Document: leaflet MAH BRAND_PL 12032-0019 change

• leaflet MAH BRAND_PL 12032-0019
• leaflet MAH BRAND_PL 18920-0013

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E-Z-HD PIL (UK) (Safety Variation) 07-16 CL80303 TX1640-3_Layout 7/18/16 2 :48(|M Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

E-Z-HD®

98 % w/w powder for oral 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-HD is and what it is used for

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

3.    How to use E-Z-HD

4.    Possible side effects

5.    How to store E-Z-HD

6.    Contents of the pack and other information

E-Z-HD 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-HD 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.

Warnings and precautions

Talk to your doctor, radiographer or nurse before using E-Z-HD 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-HD

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-HD 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-HD.

Driving and using machines

E-Z-HD 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-HD if you:

•    are allergic to barium sulfate or any of the other ingredients of E-Z-HD (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-HD. You should talk to your doctor again.

E-Z-HD contains sorbitol

E-Z-HD 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-HD contains sodium

It also contains approximately 31 0 mg sodium per 340 g dose. 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.

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TX16MD-3

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-HD must be administered orally. The powder must be reconstituted prior to administration (see section 'Special precautions for disposal and other handling' below).

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

Method of administration

Adults: The contents of one prefilled bottle (340 g) are dispersed in 65 mL of water to produce a 250 % w/v suspension which is swallowed by the patient after a suitable gas producing agent has been administered.

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.

Elderly: There are no special dosage recommendations. The dosage should be determined, from experience, by the radiologist.

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-HD 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-HD.

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

Like all medicines, E-Z-HD 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-HD may aggravate your condition.

Respiratory problems:

When E-Z-HD 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.u k/ye l lowca rd

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

E-Z-HD should be kept out of the sight and reach of children and stored below 25°C.

Do not use E-Z-HD 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-HD contains

•    The active ingredient is barium sulfate 98 % w/w.

•    The other ingredients are sorbitol (E420), acacia gum (E414), sodium citrate (E331), simeticone, citric acid anhydrous (E330), polysorbate 80 (E433), carrageenan (E407), ethyl maltol (E637), saccharin sodium (E954), strawberry flavour and cherry flavour.

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

E-Z-HD is a white powder for oral suspension. It is supplied in bottles containing 340g E-Z-HD.

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.

CL80303

This pack is for single-dose use only. E-Z-HD should be administered immediately following reconstitution and must not be stored.