Leaflet: information for the user

Barium Sulfate ROVI TAC 5 g/100 ml oral suspension

Barium Sulfate

Read this leaflet carefully before starting to take the medicine, as it contains important information for you

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

This medication is for diagnostic use only.

Sulfato de bario ROVI TAC 5 g/100 ml oral suspension belongs to a group of medications called radiological contrast agents for X-rays that contains barium sulfate without agents in suspension.

Sulfato de bario ROVI TAC 5 g/100 ml oral suspension is a radio-opaque diagnostic agent that is used, both in adults and in pediatric population, to provide opacification in computed tomography for the following cases:

• Explorations of the upper gastrointestinal tract (esophagus, stomach or small intestine), as a diagnostic aid for pathologies in these organs.
• Explorations of the proximal intestine or intestinal structures of the lower abdomen or pelvis by the enteroclysis technique (administered through a tube) as a diagnostic aid in the presence of suspected intestinal obstruction and in the study of a possible intestinal fistula.

Do not takeSULFATO DE BARIO ROVI TAC 5 g/100 ml ORAL SUSPENSION:

• If you are allergic (hypersensitive) to barium sulfate or to any of the other components of Sulfato de bario ROVI TAC 5 g/100 ml oral suspension listed in section 6.
• If you have an 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 to the mediastinum, pleural cavity, or peritoneal cavity.
• If you have esophageal or bronchial fistulas.
• If you have had recent injuries or chemical burns in the gastrointestinal tract.
• If you have insufficient blood flow (ischemia) to the intestinal wall.
• If you have a condition called necrotizing enterocolitis.
• If you are at risk of aspirating barium contrast, with swallowing disorders, as well as with limited consciousness or attention.
• If you are about to undergo gastrointestinal surgery.
• Within 7 days after an endoscopic resection.
• Within 4 weeks after concurrent radiation therapy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sulfato de bario ROVI TAC 5 g/100 ml oral suspension:

• 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 far from the stomach or conditions and diseases with a high risk of perforation, such as fistulas and gastrointestinal carcinomas, inflammatory bowel disease, diverticulitis, diverticulosis, and amebiasis, as in these cases a thorough assessment of the benefit/risk is necessary.

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

To avoid potentially severe adverse reactions, during the diagnostic process, it is essential to prevent the penetration of barium sulfate into areas outside the gastrointestinal tract (parenteral) such as tissues, vascular space, and body cavities or respiratory pathways.

In case 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 and/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.

Children

Sulfato de bario ROVI TAC 5g /100 ml oral suspension may be used in children, provided that the volume to be administered is individualized based on the child's ability to ingest, age, suspected/known pathology, and the region to be studied.

Use of SULFATO DE BARIO ROVI TAC 5 g/100 ml SUSPENSION ORAL with other medications

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

Certain medications may interact with Sulfato de bario ROVI TAC 5 g/100 ml oral suspension, 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 the barium sulfate suspension to thicken, increasing 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 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, careful consideration of the benefit of the radiological examination is necessary.

The safety of Sulfato de bario ROVI TAC 5 g/100 ml oral suspension in lactating women has not been investigated.

Contrast agents are eliminated through breast milk in minimal amounts. No harm to the infant is predictable, and your doctor will evaluate the benefit/risk before performing the examination.

The use of Sulfato de bario ROVI TAC 5 g/100 ml oral suspension is not contraindicated during lactation.

Driving and operating machinery

Sulfato de bario ROVI TAC 5 g/100 ml oral suspension does not affect driving, handling tools, or operating machinery.

SULFATO DE BARIO ROVI TAC 5 g/100 ml SUSPENSION ORAL contains sorbitol, sodium, and potassium

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with low-sodium diets should note that this medication contains 182 mg (7.6 mmol) of sodium per 150 ml of oral suspension.

Patients with renal insufficiency or low-potassium diets should note that this medication contains 39 mg (1 mmol) of potassium per 150 ml of oral suspension.

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

The medical staff will administer Sulfato de bario ROVI TAC 5 g/100 ml oral suspension 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

In infants and children, the dose will be adjusted conveniently by the doctor according to age, child's body weight, and pediatric radiodiagnostic particularities.

Use in elderly patients

For elderly patients, there are no special dosage recommendations.

Patients with liver insufficiency

No dose adjustment is necessary (see section 2: Be careful with Sulfato de bario ROVI TAC 5 g/100 ml oral suspension)

Patients with renal insufficiency

No dose adjustment is necessary (see section 2: Be careful with Sulfato de bario ROVI TAC 5 g/100 ml oral suspension)

Consult your doctor if you want 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 a large amount of stomach acid is observed in the fasting state, it is recommended, to the extent possible, to aspirate the 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, intravenously or intramuscularly, which reduces the stomach tone, decreases peristalsis, and delays gastric emptying.

Patient preparation for enteroclysis technique:

The doctor may administer an antispasmodic additionally, intravenously or intramuscularly, which reduces the intestinal tone, decreases peristalsis (intestinal muscle movement), and delays the evacuation of the contrast, 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 drink 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 moreSULFATO DE BARIO ROVI TAC 5 g/100 ml SUSPENSIÓN ORALthan 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 takeSULFATO DE BARIO ROVI TAC 5 g/100 ml SUSPENSIÓN ORAL

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

If you interrupt treatment withSULFATO DE BARIO ROVI TAC 5 g/100 ml SUSPENSIÓN ORAL

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

Like all medications, this medication 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 experience 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 between 1 and 10 of every 10,000 people):

• Allergic reactions (allergic pruritus, erythema, urticaria, laryngeal edema, bronchospasm, skin eruptions).
• Constipation.

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

• Severe to moderate allergic reactions (extensive skin reaction, hypotension).
• 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, impaction, and appendicitis.
• Gastroenteritis (intestinal cramps, nausea, vomiting, diarrhea).
• Hypokalemia.
• Hypertension.
• Arrhythmia.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not require special conditions for conservation.

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.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of SULFATE BARIUM ROVI TAC 5 g/100 ml ORAL SUSPENSION

• The active ingredient is barium sulfate. Each 150 ml of suspension contains 7.5 g of barium sulfate.
• The other components are trisodium citrate, potassium sorbate (E-202), sodium saccharin, xanthan gum, sorbitol (E-420) (fine powder), anhydrous citric acid, silicone, vanilla/caramel flavoring and purified water.

Appearance of the product and contents of the packaging

Barium sulfate ROVI TAC 5 g/100 ml oral suspension is presented in white polyethylene bottles containing 150 ml of suspension.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization :

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Responsible for manufacturing:

ITALFARMACO, S.A.

C/ San Rafael, 3 Industrial Polygon.

Alcobendas 28108- Madrid

This prospectus has been approved in: April 2017.

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

This information is intended solely for doctors and healthcare professionals.

A detachable technical sheet of Barium sulfate ROVI TAC 5 g/100 ml oral suspension is included 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.