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E-Z-CAT 4.9 % W/V ORAL SUSPENSION

Active substance(s): BARIUM SULFATE / BARIUM SULFATE / BARIUM SULFATE

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E-Z-CAT PIL (UK) 12-16 CL89905 TX1216-9_Layout 12/14/16 3:08 PM Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

E-Z-CAT



4.9 % w/v oral suspension
barium sulfate

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,
radiographer or nurse helping you with your examination
which is usually called a CT or CAT scan.
• 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, radiographer
or nurse. This includes any possible side effects not listed in
this leaflet. See section 4
In this leaflet:
1. What E-Z-CAT is and what it is used for
2. What you need to know before you use E-Z-CAT
3. How to use E-Z-CAT
4. Possible side effects
5. How to store E-Z-CAT
6. Contents of the pack and other information

Warnings and precautions
Talk to your doctor, radiographer or nurse before using E-Z-CAT
if you:
• or members of your family suffer from allergies, hay fever,
eczema or asthma
• are elderly
• are feeling weak (debilitated)
• are a baby or small child
• suffer from narrowing of the bowel or stomach (stenosis)
• suffer from a condition known as ‘gastrointestinal fistulae’
• suffer from cancer of any part of the bowel
• suffer from inflammatory intestinal disease
• suffer from a condition known as ‘diverticulitis’ or
‘diverticulosis’
• suffer from an infection known as ‘amoebiasis’
• suffer from a condition called Hirschsprung’s Disease
• have ever suffered from aspiration (where you might breathe
in food or liquid into your lungs)
• find swallowing difficult
• have ever suffered from a stroke
• have kidney problems
• suffer from constipation
• are dehydrated
• suffer from heart disease.
Children
The same warnings and precautions apply for children as for
adults.
Other medicines and E-Z-CAT
Please tell your doctor, radiographer or nurse helping you with
your X-ray examination if you are taking or have recently taken
any other medicines
E-Z-CAT may interfere with the action of other medicines taken
at the same time. Your doctor may separate the administration
of barium sulfate from that of your other medicines or other
digestive tract examinations.

1. What E-Z-CAT is and what it is used for
E-Z-CAT belongs to a group of medicines called ‘contrast media’.
It is used when you have an examination called a CT or CAT
scan where X-rays are used. It contains a chemical that helps
the X-ray show up.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. X-rays can harm unborn
babies so you will only be given an X-ray if it is essential for you.
You can continue to breast feed if you take E-Z-CAT.

E-Z-CAT will be given to you as a drink.
This medicine is for diagnostic use only. It only helps to diagnose
a problem. It cannot be used to treat any diseases.

2. What you need to know before you use E-Z-CAT
Do not use E-Z-CAT if you:
• are allergic to barium sulfate or any of the other ingredients of
E-Z-CAT (listed in section 6)
• know that you have a hole in your bowel or stomach
(gastrointestinal perforation)
• know that you have an abnormal passage connecting your
stomach with your bowel (gastrointestinal fistula)
• suffer from bleeding in your bowel or stomach
• suffer from insufficient blood supply (ischaemia) of the bowel
wall
• have an enlarged bowel - a condition called megacolon or
toxic megacolon
• have an inflamed condition of the bowel called necrotising
enterocolitis
• suffer from poor movement of your bowel - a condition called
severe ileus
• are a baby and have problems swallowing
• have recently had bowel surgery, such as a procedure called
‘hot’ colonic biopsy or snare polypectomy
• have had radiotherapy (cancer treatment) to your large bowel
(rectum) or prostate gland within the last 4 weeks
• have suffered recent injury to your bowel or stomach,
including chemical burns.

Driving and using machines
E-Z-CAT may cause you to feel dizzy. If this happens to you, do
not drive or use machinery until this effect has worn off.
E-Z-CAT contains sorbitol
E-Z-CAT contains sorbitol which may have a mild laxative effect.
The calorific value of sorbitol is 2.6 kcal/g. If you have been told
by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
E-Z-CAT contains sodium
It also contains approximately 196 mg sodium per 225 mL dose.
To be taken into consideration by patients on a controlled
sodium diet.
E-Z-CAT contains potassium
E-Z-CAT also contains approximately 57 mg potassium per
225 mL dose. To be taken into consideration by patients with
reduced kidney function or patients on a controlled
potassium diet.
E-Z-CAT contains methyl parahydroxybenzoate
It also contains methyl parahydroxybenzoate (E218) that can
cause allergic reactions, possibly delayed.
Ask your doctor if one of the above warnings is applicable to
you, or has been in the past.

If any of the above applies to you, you should not be given
E-Z-CAT. You should talk to your doctor again.

Rev. 12/16

TX1216-9

E-Z-CAT ™

4.9 % w/v oral suspension
barium sulfate
The following information is intended for medical or healthcare
professionals only:
It supplements the information provided in the package
leaflet above.
Posology and method of administration
Posology
E-Z-CAT is for oral administration.
The suspension is diluted with water to obtain a desired
concentration. Recommended dilutions are shown below in
section ‘Special precautions for disposal and other handling’.

Method of Administration
Adults and the Elderly: 350 - 450 mL of diluted suspension
30 minutes prior to the scan and the same volume 5 minutes
prior to the scan, or, as directed by the physician.
Children: The dosage will be dependent on the size, age, health
state and anatomical region to be imaged of the child. Individual
requirements should be determined, from experience, by the
radiologist.
Special precautions for disposal and other handling
Shake well before use. E-Z-CAT is intended for dilution prior to
administration. Pour the contents into a litre container. Add water
to give a total volume of 900 mL. Shake well to yield 900 mL of

E-Z-CAT PIL (UK) 12-16 CL89905 TX1216-9_Layout 12/14/16 3:08 PM Page 2

Other possible side effects:
• high blood sugar (hyperglycaemia) in diabetics
• agitation, confusion or nervousness whilst the product is
being administered
• feeling dizzy
• swollen eyes
• tinnitus (ringing in the ears)
• low blood pressure
• problems passing urine
• feeling unwell, pain including headache, fever
• swelling, weakness, muscle or speech problems.

3. How to use E-Z-CAT
Always use this medicine exactly as your doctor has told you.
Check with your doctor if you are not sure.
The recommended dose is determined by your doctor.
E-Z-CAT will be given to you as a drink.
If you are dehydrated, prone to suffering from constipation or
elderly you may be offered a laxative before you use E-Z-CAT.
After your examination, you may be given a drink, laxative or put
on a saline drip.

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 - Website:
www.mhra.gov.uk/yellowcard

4. Possible side effects
Like all medicines, E-Z-CAT can cause side effects, although not
everybody gets them.

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

5. How to store E-Z-CAT

Seek immediate medical help if you have any of the following
symptoms:
• feeling faint or loss of consciousness
• swelling of the face or throat
• difficulty in breathing or wheezing, shortness of breath.

E-Z-CAT should be kept out of the sight and reach of children.
Do not use E-Z-CAT after the expiry date which is stated on the
packaging behind the word ‘EXP’. The expiry date refers to the
last day of that month.

These are the signs of a severe and sometimes life threatening
allergic reaction, such as shock.

Do not throw away any medicines via wastewater. Ask your
doctor or nurse how to throw away medicines you no longer use.
These measures will help protect the environment.

The following side effects can also develop when you are given
this type of medicine:
Skin problems:
• itching
• redness
• rash
• sweating
• pale, clammy skin
• skin turning a blue or purple colour due to poor circulation.

6. Contents of the pack and other information
What E-Z-CAT contains

Stomach/bowel problems:
• inflammation and injury of the small intestine
• constipation
• blocked bowel (the blockage would have to be removed by a
doctor)
• diarrhoea
• feeling sick or being sick
• a bloated stomach
• excess wind (flatulence)
• bowel inflammation, ulceration or perforation (a hole)
• swollen tongue
• a damaged bowel wall lining which may lead to bacteria in
the blood, an abscess or appendicitis. You may be given
antibiotics to prevent this.
• in rare cases an enema may damage the lining of the bowel
wall. When this happens, it may result in an infection of the
bowel or its lining (peritonitis), or a type of swelling called
‘granuloma’
• small amounts of barium sulfate may leak into the blood
supply and end up in other parts of the body such as blood
vessels or arteries. This occurs rarely, but the result can be
very serious and may cause death.
• if you suffer from ulcerative colitis (inflammation of the
bowel), E-Z-CAT may aggravate your condition.
Heart problems:
• changes in heart rhythm.

• The active ingredient is barium sulfate 4.9 % w/v.
• The other ingredients are sorbitol, liquid (crystallising) (E420),
pectin (E440), xanthan gum (E415), simeticone emulsion,
sodium citrate (E331), citric acid (E330), potassium sorbate
(E202), methyl parahydroxybenzoate (E218), liquid orange
flavour, saccharin sodium (E954), carrageenan (E407),
polysorbate 80 (E433), purified water.
What E-Z-CAT looks like and contents of the pack
E-Z-CAT is a white, milky, viscous oral suspension. It is supplied
in bottles containing 225 mL E-Z-CAT.
Marketing Authorisation Holder and Manufacturer
Bracco Imaging spa
Via Egidio Folli 50, 20134 Milano, Italy
Manufacturer responsible for batch release
Bracco UK Limited,
Valley Business Centre Gordon Road - High Wycombe –
Buckinghamshire HP13 6EQ, UK

If this leaflet is difficult to see or read, and you
would like it in a different format, please
contact Bracco UK Limited, Valley Business
Centre Gordon Road - High Wycombe –
Buckinghamshire HP13 6EQ, UK.
This leaflet was last approved in 12/2016.
CL89905

Respiratory problems:
When E-Z-CAT is taken as a drink, there is a small risk that you
could breathe it in. This may lead to:
• difficulty breathing
• cough and sore throat
• pneumonia which can result in death. This is very rare.

E-Z-CAT ™

4.9 % w/v oral suspension
Barium sulfate
1.2 % w/v barium sulfate suspension. Alternatively, E-Z-CAT may
be mixed to yield a different density:-

Special precautions for storage
Store below 25°C.

Pour E-Z-CAT contents into mixing container:Do not freeze.
-

Add water to 700 mL. Yield a 1.6 % w/v suspension.

-

Add water to 600 mL. Yield a 1.8 % w/v suspension.

-

Add water to 500 mL. Yield a 2.2 % w/v suspension.

Any unused, opened product or waste material should be
disposed of in accordance with local requirements.
This pack is for single-dose use only. E-Z-CAT should be
administered immediately following dilution and must not be
stored.

Expand Transcript

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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