E-Z-Paque

This medicinal product is for diagnostic use only.

E-Z-Paque is indicated for use as a positive contrast medium for radiographic visualisation of the gastro-intestinal tract.

E-Z-Paque is indicated in adults and children.

Posology

E-Z-Paque is primarily intended for use in the upper gastro-intestinal tract.

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.

Method of administration

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Immune System Disorders

Hypersensitivity to barium sulfate or to any of the excipients listed in section 6.1.

Gastrointestinal Disorders

Patients with any of the following:

- a known or suspected perforation of the gastrointestinal tract

- known or suspected trachea-esphageal fistula (oral administration)

- gastrointestinal haemorrhage

- gastrointestinal ischemia

- megacolon or toxic megacolon

- necrotising entercolitis

- severe ileus

should not receive E-Z-Paque.

E-Z-Paque should not be used for infants with swallowing disorders.

Surgical and Medical Procedures

Barium sulfate should not be administered immediately after gastrointestinal surgery, including snare polypectomy or 'hot' colonic biopsy because of the potential for post-surgical or post-procedural leakage or the potential for gastrointestinal perforation. In case the patient has to undergo gastrointestinal surgery immediately after barium sulfate administration, caution should be exercised.

Injury, Poisoning and Procedural Complications

Barium Sulphate products should not be used during and up to four weeks after radiotherapy to the rectum or prostate. Do not use if there are new injuries or chemical burns of the gastrointestinal tract.

The product should be administered under the supervision of a physician.

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed.

Barium Sulphate should not be administered in its dry form. The powder must be reconstituted, and some of the commercially prepared suspensions require further dilution, prior to administration.

Hypersensitivity

A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention.

As stated in section 4.8, serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities. Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used. Rapid recognition, assessment, and diagnosis are crucial to the effective implementation of treatment. Imaging facilities should be staffed with well-trained personnel for the diagnosis and treatment of hypersensitivity reactions.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.

Perforation

In patients with a serious stenosis at any level of the gastro-intestinal tract, especially if it is distal to the stomach, and in the presence of conditions and ailments that increase the risk of perforation such as known gastrointestinal fistulae and carcinomas, inflammatory intestinal disease, diverticulitis and diverticulosis and amoebiasis, careful consideration of the risks and benefits of the administration of a barium sulfate suspension is required.

Aspiration

For patients who are prone to aspiration (the newborn, elderly and stroke patients), it is recommended that the procedure starts with a small ingested volume.

Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause respiratory tract inflammation and pneumonia.

Ingestion of barium is not recommended in patients with a history of food aspiration. If barium procedures are required in these patients or in patients in whom integrity of the swallowing mechanism may be compromised, proceed with caution. If this product is aspirated into the larynx, further administration should be immediately discontinued.

Obstruction/Fluid Overload

Barium Sulphate suspensions, after oral administration, have been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis.

Barium sulfate suspensions have been reported to cause fluid overload due to water absorption.

Children and patients with impaired renal function are the most susceptible to water intoxication.

Constipation or Diarrhoea

E-Z-Paque should be used with care if the patient is dehydrated, suffers from any condition or is on any other treatment that can cause constipation, or if the patient has history of constipation. In this situation a mild bulk laxative should be administered following completion of the X-ray examination. Increased intake of liquids is recommended after oral administration of barium sulfate to prevent severe constipation and the risk of impaction.

Conversely, since E-Z-Paque contains sorbitol, administration may have a mild laxative effect. The caloriic value of sorbitol is 2.6 kcal/g.

Other Possible Complications

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually unpredictable and are best treated by having the patient lie flat for an additional 10 - 30 minutes under observation.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract.

Baroliths

Baroliths consist of inspissated barium associated with faeces. They are often asymptomatic, but may be associated with abdominal pain, appendicitis, bowel obstruction, or perforation. Patients who are elderly, with impaired gastrointestinal motility, colon obstruction, electrolyte imbalance, dehydration or on a low residue diet may be at risk of developing baroliths. To reduce this risk, adequate hydration should be maintained during and in the days following barium sulfate procedure. The use of laxatives (especially in case of constipation) should be considered.

E-Z-Paque contains 2.2 g of sorbitol per 100g powder

• The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

• The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

• Patients with hereditary fructose intolerance (HFI) must not be given this medicine.

• Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Propylene glycol

E-Z-Paque contains 44 mg propylene glycol per 100 g dose. Co-administration with any substrate for alcohol deshydrogenase such as ethanol may induce serious adverse effects in neonates.

Patients on a Controlled Sodium Diet

This medicinal product contains 133 mg sodium per 100 g dose, equivalent to 6.6% of the WHO recommended maximum daily intake for sodium of 2 g sodium for an adult.

E-Z-Paque contains sulfites

The flavours of this medicinal product contain traces of sulfites, which may rarely cause severe hypersensitivity reactions and bronchospasm.

Children, Elderly and Debilitated Patients

As with any barium sulfate preparation, care should be taken when administering E-Z-Paque to children, the elderly or the debilitated. It should be used cautiously in patients with pre-existing heart disease.

No interaction studies have been performed.

Barium sulfate is biologically inert and there are no known interactions with other medicinal products. However, the presence of barium sulfate formulations in the gastrointestinal tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimise any potential change in absorption, the separate administration of barium sulfate from that of other medicines should be considered.

Other examinations of the same area of the gastrointestinal tract with another contrast agent may be complicated by the presence of barium sulfate (residue) in the gastrointestinal tract up to several days following the examination with barium contrast media.

Pregnancy

Although this product is not contraindicated in pregnancy, we would like to point out that radiographic procedures may damage the foetus, particularly during the first trimester of pregnancy. Any examination should only be carried out after careful consideration of the benefit/risk of the procedure.

Fertility

Following oral or rectal administration, barium sulfate is absorbed systemically in negligible amounts. Though barium sulfate is pharmacologically inert, no studies of its mutagenic or teratogenic potential are available.

Breastfeeding

Since the absorption of barium sulfate is negligible, its use is not contraindicated during breastfeeding.

E-Z-Paque has negligible influence on the ability to drive and use machines.

Undesirable effects may occur during or after a procedure with barium sulfate.

Skin and subcutaneous disorders together with immune system disorders, reflecting allergic reactions either to barium sulfate or the product excipients, are among the most commonly reported effects; for example, urticaria, erythema and rash.

Gastrointestinal disorders are also one of the most frequently reported class of undesirable effects; for example, diarrhoea, nausea, abdominal pain/distention, constipation.

Within the table below, clinically significant adverse reactions are listed if they have been reported during post approval use of all barium sulfate formulations. Their frequency is not known, therefore relative reporting rate (for example, less commonly) compared to overall reporting for barium sulfate is used.

More rarely and depending on the route of administration, i.e. oral or rectal, the following procedural complications have been reported:

Infections (e.g. peritonitis) subsequent to existing or new gastrointestinal perforation. Complications include adhesions and granuloma.

Subsequent to existing or procedural gastrointestinal trauma, intravasation of barium sulfate with rare subsequent venous emboli formation, including the hepatic portal vein, vena cava and pulmonary embolism that may be fatal in approx 50% of cases.

Following oral administration, aspiration, with pulmonary complications, may occur and may be fatal in rare cases.

Please see section 4.4 for measures to be taken to avoid these adverse reactions, and actions to take if such adverse reactions occur.

Very rare cases of death associated with barium sulfate administration have been reported in the literature. The majority of the deaths relate to procedural complications usually caused by failure to follow generally accepted radiological practice. Some cases had a history indicating that barium sulfate administration was highly unlikely to be a primary or even secondary causative factor in patient fatality.

Paediatric patients

The type of adverse reactions is similar in children and adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

Barium sulfate is non-toxic and absorbed systemically in negligible amounts.

Repeated use within a very short period of time has led to abdominal cramps, nausea, vomiting, diarrhoea, and constipation. These symptoms are transitory in nature and may be allowed to resolve without medical intervention or may be treated according to currently accepted standards of care.

Pharmacotherapeutic group: X-ray contrast media, barium sulfate with suspending agents, ATC code: V08BA01

The active constituent of E-Z-Paque, barium sulfate, is inert and has no pharmacological action. It serves only as a radiopaque substance to opacify the gastro-intestinal tract during X-ray examinations.

Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

There are no preclinical data of relevance to the prescriber which are additional to that already included elsewhere in the SPC.

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)

Vanilla flavour

Not applicable.

Three years.

E-Z-Paque should be administered immediately following reconstitution and must not be stored.

Store below 25 °C. Store in the original package.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

E-Z-Paque is presented as follows:

Unit dose bottle (containing 177g E-Z-Paque) composed of a high density polyethylene (HDPE) with a polypropylene screw lid having a liner of three-ply co-extruded liner (foamed polyolefin blend between two layers of solid polypropylene co-polymer) and an aluminium seal (polyethylene terephthalate (PET) film, polymer adhesive, PET tab, polyolefin foam, aluminium foil, PET layer and heat seal).

Adults: E-Z-Paque should be suspended over the density range 60 to 100 % w/v.

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.

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