E-z-cat 4.9 % w/v oral suspension – patient leaflet, side effects, dosage

1. What E-Z-CAT is and what it is used for

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.

2. What you need to know before you use E-Z-CAT

Do not use E-Z-CAT if you:

• are allergic to barium sulfate or any of the other ingredients of

  E-Z-CAT (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-CAT. You should talk to your doctor again.

Warnings and precautions

Talk to your doctor,

radiographer or nurse before

using 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.

Children

The same warnings and precautions apply for children as for adults.

Other medicines and E-Z-CAT

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-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

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-CAT.

Driving and using machines

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.

E-Z-CAT contains sorbitol, sodium, potassium and methyl parahydroxybenzoate

E-Z-CAT contains

• 16 g sorbitol in each 225 mL dose. 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.

• 8.4 mmol (194 mg) sodium (main component of cooking/table salt) per 225 mL dose This is equivalent to 9.7% of the recommended maximum daily dietary intake of sodium for an adult.
• 3 mmol (117 mg) potassium per 225 mL dose To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
• 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.

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-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’.

Method of Administration

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.

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.

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

Rev. 06/22

™

E-Z-CAT

4.9 % w/v oral suspension

Barium sulfate

3. How to use E-Z-CAT

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-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.

4. Possible side effects

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:

• 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-CAT may aggravate your condition.

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.

  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-CAT

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

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-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), carrageenan (E407), polysorbate 80 (E433), 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

Bracco UK Limited,

Magdalen Centre, The Oxford Science Park,

Oxford, OX4 4GA, UK

Manufacturer responsible for batch release

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 June 2022.

CL89909

1.2 % w/v barium sulfate suspension. Alternatively, E-Z-CAT may be mixed to yield a different density:-

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.

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

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

Store below 25°C.

Do not freeze.

™

BRACCO LABELING FILE

SIZE: BARCODE: (Code 128) CL89909

COUNTRY:

COLOR LEGEND

16.5” (H) x 8.5” (W)

GB