E-Z-Paque 96 % W/W Powder For Oral/Rectal Suspension
E-Z-Paque PIL (UK) (Safety Variation) 07-16 CL81804 TX1339-6_Layout 7/18/1 Page 1
E-Z-Paque PIL (UK) (Safety Variation) 07-16 CL81804 TX1339-6_Layout 7/18/1 Page 1
1. What E-Z-Paque is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER
E-Z-Paque™
96 % w/w powder for oral/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 E-Z-Paque is and what it is used for
2. What you need to know before you useE-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
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 may be given to you as an enema (into your back passage) or as a drink. This depends on which part of your body is being examined.
This medicine is for diagnostic use only. It only helps to diagnose a problem. It cannot be used to treat any diseases.
Warnings and precautions
Talk to your doctor, radiographer or nurse before using E-Z-Paque 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 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
• have been fitted with an artificial heart valve.
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
2. What you need to know before you use E-Z-Paque
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.
Rev. 07/16
Do not have 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.
E-Z-Paque contains sorbitol
E-Z-Paque 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-Paque contains sodium
It also contains approximately 224 mg sodium per 1 00 g powder. 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.
TX1339-6
TX1339-6
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 primarily intended for use in the upper gastro-intestinal tract but may also be administered by enema. 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, the route of administration and the section of the gastrointestinal tract to be viewed.
Adults: Single contrast of the oesophagus, stomach and duodenum -give orally 1 75 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
4. Possible side effects
5. How to store E-Z-Paque
6. Contents of the pack and other information
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 either a drink or as an enema (into your back passage). This depends upon which part of your body is being examined.
If you are being given the medicine as an enema, 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 E-Z-Paque.
After your examination, you may be given a drink, laxative or put on a saline drip.
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
By reporting side effects you can help provide more information on the safety of this medicine.
E-Z-Paque should be kept out of the sight and reach of children.
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.
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), sodium carrageenan (E407), bentonite, tragacanth (E413), citric acid (E330), simeticone, strawberry flavour, xanthan gum (E415), polyoxyethylene glyceryl mono-oleate, 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/rectal suspension. It is supplied in either a plastic bottle, plastic jug or in a plastic bag placed in a plastic bucket. The bottle contains 1 77 g, the jug 1200 g and the bucket 10 kg of E-Z-Paque. 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.
CL81804
For pack size 177 g:
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.
For pack size 1200 g:
Add required amount of water, secure cap and invert jug, tapping base to loosen powder. Shake vigorously. Reshake just prior to use. Add 900 mL water to give 1200 mL suspension at 1 00 % w/v. Add 1400 mL water to give 1 700 mL suspension at 70 % w/v. Add water to neck of jug and shake, then top up with more water and shake again to give 2000 mL suspension at 60 % w/v. Important: Always re-shake just prior to administration to the patient.
For pack size 10 kg:
To one level scoop (275 g) add the following amounts of water:
- For 60 % w/v add 370 mL water. Approximate yield 440 mL suspension.
- For 70 % w/v add 305 mL water. Approximate yield 380 mL suspension.
- For 100 % w/v add 190 mL water. Approximate yield 265 mL suspension. On addition of water shake vigorously. Reshake just prior to use.
Special precautions for storage
Store below 25 °C. Store in the original package.
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.
