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Polibar PIL (UK) (Safety Variation) 07-16 CL88D03 TX1628-2SV_Layout 7/18/1 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 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

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

Warnings and precautions

Talk to your doctor, radiographer or nurse before using 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.

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.

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.

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.

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.

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

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

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.

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).

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

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.

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.

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.

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.

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.

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 1 0-20 seconds. When ready to use shake again, 1 0-20 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)

567 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.

A
bracco BRACCO LABELING FILE
SIZE! 16.5"(H)x8.5"(W)	BARCODE: (Code 128) TX1628-2SV
country: uk
COLOR LEGEND
Black |	Pantone 285 ■
(graph gradations: 25% - 0%)