BARIGRAF 555.2 g POWDER FOR RECTAL SUSPENSION

Introduction

Package Leaflet: Information for the User

BARIGRAF555.2 grectal suspension powder

Barium sulfate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of the package leaflet:

1. What Barigraf 555.2 g is and what it is used for
2. What you need to know before you start using Barigraf 555.2 g
3. How to use Barigraf 555.2 g
4. Possible side effects

5 Conservation of Barigraf 555.2 g

1. Package contents and additional information

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

This medicinal product is for diagnostic use only.

Barigraf 555.2 g belongs to a group of medicinal products called radiological contrast media for X-rays that contain barium sulfate with suspension agents.

Barigraf 555.2 g is a radio-opaque diagnostic agent used to enhance contrast during visualization of the gastrointestinal tract using certain radiological techniques:

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

Barigraf 555.2 g is indicated in the pediatric population for opacification of the 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 start using Barigraf 555.2 g

Do not use Barigraf 555.2 g:

• If you are allergic to barium sulfate or any of the other components of this medicinal product (listed in section 6).
• If you have inflammation of the abdominal cavity walls (irritated peritoneum) (via rectal route).
• If you have or suspect a perforation of the gastrointestinal tract (via rectal route).
• If you have intestinal fistulas (via rectal route).
• If you have recently suffered injuries or chemical burns in the gastrointestinal tract (via rectal route).
• If you have insufficient blood supply (ischemia) to the intestinal wall (via rectal route).
• If you have an inflammatory disease of the intestine called "necrotizing enterocolitis" (via rectal route).
• If you are about to undergo gastrointestinal tract surgery (rectal route)
• During the 7 days following an endoscopic resection (via rectal route).
• During 4 weeks after concurrent radiotherapy (via rectal route).

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to use Barigraf 555.2 g

• If you are an elderly person with diseases, mainly cardiovascular, as the examination can be stressful for you.
• If you have stenosis (narrowing) of a high degree, especially the more distant (distal) ones 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 (formation of small pouches "diverticula" in the colon) and amoebiasis (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 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.

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 the colon diverticula, which may favor and/or aggravate infectious processes at this location.

In the event that barium sulfate coprolites (bariolites) are formed due to the thickening of barium sulfate, in this case, the administration of laxatives and/or saline purgatives (with salts or minerals) is recommended.

Using Barigraf 555.2 g with other medicines

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

Certain medicines may interact with Barigraf 555.2 g, 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, which may increase 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 medicinal product.

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 Barigraf 555.2 g has not been investigated in breastfeeding women. Contrast media 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 subjecting you to an examination.

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

Driving and using machines

Barigraf 555.2 g does not affect driving or the use of tools or machines.

Barigraf 555.2 g contains sorbitol

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

3. How to use Barigraf 555.2 g

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

The medical staff will administer Barigraf 555.2 g to you via the rectal route (via 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 characteristics of pediatric radiodiagnosis.

For elderly patients, there are no special dosage recommendations.

Consult your doctor if you wish to clarify 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 via the 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 laxatives of habitual use indicated especially 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 cleansing enema may be administered on the day of the radiological test to achieve a deep wash 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 secretion-inhibiting medications (which reduce the amount of acid produced in the stomach) before the test to increase the adhesion of the contrast medium to the walls. The additional administration of an antispasmodic (medication intended to combat contractures, cramps, and convulsions) via the intravenous or intramuscular route leads to a marked hypotonia (decrease in muscle tone) of the entire colon, which significantly improves the result of the test and the patient's acceptance.

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 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.

If you forget to use Barigraf 555.2 g

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

If you stop using Barigraf 555.2 g

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

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.

Serious 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 that are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

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

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

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

• Intestinal perforation, which may be followed by peritonitis and granulomatosis (via rectal route).
• Intravasation and embolization of barium (via rectal route).
• Bacteremia (via rectal route)
• Formation of bariolites that can cause blockage of the large intestine (via rectal route).

Side effects of unknown frequency(cannot be estimated from the available data)

• Increased or intensified intestinal obstruction (rectal route).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online reporting system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Conservation of Barigraf 555.2 g

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

Do not use this medicinal product after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Package contents and additional information

Composition of Barigraf 555.2 g

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

Appearance of the product and package contents

Barigraf 555.2 g is presented as a white or slightly creamy powder in a graduated polyethylene container. The container has a PVC tube attached that leads to a sterile siliconized rectal cannula made of polyethylene.

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 Barberá del Vallés, Barcelona. Spain.

Date of the last revision of this leaflet: January 2016

Other sources of information

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

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This information is intended only 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. More 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 of Barigraf 555.2 g is provided 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 medicinal product.

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