Prontobario HD: detailed information

Package leaflet: Information for the patient

PRONTOBARIO HD

98.45 g oral suspension powder
Barium sulfate
Read this leaflet carefully before taking/giving this medicine to your child
because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor.
If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

What PRONTOBARIO HD is and what it is used for
What you need to know before being administered PRONTOBARIO HD
How PRONTOBARIO HD will be administered
Possible side effects
How to store PRONTOBARIO HD
Contents of the pack and other information

1. What PRONTOBARIO HD is and what it is used for

PRONTOBARIO HD is a diagnostic contrast agent. The active substance of PRONTOBARIO HD is barium sulfate.
PRONTOBARIO HD is useful for visualizing the esophagus (the tube connecting the mouth to the stomach), the stomach, and part of the intestine (duodenum) in patients of all ages.

2. What you should know before being administered PRONTOBARIO HD

You will NOT be administered PRONTOBARIO HD
If you/the child:

are allergic to barium sulfate or to any of the other ingredients of this medicine (listed in section 6);
have or are suspected to have an abnormal passage (fistula) or perforation anywhere in the gastrointestinal tract;
have gastrointestinal bleeding (gastrointestinal hemorrhage);
suffer from reduced blood flow to the intestine (gastrointestinal ischemia);
have abnormal distension of the colon (megacolon or toxic megacolon);
suffer from a bowel disease characterized by intestinal tissue death (necrotizing enterocolitis);
suffer from intestinal obstruction preventing the passage of intestinal contents (ileus);
have recently undergone surgery on the gastrointestinal tract;
have undergone radiotherapy to the rectum or prostate within the last 4 weeks;
have new lesions or chemical burns of the gastrointestinal tract;
suffer from swallowing disorders.

Warnings and precautions
Inform your doctor if you/the child:

suffer from asthma;
have a tendency towards allergies (atopy), as shown by hay fever and eczema, a family history of allergies, or previous reactions to contrast agents;
suffer from severe narrowing (stenosis) of the gastrointestinal tract;
suffer from tumor, gastrointestinal fistula, inflammatory bowel disease, inflammation of small intestinal pouches (diverticulitis or diverticulosis), or parasitic infestation (amebiasis);
have a history of food aspiration and have difficulty swallowing;
have had a stroke;
are elderly;
have cystic fibrosis;
are suspected of having Hirschsprung’s disease;
suffer from constipation or reduced intestinal motility;
suffer from imbalances in blood substances (electrolytes) or are dehydrated;
are following a low-fiber diet or one containing poorly digestible foods (low-residue diet);
are following a diet low in potassium or sodium;
suffer from heart disease;
suffer from an intolerance to a sugar contained in PRONTOBARIO HD (sorbitol - fructose);

Other medicines and PRONTOBARIO HD
Inform your doctor if you/the child are taking, have recently taken, or might take any other medicines, as barium sulfate may alter the absorption of other medicines.
Pregnancy, breastfeeding and fertility
Pregnancy
Radiation should be avoided during pregnancy whenever possible, and therefore your doctor will carefully evaluate whether a radiological examination, with or without contrast medium, is necessary.
It is essential to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, before undergoing the PRONTOBARIO HD examination.
Nevertheless, you may take PRONTOBARIO HD during pregnancy.
Breastfeeding
Systemic absorption of PRONTOBARIO HD is negligible; therefore, you may take PRONTOBARIO HD while breastfeeding.
Driving and using machines
PRONTOBARIO HD does not affect the ability to drive vehicles (e.g. bicycle) or operate machinery.

3. How PRONTOBARIO HD will be administered to you

PRONTOBARIO HD will be administered by the radiologist and/or healthcare professionals.
PRONTOBARIO HD is given orally.
The recommended dose is 1 single-dose cup, but this dose may be adjusted by the radiologist depending on the type of examination.
Use in children and adolescents
The doctor will determine the dosage based on the child's age and weight, as well as the type of examination to be performed.
Use in the elderly
Individual requirements will be determined based on the radiologist's experience and the type of examination to be performed.
If you are given more PRONTOBARIO HD than you should
It is highly unlikely that you will be given more PRONTOBARIO HD than required, as your doctor will closely monitor the procedure during the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported with PRONTOBARIO HD, listed below according to their frequency.

Rare (may affect up to 1 in 1,000 people)

presence of bacteria in the blood (bacteraemia), collection of pus in the intestine and liver (intestinal abscess, liver abscess);
infection of the peritoneum, a membrane covering the internal organs of the abdomen and pelvis, appendicitis;
lung infection (pneumonia);
swollen lymph nodes (lymphadenopathy);
allergic reactions (anaphylactoid or hypersensitivity reactions), anaphylactic shock;
high blood sugar levels have been observed in diabetic patients (hyperglycaemia);
confusion, agitation, nervousness, dizziness;
fainting (syncope), loss of consciousness, difficulty speaking (dysarthria), headache, burning sensation, reduced muscle tone (hypotonia);
eye swelling, ringing in the ears (tinnitus);
heart rate too slow and/or too fast (bradycardia and tachycardia), bluish/violet discoloration of the skin and mucous membranes (cyanosis);
pallor, blood pressure too low (hypotension), vasodilation;
difficulty breathing (bronchospasm, dyspnoea), swelling of the pharynx or larynx (pharyngeal or laryngeal oedema);
aspiration of the contrast medium into the respiratory tract (aspiration pneumonia);
throat tightness, oropharyngeal pain, throat irritation, cough;
abdominal pain, nausea, vomiting;
reduced or absent blood flow to the intestine (intestinal ischaemia), gastrointestinal perforation and/or obstruction;
intestinal disorders (gastrointestinal ulcer, aggravated ulcerative colitis, gastrointestinal inflammation);
abdominal distension, abdominal discomfort, constipation, diarrhoea, retching, excessive production and accumulation of intestinal gas (flatulence), swollen tongue;
urticaria, rash, erythema, skin inflammation caused by contact with a substance (contact dermatitis);
swelling of the face and/or eyes, pruritus, excessive formation of scar tissue (granulation tissue), excessive sweating;
difficulty urinating;
pain, fever, facial oedema, swelling, fatigue (asthenia), malaise;
abnormal electrocardiogram;
accumulation of barium;
intravasation into veins.

Side effects caused by procedural errors

infections (e.g. peritonitis) following existing or new gastrointestinal perforation. Complications include adhesions and inflammation of healing tissue (granulomas);
intravasation of barium sulphate, resulting in rare formation of venous emboli (rare formation of blockage in an artery or vein) in the portal or caval veins, and pulmonary embolism, which may be fatal in 50% of cases.

Skin and subcutaneous tissue disorders together with immune system disorders, reflecting allergic reactions to barium sulphate or to the excipients of the product, are among the most commonly reported side effects. Gastrointestinal disorders are also frequently reported among the adverse effects.

Additional side effects in children
The side effects in children are comparable to those in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at the website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PRONTOBARIO HD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What PRONTOBARIO HD Contains
The active substance is barium sulfate 98.45 g.
The other components are sorbitol, acacia, disodium citrate dihydrate, simethicone, anhydrous citric acid,
polysorbate 80, carrageenan, ethyl maltol, sodium saccharin, strawberry flavor, cherry flavor.

Description of the Appearance of PRONTOBARIO HD and Package Contents
PRONTOBARIO HD is presented as a powder.
It is available in a single-dose container containing 340 g of powder for oral suspension.

Marketing Authorization Holder and Manufacturer
Bracco Imaging S.p.A. Via E. Folli, 50 – Milan
Manufacturer
Bracco Imaging s.p.a. – Bioindustry Park, Via Ribes 5, 10010 Colleretto Giacosa (TO)

The following information is intended exclusively for physicians or healthcare professionals:

INDICATIONS
Medicinal product for diagnostic use only.
PRONTOBARIO HD is a high-density, low-viscosity powder for suspension used as a contrast medium in radiological examinations of the esophagus, stomach, and duodenum. It is particularly indicated in double-contrast radiological examinations.

CONTRAINDICATIONS
Immune System Disorders
Known hypersensitivity to barium sulfate or to any of the excipients listed in section 6.

Gastrointestinal Disorders
Barium sulfate suspensions must not be administered to patients with:

known or suspected perforation anywhere in the gastrointestinal tract
known or suspected tracheoesophageal fistula
gastrointestinal bleeding
gastrointestinal ischemia
megacolon or toxic megacolon
necrotizing enterocolitis
severe pathological ileus

Barium sulfate suspensions must not be administered to children with swallowing disorders.

Medical and Surgical Procedures
Barium sulfate must not be administered immediately after gastrointestinal surgery, including polypectomy with snare or "hot biopsy" of the colon performed with forceps, due to the possible post-procedural leakage of the product or the potential risk of gastrointestinal perforation.

Trauma, Poisoning, and Procedure-Related Complications
Barium sulfate must not be administered within 4 weeks following radiotherapy to the rectum and prostate.
Do not use in cases of recent gastrointestinal lesions or chemical burns of the gastrointestinal tract.

PRECAUTIONS FOR USE
General
The medicinal product must be administered under medical supervision.
Diagnostic procedures involving the use of radiopaque contrast media must be performed under the direction of personnel trained and experienced in the specific procedure to be carried out.
Severe adverse reactions, including death, have been reported following administration of barium sulfate formulations, usually related to the method of administration, underlying pathological condition, and/or patient hypersensitivity.
Barium sulfate must not be administered in powder form, as accidental inhalation, esophageal irritation, or intestinal obstruction may occur. The powder must be reconstituted before administration.

Hypersensitivity
Barium sulfate-based preparations used as radiopaque agents contain various excipients to ensure diagnostic properties and improve patient acceptability.
Allergic reactions have been reported following the use of barium sulfate suspensions. Skin irritation, redness, inflammation, and urticaria have been reported in neonates and children following contact of barium sulfate suspension with the skin. These reactions appear to be due to flavors and/or preservatives used in the product.
A history of bronchial asthma, atopy (e.g., hay fever, eczema), family history of allergies, or previous reactions to a contrast agent requires special attention.
Anaphylactic and allergic reactions have been reported during double-contrast examinations when glucagon was used.
Rapid recognition, assessment, and diagnosis are crucial to initiate effective treatment. On-site personnel managing patients receiving contrast agents should be trained in cardiopulmonary resuscitation and/or advanced cardiac life support, if possible.

Perforation
In patients with severe stenosis at any level of the gastrointestinal tract, especially distal to the stomach, and in conditions or pathologies associated with an increased risk of perforation—such as confirmed carcinoma, gastrointestinal fistula, inflammatory bowel disease, diverticulitis, diverticulosis, and amoebiasis—careful evaluation of the risk-benefit ratio is required before administering a barium sulfate suspension.

Aspiration
In patients at risk of aspiration (neonates, elderly, stroke patients), administration should begin with reduced volumes of barium sulfate.
Vomiting following oral administration of barium sulfate may cause aspiration pneumonia.
Administration of barium sulfate to a child from a bottle or administration of large volumes via a catheter may result in aspiration into the tracheobronchial tree.
Aspiration may lead to fatal cardiopulmonary arrest in children. Aspiration of small amounts may cause respiratory tract inflammation and pneumonia.
Ingestion of barium is not recommended in patients with a history of food aspiration. Caution is required if barium administration is necessary in patients with impaired swallowing mechanisms. Administration of barium must be stopped immediately if aspiration into the larynx occurs.

Obstruction / Fluid Overload
Small bowel obstruction (ileus) due to barium sulfate suspension has been reported in pediatric patients with cystic fibrosis. Fluid overload due to water absorption has also been reported during studies in neonates suspected of having Hirschsprung’s disease.

Constipation or Diarrhea
Barium sulfate suspensions should be used with caution in dehydrated patients, in those with conditions or undergoing treatments that may cause constipation, or in patients with a history of constipation. In such cases, a mild bulk-forming laxative should be administered at the end of radiographic examinations. Increased fluid intake is recommended after oral or rectal administration of barium sulfate to prevent severe constipation and the risk of obstruction.
Conversely, since some suspensions contain D-glucitol (sorbitol), administration of these preparations may produce a mild laxative effect. If dosage instructions are followed, up to 10 g of D-glucitol (sorbitol) may be administered to adults during each procedure. The caloric value of sorbitol is 2.6 kcal/g.

Baroliths
Baroliths are solid formations of barium residue associated with feces. They are often asymptomatic but may be associated with abdominal pain, appendicitis, intestinal obstruction, or perforation.
Elderly patients, those with reduced gastrointestinal motility, electrolyte imbalance, dehydration, or on low-residue diets may be at risk of developing baroliths. To reduce this risk, adequate hydration should be maintained during and in the days following barium sulfate procedures. The use of laxatives should be considered (especially in cases of constipation).

Hereditary Fructose Intolerance
Most barium sulfate-based products contain sorbitol, which is a source of fructose.
PRONTOBARIO HD contains 1.89 g of sorbitol per dose.
If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance—a rare genetic disorder in which patients cannot metabolize fructose—consult your doctor before taking this medicine (see section 2).
Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.

Patients on Low Potassium or Sodium Diets
This medicine contains 11 mmol of sodium (259 mg) per 340 g dose. This corresponds to 13% of the maximum recommended daily dietary intake for an adult. Caution is advised in patients on a low-sodium diet, especially in cases of repeated administration.

Children, Elderly, and Debilitated Patients
As with all barium sulfate-based preparations, Prontobario HD must be administered with caution in children, elderly patients, and debilitated patients.
Prontobario HD should be used with caution in patients with pre-existing cardiac conditions.

Other Possible Complications
Anxious patients may experience weakness, pallor, tinnitus, sweating, and bradycardia following administration of a diagnostic agent. These reactions are usually unpredictable and are best managed by keeping the patient lying down under observation for an additional 10–30 minutes.
Patient preparation for gastrointestinal diagnostic exams often involves laxatives and a liquid diet. These preparations may lead to fluid loss. Patients should be promptly rehydrated after a barium sulfate suspension examination. Saline laxatives are routinely recommended in patients with a history of constipation, unless clinically contraindicated.

INTERACTIONS
Barium sulfate is biologically inert, and no interactions with other medicinal products are known. However, the presence of barium sulfate formulations in the gastrointestinal tract may alter the absorption of concomitantly administered therapeutic agents. To minimize any potential changes in absorption, administration of barium sulfate should be separated from that of other drugs.
Other examinations performed in the same gastrointestinal area using another contrast agent may be complicated by residual barium sulfate remaining in the gastrointestinal tract for several days after the barium contrast examination.

METHOD AND TIME OF ADMINISTRATION
Prontobario HD must be administered orally.
The powder must be reconstituted before administration.
Add 65 ml of water to the contents of the cup.
Close the lid tightly and invert repeatedly.
Shake vigorously for 10–20 seconds. Before administration, shake the contents again for 10–20 seconds.
Remove the lid. The patient may drink directly from the cup.
Do not use if the inner seal is damaged or missing.

DOSAGE
Prontobario HD is supplied in single-dose, disposable cups containing 340 g of powder for 250% w/v suspension.
The dose of Prontobario HD to be administered depends on the patient and the gastrointestinal segment to be visualized.
Adults: Administer the entire contents of the cup.
This dose may be adjusted by the radiologist according to the diagnostic requirement.
Elderly: Individual needs will be determined based on the radiologist’s experience and the diagnostic indication.

Pediatric Population
Children: The dose will depend on the child’s age and weight. Individual needs will be determined based on the radiologist’s experience.