Barium sulfuricum Medana

Package Leaflet: Information for the Patient

Barium sulfuricum Medana, 1 g/ml, Oral and Rectal Suspension

Barii sulfas

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product 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, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Barium sulfuricum Medana and what is it used for
• 2. Important Information Before Using Barium sulfuricum Medana
• 3. How to Use Barium sulfuricum Medana
• 4. Possible Side Effects
• 5. How to Store Barium sulfuricum Medana
• 6. Contents of the Package and Other Information

1. What is Barium sulfuricum Medana and What is it Used For

Barium sulfuricum Medana suspension is a positive contrast agent used in X-ray diagnostics of the gastrointestinal tract. It does not dissolve in water and is not absorbed from the gastrointestinal tract. Unlike soluble barium salts, it does not cause poisoning. The mechanism of action is based on its ability to absorb X-rays. After administration of the contrast agent (orally or as a rectal enema), the mucous membrane relief and the lumen of the gastrointestinal tract are visualized in the X-ray examination, allowing for the detection of pathological changes in the esophagus, stomach, small intestine, or large intestine. The medicinal product does not affect the secretory and motor functions of the gastrointestinal tract. It is excreted unchanged in the feces.

Indications for Use

The medicinal product is intended exclusively for radiological diagnostics. Radiological examinations of the gastrointestinal tract: esophagus, stomach, small intestine, and large intestine.

2. Important Information Before Using Barium sulfuricum Medana

When Not to Use Barium sulfuricum Medana:

Warnings and Precautions

Before starting treatment with Barium sulfuricum Medana, discuss it with your doctor or pharmacist. Particular caution should be exercised when using Barium sulfuricum Medana:

Barium sulfuricum Medana and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicinal product. Pregnancy Do not perform radiological examinations on pregnant women due to the risk to the fetus. The conditions for safe use of the medicinal product in pregnant women have not been established. Breastfeeding It can be used during breastfeeding, but medical consultation is recommended.

Driving and Using Machines

The medicinal product does not affect the ability to drive and use machines.

Barium sulfuricum Medana Contains Sorbitol (E 420), Methyl Parahydroxybenzoate (E 218), Propyl Parahydroxybenzoate (E 216), Ethanol (from Flavor), and Sodium

The medicinal product contains 33 mg of sorbitol in each ml of suspension. Sorbitol is a source of fructose. If hereditary fructose intolerance has been previously diagnosed in an adult or child, the patient should consult a doctor before taking the medicinal product or giving it to a child. If the dose of sorbitol taken with Barium sulfuricum Medana exceeds 140 mg/kg body weight per day, sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. The medicinal product contains 0.75 mg of methyl parahydroxybenzoate in each ml of suspension. The medicinal product contains 0.25 mg of propyl parahydroxybenzoate in each ml of suspension. The medicinal product may cause allergic reactions (possible late reactions). The medicinal product contains 162 mg of sodium (main component of common salt) in a bottle (200 ml suspension). This corresponds to 8.1% of the maximum recommended daily intake of sodium in the diet for adults. The medicinal product contains 0.04 mg of alcohol (ethanol) in each ml of suspension. The amount of alcohol in 200 ml of this medicinal product is equivalent to 0.2 ml of beer or 0.08 ml of wine. The small amount of alcohol in this medicinal product will not cause noticeable effects.

3. How to Use Barium sulfuricum Medana

This medicinal product should always be used in accordance with the doctor's or pharmacist's recommendations. If you have any doubts, consult your doctor or pharmacist. The medicinal product is intended exclusively for radiological diagnostic examinations. For use under medical supervision. The amount of suspension administered should be determined each time by the doctor performing the examination. The usual dose of Barium sulfuricum Medana is 80-200 g (45-112 ml) of suspension, depending on the section of the gastrointestinal tract examined, the patient's body weight, the duration of the examination, etc. To obtain a uniform suspension, the bottle should be shaken several times before opening. The medicinal product should be warmed to body temperature before administration. Orally - for examination of the esophagus, stomach, duodenum, and small intestine. Rectally in the form of an enema - for examination of the large intestine:

• by the double contrast method, the medicinal product is not diluted;
• by the conventional method, the medicinal product should be diluted with water in a 1:1 ratio.

After completing the gastrointestinal examination, an attempt should be made to remove the remaining contrast agent (through proper hydration, possibly using laxatives) to prevent complications related to the retention of barium sulfate in the gastrointestinal tract.

Use of a Higher Dose of Barium sulfuricum Medana Than Recommended

In case of ingestion of a higher dose of the medicinal product than recommended, medical consultation is necessary (see section 4). If you have any further doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Barium sulfuricum Medana can cause side effects, although not everybody gets them. Side effects related to the use of Barium sulfuricum Medana most often result from incorrect administration technique or the presence of diseases that impair the resilience of the gastrointestinal tract walls. The occurrence of side effects is very rare and they are usually mild.

Nervous System Disorders

Very rare (occurring in less than 1 in 10,000 patients, including single cases): Migraine headaches. Accidental entry of barium sulfate into the bloodstream may cause irreversible brain damage.

Cardiac Disorders

Very rare (occurring in less than 1 in 10,000 patients, including single cases): Changes in ECG, decrease in blood pressure. Accidental entry of barium sulfate into the bloodstream (e.g., during rectal enema) may cause complications such as cardiac arrest, arrhythmias, ventricular fibrillation, bradycardia, asystole.

Vascular Disorders

Accidental entry of barium sulfate into the bloodstream (e.g., during rectal enema) may cause disseminated intravascular coagulation (DIC).

Respiratory, Thoracic, and Mediastinal Disorders

Accidental entry of barium sulfate into the bloodstream (e.g., during rectal enema) may cause complications such as pulmonary embolism, respiratory failure.

Gastrointestinal Disorders

Dysphagia (difficulty swallowing food), constipation, diarrhea, intestinal obstruction, abdominal cramps, barium granuloma, appendicitis. The cause of abdominal cramps and diarrhea may be the use of too much medicinal product in the rectal enema. In elderly people, barium sulfate may remain in the gastrointestinal tract for up to 4-6 days after administration. Incorrectly performed rectal enema may cause colitis, proctitis, or perforation of the colon, resulting in peritonitis.

Skin and Subcutaneous Tissue Disorders

Hypersensitivity reactions - urticaria, itching, erythema, generalized rash, periorbital edema, contact dermatitis. These symptoms may occur immediately or with some delay after the examination.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicinal product.

5. How to Store Barium sulfuricum Medana

Store the medicinal product out of the sight and reach of children. Do not store above 25°C. Do not store in the refrigerator or freeze. Do not use this medicinal product after the expiry date stated on the packaging. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Barium sulfuricum Medana Contains

• The active substance of the medicinal product is barium sulfate. Each ml of suspension contains 1 g of barium sulfate.
• The other ingredients of the medicinal product are: sodium carmellose; pectin; citric acid monohydrate; sodium carbonate decahydrate; sorbitol 70% (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216); flavor and aroma correcting substance, linden; purified water.

What Barium sulfuricum Medana Looks Like and What the Package Contains

A colorless PET bottle closed with a polyethylene cap with a guarantee ring and a sealing ring or a sealing insert. The bottle contains 200 ml of suspension.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A. Medana Branch in Sieradz ul. Władysława Łokietka 10, 98-200 Sieradz

Date of Last Revision of the Package Leaflet: