Package Insert: Information for the User

Barigraf TAC,10 goral powder for suspension

Barium Sulfate

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you/your child and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Barigraf TAC and how is it used

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

3.How to take Barigraf TAC

4.Possible adverse effects

5.Storage of Barigraf TAC

6. Contents of the package and additional information

This medication is solely for diagnostic use.

Barigraf TAC belongs to the group of medications known as radiological contrast media for X-rays that contains barium sulfate with suspended agents, classifying it within the ATC (anatomical therapeutic chemical classification) in the VO8BA01 pharmacotherapeutic group.

Barigraf TAC is a radio-opaque diagnostic agent used, in both adults and pediatric populations, to intensify contrast during visualization of the esophagus, and gastrointestinal tract through radiological techniques:

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Do not take Barigraf TAC:

• If you are allergic (hypersensitive) to barium sulfate or to 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 narrowing of the pylorus (pyloric stenosis).
• If you have or suspect you have a perforation of the gastrointestinal tract.
• If you have postoperative gastrointestinal suture dehiscence (suture opening).
• If you have a history or suspicion of intestinal perforation.
• If you have intestinal fistulas.
• If you have esophageal or bronchoesophageal fistulas.
• If you have had 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

• 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 those located in the distal part of the stomach or conditions and diseases with a high risk of perforation, such as fistulas and known gastrointestinal carcinomas, inflammatory bowel disease, diverticulitis, diverticulosis, and amebiasis, as a meticulous benefit/risk assessment is required in these cases.

During the radiological examination, the penetration of barium sulfate into 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, immediate specialized medical intervention, intensive care, or surgery is necessary.

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

In the case of barium sulfate coprolite formation (bariolites) due to the thickening of barium sulfate, laxatives and/or saline purgatives (with salts or minerals) are recommended.

Other medications and Barigraf TAC

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 TAC, 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 lactationIf you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

The use of Barigraf TAC is not contraindicated during breastfeeding.

Driving and operating machines

Barigraf TAC does not affect driving, handling tools, or operating machines.

Barigraf TAC contains sorbitol and sodium

This medication contains 12.23 g of sorbitol in each packet.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a fructose intolerance or hereditary fructose intolerance (HF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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

Follow exactly the administration instructions for 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 conveniently by the doctor according to age, body weight, and the particularities of pediatric radiodiagnosis.

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 exploration:

If excessive stomach acid secretion is observed in the fasting state, it is recommended, to the extent possible, to aspirate gastric secretions 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 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, intravenously or intramuscularly, which reduces stomach tone, decreases peristalsis, and delays gastric emptying.

Patient preparation for enteroclysis examination:

The doctor may administer an antispasmodic additionally, intravenously or intramuscularly, which reduces intestinal tone, decreases peristalsis (intestinal muscle wave movement), and delays contrast evacuation, with the aim of improving the test result.

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.

Patients with liver insufficiency:

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

Patients with renal insufficiency:

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

If you take more Barigraf TAC than you should

In rare cases, 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 Toxicological Information Service. Phone 91.562.04.20.

If you forgot to take Barigraf TAC

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

If you interrupt treatment with Barigraf TAC

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

Like all medications, Barigraf TAC 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.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Rare Adverse Effects(it is likely that they will occur in 1 to 10 of every 10,000 people)

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

Very Rare Adverse Effects(it is likely that they will occur in less than 1 of every 10,000 people)

• Intravasation and embolization of barium.
• Formation of barium bezoars that may cause intestinal blockage.

Adverse Effects of Unknown Frequency

• Aspiration pneumonitis.
• Increased or intensified intestinal obstruction.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: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.

Conserve in the original packaging to protect it from humidity.

Keep out of the sight and reach of children.

Do not use Barigraf TAC after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

Composition of Barigraf TAC

• Barigraf TAC contains as active ingredient 10.00 g sulfate of barium per each 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 packaging

Barigraf TAC is presented in a dispenser packaging 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, aluminum.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona. Spain

Responsible for manufacturing

Laboratorios Edefarm S.L

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

O

Laboratorios ERN, S.A.

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

Last review date of this prospectus: September 2019.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.

THIS INFORMATION IS INTENDED ONLY FOR DOCTORS AND HEALTHCARE PROFESSIONALS

A complete technical sheet of Barigraf TAC is included as a detachable section at the end of this prospectus, in order to facilitate doctors or healthcare professionals with scientific and practical information on the administration and use of this medication.