BARILUX 764.32 g POWDER FOR ORAL AND RECTAL SUSPENSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Barilux 764.32 g powder for oral and rectal suspension.

Barium sulfate (DCI)

Contents of the package leaflet:

1. What is Barilux 764.32 g and what is it used for.

1. Before taking Barilux 764.32 g.

1. How to take Barilux 764.32 g.

1. Possible side effects.

1. Storage of Barilux 764.32 g.

1. Further information.

1. What is Barilux 764.32 g and what is it used for

This medicinal product is for diagnostic use only.

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

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

• Oral use:

• For simple contrast X-ray examinations of the upper gastrointestinal tract (esophagus, stomach, or small intestine), as a diagnostic aid for pathologies in these organs.
• For X-ray examinations using the enteroclysis bifasic technique (administered through a probe) as a diagnostic aid for pathologies in the small intestine.

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

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 764.32 g

Do not take Barilux:

• during the 7 days following an endoscopic resection (by oral and rectal route).
• during 4 weeks after concomitant radiotherapy (by oral and rectal route).

Be careful with 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, especially the most distant (distal) 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 assessment of the benefit/risk is necessary.

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

You should also ensure adequate hydration after the procedure to avoid 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 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, it is recommended to administer laxatives and/or saline purgatives (with salts or minerals)

Use of other medicines

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

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

• Medicines that reduce intestinal peristalsis (contractions in the form of a wave along the intestine): Taking these medicines may cause thickening of the barium sulfate suspension and increase the risk of constipation.

Use of Barilux with food and drinks

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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 it is 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 eliminated in breast milk in minimal amounts. No harm to the infant is expected, and your doctor will assess the benefit/risk before performing the examination.

The use of Barilux is not contraindicated during breastfeeding

Driving and using machines

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

Important information about some of the components of Barilux

Patients with low-sodium diets should note that this medicine contains 4.152 - 5.072 mg (180.8 - 220.8 mmol) of sodium per single-dose bag of 800 g of Barilux

3. How to take Barilux 764.32 g

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

The medical staff will administer Barilux orally or rectally (through an enema).

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 pediatric radiodiagnosis.

For elderly patients, there are no special dosage recommendations.

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

Preparation of the patient

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

Preparation of the patient for the use of barium contrast by oral route:

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

If abundant acid secretion (stomach acidity) is observed on an empty stomach, it is recommended, as far as 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 objective of increasing the adherence of the contrast medium to the stomach walls. The test result improves if an antispasmodic is additionally administered intravenously or intramuscularly, which decreases the tone of the stomach, reduces peristalsis, and delays stomach emptying.

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

Preparation of the patient for X-ray examination using the enteroclysis bifasic technique:

The doctor may additionally administer an antispasmodic intravenously or intramuscularly, which decreases the tone of the intestine, reduces peristalsis (wave-like movement of the intestinal muscles), and delays the evacuation of the contrast, with the objective of improving the test result.

Preparation of the patient for pediatric use:

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

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

Preparation of the patient for the use of barium contrast by rectal route:

To obtain an accurate X-ray examination of the large intestine, it is essential to perform a complete cleaning of the colon and eliminate mucus. In this case, it is recommended to administer common laxatives indicated especially for radiological preparation the day before the examination. From this moment on, the patient should take abundant 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 complementarily on the day of the radiological examination to achieve a deep cleansing of the large intestine. At the time of the examination, 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 examination 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 (decrease in muscle tone) of the entire colon, which significantly improves the test result and patient acceptance.

Patient with hepatic insufficiency:

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

Patient with renal insufficiency:

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

If you use more Barilux 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. In these 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

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

If you interrupt treatment with Barilux

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

4. Possible side effects

Like all medicines, Barilux can cause side effects, although not everybody gets them.

Severe 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, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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

• allergic reactions (urticaria, anaphylactic shock, skin rashes) (by oral and rectal route).

Very rare side effects(it is likely that they affect less than 1 in every 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 route).
• bacteremia (by rectal route)
• formation of barioliths that can cause blockage of the large intestine (by oral and rectal route).

Side effects of unknown frequency

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

5. Storage of Barilux 764.32 g

This medicinal product does not require any special storage temperature.

Keep in the original packaging to protect it from moisture

Keep out of the reach and sight of children.

Do not use Barilux after the expiration date stated on the packaging. The expiration 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

• The active substance is barium sulfate. 1 single-dose bag of 800 g of powder contains 764.32 g of barium sulfate
• The other components are: sodium carmellose; sodium saccharin; 3-ethoxy-4-hydroxybenzaldehyde (ethyl vanillin); sodium citrate; polysorbate 20; dimethicone.

Appearance of the product and packaging contents

Barilux is a white powder used to prepare a suspension.

Barilux is available in clinical packaging containing 5 single-dose bags of 800 g of powder for oral and rectal 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.

For any information about this medicine, please contact the Marketing Authorization Holder.

This leaflet was approved in December 2010

This information is intended only for healthcare professionals:

The complete technical data sheet of Barilux 764.32 powder for oral and rectal suspensionis included as a detachable section at the end of this leaflet, in order to provide healthcare professionals with scientific and practical information on the administration and use of this medicinal product.