E-Z-PAQUE 96 % W/W POWDER FOR ORAL SUSPENSION - patient leaflet, side effects, dosage

Patient leaflet - E-Z-PAQUE 96 % W/W POWDER FOR ORAL SUSPENSION

E-Z-Paque™

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

1. what e-z-paque is and what it is used for

E-Z-Paque 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-Paque 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-paque

Do not use E-Z-Paque if you:

are allergic to barium sulfate or any of the other ingredients of E-Z-Paque (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.

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

Warnings and precautions

Talk to your doctor, radiographer or nurse before using

E-Z-Paque if you:

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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’
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-Paque

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-Paque 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.

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-Paque.

Driving and using machines

E-Z-Paque 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-Paque contains sorbitol

This medicine contains 2.2 g of sorbitol per 100 g powder. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

E-Z-Paque contains propylene glycol

This medicine contains 44 mg of propylene glycol per 100 g powder. If your child is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the child is given other medicines that contain propylene glycol or alcohol.

E-Z-Paque contains sodium

This medicinal product also contains approximately 133 mg sodium (main component of cooking/table salt) in each 100 g dose. This is equivalent to 6.6% of the recommended maximum daily dietary intake of sodium for an adult.

E-Z-Paque may contain sulfites

The flavours of this medicinal product may contain traces of sulfites, which may cause severe hypersensitivity reactions and bronchospasm.

Ask your doctor if one of the above warnings is applicable to you, or has been in the past.

Rev. 06/21

E-Z-Paque ™

96 % w/w 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

E-Z-Paque is intended for use in the upper gastrointestinal tract.

The powder must be reconstituted prior to administration (see section ‘Special precautions for disposal and other handling’ below).

The administered dose of E-Z-Paque will depend on the patient in question and the section of the gastrointestinal tract to be viewed.

Adults: Single contrast of the oesophagus, stomach and duodenum -give orally 175 to 300 mL of suspension at 100 % w/v.

Small bowel – give orally 250 to 300 mL of suspension at 60 % 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: E-Z-Paque should be suspended over the density range 60 to 100 % w/v.

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

3. how to use e-z-paque

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-Paque 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-Paque.

After your examination, you may be given a drink, laxative or put on a saline drip.

4. possible side effects

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

Like all medicines, E-Z-Paque 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.

5. how to store e-z-paque

E-Z-Paque should be kept out of the sight and reach of children.

Store below 25°C in the original package.

Do not use E-Z-Paque 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.

6. contents of the pack and other information

What E-Z-Paque contains

The active ingredient is barium sulfate 96 % w/w.
The other ingredients are sorbitol (E420), sodium citrate (E331), pectin (E440), carrageenan (E407), tragacanth (E413), citric acid anhydrous (E330), simeticone, strawberry flavour, xanthan gum (E415), polysorbate 80 (E433), propylene glycol, saccharin sodium (E954) and vanilla flavour.

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-Paque may aggravate your condition.

What E-Z-Paque looks like and contents of the pack

E-Z-Paque is a white powder for oral suspension with a vanilla and strawberry odour. It is supplied in a plastic bottle which contains 177 g.

Marketing Authorisation Holder and Manufacturer

Bracco UK Limited,

Magdalen Centre, The Oxford Science Park,

Oxford, OX4 4GA, UK

If this leaflet is difficult to see or read, and you would like it in a different format, please contact Bracco UK Limited, Magdalen Centre, The Oxford Science Park, Oxford, OX4 4GA, UK.

This leaflet was last revised in 10/2021.