Barilux 830 mg/ml oral and rectal suspension

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Barilux 830 mg/ml oral and rectal suspension.

Barium sulfate (INN)

Package leaflet contents:

1. What Barilux 830 mg/ml is and what it is used for.
2. What you need to know before taking Barilux 830 mg/ml.
3. How to take Barilux 830 mg/ml.
4. Possible side effects.
5. Storage of Barilux 830 mg/ml.
6. Contents of the pack and other information.

1. What Barilux 830 mg/mL is and what it is used for

This medicinal product is for diagnostic use only.

Barilux belongs to a group of medicines called radiological contrast agents for X-rays containing barium sulfate with suspending agents.

Barilux is a radiopaque diagnostic agent used to enhance contrast during visualization of the gastrointestinal tract by certain radiological techniques:

• Oral use:

  • For single-contrast X-ray examinations of the upper gastrointestinal tract (esophagus, stomach, or small intestine), as an aid in the diagnosis of pathologies in these organs.
  • For X-ray examinations using the biphasic enteroclysis technique (administered via a tube), as an aid in the diagnosis of pathologies in the small intestine.

• Rectal use (administered via an enema into the intestine): for single-contrast and double-contrast X-ray examinations of the lower gastrointestinal tract (rectum, sigmoid, and colon), as an aid in the diagnosis of pathologies in these organs.

Barilux is indicated in the pediatric population for opacification of the upper and lower gastrointestinal tract only in single-contrast X-ray examinations, as an aid in the diagnosis of pathologies in these organs.

2. What you need to know before taking Barilux 830 mg/ml

Do not take Barilux:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• if you have inflammation of the abdominal cavity wall (irritated peritoneum) (oral and rectal use).
• if you have or suspect complete gastrointestinal tract obstruction (oral use only).
• if you have narrowing of the pylorus (pyloric stenosis) (oral use only).
• if you have or suspect gastrointestinal tract perforation (oral and rectal use).
• if you have postoperative gastrointestinal suture dehiscence (opening of the suture) (oral use only).
• if you have a history of or suspect intestinal perforation (oral use only).
• if you have intestinal fistulas (oral and rectal use).
• if you have tracheoesophageal or bronchoesophageal fistulas (oral use only).
• if you have recently suffered injuries or chemical burns to the gastrointestinal tract (oral and rectal use).
• if you have inadequate blood supply (ischemia) to the intestinal wall (oral and rectal use).
• if you have a bowel inflammatory disease called "necrotizing enterocolitis" (oral and rectal use).
• if you are about to undergo gastrointestinal surgery (oral and rectal use).
• within 7 days after endoscopic resection (oral and rectal use).
• within 4 weeks after concomitant radiotherapy (oral and rectal use).

Warnings and precautions

Consult your doctor or pharmacist before taking Barilux:

• if you are an elderly person with diseases, particularly cardiovascular conditions, as the examination may be stressful for you.

• if you have high-grade stenosis (narrowing), especially those located further from the stomach (distal), or conditions and diseases with a high risk of perforation, such as known gastrointestinal fistulas and carcinomas, inflammatory bowel disease, diverticulitis (inflammation of a diverticulum), diverticulosis, and amebiasis (infection caused by amoebae), as in these cases a careful benefit/risk assessment is required.

• during radiological examination, penetration of barium sulfate into parenteral areas such as tissues, vascular space, body cavities, or airways must 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, penetration of barium sulfate into areas outside the gastrointestinal tract (parenteral) such as tissues, vascular space, body cavities, or airways must be prevented.

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

• during radiological examination, barium sulfate may accumulate in colonic diverticula, potentially promoting and/or worsening infectious processes at these sites.

• if barium sulfate concretions (baroliths) form due to thickening of the barium sulfate suspension, administration of laxatives and/or saline purgatives (containing salts or minerals) is recommended.

Other medicines and Barilux

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Barilux; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are taking any of the following medicines:

Medicines that reduce intestinal peristalsis (wave-like contractions along the intestine): Taking these medicines may cause thickening of the barium sulfate suspension, which could increase the risk of constipation.

Pregnancy, breastfeeding, and fertility

If you think you are pregnant or breastfeeding, believe you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The safety of barium contrast agents in pregnant patients has not been sufficiently established. 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, due to the teratogenic effects of radiation exposure during pregnancy, regardless of whether a contrast agent is used or not, the benefit of the radiological examination must be carefully evaluated.

Breastfeeding
The safety of Barilux in women who are breastfeeding has not been investigated. Contrast agents are excreted in breast milk in minimal amounts. Harm to the infant is not expected, and your doctor will assess the benefit/risk ratio before proceeding with the examination.

The use of Barilux is not contraindicated during breastfeeding.

Driving and using machines

Barilux does not affect the ability to drive or operate tools or machinery.

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

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

Patients with renal insufficiency or those on potassium-restricted diets should be aware that this medicine contains 1.7 mg (0.03 mmol) of potassium per milliliter of suspension.

This medicine contains 6.67 mg of sorbitol per milliliter. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, please consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine 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 of age).

3. How to take Barilux 830 mg/ml

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

Medical personnel will administer Barilux orally, via a tube, or rectally (by enema).

Your doctor will determine the correct amount and dosing schedule required for your radiographic examination, depending on your age, weight, and the technique to be used.

Use in children and adolescents

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

For elderly patients, there are no special dosage recommendations.

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

Patient preparation

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

Patient preparation for oral barium contrast use:

Patient preparation for X-ray examination of the stomach:

If abundant acidic secretion (stomach acidity) is observed on an empty stomach, it is advisable, whenever possible, to aspirate the gastric secretion or schedule the examination for another day (in the morning, as early as possible).

Some physicians use acid secretion inhibitors (medications that reduce the amount of acid produced in the stomach) before performing the X-ray examination, in order to enhance the adherence of the contrast medium to the stomach walls. The test result may be further improved by additionally administering, intravenously or intramuscularly, an antispasmodic agent that reduces stomach tone, decreases peristalsis, and delays gastric emptying.

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

Patient preparation for X-ray examination using biphasic enteroclysis technique:

Your doctor may additionally administer, intravenously or intramuscularly, an antispasmodic agent that reduces intestinal tone, decreases peristalsis (wave-like muscle movements in the intestine), and delays contrast evacuation, in order to improve the test result.

Patient preparation for pediatric use:

Newborns (neonates) do not need to be fasting. Children aged 1–24 months should fast for 4 hours before the procedure; children aged 2–4 years for 6 hours; and children aged 4–14 years for 8 hours before the examination, although in the latter case they may drink some water up to 3 hours before the study.

In young children, it is advisable not to give the last feeding in order to facilitate contrast ingestion.

Patient preparation for rectal barium contrast use:

To obtain an accurate X-ray examination of the large intestine, complete cleansing of the colon and removal of mucus are essential. In this case, it is recommended to administer standard laxatives the day before the examination, specifically indicated for radiological preparation. From that point onward, the patient should drink plenty of fluids (approximately 2–3 liters), but only in the form of tea, water, vegetable soup, fruit juice, etc. Milk and alcohol must be avoided.

If necessary, a cleansing enema may additionally be administered on the day of the radiological examination to achieve a thorough cleansing of the large intestine. At the time of the examination, the large intestine must be free of any residues that could interfere with the radiological study.

Medications that inhibit secretion (reducing the amount of acid produced in the stomach) may be administered prior to the examination to enhance contrast medium adherence to the intestinal walls. Additionally administering an antispasmodic agent (a medication intended to relieve spasms, cramps, and convulsions) intravenously or intramuscularly results in marked hypotonia (reduced muscle tone) of the entire colon, significantly improving the examination outcome and patient tolerance.

Patients with hepatic impairment:

Dosage adjustment is not necessary (see section 2: Special warnings and precautions for use with Barilux).

Patients with renal impairment:

Dosage adjustment is not necessary (see section 2: Special warnings and precautions for use with Barilux).

If you take more Barilux than you should

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

In examinations involving high doses of barium enema, an electrolyte imbalance in blood serum may occur due to the large amount of water retained by the contrast medium. In such cases, the risk may be reduced by adding sodium chloride to the enema fluid. Serum electrolyte balance is restored through appropriate infusion therapy.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91.562.04.20.

If you forget to take Barilux

Do not take a double dose to make up for a missed dose.

If you stop using Barilux

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Serious adverse reactions reported with barium sulfate formulations are generally associated with faulty administration techniques or pre-existing pathological conditions.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Rare adverse effects (likely to affect between 1 and 10 people in 10,000)

• Allergic reactions (urticaria, anaphylactic shock, skin rashes) (by oral and rectal routes).

Very rare adverse effects (likely to affect less than 1 in 10,000 people)

• Intestinal perforation, which may be followed by peritonitis and granulomatosis (by rectal route).
• Intravasation and embolization of barium (by oral and rectal routes).
• Bacteremia (by rectal route).
• Formation of baroliths which may cause obstruction of the large intestine (by oral and rectal routes).

Adverse effects of unknown frequency

• Aspiration pneumonitis (oral route).
• Increase or worsening of intestinal obstruction (oral and rectal routes).

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Barilux 830 mg/ml

This medicine does not require any special storage temperature.

Keep in the original packaging to protect from moisture.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after "Expiry". The expiry date refers to 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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Barilux

• The active substance is barium sulfate. 1 millilitre 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 carmellose, carmellose (carboxymethyl cellulose) (Cekol 30), sodium citrate dihydrate, anhydrous citric acid, sorbitol (E-420), sodium saccharin, potassium sorbate (E-202), sodium benzoate (E-211), liquid strawberry flavoring, dimethicone (Silfar 350), polysorbate 20 (Tween 20), purified water.

Appearance of the product and contents of the container

Barilux is available in clinical packs containing 4 multidose bottles, each with 2000 ml of suspension.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

AVALON LABORATORIOS S.L.

Calle La Cora, number 4, Local 1,

18006 Granada (Granada), Spain

Manufacturer:

Sanochemia Pharmazeutika GmbH.

Landegger Straße 7.

A-2491 Neufeld an der Leitha, Austria.

For any information regarding this medicinal product, please contact the Marketing Authorisation Holder:

Date of the most recent revision of this leaflet: June 2021

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).