Barigraf Tac powder for oral suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Barigraf TAC, 10 g powder for oral suspension

Barium Sulfate

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you/your child and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine is for diagnostic use only.

Barigraf TAC belongs to the group of medicines known as X-ray contrast media containing barium sulfate with suspending agents, classified within the ATC (anatomical therapeutic chemical classification) under the pharmacotherapeutic group VO8BA01.

Barigraf TAC is a radiopaque diagnostic agent used in both adults and pediatric populations to enhance contrast during radiological visualization of the esophagus and gastrointestinal tract:

• For computed tomography (CT) examinations of the upper gastrointestinal tract (esophagus, stomach, or small intestine), as an aid in diagnosing pathologies affecting these organs.
• For CT examinations using the enteroclysis technique (administered via a tube), as a diagnostic aid in suspected intestinal obstruction and in the evaluation of possible intestinal fistula.

2. What you need to know before taking Barigraf TAC

Do not take Barigraf TAC:

• If you are allergic (hypersensitive) to barium sulfate or to any of the other components of this medicine (listed in section 6).
• If you have inflammation of the abdominal cavity walls (irritated peritoneum).
• If you have or suspect you have a complete gastrointestinal tract obstruction.
• If you have pyloric narrowing (pyloric stenosis).
• If you have or suspect a gastrointestinal tract perforation.
• If you have postoperative gastrointestinal suture dehiscence (opening of the suture).
• If you have a history of or suspect 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 esophagogastrointestinal tract.
• If you have inadequate blood supply (ischemia) to the intestinal wall.
• If you have a bowel inflammatory disease called "necrotizing enterocolitis".
• If you are about to undergo gastrointestinal tract surgery.
• During the 7 days following endoscopic resection.
• During the 4 weeks following concomitant radiotherapy.

Warnings and precautions

• If you are an elderly person with diseases, particularly cardiovascular conditions, as the examination may be stressful for you.
• If 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, and 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 respiratory tract must be prevented to avoid potentially serious adverse reactions.

You should also ensure adequate hydration after the procedure to prevent severe constipation.

To avoid potentially serious adverse reactions, during the diagnostic process, barium sulfate must not penetrate outside the gastrointestinal tract (i.e., into parenteral areas) such as tissues, vascular space, body cavities, or respiratory tract.

In case of massive product aspiration, 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 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 (with salts or minerals) is recommended.

Other medicines and Barigraf TAC

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

Certain medicines may interact with Barigraf TAC. 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 TAC in breastfeeding women has not been investigated. Contrast agents are excreted in breast milk in minimal amounts. Harm to the infant is not expected, but your doctor will assess the benefit/risk balance before proceeding with the examination.

The use of Barigraf TAC is not contraindicated during breastfeeding.

Driving and use of machines

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

Barigraf TAC contains sorbitol and sodium

This medicine contains 12.23 g of sorbitol per sachet.

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains 415 mg of sodium (the main component of table/cooking salt) per single-dose sachet. This corresponds to 21% of the maximum recommended daily sodium intake for an adult.

3. How to take Barigraf TAC

Follow exactly the administration instructions for Barigraf TAC provided by your doctor. If in doubt, consult your doctor or pharmacist.

Medical personnel will administer Barigraf TAC orally. Your doctor will determine the appropriate amount and dosing 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 completion of the examination.

Patient preparation

You should drink plenty of water after the examination to reduce the risk of constipation.

Patient preparation for gastric examination:

If abundant acid secretion (acid reflux) is observed while fasting, it is advisable, whenever possible, to aspirate the gastric secretion or schedule the examination for another day (in the morning, as early as possible).

Some physicians use acid secretion inhibitors (medications that reduce the amount of acid produced in the stomach) prior to computed tomography scanning, in order to enhance adherence of the contrast medium to the stomach walls. The test result may be improved by additionally administering, intravenously or intramuscularly, an antispasmodic agent that reduces gastric tone, decreases peristalsis, and delays gastric emptying.

Patient preparation for enteroclysis technique:

Your doctor may additionally administer, intravenously or intramuscularly, an antispasmodic agent that reduces intestinal tone, decreases peristalsis (the wave-like muscle contractions of the intestine), and delays contrast evacuation, in order to improve the test result.

Pediatric patient preparation:

Newborn patients (neonates) do not need to be fasting. Children aged 1–24 months should fast for 4 hours prior to the procedure; children aged 2–4 years for 6 hours; and children aged 4–14 years for 8 hours before the examination, although in the latter group, small amounts of water may be allowed up to 3 hours before the study.

In young children, it is recommended not to give the last feeding immediately before contrast administration to facilitate ingestion of the contrast medium.

Patients with hepatic impairment:

Dose adjustment is not necessary (see section 2: Warnings and precautions).

Patients with renal impairment:

Dose adjustment is not necessary (see section 2: Warnings and precautions).

If you take more Barigraf TAC 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 case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91.562.04.20.

If you forget to take Barigraf TAC

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

If you stop using Barigraf TAC

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

4. Possible adverse effects

Like all medicines, Barigraf TAC may cause adverse effects, although not everyone experiences them.

Serious adverse reactions reported with 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 effects not listed in this leaflet, please inform your doctor or pharmacist.

Rare adverse effects (likely to affect between 1 and 10 in 10,000 people)

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

Very rare adverse effects (likely to affect less than 1 in 10,000 people)

• Intravasation and barium embolization.
• Formation of baroliths that may cause obstruction of the large intestine.

Adverse effects of unknown frequency

• Aspiration pneumonitis.
• Worsening or intensification of intestinal obstruction.

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Barigraf TAC

No special storage conditions are required.

Keep in the original packaging to protect from moisture.

Keep out of the sight and reach of children.

Do not use Barigraf TAC after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Barigraf TAC

• Barigraf TAC contains as the active substance 10.00 g of barium sulfate per sachet.
• The other components are citric acid monohydrate, sodium citrate (E-331), tragacanth gum, orange flavouring, sodium saccharin (E-954ii), anhydrous colloidal silica, simethicone, micronized sorbitol (E-420), microcrystalline cellulose and sodium carboxymethylcellulose (Avicel CL-611).

Appearance of the product and contents of the pack

Barigraf TAC is supplied in a dispensing container containing 30 single-dose sachets of 33.72 g (corresponding to 10 g of barium sulfate).

Each single-dose sachet consists of 4 layers: coated paper, polyethylene, heat-sealable resin, and aluminium.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios ERN, S.A.

C/Perú, 228 - 08020 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain.

Date of the most recent review of this summary: September 2019.

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

The complete package leaflet of Barigraf TAC is included as a detachable section at the end of this summary, to provide physicians and healthcare professionals with scientific information, as well as practical guidance on the administration and use of this medicinal product.