BARIUM SULFATE ROVI TAC 5 G/100 ML ORAL SUSPENSION

Introduction

Leaflet: Information for the user

Barium sulfate ROVI TAC 5 g/100 ml oral suspension

Barium sulfate

Read the entire 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 to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION and what is it used for
2. What you need to know before taking BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION
3. How to take BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION
4. Possible side effects
5. Storage of BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION
6. Package contents and additional information

1. What is BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION and what is it used for

This medicine is for diagnostic use only.

Barium sulfate ROVI TAC 5 g/100 ml oral suspension belongs to the group of medicines called radiological contrast media for X-rays that contain barium sulfate without suspending agents.

Barium sulfate ROVI TAC 5 g/100 ml oral suspension is a radiopaque diagnostic agent used in both adults and 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 using the enteroclysis technique (administered through a probe) as a diagnostic aid in cases of suspected intestinal obstruction and in the study of a possible intestinal fistula.

2. What you need to know before taking BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION

Do not takeBARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION:

• If you are allergic (hypersensitive) to barium sulfate or any of the other components of Barium sulfate ROVI TAC 5 g/100 ml oral suspension listed in section 6.
• If you have inflammation of the walls of the abdominal cavity (irritated peritoneum).
• If you have or suspect 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 (opening of the suture)
• If you have a history or suspect you have intestinal perforation
• If you have intestinal fistulas to the mediastinum, pleural cavity, or peritoneal cavity
• If you have tracheoesophageal or bronchoesophageal fistulas
• If you have recently suffered injuries or chemical burns to the gastrointestinal 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 at risk of barium contrast aspiration, with swallowing disorders, as well as with limited consciousness or attention
• 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

Consult your doctor or pharmacist before starting to take Barium sulfate ROVI TAC 5 g/100 ml oral suspension:

• 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 amoebiasis (infection caused by amoebas), as in these cases it is necessary to perform a meticulous assessment of the benefit/risk.

You should also ensure adequate hydration after the procedure to avoid 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 into the 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, which can favor and/or aggravate infectious processes at this location.

In case barium sulfate coprolites (bariolites) form due to thickening of the barium sulfate, in this case, administration of laxatives and/or saline purgatives (with salts or minerals) is recommended

Children

Barium sulfate ROVI TAC 5g/100 ml oral suspension can be used in children, provided that the volume to be administered is individualized depending on the child's intake capacity, as well as their age, suspected/known pathology, and studied region.

Use ofBARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSIONwith other medicines

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

Certain medicines may interact with Barium sulfate ROVI TAC 5 g/100 ml oral suspension, in which case it may be necessary to change the dose or interrupt treatment with one of the medicines. It is especially important that you inform your doctor if you are using any of the following medicines:

• Medicines that reduce intestinal peristalsis (contractions in the form of a wave along the intestine): Taking these medicines can cause thickening of the barium sulfate suspension, which can increase 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.

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 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 Barium sulfate ROVI TAC 5 g/100 ml oral suspension has not been investigated in breastfeeding women.

Contrast media are eliminated in breast milk in minimal amounts. No harm to the infant is expected, and your doctor will assess the benefit/risk before performing the examination.

The use of Barium sulfate ROVI TAC 5 g/100 ml oral suspension is not contraindicated during breastfeeding

Driving and using machines

Barium sulfate ROVI TAC 5 g/100 ml oral suspension does not affect driving or the use of tools or machines.

BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION contains sorbitol, sodium, and potassium

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

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

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

3. How to take BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Medical personnel will administer Barium sulfate ROVI TAC 5 g/100 ml oral suspension to you 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 accordingly by the doctor based on the child's age, body weight, and the specific requirements of pediatric radiodiagnosis.

Use in elderly patients

For elderly patients, there are no special dosage recommendations.

Patient with hepatic impairment

No dose adjustment is necessary (see section 2: Take special care with Barium sulfate ROVI TAC 5 g/100 ml oral suspension)

Patient with renal impairment

No dose adjustment is necessary (see section 2: Take special care with Barium sulfate 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 examination:

If abundant acid secretion (stomach acidity) is observed on an empty stomach, it is recommended, as far as 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 inhibitor medications (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 additionally administered intravenously or intramuscularly, which decreases the tone of the stomach, reduces peristalsis, and delays stomach emptying.

Patient preparation for examination using the enteroclysis technique:

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

Patient preparation for pediatric use:

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

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

If you take moreBARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSIONthan 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 takeBARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION

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

If you interrupt treatment withBARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious 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 think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Rare side effects(it is likely that they will affect between 1 and 10 in every 10,000 people):

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

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

• Severe to moderate allergic reactions (extensive skin response, hypotension).
• Intravasation and embolization of barium.
• Formation of bariolites that can cause blockage of the large intestine.

Side effects of unknown frequency:

• Aspiration pneumonitis.
• Increased or intensified intestinal obstruction, impaction, and appendicitis.
• Gastroenteritis (intestinal cramps, nausea, vomiting, diarrhea).
• Hypokalemia.
• Hypertension.
• Arrhythmia.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them 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 medicine.

5. Storage of BARium SULFATE ROVI TAC 5 g/100 ml ORAL SUSPENSION

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition ofBARium SULFATE 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 ingredients are trisodium citrate, potassium sorbate (E-202), sodium saccharin, xanthan gum, sorbitol (E-420) (fine powder), anhydrous citric acid, silicone, vanilla/caramel flavor, and purified water.

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Manufacturer:

ITALFARMACO, S.A.

C/ San Rafael, 3 Polígono Industrial.

Alcobendas 28108- Madrid

This leaflet was approved in: April 2017.

Detailed information on this medicine 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 healthcare professionals

The complete technical data sheet of Barium sulfate ROVI TAC 5 g/100 ml oral suspension is included as a detachable section at the end of this leaflet, in order to provide doctors and healthcare professionals with scientific and practical information on the administration and use of this medicine.