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POLIBAR 94 % W/W POWDER FOR RECTAL SUSPENSION

Active substance(s): BARIUM SULFATE

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Polibar PIL (UK) (CIMBAR) TX1628-2 CL88D01 02-16 _Layout 2/10/16 4:25 PM Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Polibar

®

94 % w/w powder
for rectal suspension
barium sulfate
Read all of this leaflet carefully before you have this medicine.
• 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.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, radiographer
or nurse helping you with your X-ray examination.
In this leaflet:
1. What Polibar is and what it is used for
2. Before you have Polibar
3. How Polibar will be given to you
4. Possible side effects
5. How to store Polibar
6. Further information

Talk to your doctor before you have Polibar 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 (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.
If any of the above applies to you, talk to your doctor before you
have Polibar.
Using other medicines
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, including medicines obtained without a
prescription. 
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.

Pregnancy and breast-feeding
Tell the doctor or nurse if you know that you are pregnant or you
are trying to become pregnant. X-rays can harm unborn babies so
you will only be given an X-ray if it is essential for you.

Polibar will be given to you as an enema (into your back passage).

You can continue to breast feed if you take Polibar.

This medicine is for diagnostic use only. It only helps to diagnose
a problem. It cannot be used to treat any diseases.

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.

2. Before you have Polibar
Do not have Polibar if you:
• are allergic (hypersensitive) to barium sulfate or any of the
other ingredients of Polibar (see section 6)
• know that you have a hole or blockage in your bowel
(gastrointestinal perforation or obstruction)
• 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
colonic 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.

3. How Polibar will be given to you
Adults, the elderly and children: Your doctor determines how
much Polibar is used.
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.

If any of the above applies to you, you should not be given
Polibar. You should talk to your doctor again.

Rev. 02/16

TX1628-2

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
Polibar is for rectal (enema) administration. The powder must be
reconstituted prior to administration (see section ‘Special
precautions for disposal and other handling’ below).
The administered dose of Polibar will depend on the patient in
question and the section of the gastrointestinal tract to be viewed.
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.
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.
Elderly: There are no special dosage recommendations. The
dosage should be determined, from experience, by the radiologist.
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).
Reconstitution information for use of Polibar is provided below.

Polibar PIL (UK) (CIMBAR) TX1628-2 CL88D01 02-16 _Layout 2/10/16 4:25 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 reach and sight 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.

Your doctor or nurse will make sure your medicine is correctly
stored and disposed of.

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

6. Further information

The following side effects can also develop when you are given
this type of medicine:

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, and citric acid
anhydrous (E330).

Skin problems:
• itching
• redness
• rash
• sweating
• pale, clammy skin
• skin turning a blue or purple colour due to poor circulation.

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.

Stomach/bowel problems:
• constipation
• blocked bowel (the blockage would have to be removed by
a doctor)
• diarrhoea
• feeling sick or being sick
• stomach pain or 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.

Marketing Authorisation Holder
Bracco Imaging spa,
Via Egidio Folli 50, 20134 Milano, Italy
Manufacturer responsible for batch release
Bracco UK Limited,
Wooburn Green, Bucks, HP10 0HH, UK

If this leaflet is difficult to see or read, and you
would like it in a different format, please
contact Bracco UK Limited, Wooburn Green,
Bucks, HP10 0HH, UK.
This leaflet was last approved in May 2016.
CL88D01

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.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

Polibar ®
94 % w/w powder for rectal suspension
barium sulfate
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 oC)
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.

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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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