BARILUX 830 mg/ml ORAL AND RECTAL SUSPENSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Barilux 830 mg/ml oral and rectal suspension.

Barium sulfate (DCI)

Contents of the pack:

1. What Barilux 830 mg/ml is and what it is used for.
2. What you need to know before you take 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 medicinal products called radiological contrast agents for X-rays that contain barium sulfate with suspension agents.

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 simple contrast and 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. What you need to know before you take Barilux 830 mg/ml

Do not take Barilux:

• if you are allergic to the active substance or to any of the other ingredients of this medicinal product (listed in section 6).
• If you have inflammation of the walls of the abdominal cavity (irritated peritoneum) (by oral and rectal route).
• If you have or suspect a complete obstruction of the gastrointestinal tract (only for oral use).
• If you have pyloric stenosis (only for oral use).
• If you have or suspect a perforation of the gastrointestinal tract (by oral and rectal route).
• If you have postoperative gastrointestinal suture dehiscence (opening of the suture) (only for oral use).
• If you have a history or suspect intestinal perforation (only for oral use).
• If you have intestinal fistulas (by oral and rectal route).
• If you have tracheoesophageal or bronchoesophageal fistulas (only for oral use).
• If you have had recent injuries or chemical burns in the gastrointestinal tract (by oral and rectal route).
• If you have insufficient blood supply (ischemia) to the intestinal wall (by oral and rectal route).
• If you have an inflammatory disease of the intestine called "necrotizing enterocolitis" (by oral and rectal route).
• If you are about to undergo gastrointestinal surgery (oral and rectal route)
• During the 7 days following an endoscopic resection (by oral and rectal route).
• During 4 weeks after concomitant radiotherapy (by oral and rectal route).

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 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 it is necessary to carry out a meticulous assessment of the benefit/risk.

• During the radiological examination, the penetration of barium sulfate into parental areas such as tissues, vascular space, and body cavities or into the 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 into the 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, which may favor and/or aggravate infectious processes at this location.

• In the event that barium sulfate coprolites (barioliths) form due to the thickening of barium sulfate, in this case, it is recommended to administer laxatives and/or saline purgatives (with salts or minerals)

Other medicines and Barilux

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

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 are using 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 may increase the risk of constipation.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

It has not been sufficiently demonstrated that the use of barium contrast agents 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.

Breastfeeding

The safety of Barilux has not been investigated in breastfeeding women. Contrast agents are eliminated in breast milk in minimal amounts. No harm to the breastfed child 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.

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

This medicinal product 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 recommended daily sodium intake for an adult.

Patient with renal insufficiency or low-potassium diets should note that this medicinal product contains 1.7 mg (0.03 mmol) of potassium per milliliter of suspension

This medicinal product contains 6.67 mg of sorbitol in each milliliter. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder, in which the patient cannot break down fructose, consult your doctor before taking this medicinal product.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medicinal product contains 4.10 mg of sodium benzoate in each 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 of this medicinal product indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Medical personnel will administer Barilux to you orally, through a probe, or rectally (through 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 to be used.

Use in children and adolescents

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 completed.

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 gastric secretion or perform the examination on another day (in the morning, as early as possible).

Some professionals use acid secretion inhibitor medications (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 agent to the stomach walls. The test result improves if an antispasmodic is administered additionally, by intravenous or intramuscular route, which decreases the tone of the stomach, reduces 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.

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

Your doctor may administer an antispasmodic to you additionally, by intravenous or intramuscular route, 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 aim of improving the test result.

Preparation of the patient for pediatric use:

Newborns do not need to be fasting. As 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 up to 3 hours before the study.

In small children, it is recommended not to provide the last meal to facilitate the intake of 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 usual laxatives indicated especially for radiological preparation the day before the examination. 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 complementarily on the day of the radiological examination to achieve a deep cleansing of the large intestine. For the time being, the large intestine should be free of those residues that affect the development of the radiological examination.

It is possible to administer acid secretion inhibitor medications before the examination to increase the adherence of the contrast agent to the walls. The additional administration of an antispasmodic by intravenous or intramuscular route 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: Take special care with Barilux)

Patient with renal insufficiency:

No dose adjustment is necessary (see section 2: Take special care 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 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. Phone 91.562.04.20.

If you forget to take Barilux

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

If you stop taking Barilux

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

4. Possible side effects

Like all medicines, this medicine 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 think you have any of the side effects listed, or if you notice any other unusual effects, tell your doctor or pharmacist.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Barilux 830 mg/ml

This medicinal product does not require any special storage temperature

Keep the container in the outer carton to protect it from moisture

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Barilux

• The active ingredient 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 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 flavor, dimethicone (Silfar 350), polysorbate 20 (Tween 20), purified water.

Appearance of the Product and Container Content

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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.