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E-Z-HD 98 % W/W POWDER FOR ORAL SUSPENSION

Active substance(s): BARIUM SULFATE

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E-Z-HD PIL (UK) (Safety Variation) 07-16 CL80303 TX1640-3_Layout 7/18/16 2:48 PM Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

E-Z-HD

Warnings and precautions
Talk to your doctor, radiographer or nurse before using E-Z-HD if you:

®

98 % w/w powder for
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 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 E-Z-HD is and what it is used for
2. What you need to know before you use E-Z-HD
3. How to use E-Z-HD
4. Possible side effects
5. How to store E-Z-HD
6. Contents of the pack and other information

• 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-HD
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.
E-Z-HD 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-HD is and what it is used for
E-Z-HD 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.
E-Z-HD 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.

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-HD.
Driving and using machines
E-Z-HD may cause you to feel dizzy. If this happens to you, do
not drive or use machinery until this effect has worn off.

2. What you need to know before you use E-Z-HD
Do not have E-Z-HD if you:
• are allergic to barium sulfate or any of the other ingredients
of E-Z-HD (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.

E-Z-HD contains sorbitol
E-Z-HD 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-HD contains sodium
It also contains approximately 310 mg sodium per 340 g dose.
Please tell your doctor, radiographer or nurse if you are on a low
sodium (salt) diet.
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-HD. You should talk to your doctor again.

Rev. 07/16

TX1640-3

E-Z-HD®
98 % w/w powder for 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-HD must be administered orally. The powder must be
reconstituted prior to administration (see section ‘Special
precautions for disposal and other handling’ below).
The administered dose of E-Z-HD will depend on the patient in
question and the section of the gastrointestinal tract to be viewed.

Method of administration
Adults: The contents of one prefilled bottle (340 g) are dispersed
in 65 mL of water to produce a 250 % w/v suspension which is
swallowed by the patient after a suitable gas producing agent has
been administered.
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.
Elderly: There are no special dosage recommendations. The
dosage should be determined, from experience, by the
radiologist.

E-Z-HD PIL (UK) (Safety Variation) 07-16 CL80303 TX1640-3_Layout 7/18/16 2:48 PM Page 2

Respiratory problems:
When E-Z-HD 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.

3. How to use E-Z-HD
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-HD 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-HD.
After your examination, you may be given a drink, laxative or put
on a saline drip.

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

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

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.

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

These are the signs of a severe and sometimes life threatening
allergic reaction, such as shock.
5. How to store E-Z-HD
The following side effects can also develop when you are given
this type of medicine:

E-Z-HD should be kept out of the sight and reach of children and
stored below 25°C.

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

Do not use E-Z-HD 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.

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-HD may aggravate your condition.

6. Contents of the pack and other information
What E-Z-HD contains
• The active ingredient is barium sulfate 98 % w/w.
• The other ingredients are sorbitol (E420), acacia gum (E414),
sodium citrate (E331), simeticone, citric acid anhydrous
(E330), polysorbate 80 (E433), carrageenan (E407), ethyl
maltol (E637), saccharin sodium (E954), strawberry flavour
and cherry flavour.
What E-Z-HD looks like and contents of the pack
E-Z-HD is a white powder for oral suspension. It is supplied in
bottles containing 340g E-Z-HD.
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

Heart problems:
• changes in heart rhythm.

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.
CL80303

E-Z-HD®
98 % w/w powder for oral suspension
barium sulfate

Special precautions for disposal and other handling

Special precautions for storage

Reconstitution information for use of E-Z-HD is provided below.

This medicinal product should be stored below 25°C.

1.
2.
3.
4.

Any unused, opened product or waste material should be
disposed of in accordance with local requirements.

Add 65 mL of water to bottle.
Secure lid and invert bottle, tapping base to loosen powder.
Shake well for 10-20 secs. Leave until required.
Immediately before giving to patient to drink shake again for
10-20 secs.

This pack is for single-dose use only. E-Z-HD should be
administered immediately following reconstitution and must not
be stored.

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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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