Label: information for the user

BARIgraf AD333.2 goral suspension powder

Barium Sulfate

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

1. What isBarigraf ADand what it is used for

2. What you need to know before starting to takeBarigraf AD

3. How to takeBarigraf AD

4. Possible adverse effects

5. Storage ofBarigraf AD

6. Contents of the package and additional information

This medication is solely for diagnostic use.

Barigraf AD belongs to the group of medications known as radiological contrast agents for X-rays that contain barium sulfate with suspended agents.

Barigraf AD is a radio-opaque diagnostic agent used to intensify contrast during visualization of the esophagus and gastrointestinal tract through certain radiological techniques:

• Its oral use is indicated as a contrast medium in radiological explorations (radiographs) of the esophagus, stomach, and duodenum, through the double contrast technique.

Barigraf AD is indicated in pediatric populations for opacification of the upper and lower gastrointestinal tract only in X-ray contrast explorations as a diagnostic aid for pathologies in said organs..

Do not take Barigraf AD:

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have inflammation of the abdominal cavity walls (irritated peritoneum).
• If you have a complete obstruction of the gastrointestinal tract.
• If you have a 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 (suture opening).
• If you have a history or suspicion of intestinal perforation.
• If you have intestinal fistulas.
• If you have tracheoesophageal or bronchoesophageal fistulas.
• If you have suffered recent injuries or chemical burns in the esophagogastric tract.
• If you have insufficient blood flow (ischemia) to the intestinal wall.
• If you have a condition called necrotizing enterocolitis.
• If you are about to undergo gastrointestinal tract surgery.
• Within 7 days after an endoscopic resection.
• Within 4 weeks after concurrent radiation therapy.

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 may be stressful for you.
• If you have high-grade stenosis, especially the more 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 a thorough assessment of the benefit/risk is necessary.

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

To avoid potentially severe 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 respiratory tracts should be prevented.

In the event of massive aspiration of the product, intravascular penetration, or perforation, specialized medical intervention, intensive care, or even surgery is necessary.

During the radiological examination, barium sulfate may accumulate in the colon diverticula, potentially favoring and/or worsening infectious processes in this location.

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

Other medications and Barigraf AD

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with Barigraf AD, in which case it may be necessary to change the dose or discontinue treatment with one of the medications. It is especially important to inform your doctor if you are using 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, which may increase the risk of constipation.

Pregnancy and lactation

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

The use of barium contrast agents in pregnant women 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 AD in women breastfeeding their children has not been investigated. Contrast agents are eliminated in breast milk in minimal amounts. No harm to the infant is predictable, and your doctor will evaluate the benefit/risk before subjecting you to an examination.

The use of Barigraf AD is not contraindicated during breastfeeding.

Driving and operating machines

Barigraf AD does not affect driving, handling tools, or machines.

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

This medication contains 0.22 mg of sodium (main component of table salt/for cooking) in each gram of Barigraf AD, corresponding to 73.6 mg of sodium per 340 g vial of Barigraf AD. This represents 3.68% of the recommended daily maximum sodium intake for an adult.

This medication contains 12.88 mg of sorbitol in each gram of Barigraf AD (4.38 g per 340 g vial of Barigraf AD).If your doctor has indicated that you (or your child) have a condition of intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before receiving this medication.

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

The medical staff will administer Barigraf AD orally.

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 conveniently by the doctor according to age, body weight, and pediatric radiodiagnostic particularities.

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 stomach X-ray exploration:

If excessive gastric acid secretion is observed in the fasting state, your doctor may aspirate 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 inhibitors (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 additional antispasmodic is administered intravenously or intramuscularly, which reduces stomach tone, decreases peristalsis, and delays stomach evacuation.

To extend the different regions of the stomach, it is recommended to administer simultaneously a medication with a carbon dioxide-forming effect.

Patient preparation for pediatric use:

Newborns (neonates) do not need to be fasting. As for children aged 1-24 months, they should be fasting for 4 hours before the test, 6 hours for children aged 2-4 years, and 8 hours for children aged 4-14 years, although in the latter case, they may take a little water up to 3 hours before the study.

In young children, it is recommended not to provide the last meal to facilitate the ingestion of the contrast.

If you take more Barigraf AD than you should

In rare cases, repeated administration of barium sulfate suspensions may cause stomach contractions and diarrhea. These reactions are transient and not considered serious.

In examinations where high doses of barium enema are administered, it may cause an alteration of the electrolyte balance in the blood due to the large amount of water retained by the contrast. In such cases, it is possible to reduce the risk by adding a sodium chloride enema. The electrolyte balance in the blood is restored through appropriate infusion therapy.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 91.562.04.20 indicating the medication and the amount ingested.

If you forgot to take Barigraf AD

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

If you interrupt treatment with Barigraf AD

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

Like all medications, Barigraf AD may produce adverse effects, although not all people 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.

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).

• Barium entry into the bloodstream and occlusion of a blood vessel.
• Formation of barium granules that may cause intestinal blockage.

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

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

Reporting 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 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.

No requires special conservation conditions.

Keep in the original packaging to protect it from humidity.

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. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or in the trash. Dispose of the 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 the packaging and medications you no longer need. In this way, you will help protect the environment..

Composition of Barigraf AD

• The active ingredient is Barium Sulfate.100 gof oral suspension powder contains98 gof barium sulfate.
• One vial of340 gof oral suspension powder contains333.2 gof barium sulfate.
• The other components are: Sorbitol (E-420), Etilmaltol, Sodium Saccharin (E-954), Sodium Citrate (E-331), Citric Acid Monohydrate, Hydrolyzed Carrageenan, Gatti Gum, Cassis Essence, Strawberry Essence, Simeticone, Polyethylene Glycol 20 Glyceril Laurate, Aluminum FD&C Red No. 40.

Appearance of the product and contents of the packaging

Barigraf AD is presented in the form of powder in a single-dose polyethylene vial.

Each package contains340 gof oral suspension powder.

Barigraf AD is presented in packages of 1 unit and a clinical package of 10 units.

Only some package sizes may be commercially available.

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.

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 doctors and healthcare professionals:

Instructions for the correct preparation of the suspension

Turn the vial upside down to loosen the powder. It is recommended to mix the contents of the vial first with a little water until a homogeneous paste is obtained. Then, add more water to the paste gradually until the desired powder-to-water ratio is reached (see section 4.2 Posology and administration form of the Technical Dossier). Mix the mass intensively for 1 minute, let it rest for 5 minutes, and mix it intensively again for 1 minute. Check that all the powder has been moistened and that there are no lumps.

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

In the case of using a mechanical agitator/mixer, special care must be taken to avoid incorporating any air bubbles into the preparation.

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

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

The complete technical dossier of Barigraf AD 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 dossier (the technical dossier must be included in the box).