BARIGRAF TAC POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Barigraf TAC,10 gpowder for oral 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.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

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

This medicinal product is for diagnostic use only.

Barigraf TAC belongs to a group of medicinal products called radiological contrast media for X-rays that contain barium sulfate with suspension agents, classified within the ATC (anatomical, therapeutic, and chemical) classification in the pharmacotherapeutic group VO8BA01.

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

• For computed tomography scans of the upper gastrointestinal tract (esophagus, stomach, or small intestine), as a diagnostic aid for pathologies in these organs.
• For computed tomography scans using the enteroclysis technique (administered through a probe) as a diagnostic aid in suspected intestinal obstruction and in the study of possible intestinal fistula.

2. What you need to know before you take Barigraf TAC

Do not take Barigraf TAC:

• If you are allergic (hypersensitive) to barium sulfate or any of the other components of this medicinal product (listed in section 6).

• If you have inflammation of the walls of the abdominal cavity (irritated peritoneum).
• If 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 dehiscence of postoperative gastrointestinal suture (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 had recent 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

• 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 amebiasis (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 respiratory tract should 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, the penetration of barium sulfate into areas outside the gastrointestinal tract (parenteral) such as tissues, vascular space, and body cavities or 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 colon diverticula, potentially favoring and/or aggravating infectious processes at this location.

In the event that barium sulfate coprolites (barioliths) 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.

Other medicines and Barigraf TAC

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 TAC, 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 use 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 lactationIf 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 TAC in breastfeeding women has not been investigated. 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 performing the examination.

The use of Barigraf TAC is not contraindicated during breastfeeding.

Driving and using machines

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

Barigraf TAC contains sorbitol and sodium

This medicinal product contains 12.23 g of sorbitol in each sachet.

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 taking this medicinal product. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medicinal product contains 415 mg of sodium (main component of table/cooking salt) in each single-dose sachet. This is equivalent to 21% of the maximum recommended daily intake of sodium for an adult.

3. How to take Barigraf TAC

Follow the administration instructions of Barigraf TAC indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The medical staff will administer Barigraf TAC 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.

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 the pediatric radiodiagnosis.

For elderly patients, there are no special dosage recommendations.

Consult your doctor if you wish to clarify the examination procedure. It is important to follow your doctor's instructions once the examination is finished.

Patient preparation

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

Patient preparation for stomach examination:

If abundant acid secretion (stomach acidity) is observed on an empty stomach, it is recommended, as far as possible, to aspirate gastric secretion 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 computed tomography scan, 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, via intravenous or intramuscular route, which decreases stomach tone, reduces peristalsis, and delays stomach emptying.

Patient preparation for examination using the enteroclysis technique:

The doctor may administer an antispasmodic via intravenous or intramuscular route, which decreases intestinal tone, reduces peristalsis (wave-like movement of intestinal muscles), and delays contrast emptying, with the aim of improving the test result.

Patient preparation for pediatric use:

Newborns do not need to be fasting. Children from 1-24 months should be fasting from 4 hours before the test, children from 2-4 years 6 hours before, and children from 4-14 years 8 hours before, although in the latter case, they may drink some water up to 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.

Patient with hepatic impairment:

No dose adjustment is necessary (see section 2: Warnings and precautions).

Patient with renal impairment:

No dose adjustment is 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 not considered serious. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91.562.04.20.

If you forget to take Barigraf TAC

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

If you stop taking Barigraf TAC

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

4. Possible side effects

Like all medicinal products, Barigraf TAC can cause side effects, although not everybody gets them.

Severe adverse reactions reported with the administration of barium sulfate formulations are generally associated with defective administration techniques 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(it is likely that they affect between 1 and 10 in every 10,000 people)

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

Very rare side effects(it is likely that they affect less than 1 in every 10,000 people)

• Intravasation and embolization of barium.
• Formation of barium coprolites that can cause blockage of the large intestine.

Side effects of unknown frequency

• Aspiration pneumonitis.
• Increased or intensified intestinal obstruction.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Barigraf TAC

No special storage conditions are required.

Keep in the original package 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 package. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Barigraf TAC

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

Appearance of the product and contents of the pack

Barigraf TAC is presented in a dispenser package containing 30 single-dose sachets of 33.72 g (corresponding to 10 g of barium sulfate).

Each single-dose sachet is formed by 4 layers: coated paper, polyethylene, thermosetting resin, and aluminum.

Marketing authorization holder and manufacturer

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.

Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona. Spain.

Date of the last revision of this leaflet: September 2019.

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.

THIS INFORMATION IS INTENDED ONLY FOR MEDICAL PROFESSIONALS

The complete technical specifications of Barigraf TAC are included as a detachable section at the end of this leaflet, in order to provide medical professionals with scientific information and practical information on the administration and use of this medicinal product.