PROSPECTO : INFORMATION FOR THE USER

Barilux AD 327.25 g powder for oral suspension.

Barium Sulfate (D.C.I.)

1. Before taking Barilux AD 327.25 g.

1. How to take Barilux AD 327.25 g.

1. Possible adverse effects.

1. Storage of Barilux AD 327.25 g.

1. Additional information.

This medication is solely for diagnostic use.

Barilux AD belongs to the group of medications known as radiological contrast agents for X-rays that contain barium sulfate without suspending agents, classified within the ATC (anatomical-therapeutic-chemical classification) in the pharmacotherapeutic group VO8BA01.

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

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

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

Do not take Barilux AD:

• if you are allergic (hypersensitive) to the active ingredient 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 narrowing of the pylorus (pyloric stenosis).
• if you have or suspect a perforation of the gastrointestinal tract.
• if you have postoperative gastrointestinal suture dehiscence (suture opening).
• if you have a history or suspicion of intestinal perforation.
• if you have intestinal fistulas.
• if you have tracheoesophageal or bronchoesophageal fistulas.
• if you have recently suffered injuries or chemical burns in the esophagogastric tract.
• if you have insufficient blood flow (ischemia) to the intestinal wall.
• if you have a condition called "necrotizing enterocolitis" (inflammatory disease of the intestine).
• if you are about to undergo gastrointestinal surgery.
• within 7 days after an endoscopic resection.
• within 4 weeks after concurrent radiation therapy.

Be especially careful with Barilux AD

Special attention should be paid when administering Barilux:

• If you are an elderly person with diseases, mainly cardiovascular, as the examination may be stressful for you.
• If you have high-grade stenosis, especially in the distal parts of the stomach or conditions and diseases with a high risk of perforation, such as fistulas and gastrointestinal carcinomas, inflammatory bowel disease, diverticulitis, diverticulosis, and amebiasis, a meticulous assessment of the benefit/risk ratio is necessary.

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

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

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

In the event of massive aspiration of the product, intravascular penetration, or perforation, immediate specialized medical intervention, intensive care, or surgery is necessary.

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

In the case of the formation of barium sulfate coprolites (bariolites) due to the thickening of barium sulfate, laxatives and/or saline purgatives (with salts or minerals) are recommended.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Certain medications may interact with Barilux AD, in which case it may be necessary to change the dose or discontinue treatment with one of the medications. It is especially important to inform your doctor if you are using any of the following medications:

• Medications that reduce intestinal peristalsis (contractions in the form of waves along the intestine): Taking these medications 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 medication.

The use of barium contrast agents in pregnant women has not been sufficiently demonstrated to be 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 non-use of a contrast agent, the benefit of the radiological examination should be carefully evaluated.

The safety of Barilux in women breastfeeding their children has not been investigated. Contrast agents are eliminated through breast milk in minimal amounts. No damage is predictable for the infant, and your doctor will evaluate the benefit/risk before undergoing an examination.

The use of Barilux AD is not contraindicated during breastfeeding.

Driving and operating machines

Barilux AD does not affect driving, handling tools, or operating machines.

Important information about some components of Barilux AD

Patients with low-sodium diets should note that this medication contains 451 mg (19.6 mmol) of sodium per 340 g vial of Barilux.

This medication contains sorbitol. If your doctor has indicated that you are intolerant to certain sugars, consult with them before taking/using this medication.

Barilux AD may cause a mild laxative effect due to the presence of 10.4 g of sorbitol per 340 g vial.

Caloric value: 2.6 kcal/g of sorbitol.

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

The medical staff will administer Barilux AD orally.

Your 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 conveniently by the doctor according to age, body weight of the child, and the particularities of pediatric radiodiagnosis.

For elderly patients, there are no special dosage recommendations.

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

Patient Preparation

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

Patient preparation for stomach X-ray exploration:

If an abundant acidic secretion (stomach acid) is observed in the fasting state, it is recommended, to the extent 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 exploration, with the aim of increasing the adherence of the contrast medium to the stomach walls. The test result improves if an additional antispasmodic is administered intravenously or intramuscularly, which reduces the stomach tone, decreases peristalsis, and delays stomach evacuation.

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

Patient preparation for pediatric use:

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

In young children, it is recommended not to provide the last meal to facilitate the ingestion of the contrast.

Patients with liver insufficiency:

No dose adjustment is necessary (see section 2: Be careful with Barilux)

Patients with renal insufficiency:

No dose adjustment is necessary (see section 2: Be careful with Barilux)

If you use more Barilux AD than you should

In rare cases, repeated administration of barium sulfate suspensions may cause stomach cramps and diarrhea. These reactions are transient and not considered serious.

In explorations where high doses of barium enema are administered, it may cause an alteration of the electrolyte balance in the blood due to the large amount of water retained by the contrast. In such cases, it is possible to reduce the risk by adding sodium chloride to the enema liquid. The electrolyte balance in the blood is restored through adequate infusion therapy.

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

If you forgot to take Barilux AD

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Barilux AD

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Barilux AD may produce adverse effects, although not everyone will experience them.

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Rare Adverse Effects(it is likely that they will occur in 1 to 10 of every 10,000 people)

• Allergic reactions (urticaria, anaphylactic shock, skin eruptions).

Very Rare Adverse Effects(it is likely that they will occur in less than 1 of every 10,000 people)

• Intravascular injection and embolization of barium.
• Formation of barium bezoars that may cause intestinal blockage.

Adverse Effects of Unknown Frequency

• Aspiration pneumonitis.
• Increased or intensified intestinal obstruction.

This medication does not require any special temperature for conservation

Keep in the original packaging to protect it from humidity.

Keep out of the reach and sight of children.

Do not use Barilux AD after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help to protect the environment.

Composition of Barilux AD

• The active substance is barium sulfate. 100 g of powder for suspension contains 96.25 g of barium sulfate.
• 1 single-dose vial of 340 g of powder for suspension contains 327.25 g of barium sulfate.
• The other components are: sorbitol, sodium citrate, dimethicone, sodium saccharin, 3-ethoxy-4-hydroxybenzaldehyde; ethylvanillin; polisorbate 20.

Appearance of the product and contents of the package

Barilux AD is available in clinical containers containing 23 vials of 340 g of powder for oral suspension each.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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

Responsible for Manufacturing:

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

This leaflet was approved in December 2010.