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POLIBAR 94 % W/W POWDER FOR RECTAL SUSPENSION

Active substance(s): BARIUM SULFATE

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Polibar PIL (UK) (Safety Variation) 07-16 CL88D03 TX1628-2SV_Layout 7/18/16 3:25 PM Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Polibar

Warnings and precautions
Talk to your doctor, radiographer or nurse before using Polibar if you:

®

94 % w/w powder
for rectal 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 X-ray examination.
• 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

• 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 (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 kidney problems
• suffer from constipation
• are dehydrated
• suffer from heart disease
• have been fitted with an artificial heart valve.
Children
The same warnings and precautions apply for children as for adults.
Other medicines and Polibar
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.

In this leaflet:
1. What Polibar is and what it is used for
2. What you need to know before you usePolibar
3. How to use Polibar
4. Possible side effects
5. How to store Polibar
6. Contents of the pack and other information

Polibar 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 Polibar is and what it is used for
Polibar belongs to a group of medicines called ‘contrast media’.
It is used when you have an X-ray of your digestive system. It
contains a chemical that helps the X-ray show up. This gives
a clearer ‘picture’ of your digestive system on the X-ray.
Polibar will be given to you as an enema (into your back
passage).
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 have Polibar
Do not have Polibar if you:
• are allergic to barium sulfate or any of the other ingredients
of Polibar (listed in section 6)
• know that you have a hole in your bowel (gastrointestinal
perforation)
• know that you have an abnormal passage connecting your
stomach with your bowel (gastrointestinal fistula)
• suffer from bleeding in your bowel
• 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
• 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, including chemical
burns.
If any of the above applies to you, you should not be given
Polibar. You should talk to your doctor again.

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 Polibar.
Driving and using machines
Polibar may cause you to feel dizzy. If this happens to you, do not
drive or use machinery until this effect has worn off.
Polibar contains sodium
678 mg of Sodium per 397g pack.
Polibar contains sorbitol
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.

3. How to use Polibar
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.
Polibar will be given to you as an enema (into your back
passage). You will need to get into the best position for this.
You may be asked to lie on your side with one knee bent to
your chest. A tube will be gently inserted into your back
passage (anus). The medicine will then flow into your bowel.
If you are dehydrated, prone to suffering from constipation or
elderly you may be offered a
laxative before you use
Polibar.
After your examination, you
may be given a drink, laxative
or put on a saline drip.
Rev. 07/16

TX1628-2SV

Polibar ®
94 % w/w powder for rectal 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

The actual administered dose should be determined, from
experience, by the radiologist.
Children: The dosage will be dependent on the size, age, health
state and anatomic region to be imaged of the child. Individual
requirements should be determined, from experience, by the
radiologist.

Polibar is for rectal (enema) administration.
The administered dose of Polibar will depend on the patient in
question and the section of the gastrointestinal tract to be viewed.

Elderly: There are no special dosage recommendations.
The dosage should be determined, from experience, by
the radiologist.

Adults: Usual Dosage Range 150 - 750 g barium sulfate in a
suitable suspension.
Double contrast of the large bowel - Give as required between
60 -115 % w/v.
Single contrast of the large bowel - Give as required between
20- 40 % w/v.

Special precautions for disposal and other handling
Adults: Polibar should be suspended over the density range of
20 - 115 % w/v (20 - 60 % w/w).

Polibar PIL (UK) (Safety Variation) 07-16 CL88D03 TX1628-2SV_Layout 7/18/16 3:25 PM Page 2

4. Possible side effects

5. How to store Polibar

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

Polibar should be kept out of the sight and reach of children.
Do not use Polibar 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.

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.

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.

These are the signs of a severe and sometimes life threatening
allergic reaction, such as shock.
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.
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), Polibar may aggravate your condition.

6. Contents of the pack and other information
What Polibar contains
• The active ingredient is barium sulfate 94 % w/w.
• The other ingredients are gum ghatti, sorbitol (E420),
sodium citrate (E331), sodium carrageenan (E407),
simeticone, polyoxyethylene glyceryl mono-oleate,
citric acid anhydrous (E330).
What Polibar looks like and contents of the pack
Polibar is a white powder for rectal suspension. It is supplied in
enema bags containing 397 g, 567 g or 680 g Polibar. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
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 06/2016.
CL88D03

Heart problems:
• changes in heart rhythm.
Respiratory problems:
• difficulty breathing
• cough and sore throat.
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.
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
By reporting side effects you can help provide more information
on the safety of this medicine.

Polibar ®
94 % w/w powder for rectal suspension
barium sulfate
Reconstitution information for use of Polibar is provided below.
Attach clamp to tubing and close. Study the appropriate graph
below. This shows the density range and how much water to use
for each density. Measure the indicated quantity of warm (40 °C)
water and add this to the bag through the red snap-cap seal.
Hold the bag by the finger holes and shake vigorously for 10-20
seconds. When ready to use shake again, 10-20 seconds. Then
with the thumb and forefinger pop the red ball at the bag tube
junction into the bag. Run barium through the tubing - attach
rectal tube. The kit is now ready.
Water to be added (mL)
397 g enema bag

567 g enema bag

680 g enema bag

This pack is for single-dose use only. Polibar should be
administered immediately following reconstitution and must
not be stored.
Special precautions for storage
Store below 25 °C. Store in the original package.
Any unused, opened product or waste material should be
disposed of in accordance with local requirements.

Polibar PIL (UK) (Safety Variation) 07-16 CL88D03 TX1628-2SV_Layout 7/18/16 3:25 PM Page 3

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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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