BARILUX AD 327.25 g ORAL SUSPENSION POWDER

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Barilux AD 327.25 g oral suspension powder.

Barium sulfate (DCI)

Contents of the package leaflet:

1. What Barilux AD 327.25 g is and what it is used for.

1. Before taking Barilux AD 327.25 g.

1. How to take Barilux AD 327.25 g.

1. Possible side effects.

1. Storage of Barilux AD 327.25 g.

1. Further information.

1. What Barilux AD 327.25 g is and what it is used for

This medicinal product is for diagnostic use only.

Barilux AD belongs to a group of medicinal products known as radiological contrast media for X-rays containing barium sulfate without suspending agents, classified within the ATC (anatomical, therapeutic, and chemical classification) in the pharmacotherapeutic group VO8BA01.

Barilux AD is a radio-opaque diagnostic agent used to enhance contrast during visualization of the esophagus and gastrointestinal tract using certain radiological techniques:

• Its oral use is indicated as a contrast medium in radiological examinations (radiographs) of the esophagus, stomach, and duodenum using the double contrast technique.

Barilux is indicated in the pediatric population for opacification of the upper and lower gastrointestinal tract only in simple contrast X-ray examinations as a diagnostic aid for pathologies in these organs.

2. Before taking Barilux AD 327.25 g

Do not take Barilux AD:

• if you are allergic (hypersensitive) to the active substance or any of the other components of Barilux.

• if you have inflammation of the abdominal cavity walls (irritated peritoneum)
• if you have a complete obstruction of the gastrointestinal tract.
• if you have pyloric stenosis (narrowing of the pylorus).
• if you have or suspect you have a perforation of the gastrointestinal tract.
• if you have postoperative gastrointestinal suture dehiscence (opening of the suture).
• if you have a history of or suspect intestinal perforation.
• if you have intestinal fistulas.
• if you have tracheoesophageal or bronchoesophageal fistulas.
• if you have had recent injuries or chemical burns in the esophagogastric tract.
• if you have insufficient blood supply (ischemia) to the intestinal wall.
• if you have an inflammatory disease of the intestine called "necrotizing enterocolitis"
• if you are about to undergo gastrointestinal surgery
• within 7 days after an endoscopic resection.
• within 4 weeks after concurrent radiotherapy.

Special warnings and precautions for use

Particular attention should be paid when administering Barilux:

• If you are an elderly person with diseases, mainly cardiovascular, as the examination can be stressful for you.
• If you have high-grade stenosis (narrowing), especially distal (far) from the stomach or conditions and diseases with a high risk of perforation, such as fistulas and known gastrointestinal carcinomas, inflammatory bowel disease, diverticulitis (inflammation of a diverticulum), diverticulosis, and amebiasis (infection caused by amoebas), as in these cases, a meticulous benefit/risk assessment is necessary.

During the radiological examination, the penetration of barium sulfate into parental areas such as tissues, vascular space, and body cavities or into the respiratory tract should be prevented to avoid potentially serious adverse reactions.

You should also ensure adequate hydration after the procedure to prevent severe constipation.

To avoid potentially serious adverse reactions, during the diagnostic process, the penetration of barium sulfate into areas outside the gastrointestinal tract (parenteral) such as tissues, vascular space, and body cavities or into the respiratory tract should be prevented.

In case of massive aspiration of the product, intravasation (penetration into blood vessels), or perforation, immediate specialized medical intervention, intensive care, or even surgery may be necessary.

During the radiological examination, barium sulfate may accumulate in colon diverticula, potentially favoring and/or aggravating infectious processes at this location.

In case barium sulfate coprolites (barioliths) form due to thickening of the barium sulfate, in this case, the administration of laxatives and/or saline purgatives (with salts or minerals) is recommended.

Interaction with other medicinal products

Tell your doctor or pharmacist if you are using or have recently used other medicinal products, including those obtained without a prescription.

Certain medicinal products may interact with Barilux AD; in these cases, it may be necessary to change the dose or interrupt treatment with one of the medicinal products. It is especially important that you inform your doctor if you are using any of the following medicinal products:

• Medicinal products that reduce intestinal peristalsis (contractions in the form of waves along the intestine): Taking these medicinal products may cause thickening of the barium sulfate suspension and increase the risk of constipation.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicinal product.

It has not been sufficiently demonstrated that the use of barium contrast media in pregnant patients is safe. Radiological examinations should not be performed in pregnant women unless strictly necessary or when the benefit to the mother outweighs the risk to the fetus. In any case, given the teratogenic effects of radiation exposure during pregnancy, regardless of the use or not of a contrast agent, the benefit of the radiological examination should be carefully assessed.

The safety of Barilux in breastfeeding women has not been investigated. Contrast media are excreted in breast milk in minimal amounts. No harm to the breastfed child is expected, and your doctor will assess the benefit/risk before performing the examination.

The use of Barilux AD is not contraindicated during breastfeeding.

Driving and using machines

Barilux AD does not affect driving or the use of tools or machines.

Important information about some of the ingredients of Barilux AD

Patients on low-sodium diets should note that this medicinal product contains 451 mg (19.6 mmol) of sodium per 340 g glass of Barilux.

This medicinal product contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking/using this medicinal product.

Barilux AD may have a mild laxative effect because it contains 10.4 g of sorbitol per 340 g glass.

Caloric value: 2.6 kcal/g of sorbitol.

3. How to take Barilux AD 327.25 g

Follow the instructions for administration of Barilux AD exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The medical staff will administer Barilux AD orally.

The doctor will determine the correct amount and administration schedule of the product required for your radiographic examination, depending on your age, weight, and the technique to be used.

In infants and children, the dose will be adjusted accordingly by the doctor based on the child's age, body weight, and the specific requirements of the pediatric radiodiagnosis.

For elderly patients, there are no special dosage recommendations.

Consult your doctor if you need clarification regarding the examination procedure. It is essential to follow your doctor's instructions once the examination is completed.

Preparation of the patient

You should drink plenty of water after the examination to reduce the risk of constipation.

Preparation of the patient for X-ray examination of the stomach:

If abundant acid secretion (stomach acidity) is observed while fasting, it is recommended, whenever possible, to aspirate the gastric secretion or perform the examination on another day (in the morning, as early as possible).

Some professionals use acid secretion inhibitors (which reduce the amount of acid produced in the stomach) before performing the X-ray examination to increase the adherence of the contrast medium to the stomach walls. The test result improves if an antispasmodic is administered additionally, either intravenously or intramuscularly, which reduces the tone of the stomach, decreases peristalsis, and delays stomach emptying.

To extend the different regions of the stomach, it is recommended to administer a medication with a carbon dioxide-forming effect simultaneously.

Preparation of the patient for pediatric use:

Newborns do not need to be fasting. For children 1-24 months, they should be fasting from 4 hours before the test, 6 hours before for children 2-4 years, and 8 hours before for children 4-14 years, although in the latter case, they may drink a little water up to 3 hours before the study.

In small children, it is recommended not to provide the last meal to facilitate the intake of the contrast medium.

Patients with hepatic impairment:

No dose adjustment is necessary (see section 2: Special warnings and precautions for use)

Patients with renal impairment:

No dose adjustment is necessary (see section 2: Special warnings and precautions for use)

If you use more Barilux AD than you should

Rarely, repeated administration of barium sulfate suspensions may cause stomach spasms and diarrhea. These reactions are transient and not considered serious.

In examinations where high doses of barium enema are administered, an alteration of the electrolyte balance in the blood serum may occur due to the large amount of water retained by the contrast medium. In such cases, the risk can be reduced by adding sodium chloride to the enema liquid. The electrolyte balance in the serum is restored through adequate infusion therapy.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91.562.04.20.

If you forget to take Barilux AD

Do not take a double dose to make up for forgotten doses.

If you stop taking Barilux AD

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicinal products, Barilux AD can cause side effects, although not everybody gets them.

Serious adverse reactions, reported with the administration of barium sulfate formulations, are generally associated with a defective administration technique or pre-existing pathological conditions.

If you experience any of the side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Rare side effects(it is likely that they will affect between 1 and 10 in every 10,000 people)

• allergic reactions (urticaria, anaphylactic shock, skin rashes).

Very rare side effects(it is likely that they will affect less than 1 in every 10,000 people)

• intravasation and embolization of barium.
• formation of bariolites that can cause blockage of the large intestine.

Side effects of unknown frequency

• Aspiration pneumonitis.
• Increased or intensified intestinal obstruction.

5. Storage of Barilux AD 327.25 g

This medicinal product does not require any special storage temperature.

Keep the container in the original packaging to protect it from moisture.

Keep out of the reach and sight of children.

Do not use Barilux AD after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Barilux AD

• The active substance is barium sulfate. 100 g of powder for suspension contain 96.25 g of barium sulfate.
• 1 single-dose glass of 340 g of powder for suspension contains 327.25 g of barium sulfate
• The other ingredients are: sorbitol, sodium citrate, dimethicone, sodium saccharin, 3-ethoxy-4-hydroxybenzaldehyde; ethyl vanillin; polysorbate 20.

Appearance of the product and packaging contents

Barilux AD is available in clinical packaging containing 23 single-dose glasses of 340 g of powder for oral suspension each.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Iberoinvesa Pharma S.L. Calle Zurbarán 18, 6º. 28010. Madrid. Spain.

Manufacturer:

Sanochemia Pharmazeutika AG. Landegger Str. 7. A-2491 Neufeld/Leitha. Austria.

This leaflet was approved in December 2010.