Leaflet: information for the user

BARIGRAF555,2 grectal suspension powder

Barium sulfate

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Barigraf 555,2 g and what it is used for

2.What you need to know before starting to use Barigraf 555,2 g

3.How to use Barigraf 555,2 g

4.Possible side effects

5Storage of Barigraf 555,2 g

6.Contents of the pack and additional information

This medication is solely for diagnostic use.

Barigraf555,2 gbelongs to the group of medications known as radiological contrast media for X-rays that contain barium sulfate with suspended agents.

Barigraf555,2 gis a radio-opaque diagnostic agent used to intensify contrast during visualization of the gastrointestinal tract through certain radiological techniques:

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

Barigraf555,2 gis indicated in pediatric populations for opacification of the lower gastrointestinal tract only in simple X-ray contrast explorations as a diagnostic aid for pathologies in these organs.

Do not use Barigraf 555,2 g:

• If you are allergic to barium sulfate or any of the other components of this medication (listed in section 6).
• If you have an inflamed abdominal wall (irritated peritoneum) (via rectal).
• If you have or suspect you have a perforation of the gastrointestinal tract (via rectal).
• If you have intestinal fistulas (via rectal).
• If you have had recent injuries or chemical burns in the gastrointestinal tract (via rectal).
• If you have insufficient blood flow (ischemia) to the intestinal wall (via rectal).
• If you have a condition called necrotizing enterocolitis (via rectal).
• If you are about to undergo surgery on the gastrointestinal tract (via rectal).
• Within 7 days after an endoscopic resection (via rectal).
• Within 4 weeks after concurrent radiation therapy (via rectal).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Barigraf 555,2 g.

• If you are an elderly person with diseases, mainly cardiovascular, as the examination may be stressful for you.
• If you have high-grade stenosis (narrowing), especially in the distal parts of the stomach or conditions and diseases with a high risk of perforation, such as fistulas and gastrointestinal carcinomas, inflammatory bowel disease, diverticulitis (inflammation of a diverticulum), diverticulosis (formation of small pouches "diverticula" in the colon), and amebiasis (infection caused by amoebas), as in these cases a thorough assessment of the benefit/risk is necessary.

During the radiological examination, the penetration of barium sulfate into 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.

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 or worsening infectious processes in this location.

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

Use of Barigraf 555,2 g with other medications

Inform your doctor if you are taking, have recently taken, or may need to take any other medication.

Certain medications may interact with Barigraf 555,2 g, in which case 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 use 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, increasing the risk of constipation.

Pregnancy and lactation

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

The use of barium contrast agents in pregnant patients 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 Barigraf 555,2 g in lactating women has not been investigated. Contrast agents are eliminated through breast milk in minimal amounts. No harm to the infant is predictable, and your doctor will evaluate the benefit/risk before performing the examination.

The use of Barigraf 555,2 g is not contraindicated during lactation.

Driving and operating machinery

Barigraf 555,2 g does not affect driving, handling tools, or operating machinery.

Barigraf 555,2 g contains sorbitol

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The medical staff will administer Barigraf 555,2 g via rectal (using 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 conveniently by the doctor according to age, body weight, and the particularities of pediatric radiodiagnosis.

For elderly patients, there are no special dosage recommendations.

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

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 rectal:

To obtain an exact X-ray examination of the large intestine, it is indispensable to perform a complete cleansing of the colon and eliminate mucus. In this case, it is recommended to administer laxatives of habitual use, especially indicated for radiological preparation, the day before the test. 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 supplementary cleansing enema may be administered on the day of the radiological test to achieve a deep cleansing of the large intestine. At the time in question, the large intestine should be free of those residues that affect the development of the radiological examination.

It is possible to administer medications that inhibit secretion (which reduce the amount of acid produced in the stomach) before the test to increase the adherence of the contrast medium to the walls. The additional administration of an antispasmodic (a medication intended to combat spasms, cramps, and convulsions) via intravenous or intramuscular injection leads to a marked hypotonia (decrease in muscle tone) of the entire colon, which significantly improves the test result and patient acceptance.

If you use more Barigraf 555,2 g 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 explorations where high doses of barium enema are administered, it may cause an alteration of the electrolyte balance in the blood serum 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 serum is restored through adequate infusion therapy.

If you forgot to use Barigraf 555,2 g

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

If you interrupt treatment with Barigraf 555,2 g

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

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 a defective administration technique or pre-existing pathological conditions.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Rare Adverse Effects(may affect up to 1 in 1,000 people)

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

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

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

Adverse Effects of Unknown Frequency(cannot be estimated from available data)

- Increase or intensification of intestinal obstruction (via rectum).

Reporting Adverse Effects

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Barigraf 555.2 g

• The active principle is barium sulfate. Each 100 g of Barigraf 555.2 g contains 97.4 g of barium sulfate.
• The other components are: Pectin, Sodium citrate (E-331), Dimethicone at 30%, Tragacanth gum (E-413), Sorbitol (E-420), Hydrolyzed carrageenan (E-407).

Appearance of the product and contents of the packaging

Barigraf 555.2 g is presented in the form of a white or slightly cream-colored powder in a graduated polyethylene container. The container has a PVC non-toxic tube attached that discharges into a sterile siliconized polyethylene rectal cannula.

Each container contains 570 g of powder.

Holder of the marketing authorization :

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturing responsible parties:

Laboratorios Edefarm S.L

Polígono Industrial Echilagar del Rullo. Nave 117. 46191 Vilamarxant. Valencia. Spain.

Or

Laboratorios ERN, S.A.

Gorcs i LLadó, 188 – 08210 Barberá del Vallés, Barcelona. Spain.

Last review date of this leaflet: January 2016

Other sources of information

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

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This information is intended solely for healthcare professionals:

Instructions for the correct preparation of the suspension:

Add a small amount of hot water and shake. Add more water to achieve the desired concentration. Additional water can be added during administration if necessary. Shake vigorously before use. If a double-contrast examination is desired, air or a gas-producing agent can be added.

The complete technical data sheet for Barigraf 555.2 g is supplied as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this medication.

Please consult the technical data sheet (the technical data sheet must be included in the box).