ONCOTICE POWDER FOR INSTILLATION FLUID FOR INTRAVESICAL USE CONTAINING 2-8 X 10^8 CFU TICE BCG

Active substance: BCG TICE STRAIN

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406806A03

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Technical Info

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2-8 X 10 CFU Tice BCG
8

®

For Position Only

OncoTICE® powder for
suspension

INFORMATION FOR THE DOCTOR
1. TRADE NAME OF THE MEDICINAL PRODUCT
OncoTICE® powder for instillation fluid for intravesical
use containing 2-8 x 108 CFU Tice BCG.

Information for the patient
Read all of this leaflet carefully before
you start using this medicine.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
please ask your doctor or pharmacist.
• This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious,
or if you notice any side effect not
listed in this leaflet, please tell your
doctor or pharmacist.
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:
• treat bladder cancer
• prevent bladder cancer from coming
back after bladder surgery.
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:
• You have a urinary tract infection
(UTI). This must be treated first.
• You have blood in your urine.
• You have or think you have TB
(tuberculosis). Before you have
Oncotice, your doctor may do a skin
reaction test, to see if you have TB.
This is called a Tuberculin Test. If you
have had Oncotice before, this may
give you a positive result in this test.
• You are HIV-positive. You may need
to have a blood test for HIV. Tell your
doctor if any of the following apply
to you:
❍ you have been a drug user and have
shared a needle
❍ you have had unsafe sex
❍ you have had a blood transfusion.
• You have problems with your immune
system. This could be something which
runs in the family, or is caused by an
illness or other medicines you are
taking. Do not have Oncotice if any of
the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before being given Oncotice.
Take special care with Oncotice
Check with your doctor or pharmacist
before being given the medicine if:
• Your bladder wall or the tube coming
into your bladder from your kidneys

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(called the ‘ureter’) have been damaged during
previous treatment. Treatment with Oncotice
will not be given until this has healed.
If you are not sure if any of the above apply to
you talk to your doctor or pharmacist before
being given Oncotice.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
OncoTICE BCG 12.5mg per vial containing 2-8 x 108 CFU
Tice BCG.
After reconstitution in 50 ml saline the suspension
contains 0.4-1.6 x 107 CFU/ml.
OncoTICE is a freeze-dried preparation containing
attenuated bacilli of Mycobacterium bovis, prepared
from a culture of Bacillus Calmette-Guérin (BCG). For
excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for instillation fluid for intravesical use.

Gross haematuria. In these cases OncoTICE therapy
Also commonly observed are malaise, a low
4.7 Effects on ability to drive and use machines
to medium grade fever and/or influenzashould be stopped or postponed until the haematuria has
Not applicable
like symptoms (fever, rigors, malaise and
been successfully treated or has resolved.
4.8 Undesirable effects
myalgia). These symptoms usually appear
In patients with a positive Tuberculin test, OncoTICE
The side effects of intravesical OncoTICE therapy are
within 4 hours after instillation and last
instillations are contra-indicated only if there is
generally mild and transient. Toxicity and side-effects
for 24 to 48 hours. Fever higher than 39°C
supplementary medical evidence for an active
appear to be directly related to the cumulative CFU
typically resolves within 24 to 48 hours
tuberculous infection.
count of BCG administered with the various instillations.
when treated with antipyretics (preferably
Approximately 90% of patients develop local irritative
paracetamol) and fluids. However, it is
Treatment with anti-tuberculosis drugs like streptomycin,
symptoms in the bladder. Pollakiuria and dysuria
frequently not possible to distinguish these
para-amino-salicylic acid (PAS), isoniazid (INH), rifampicin
are reported very frequently. The cystitis and typical
uncomplicated febrile reactions from early
and ethambutol.
inflammatory reactions (granulomas) which occur in
systemic BCG infection and antituberculosis
Impaired immune response irrespective of whether this
the mucosa of the bladder after instillation of BCG, and
treatment may be indicated. Fever above 39°C
impairment is congenital or caused by disease, drugs or
which cause these symptoms, may be an essential
that does not resolve within 12 hours despite
other therapy.
antipyretic therapy must be considered as
part of the anti-tumour activity of the BCG. In most
systemic BCG-infection, necessitating clinical
cases, the symptoms disappear within two days after
Positive HIV serology.
confirmatory diagnostics and treatment.
instillation and the cystitis does not require treatment.
Pregnancy and lactation.
Systemic BCG infections could be due to
During maintenance treatment with BCG, the symptoms
traumatic catheterisation, bladder perforation
of cystitis may be more pronounced and prolonged.
4.4 Special warnings and special precautions for use
or premature BCG instillation after extensive
In these cases, when severe symptoms are present,
Before the first intravesical instillation of OncoTICE, a
TUR of a superficial carcinoma of the bladder.
isoniazid (300 mg daily) and analgesics can be given
Tuberculin test (PPD) should be performed. If the test is
These systemic infections may be manifested
until disappearance of symptoms.
positive, OncoTICE instillations are contraindicated only
initially by pneumonitis, hepatitis and/or
if there is supplementary medical evidence for an active Table 1 Side effects reported during post-marketing
cytopenia after a period of fever and malaise
tuberculous infection.
surveillance
during which symptoms progressively
Traumatic catheterisation or other injuries to the urethra
MedDRA SOClass
Preferred terms
or bladder mucosa can promote systemic BCG infection. Occurrence
Administration of OncoTICE should be delayed in such
Very common
Renal and urinary disorders
Cystitis, dysuria, pollakiuria, haematuria
(>1/10)
patients until mucosal damage has healed.
General disorders and administration site conditions
Influenza-like illness, pyrexia, malaise, fatigue
It is recommended that patients known to be at risk
Common
Infections and infestations
Urinary tract infection
of HIV infection be adequately screened prior to
(>1/100, <1/10)
Blood and lymphatic system disorders
Anaemia
commencing therapy.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Taking other medicines
OncoTICE is indicated for treatment of primary or
Please tell your doctor or pharmacist if you are
concurrent carcinoma-in-situ of the urinary bladder
taking, or have recently taken any other medicine.
and for the prevention of recurrence of high grade
This includes medicines obtained without a
and/or relapsing superficial papillary transitional cell
prescription, including herbal medicines.
carcinoma of the urinary bladder (Stage Ta (grade 2 or 3)
or T1 (grade 1,2 or 3)) after transurethral resection.
Do not have Oncotice and talk to your doctor
OncoTICE is only recommended for stage Ta grade
straight away if:
1 papillary tumours, when there is judged to be a high
• You are taking medicines for TB.
risk of tumour recurrence.
The following can lower the effect of Oncotice:
• antibiotics
4.2 Posology and method of administration
• medicines which affect the immunesystem
For preparation of the OncoTICE suspension see
(immuno-suppressants)
section 6.6.
• medicines which affect the production of bone
Dosage
marrow cells (bone marrow suppressants)
Adults and the elderly
• radiation treatment.
Patients should be monitored for the presence of
The contents of one vial of OncoTICE, reconstituted and
If you are having any of these medicines or are
symptoms of systemic BCG infection and signs of toxicity
diluted as indicated, are instilled into the urinary bladder.
having radiation treatment, your doctor will
after each intravesical treatment.
probably delay giving you Oncotice.
Induction treatment
Weekly instillation with OncoTICE during the first 6 weeks.
Using Oncotice with food and drink
OncoTICE should not be administered intravenously,
When used as an adjuvant therapy after TUR of a
• Do not drink any liquid for 4 hours before
subcutaneously or intramuscularly.
you are given Oncotice.
superficial urothelial cell carcinoma of the bladder
In order to protect the partner, the patient should be
• Do not drink any liquid for 2 hours after you
(see “Therapeutic indications”), treatment with
recommended to either refrain from intercourse within
have been given Oncotice.
OncoTICE should be started between 10 and 15 days
one week after OncoTICE instillation, or to use a condom.
after performing the TUR. Treatment should not be
Pregnancy and breast-feeding
The use of OncoTICE may sensitise patients to tuberculin
started until mucosal lesions after TUR have healed.
Do not have Oncotice if you are pregnant or
resulting in a positive reaction to PPD.
Treatment should also be delayed in cases of gross
breast-feeding. Ask your doctor or pharmacist
haematuria or major bladder irritability.
for advice before taking any medicine if you
Reconstitution and preparation of the OncoTICE
are pregnant or breast-feeding.
Maintenance treatment
suspension for instillation and administration should be
Maintenance treatment consists of weekly instillation
Driving and using machines
performed under aseptic conditions.
with OncoTICE during 3 consecutive weeks at months 3,
Oncotice will not affect your being able to
Spillage of OncoTICE suspension may cause Tice BCG
drive or use any tools or machines.
6, and 12 after initiation of the treatment. The need for
contamination. Any spilled OncoTICE suspension should
maintenance treatment every 6 months beyond the first
Important information about some of the
be cleaned by covering with paper towels soaked with
year of treatment should be evaluated on the basis of
ingredients of Oncotice
tuberculocidal disinfectant, such as household bleach,
tumour classification and clinical response.
• Oncotice contains lactose (a type of sugar).
for at least 10 minutes. All waste materials should be
If you have been told by your doctor that you
Children
disposed of as biohazard material
cannot tolerate or digest some sugars, talk to
Not recommended.
Accidental exposure to Tice BCG could occur through
your doctor before being given this medicine.
Intravesical instillation
self-inoculation, by dermal exposure through an open
• This medicine contains a very small amount
wound, or by inhalation or ingestion of OncoTICE
Insert a catheter via the urethra into the bladder and
of potassium (less than 1mmol or 39mg
suspension. Tice BCG exposure should not produce
drain the bladder completely. Connect the 50ml syringe
per dose). This means it is essentially
significant adverse health outcomes in healthy
‘potassium-free’.
containing the prepared OncoTICE suspension to the
individuals. However, in case of suspected, accidental
catheter, and instil the suspension into the bladder.
3. How Oncotice is given
self-inoculation, PPD skin testing is advised at the time
After instillation, remove the catheter. The instilled
of the accident and six weeks later to detect skin test
OncoTICE suspension must remain in the bladder for a
You will always be given Oncotice by a doctor
conversion.
period of 2 hours. During this period care should be taken
or nurse.
that the instilled OncoTICE suspension has sufficient
4.5 Interactions with other medicaments and other forms of
contact with the whole mucosal surface of the bladder.
Before it is given
interaction
Therefore the patient should not be immobilised or, in
• Do not drink any liquid the 4 hours before
Tice BCG is sensitive to most antibiotics and in particular
Oncotice is given to you.
case of a bed-ridden patient, should be turned over from
to the routinely used anti-tuberculosis drugs like
• You will be asked to pass water immediately
back to abdomen and vice versa every 15 minutes. After
streptomycin, para-amino salicylic acid (PAS), isoniazid
before Oncotice is given to you.
two hours, have the patient void the instilled suspension
(INH), rifampicin and ethambutol. Therefore the antiin a sitting position.
Being given your medicine
tumour activity of OncoTICE may be influenced by
Urine should be voided in a sitting position for 6 hours
• First your genital area will be cleaned with a
concomitant therapy with antibiotics. If a patient is being
after treatment and two cups of household bleach should
sterile solution.
treated with an antibiotic it is recommended to postpone
be added to the toilet before flushing. The bleach and
• A nurse will then pass a small flexible tube
the intravesical instillation until the end of the antibioticurine should be left to stand in the toilet for 15 minutes
into your bladder. This will remove any urine
treatment (see also “Contra-indications”).
before flushing.
that is still in your bladder.
• Oncotice is then run into your bladder through
Immunosuppressants and/or bone marrow depressants
NOTE: The patient must not ingest any fluid for a
this tube. This will only take a few minutes.
and/or radiation may interfere with the development
period starting 4 hours prior to instillation, until bladder
• The tube will then be removed.
of the immune response and thus with the anti-tumour
evacuation is permitted (i.e. 2 hours after instillation).
efficacy and should therefore not be used in combination
After it has been given
with OncoTICE.
• Oncotice will be left in your bladder for 2 hours. 4.3 Contra-indications
Urinary tract infections. Therapy with OncoTICE should be
• During this time you should move around
4.6 Pregnancy and lactation
interrupted until the bacterial culture from urine becomes
a little. This makes sure that the Oncotice is
OncoTICE instillation for carcinoma of the bladder
negative and therapy with antibiotics and/or urinary
spread around all of your bladder.
is contraindicated during pregnancy and lactation
antiseptics is stopped.
(see section 4.3).

Respiratory, thoracic and mediastinal disorders

Abdominal pain, nausea, vomiting, diarrhoea

Musculoskeletal and connective tissue disorders

Arthralgia, arthritis, myalgia

Renal and urinary disorders

Urinary incontinence, micturition urgency, urine analysis abnormal

General disorders and administration site conditions
Uncommon
(>1/1,000, <1/100)

Pneumonitis

Gastrointestinal disorders

Rigors

Infections and infestations

Tuberculous infections1 

Blood and lymphatic system disorders

Pancytopenia, thrombocytopenia

Hepatobiliary disorders

Hepatitis

Skin and subcutaneous tissue disorders

Rashes, eruptions and exanthems NEC1

Renal and urinary disorders

Bladder constriction, pyuria, urinary retention, ureteric obstruction

Investigations

Hepatic enzyme increased

Rare
Respiratory, thoracic and mediastinal disorders
(>1/10,000, <1/1,000)
Reproductive system and breast disorders

Cough

Very rare
(<1/10,000)

Infections and infestations

Pharyngitis, orchitis, Reiter’s syndrome, Lupus vulgaris

Blood and lymphatic system disorders

Lymphadenopathy

Metabolism and nutrition disorders

Anorexia

Psychiatric disorders

Confusional state

Nervous system disorders

Dizziness, dysaesthesia3, hyperaesthesia3, paraesthesia, somnolence,
headache, hypertonia, neuralgia3

Eye disorders

Conjunctivitis

Ear and labyrinth disorders

Vertigo3

Vascular disorders

Hypotension

Respiratory, thoracic and mediastinal disorders

Bronchitis, dyspnoea, rhinitis

Gastrointestinal disorders

Dyspepsia3, flatulence3

Skin and subcutaneous tissue disorders

Alopecia, hyperhidrosis

Epididymitis

Musculoskeletal and connective tissue disorders

Back pain

Renal and urinary disorders

Renal failure acute

Reproductive system and breast disorders

Balanoposthitis, prostatitis, vulvovaginal discomfort 3

General disorders and administration site conditions

Chest pain, oedema peripheral, granuloma2

Investigations

Prostatic specific antigen increased, weight decreased

NEC = not elsewhere classified
1
 High Level Term instead of Preferred Term
2
 Granuloma NOS has been observed in various organs including the aorta, bladder, epididymis, gastrointestinal tract, kidney, liver, lungs, lymphnodes,
peritoneum, prostate
3
 Only isolated cases reported during post-marketing surveillance

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406806A03

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Technical Info

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INFORMATION FOR THE DOCTOR

4.9

5.0
5.1

5.2

5.3

increase. Patients with symptoms of therapy6. PHARMACEUTICAL PARTICULARS
induced systemic BCG infection should be
6.1 List of excipients
adequately treated with anti-tuberculosis drugs
Lactose
according to treatment schedules used for
Asparagine
Citric Acid (E330)
tuberculosis infections. In these cases, further
Dibasic Potassium Phosphate
treatment with Tice BCG is contraindicated.
Magnesium Sulfate
Reporting of suspected adverse reactions
Iron Ammonium Citrate
Reporting suspected adverse reactions after
Glycerol (E422)
authorisation of the medicinal product is
Zinc formate
important. It allows continued monitoring
Ammonium Hydroxide (E527)
of the benefit/risk balance of the medicinal
6.2 Incompatibilities
product. Healthcare professionals are asked
OncoTICE is incompatible with hypo and hypertonic
to report any suspected adverse reactions
solutions. OncoTICE should only be mixed with
via the Yellow Card Scheme, website
physiological saline as described in section 6.6. Other
www.mhra.gov.uk/yellowcard.
incompatibility studies have not been performed.
Overdose
6.3 Shelf life
Overdosage occurs when more than one vial
12 months
of OncoTICE is administered per instillation.
In-use stability of the reconstituted product has been
In case of overdosage, the patient should be
demonstrated for 2 hours at 2-8°C protected from light.
closely monitored for signs of systemic BCG
From a microbiological point of view, unless the method
infection and if necessary treated with antiof opening/reconstitution/dilution precludes the risk of
tuberculosis drugs.
microbial contamination, the product should be used
PHARMACOLOGICAL PROPERTIES
immediately. If not used immediately, in-use storage
times and conditions are the responsibility of the user.
Pharmacodynamic properties
OncoTICE is an immunostimulating agent
6.4 Special precautions for storage
(ATC code L 03-AX03).
Store at 2-8ºC, protect from light.
It has anti-tumor activity, but the exact
mechanism of action is not known. Study data 6.5 Nature and contents of containers
2 ml Type 1 glass vials in packs of 1 and 3.
suggest that an active non-specific immune
response takes place. BCG invokes a local
6.6 Instruction for use and handling (and disposal)
inflammatory response involving a variety of
OncoTICE contains live, attenuated mycobacteria.
immune cells, such as macrophages, natural
Because of the potential risk for transmission, it should
killer cells and T cells.
be prepared, handled and disposed of as a biohazard
material (see section 4.4).
Pharmacokinetic Properties
Perform the following procedures under aseptic
For the treatment and recurrence prophylaxis
conditions using sterile physiological saline solution as
of bladder cancer, the attachment of BCG
the diluent and suitable techniques to ensure protection
to the bladder wall after voiding has been
of the health care worker:
shown to be important. This allows a targeted
pharmacological effect at the site of application.
Reconstitution
Transfer 50ml of the diluent into a sterile container and
Preclinical safety data
As a result of the wide clinical application of
add 1ml from the sterile container to the vial. Allow
BCG vaccination in the preceding decades
to stand for a few minutes then gently swirl until a
the risks of BCG in human subjects are wellhomogenous suspension is obtained. Forceful agitation
characterised. Intra-vesical administration to
should be avoided.
dogs has been found to be safe and without
Preparation of the solution for instillation
significant toxicity. No evidence of birth defects,
Transfer the reconstituted contents of the vial back into
genetic damage or carcinogenecity in humans
the container. Rinse the vial by transfering 1ml from
are available from the extensive adverse
the container back into the vial, then add back to the
reaction literature of BCG used as a vaccine.
container. Mix the suspension carefully.

The suspension, with a total volume of 50ml is now
ready for instillation; it contains a total of 2-8 x 108 CFU
of Tice BCG.
7. MARKETING AUTHORISATION HOLDER
N V Organon, Kloosterstraat 6, PO Box 20, 5340 BH, Oss,
The Netherlands
8. MARKETING AUTHORISATION NUMBER
PL 05003/0046
9. DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
4 August 2000
10. DATE OF (PARTIAL) REVISION OF THE TEXT
March 2014
SPC.ONC.14.UK.4035-UV52

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OncoTICE® powder for
suspension

Very Rare
(affects less than 1 in every 10,000 people)
• headache
• back pain
2-8 X 108 CFU Tice® BCG
• increased muscle tension
• swollen legs or arms
Information for the patient
• low blood pressure
• Do not drink any liquid for 2 hours after you • blood problems (shown in blood tests)
• flatulence or discomfort following meals
have been given Oncotice.
• After 2 hours you will be asked to pass water, • loss of appetite or weight loss
• hair loss
to empty your bladder. You should do this
• prickling or itching skin
while sitting down to avoid splashing your
• open sores on your skin
urine around the toilet.
• eye infection
During the next 6 hours
• feeling confused, sleepy or dizzy
• If you need to pass water again, also do this • kidney problems
while sitting down.
• Every time you pass water, add two cups of Tell your doctor if any side effect is
severe or lasts longer than 48 hours.
household bleach to the toilet.
If you notice any side effects not
• Leave the bleach and urine to stand in the
listed in this leaflet, tell your doctor or
toilet for 15 minutes before flushing.
pharmacist.
How often Oncotice is given
Oncotice is usually given once a week for 6 weeks. Reporting of side effects
After this some people have ‘maintenance
If you get any side effects, talk to your
therapy’, where you may be given more doses.
doctor, pharmacist or nurse. This includes
Your doctor will talk to you about this.
any possible side effects not listed in this
leaflet. You can also report side effects
Having sex in the week after having Oncotice
If you have sexual intercourse during the week directly via the Yellow Card Scheme
after being given the medicine, you must use a Website: www.mhra.gov.uk/yellowcard.
condom. This will lower the chance of the BCG By reporting side effects you can help
provide more information on the safety
bacteria being passed to your partner.
of this medicine.
If you have more Oncotice than you should
Oncotice is made up from a standard bottle by
5. How to store Oncotice
your doctor, pharmacist or nurse. It is unlikely
that you will receive too much Oncotice. If you do Keep Oncotice out of the reach and
have too much, your doctor will check carefully to sight of children. Oncotice will be
see whether you have BCG infection. If necessary stored in the hospital according to the
you will need to have treatment for TB.
instructions given by the manufacturer
on the packaging. Store at 2 °C to 8 °C
4. Possible side effects
(in a refrigerator). Do not use Oncotice
after the expiry date which is stated on
Like all medicines, Oncotice can cause side
the carton and label.
effects, although not everybody gets them.
6. Further information
If you notice the following side effects, see
your doctor straight away:
• a high temperature (fever) above 39 °C that What Oncotice contains
• The active substance is Bacillus
lasts for more than 12 hours, even after
Calmette-Guérin (BCG). It is a
taking medicines like paracetamol to lower
specially treated bacteria to be used
your temperature.
as a medicine.
• signs of a BCG or TB infection:
• The other ingredients are: lactose,
❍ cough or bronchitis
asparagine, citric acid (E330), potassium
❍ chest pain or tightness
phosphate, magnesium sulfate, iron
❍ sweating
❍ sore throat
ammonium citrate, glycerol (E422),
❍ cold in the nose
ammonium hydroxide (E527), zinc
❍ swelling of your lymph glands.
formate.
See your doctor straight away if you notice
What Oncotice looks like and contents
any of these side effects.
of the pack
Oncotice is a freeze-dried powder, packed
Other side effects include:
in 2 ml glass vials (available in packs of
Very common
1 or 3), each containing 1 dose of 12.5 mg
(affects more than 1 in 10 people)
8
• bladder infection, pain when passing water, (equivalent to 2 to 8 x 10  CFU) of BCG.
having to pass water often, feeling the need The Marketing authorisation holder
to pass water and bloody urine. Usually this and manufacturer is:
goes away within two days.
• flu-like symptoms such as fever and feeling N.V. Organon
PO Box 20, 5340 BH, Oss
off-colour and tired (malaise). This usually
The Netherlands
happens about 4 hours after treatment and
lasts for 24 to 48 hours.
This leaflet was last revised in:
Common
March 2014
(affects less than 1 in 10 people)
• painful joints or arthritis
To listen to or request a copy of
• muscle pain or stiffness
this leaflet in braille, large print or
• feeling sick (nausea) and being sick (vomiting) audio please call, free of charge:
• abdominal pain or diarrhoea
0800 198 5000 (UK Only)
• chest infection
Please be ready to give the following
• anaemia
information:
• problems with passing water or having a
Product name: Oncotice
large amount of blood in your urine
Reference Number: PL 05003/0046
• shivering with a high temperature (fever).
This is a service provided by the Royal
Uncommon
National Institute for Blind People
(affects less than 1 in 100 people)
• skin rash
• jaundice (yellow colour of your skin or eyes) PIL.ONC.13.UK.4019-3 vials+ UV52
• pus in your urine
• difficulty passing water
• low blood count (shown in blood tests)
Rare
(affects less than 1 in every 1,000 people)
• inflammation of the genitals or prostate.

o

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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