PATIENT INFORMATION LEAFLET

Barilux 50 mg / ml oral and rectal suspension concentrate

Barium Sulfate

This medication is only for diagnostic use.

Barilux belongs to a group of medications called radiological contrast agents for X-rays that contain barium sulfate with suspended agents, classified within the ATC (anatomical therapeutic chemical classification) in the VO8BA02 pharmacotherapeutic group.

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

• Oral use in adults and pediatric population:

• Rectal use (administered through an enema in the intestine):It is indicated only in adults for computed tomography explorations of the lower gastrointestinal tract (rectum, sigmoid, and colon), as a diagnostic aid for pathologies in these organs

Do not take Barilux:

• if you are allergic (hypersensitive) to the active ingredient or any of the other components of Barilux (oral and rectal routes).

• if you have an inflammation of the abdominal cavity walls (irritated peritoneum) (oral and rectal routes).

• if you have a complete obstruction of the gastrointestinal tract (only for oral use).

• if you have a narrowing of the pylorus (pyloric stenosis) (only for oral use).

• if you have or suspect a perforation of the gastrointestinal tract (oral and rectal routes).

• if you have a postoperative gastrointestinal suture dehiscence (suture opening) (only for oral use).

• if you have a history or suspicion of intestinal perforation (only for oral use).

• if you have intestinal fistulas (oral and rectal routes).

• if you have tracheoesophageal or bronchoesophageal fistulas (only for oral use).

• if you have had recent injuries or chemical burns in the gastrointestinal tract (oral and rectal routes).

• if you have insufficient blood flow to the intestinal wall (ischemia) (oral and rectal routes).

• if you have a condition called necrotizing enterocolitis (oral and rectal routes).

• -if you are about to undergo gastrointestinal tract surgery (oral and rectal routes)

• within 7 days after an endoscopic resection (oral and rectal routes).

• within 4 weeks after concurrent radiation therapy (oral and rectal routes).

Be especially careful with Barilux

Special attention should be paid when administering Barilux:

• If you are an elderly person with diseases, mainly cardiovascular, as the test may be stressful for you.

• If you have high-grade stenosis, especially those located far from 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 benefit/risk assessment is necessary.

During the radiological examination, the penetration of barium sulfate into parenteral 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 (parenteral) 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 may be necessary.

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

In the event of barium sulfate coprolite (bariolite) formation due to barium sulfate thickening, laxatives and/or saline purgatives 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, and in these cases, the dose may need to be changed or the treatment interrupted 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 lactating women has not been investigated. Contrast agents are eliminated through breast milk in minimal amounts. No damage to the infant is predictable, and your doctor will evaluate the benefit/risk before subjecting you to an examination.

The use of Barilux is not contraindicated during lactation.

Driving and operating machines

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

Important information about some of the components of Barilux

Barilux contains maltitol as an excipient. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with low-sodium diets should note that this medication contains 1.89-2.00 mg of sodium (0.082-0.087 mmol) of sodium per 1 ml of concentrate for suspension.

Patients with renal insufficiency or low-potassium diets should note that this medication contains 0.89 mg (0.176 mmol) of potassium per 1 ml of concentrate for suspension.

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

Medical personnel will administer Barilux orally or rectally (via enema).

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 as needed by your doctor based on age, body weight, and the specific pediatric radiodiagnostic technique.

Consult your doctor if you wish to clarify the procedure for the examination. It is essential to follow your doctor's instructions after the examination.

Patient Preparation

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

Patient preparation for stomach exploration:

If excessive stomach acid (gastric acidity) is observed in the fasting state, it is recommended, to the extent possible, to aspirate gastric secretions 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 computed tomography scan, 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 stomach tone, decreases peristalsis, and delays stomach evacuation.

Patient preparation for exploration using the enteroclysis technique:

Your doctor may administer an additional antispasmodic intravenously or intramuscularly, which reduces intestinal tone, decreases peristalsis (intestinal muscle wave movement), and delays contrast evacuation, with the aim of improving the test result.

Patient preparation for pediatric use:

Newborns (neonates) do not need to be fasting. For children aged 1-24 months, they should be fasting for 4 hours before the test, 6 hours for children aged 2-4 years, and 8 hours for children aged 4-14 years, although in the latter case, they may drink a small amount of 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 medium.

Patient preparation for the use of barium contrast via the rectum:

To obtain a computed tomography scan of the large intestine, it is essential to perform a complete colon cleansing and eliminate mucosity. In this case, it is recommended to administer laxatives of habitual use, especially for radiological preparation, the day before the test. From this moment on, the patient should drink plenty of liquid (approximately 2-3 liters), but only in the form of tea, water, vegetable soup, fruit juice, etc. Milk and alcohol should be avoided.

If necessary, a cleansing enema may be administered on the day of the radiological test to achieve a deep cleansing of the large intestine. At this point, the large intestine should be free of residues that affect the development of the radiological examination.

It is possible to administer acid secretion inhibitors before the test to increase the adherence of the contrast medium to the walls. The additional administration of an antispasmodic intravenously or intramuscularly leads to a marked hypotonia (muscle tone decrease) of the entire colon, which significantly improves the test result and patient acceptance.

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 than you should

In rare cases, repeated administration of barium sulfate suspensions may cause stomach spasms 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 medium. 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 appropriate infusion therapy.

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

If you forget to take Barilux

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

If you interrupt treatment with Barilux

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

Like all medications, Barilux may produce adverse effects, although not all people 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) (oral and rectal routes).

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

• intestinal perforation, which may be followed by peritonitis and granulomatosis (rectal route).
• intravasation and embolization of barium (oral and rectal routes).
• bacteremia (rectal route).
• formation of barium bezoars that may cause intestinal obstruction (oral and rectal routes).

Adverse Effects of Unknown Frequency

• aspiration pneumonitis (oral route)
• increase or intensification of intestinal obstruction (oral and rectal routes)

Do not store at temperatures above 25 °C.

Keep out of the reach and sight of children.

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Barilux Composition

• The active substance is barium sulfate. 1 ml of concentrate for suspension contains 50 mg of barium sulfate.

1 single-dose vial of 750 ml containing 150 ml of concentrate for suspension contains 7.5 g of barium sulfate.

1 multidose vial of 2000 ml with 2000 ml of concentrate for suspension contains 100 g of barium sulfate.

• The other components are: Xantam gum, microcrystalline cellulose-sodium carmellose (85:15), maltitol, sodium citrate dihydrate, anhydrous citric acid, sodium saccharin, potassium sorbate, sodium benzoate, strawberry flavoring, liquid, purified water

Product Appearance and Packaging Contents

Barilux is available in clinical containers that contain:

• 20 single-dose vials of 750 ml with 150 ml of concentrate for suspension each.
• 4 multidose vials of 2,000 ml with 2000 ml of concentrate for suspension each

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

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

Responsible Manufacturer:

Lichtenheldt GmbH Industriestrasse 7-9 Justus-Liebig-Weg 1 D-23812 Wahlstedt. Germany

For any information about this medication, please contact the Marketing Authorization Holder:

This prospectus was approved in January 2011

This information is intended solely for doctors or healthcare professionals:

The complete technical data sheet forBarilux 50 mg/ml concentrate for oral and rectal suspensionis included as a detachable section at the end of this prospectus, in order to facilitate doctors or healthcare professionals with scientific and practical information on the administration and use of this medication.