Patient leaflet - E-z-paque 96 % w/w powder for oral suspension
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.
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.
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CLE4204
E-Z-Paque 96 % w/w oral suspension
barium sulfate
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
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.
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.
Heart problems:
- changes in heart rhythm.Respiratory problems: When E-Z-Paque 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.
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 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.
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.
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.
CLE4204
Do not use if inner seal is broken or missing.
'Add water to approximately 2.5 cm above barium level. Secure lid, invert bottle and shake vigorously. Add more water to desired % w/v line on bottle. Replace lid and shake for 30 seconds. Important: Always re-shake just prior to administration to the patient.
Special precautions for storage
Store below 25 °C. Store in the original package.
Do not use if inner seal is broken or missing.
E-Z-Paque should be administered immediately following reconstitution and must not be stored.
Any unused, opened product or waste material should be disposed of in accordance with local requirements.
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BRACCO LABELING FILE
COUNTRY:
COLOR LEGEND
16.5” (H) x 8.5” (W)
UK
Brand name is 24 pt Optima Bold Generic is 14 pt Optima Bold Headings are 9 pt Optima Bold Copy text is 9/10.5 pt Optima Regular