BARIGRAF AD 333.2 g ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

BARIGRAF AD333.2 goral powder for suspension

Barium sulfate

Read all of this leaflet carefully before you start taking 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the package leaflet

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

1. What is Barigraf AD and what is it used for

This medicinal product is for diagnostic use only.

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

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

• Its oral use is indicated as a contrast medium in radiological examinations (X-rays) of the esophagus, stomach, and duodenum, using the double contrast technique.

Barigraf AD 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 Barigraf AD

Do not take Barigraf AD:

• If you are allergic (hypersensitive) to the active substance or 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).
• If you have or suspect you have a complete obstruction of the gastrointestinal tract.
• If you have narrowing of the pylorus (pyloric stenosis).
• If you have or suspect you have a perforation of the gastrointestinal tract.
• If you have a postoperative gastrointestinal suture dehiscence (opening of the suture).
• If you have a history or suspect you have intestinal perforation.
• If you have intestinal fistulas.
• If you have tracheoesophageal or bronchoesophageal fistulas.
• If you have recently suffered injuries or chemical burns in the esophagogastric tract.
• If you have insufficient blood supply (ischemia) to the intestinal wall.
• If you have an inflammatory disease of the intestine called "necrotizing enterocolitis".
• If you are about to undergo gastrointestinal surgery.
• During the 7 days following an endoscopic resection.
• During 4 weeks after concurrent radiotherapy.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Barigraf AD.

Special attention should be paid when administering Barigraf AD:

• 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, 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.

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

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

Other medicines and Barigraf AD

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

Certain medicinal products may interact with Barigraf AD, in these cases, it may be necessary to change the dose or interrupt treatment with one of the medicinal products. It is especially important that you inform your doctor if you are using any of the following medicinal products:

• Medicinal products that reduce intestinal peristalsis (contractions in the form of a wave along the intestine): Taking these medicinal products 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 AD 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 Barigraf AD is not contraindicated during breastfeeding.

Driving and using machines

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

Barigraf AD contains sodium (sodium saccharin, sodium citrate) and sorbitol (E-420)

This medicinal product contains 0.22 mg of sodium (main component of table salt/cooking salt) per gram of Barigraf AD, which corresponds to 73.6 mg of sodium per 340 g glass of Barigraf AD. This is equivalent to 3.68% of the maximum recommended daily sodium intake for an adult.

This medicinal product contains 12.88 mg of sorbitol per gram of Barigraf AD (4.38 g per 340 g glass of Barigraf AD). 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 disease in which the patient cannot break down fructose, consult your doctor before receiving this medicinal product.

3. How to take Barigraf AD

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

The medical staff will administer Barigraf AD orally.

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.

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 wish to clarify 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 X-ray examination of the stomach:

If abundant acid secretion (gastric acidity) is observed on an empty stomach, your doctor may aspirate the gastric secretion as much as possible 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 medium 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 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 the latter case, they may drink a little water until 3 hours before the study.

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

If you take more Barigraf AD than you should

Rarely, repeated administration of barium sulfate suspensions may cause stomach contractions and diarrhea. These reactions are transient and are 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 medium. In these cases, the risk can be reduced by adding a sodium chloride enema. The electrolyte balance in the serum is restored by adequate infusion therapy.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91.562.04.20 indicating the medicinal product and the amount ingested.

If you forget to take Barigraf AD

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

If you stop taking Barigraf AD

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

4. Possible side effects

Like all medicinal products, Barigraf AD 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.

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)

• Entry of barium into the bloodstream and blockage of a blood vessel.
• Formation of barioliths that can cause blockage of the large intestine.

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

• Aspiration pneumonitis.
• Increased or intensified intestinal obstruction.
• Inflammations of the large intestine, barium sulfate may be retained and cause or worsen infectious processes.

Reporting of side effects

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

5. Storage of Barigraf AD

No special storage conditions are required.

Keep the medicinal product in the original packaging 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 stated on the packaging. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Barigraf AD

• The active substance is barium sulfate. 100 g of oral powder for suspension contain 98 g of barium sulfate.
• 1 glass of 340 g of oral powder for suspension contains 333.2 g of barium sulfate.
• The other ingredients are: Sorbitol (E-420), Ethylmaltol, Sodium saccharin (E-954), Sodium citrate (E-331), Citric acid monohydrate, Hydrolyzed carrageenan, Gatti gum, Cassis essence, Strawberry essence, Simethicone, Polyethylene glycol 20 glyceryl laurate, Red aluminum lacquer FD&C No. 40.

Appearance of the product and packaging contents

Barigraf AD is presented as a powder in a single-dose polyethylene glass.

Each packaging contains 340 g of oral powder for suspension.

Barigraf AD is presented in packaging of 1 unit and clinical packaging of 10 units.

Only some packaging sizes may be marketed.

Marketing authorization holder:

Laboratorios ERN, S.A.

C/Perú, 228 - 08020 Barcelona, Spain

Manufacturers:

Laboratorios Edefarm S.L

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

Or

Laboratorios ERN, S.A.

C/Gorgs Lladó, 188

Pol. Ind. Can Salvatella

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 Health 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

Loosen the powder from the bottom of the glass by inverting it. It is recommended to mix the contents of the glass first with a little water until a homogeneous paste is obtained. Then, more water should be added gradually to the paste until the desired powder/water ratio is reached (see section 4.2 Posology and method of administration of the Summary of Product Characteristics). Mix the mass intensively for 1 minute, let it rest for 5 minutes, and mix intensively again for 1 minute. Check that all the powder has been moistened and that there are no lumps.

The suspension, once prepared, should be administered 15 minutes before starting the radiological examination.

In the case of using a mechanical agitator/mixer, care should be taken to ensure that no air bubbles are incorporated into the preparation.

The resulting suspension should have a uniform consistency and be free of particle aggregates.

If it is necessary to administer the suspension at body temperature, hot water at 35-40°C can be used. The water should not be heated above 60°C due to the presence of thermosensitive excipients. In this case, the temperature of the suspension should be checked.

The complete Summary of Product Characteristics of Barigraf AD 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 Summary of Product Characteristics (the Summary of Product Characteristics must be included in the box).