E-Z-Cat 4.9 % W/V Oral Suspension
Odd
1. What E-Z-CAT is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER
E-Z-CAT ™
4.9 % w/v oral suspension barium sulfate
Read all of this leaflet carefully before you have this medicine.
• 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 examination which is usually called a CT or CAT scan.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, radiographer or nurse helping you with your examination.
In this leaflet:
1. What E-Z-CAT is and what it is used for
2. Before you have E-Z-CAT
3. How E-Z-CAT will be given to you
4. Possible side effects
5. How to store E-Z-CAT
6. Further information
E-Z-CAT belongs to a group of medicines called 'contrast media'. It is used when you have an examination called a CT or CAT scan where X-rays are used. It contains a chemical that helps the X-ray show up.
E-Z-CAT 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.
Talk to your doctor before you have E-Z-CAT 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.
If any of the above applies to you, talk to your doctor before you have E-Z-CAT.
Using other medicines
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-CAT 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
Tell the doctor or nurse if you know that you are pregnant or you are trying to become pregnant. 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-CAT.
Driving and using machines
2. Before you have E-Z-CAT
E-Z-CAT may cause you to feel dizzy. If this happens to you, do not drive or use machinery until this effect has worn off.
Do not have E-Z-CAT if you:
are allergic (hypersensitive) to barium sulfate or any of the other ingredients of E-Z-CAT (see section 6) know that you have a hole or blockage in your bowel or stomach (gastrointestinal perforation or obstruction) 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 severe constipation
suffer from a stomach condition called impaired gastric emptying
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.
Important information about some of the ingredients of E-Z-CAT
E-Z-CAT 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.
It also contains approximately 206 mg sodium per 225 mL dose. Please tell your doctor, radiographer or nurse if you are on a low sodium (salt) diet.
E-Z-CAT also contains approximately 50 mg potassium per 225 mL dose. Please tell your doctor, radiographer or nurse if you have kidney problems (reduced renal function) or are on a low potassium diet.
It also contains methyl parahydroxybenzoate (E218) that can cause allergic reactions, possibly delayed.
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-CAT. You should talk to your doctor again.
TX1216-6
Rev. 07/10 TX1216-6
The following information is intended for medical or healthcare professionals only:
It supplements the information provided in the package leaflet above.
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.
Posology and method of administration
E-Z-CAT is for oral administration.
The suspension is diluted with water to obtain a desired concentration. Recommended dilutions are shown below in section 'Special precautions for disposal and other handling'.
Adults and the Elderly: 350 - 450 mL of diluted suspension 30 minutes prior to the scan and the same volume 5 minutes prior to the scan, or, as directed by the physician.
Special precautions for disposal and other handling
Shake well before use. E-Z-CAT is intended for dilution prior to administration. Pour the contents into a litre container. Add water to give a total volume of 900 mL. Shake well to yield 900 mL of 1.2 % w/v barium sulfate suspension. Alternatively, E-Z-CAT may be mixed to yield a different density:-
3. How E-Z-CAT will be given to you
Odd
Adults, the elderly and children: Your doctor determines how much E-Z-CAT is used.
E-Z-CAT 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-CAT.
After your examination, you may be given a drink, laxative or put on a saline drip.
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. How to store E-Z-CAT
6. Further information
Like all medicines, E-Z-CAT 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:
• constipation
• blocked bowel (the blockage would have to be removed by a doctor)
• diarrhoea
• feeling sick or being sick
• stomach pain or 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-CAT may aggravate your condition.
E-Z-CAT should be kept out of the reach and sight of children.
Do not use E-Z-CAT 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.
Your doctor or nurse will make sure your medicine is correctly stored and disposed of.
What E-Z-CAT contains
• The active ingredient is barium sulfate 4.9 % w/v.
• The other ingredients are sorbitol, liquid (crystallising) (E420), pectin (E440), xanthan gum (E415), simeticone emulsion, sodium citrate (E331), citric acid (E330), potassium sorbate (E202), methyl parahydroxybenzoate (E218), liquid orange flavour, saccharin sodium (E954), sodium carrageenan (E407), polyoxyyethylene glyceryl mono-oleate, purified water.
What E-Z-CAT looks like and contents of the pack
E-Z-CAT is a white, milky, viscous oral suspension. It is supplied in bottles containing 225 mL E-Z-CAT.
Marketing Authorisation Holder and Manufacturer responsible for batch release in the EU
Bracco UK Limited,
Wooburn Green, Bucks, HP10 0HH, UK
If this leaflet is difficult to see or read, and you would like it in a different format, please contact Bracco UK Limited, Wooburn Green, Bucks, HP10 0HH, UK.
This leaflet was last approved in 07/2010.
Heart problems:
• changes in heart rhythm.
Respiratory problems:
When E-Z-CAT 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.
Pour E-Z-CAT contents into mixing container:- Add water to 700 mL. Yield a 1.6 % w/v suspension.
- Add water to 600 mL. Yield a 1.8 % w/v suspension.
- Add water to 500 mL. Yield a 2.2 % w/v suspension.
This pack is for single-dose use only. E-Z-CAT should be administered immediately following dilution and must not be stored.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Do not freeze.
Any unused, opened product or waste material should be disposed of in accordance with local requirements.
