Barigraf 555.2 g powder for rectal suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BARIGRAF 555.2 g powder for rectal suspension

Barium sulfate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Barigraf 555.2 g is and what it is used for
2. What you need to know before using Barigraf 555.2 g
3. How to use Barigraf 555.2 g
4. Possible side effects
5. Storage of Barigraf 555.2 g
6. Contents of the pack and other information

1. What Barigraf 555.2 g is and what it is used for

This medicine is for diagnostic use only.

Barigraf 555.2 g belongs to the group of medicines known as radiological contrast media for X-rays containing barium sulfate with suspension agents.

Barigraf 555.2 g is a radiopaque diagnostic agent used to enhance contrast during visualization of the gastrointestinal tract by means of certain radiological techniques:

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

Barigraf 555.2 g is indicated in the pediatric population for opacification of the lower gastrointestinal tract only in single-contrast X-ray examinations, as a diagnostic aid in pathologies affecting these organs.

2. What you need to know before using Barigraf 555.2 g

Do not use Barigraf 555.2 g:

• If you are allergic to barium sulfate or to any of the other ingredients of this medicine (listed in section 6).
• If you have inflammation of the abdominal cavity walls (irritated peritoneum) (administered rectally).
• If you have or suspect a gastrointestinal tract perforation (administered rectally).
• If you have intestinal fistulas (administered rectally).
• If you have recently suffered injuries or chemical burns to the gastrointestinal tract (administered rectally).
• If you have inadequate blood supply (ischemia) to the intestinal wall (administered rectally).
• If you have a bowel inflammatory disease called "necrotizing enterocolitis" (administered rectally).
• If you are about to undergo gastrointestinal surgery (administered rectally).
• During the 7 days following endoscopic resection (administered rectally).
• During 4 weeks after concomitant radiotherapy (administered rectally).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Barigraf 555.2 g if:

• You are an elderly person with diseases, particularly cardiovascular conditions, as the examination may be stressful for you.
• 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 (formation of small pouches called "diverticula" in the colon), or amebiasis (infection caused by amoebae), as in these cases a careful benefit/risk assessment is required.

During the 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.

In case of massive aspiration of the product, intravasation (entry 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 colonic diverticula, potentially promoting and/or worsening infectious processes at these sites.

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

Use of Barigraf 555.2 g with other medicines

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

Certain medicines may interact with Barigraf 555.2 g. 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, increasing the risk of constipation.

Pregnancy and breastfeeding

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.

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—the benefit of the radiological examination must be carefully evaluated.

The safety of Barigraf 555.2 g in breastfeeding women has not been investigated. Contrast agents are excreted in breast milk in minimal amounts. Harm to the infant is not expected. Your doctor will assess the benefit/risk balance before proceeding with the examination.

The use of Barigraf 555.2 g is not contraindicated during breastfeeding.

Driving and use of machines

Barigraf 555.2 g does not affect the ability to drive or operate tools or machinery.

Barigraf 555.2 g contains sorbitol

This medicine contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult him before using this medicine.

3. How to use Barigraf 555.2 g

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Medical personnel will administer Barigraf 555.2 g to you rectally (by means of 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.

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 rectal administration of barium contrast:

To obtain an accurate X-ray examination of the large intestine, it is essential to completely clean the colon and remove mucus. For this reason, it is recommended to take usual laxatives the day before the test, specifically indicated for radiological preparation. From this time onward, the patient should drink large amounts 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 examination.

Medications that inhibit secretion (reducing the amount of acid produced in the stomach) may be administered before the test to enhance adherence of the contrast medium to the intestinal walls. Additionally, administration of an antispasmodic (a medicine intended to relieve spasms, cramps, and convulsions) by intravenous or intramuscular route leads to marked hypotonia (reduced muscle tone) of the entire colon, significantly improving the examination results and patient tolerance.

If you use more Barigraf 555.2 g 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 where high doses of barium enema are administered, an electrolyte imbalance in blood serum may occur due to the large amount of water retained by the contrast agent. In such cases, the risk may be reduced by adding sodium chloride to the enema fluid. The electrolyte balance in serum is restored through appropriate infusion therapy.

If you forget to use Barigraf 555.2 g

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

If you stop treatment with Barigraf 555.2 g

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse reactions reported with the administration of 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 effect not listed in this leaflet, inform your doctor or pharmacist.

Rare adverse effects (may affect up to 1 in 1,000 people)

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

Very rare adverse effects (may affect up to 1 in 10,000 people)

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

Adverse effects with unknown frequency (cannot be estimated from the available data)

• Increase or worsening of intestinal obstruction (by rectal route).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Barigraf 555.2 g

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 EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Barigraf 555.2 g

• The active substance 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 30%, Tragacanth gum (E-413), Sorbitol (E-420), Hydrolyzed carrageenan (E-407).

Presentation of the product and contents of the pack

Barigraf 555.2 g is presented as a white or slightly creamy powder in a graduated polyethylene container. The container is fitted with a non-toxic PVC tube leading into a sterile, silicone-coated polyethylene rectal cannula.

Each container contains 570 g of powder.

Marketing Authorization Holder:

LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain

Manufacturers:

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 Barberà del Vallès, Barcelona. Spain.

Date of the most recent revision of this leaflet: January 2016

Other sources of information

Detailed and up-to-date 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/

This information is intended for healthcare professionals only:

Instructions for the correct preparation of the suspension:

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

The complete Summary of Product Characteristics for Barigraf 555.2 g is supplied as a separate document within the product package, providing healthcare professionals with additional scientific and practical information on the administration and use of this medicinal product.

Please consult the Summary of Product Characteristics (the Summary of Product Characteristics must be included in the package).