeze-dried powder, packed in 2 ml glass vials (available in packs of 1 or 3), each containing 1 dose of 12.5 mg (equivalent to 2 to 8 x 108 CFU) of BCG.
Marketing Authorisation Holder:
Manufacturer is:
This leaflet was last revised in April 2020
To listen to or request a copy of this leaflet in braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name: Oncotice
Reference Number: PL 00025/0639
This is a service provided by the Royal National Institute for Blind People
© Merck Sharp & Dohme Limited 2020. All rights reserved.
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