PROSPECTO : INFORMATION FOR THE USER

Barilux 830 mg/ml oral and rectal suspension.

Barium Sulfate (D.C.I.)

This medication is for diagnostic use only.

Barilux belongs to a group of medications called radiological contrast agents for X-rays that contain barium sulfate with suspended agents.

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

• Oral use:

• Rectal use (administered through an enema in the intestine):for simple and double-contrast X-ray explorations of the lower gastrointestinal tract (rectum, sigmoid, and colon), as a diagnostic aid for pathologies in these organs

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

Do not take Barilux:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have an inflamed abdominal wall (irritated peritoneum) (oral and rectal use).
• 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 you have a perforation of the gastrointestinal tract (oral and rectal use).
• 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 use).
• if you have tracheoesophageal or bronchoesophageal fistulas (only for oral use).
• if you have recent injuries or chemical burns in the gastrointestinal tract (oral and rectal use).
• if you have insufficient blood flow (ischemia) to the intestinal wall (oral and rectal use).
• if you have a condition called necrotizing enterocolitis (oral and rectal use).
• if you are about to undergo gastrointestinal tract surgery (oral and rectal use)
• within 7 days after an endoscopic resection (oral and rectal use).
• within 4 weeks after concurrent radiation therapy (oral and rectal use).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 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, as a thorough assessment of the benefit/risk is necessary in these cases.

• During the radiological examination, it is essential to prevent the penetration of barium sulfate into areas such as tissues, vascular space, and body cavities or respiratory tracts 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, it is necessary to prevent the penetration of barium sulfate into areas outside the gastrointestinal tract (parenteral) such as tissues, vascular space, and body cavities or respiratory tracts.

• In case 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 and/or worsening infectious processes in this location.

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

Other medications and Barilux

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Certain medications may interact with Barilux, and in these cases, 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, breastfeeding, and fertility

If you think you are pregnant or breastfeeding, or if you are planning to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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.

BreastfeedingNo studies have investigated the safety of Barilux in women who were breastfeeding their babies. Contrast agents are eliminated in breast milk in minimal amounts. No harm is expected to the infant, and your doctor will evaluate the benefit/risk before submitting you to an examination.

The use of Barilux is not contraindicated during breastfeeding

Driving and operating machinery

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

Barilux contains sodium, potassium, sorbitol (E-420), and sodium benzoate (E-211).

This medication contains 3.59 – 4.27 mg of sodium (main component of table salt/cooking salt) per milliliter of suspension.This is equivalent to 0.18 – 0.21% of the maximum daily sodium intake recommended for an adult.

Patients with renal insufficiency or low-potassium diets should note that this medication contains 1.7 mg (0.03 mmol) of potassium per milliliter of suspension.

This medication contains 6.67 mg sorbitol per milliliter.Sorbitol is a source of fructose.If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (IHF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication contains 4.10 mg of sodium benzoate per milliliter. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Follow the exact administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The medical staff will administer Barilux orally, through a tube or rectally (via an 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 used.

Use in children and adolescents

In infants and children, the dose will be adjusted as needed by the doctor based on age, body weight, and the specific pediatric radiodiagnostic requirements.

For elderly patients, there are no special dosage recommendations.

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

Patient preparation

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

Patient preparation for the use of barium contrast via oral route:

Patient preparation for X-ray examination of the stomach:

If excessive stomach acid (gastric acidity) is observed in the fasting state, it is recommended, if 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, 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 gastric emptying.

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

Patient preparation for X-ray examination using the bifasic enteroclisis technique:

Your doctor may administer an additional antispasmodic intravenously or intramuscularly to reduce the tone of the intestine, decrease peristalsis (intestinal muscle movement), and delay the evacuation of the contrast, with the aim of improving the test result and patient acceptance.

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 take 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.

Patient preparation for the use of barium contrast via rectal route:

To obtain an accurate X-ray examination of the large intestine, it is essential to perform a complete colon cleansing and eliminate mucus. In this case, it is recommended to administer laxatives specifically indicated for radiological preparation the day before the test. From this moment on, the patient should take 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 examination 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 intestinal walls. The additional administration of an antispasmodic intravenously or intramuscularly leads to a significant 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 lead to stomach spasms and diarrhea. These reactions are transient and not considered serious.

In examinations 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 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 medication, ask your doctor or pharmacist.

Like all medications, this medication 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 between 1 and 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 fewer than 1 of every 10,000 people)

• Intestinal perforation, which may be followed by peritonitis and granulomatosis (rectal route).
• Barium intravasation and embolization (oral and rectal routes).
• Bacteremia (rectal route).
• Barium granuloma formation that may cause large intestine obstruction (oral and rectal routes).

Adverse Effects of Unknown Frequency

• Aspiration pneumonitis (oral route).
• Increased or intensified intestinal obstruction (oral and rectal routes).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require any special temperature for conservation

Store in the original packaging to protect it from humidity

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “Expiration”. 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 unused medications. In this way, you will help protect the environment.

Composition of Barilux

• The active principle is barium sulfate. 1 milliliter of Barilux suspension contains 0.83 g of barium sulfate.

A multidose bottle with 2000 ml of Barilux suspension contains 1660 g of barium sulfate.

• The other components are: Xanthan gum, sodium caramel, sodium carmelose (carboxymethyl cellulose) (Cekol 30), sodium citrate dihydrate, anhydrous citric acid, sorbitol (E-420), sodium saccharin, potassium sorbate (E-202), sodium benzoate (E-211), strawberry flavoring, dimethicone (Silfar 350), polysorbate 20 (Tween 20), purified water.

Appearance of the product and contents of the packaging

Barilux is available in clinical containers containing 4 multidose bottles of 2,000 ml suspension each.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

AVALON LABORATORIOS S.L.

Calle La Cora, number 4, Local 1,

18006 Granada (Granada) Spain

Responsible for Manufacturing:

Sanochemia Pharmazeutika GmbH.

LandeggerStreet7.

A-2491 Neufeldan derLeitha.Austria.

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

Last review date ofthis leaflet: June 2021

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).