GASTROGRAFIN 370 MG IODO/ML ORAL AND RECTAL SOLUTION

Introduction

Package Leaflet: Information for the User

Gastrografin 370 mg Iodo/ml Oral and Rectal Solution

Sodium Amidotrizoate and Meglumine Amidotrizoate (DCI)

Contents of the Package Leaflet:

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

1. What is Gastrografin and what is it used for

This medicinal product is for diagnostic and therapeutic use.

Diagnostic use

• Gastrografin is a contrast medium used for X-ray examination of the gastrointestinal tract. It can only be administered orally and rectally (as an enema), and is mainly indicated when the use of barium sulfate is unsatisfactory, undesirable, or contraindicated. The indications include:

• Early diagnosis of a perforation (opening of an organ or viscus) or anastomotic defect (defective union), radiologically undetectable, in the esophagus and/or gastrointestinal tract, as well as acute perforations (peptic ulcer, diverticulum - herniation of the digestive tube in the form of a sac?), after total or partial removal of the stomach or intestine (risk of perforation or leakage).
• Suspicion of partial or complete stenosis (narrowing), intestinal obstruction, colon obstruction, and acute bleeding (acute bleeding).
• Megacolon (marked and pathological dilation of the colon).
• Visualization of a foreign body or tumor before performing an endoscopy.
• Visualization of a gastrointestinal fistula (pathological tract that communicates two different areas of the digestive tube).

• Gastrografin is used with barium sulfate to accelerate gastrointestinal transit. In addition to the aforementioned indications, Gastrografin can be used for the same indications as barium sulfate, except for the visualization of mucosal conditions.

• Gastrografin is used for computed tomography (CT, obtaining images of sections of a specific region of the body) to provide opacification of the entire upper gastrointestinal tract (esophagus, stomach, or small intestine) and lower gastrointestinal tract (large intestine and rectum) as a diagnostic aid for pathologies in these organs.

Therapeutic use

• Treatment of uncomplicated meconium ileus (intestinal obstruction that occurs in newborns).

2. What you need to know before you use Gastrografin

Do not use Gastrografin

• If you are allergic to the active substances or to any of the other components of this medicinal product (listed in section 6).
• If you have a known allergy to iodinated contrast media.

• In patients at risk of aspiration or bronchoesophageal fistula.
• If you have clinical hyperthyroidism (overactive thyroid gland).

Do not use Gastrografin undiluted

• If you have lost a lot of body fluid or water (e.g., severe diarrhea, vomiting).
• In children under 10 years of age.
• If it is possible that Gastrografin could inadvertently enter your respiratory system.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Gastrografin.

• If you have alterations in hydration and electrolyte balance.
• If you have states of excitement, anxiety, or intense pain.
• If you have a history of allergic reactions (e.g., shellfish allergy, hay fever/acute seasonal allergic rhinitis, hives).
• If you have a history of bronchial asthma.
• If you have or are suspected to have hyperthyroidism (overactive thyroid gland) or goiter (enlargement of the thyroid gland), as iodinated contrast media can interfere with thyroid function, worsen or induce hyperthyroidism, and thyrotoxic crisis (a serious complication of an overactive thyroid gland).
• If you have severe cardiovascular disease, as it increases the risk of suffering a severe hypersensitivity reaction (allergy).
• If you have a significant deterioration in your state of health.

• If you are also going to be administered barium sulfate. In this case, you should pay attention to the contraindications, precautions, and relevant side effects of this preparation.
• In case of prolonged retention of Gastrografin in the gastrointestinal tract (e.g., obstruction, stasis), tissue damage, bleeding, necrosis, and intestinal perforation can occur.
• Interference with diagnostic tests: If you are going to have any tests for the diagnosis of thyroid-related diseases, inform your doctor, as it may alter the results. You should wait at least 16 days after using Gastrografin.

Before you receive Gastrografin, tell your doctor if any of these cases apply to you.Your doctor will decide if the planned diagnostic test is possible or not. Your thyroid function may be examined before receiving Gastrografin, and you may be given a thyroid-inhibiting medication (medication to reduce thyroid gland function).

The doctor should examine the thyroid function of newborns who have been exposed to Gastrografin, either during pregnancy or after birth, because an excess of iodine can cause hypothyroidism (underactive thyroid gland), which may require treatment.

Using Gastrografin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that you inform your doctor if you are using any of the following medicines.

• Beta-blocker medicines (such as propranolol or atenolol): allergic reactions due to contrast media can be worsened, especially in the presence of bronchial asthma. Additionally, if you are being treated with beta-blockers, you may not respond to standard treatment for allergic reactions with beta-agonists (which promote bronchodilation).

• Interleukin-2: If you are using this medicine (for the immune system), you should know that it increases the incidence of delayed reactions to contrast media (e.g., fever, rash, flu-like symptoms, joint pain, and itching).

• Diuretics: If you are using diuretics, you should know that saline rehydration is necessary to minimize the risk of acute renal failure.

• Radioactive medicines: If you are using this medicine, you should know that the ability to capture radioactive medicines used in the diagnosis and treatment of thyroid-related pathologies can be reduced for several weeks after the administration of iodinated contrast media.

Pregnancy, Breastfeeding, and Fertility

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 demonstrated that contrast media are safe for use in pregnant patients. Since, whenever possible, exposure to radiation should be avoided during pregnancy, the benefits of any radiological examination, with or without contrast medium, should be carefully weighed against the potential risks.

It is not known if Gastrografin passes into breast milk. Some data suggest that the risk to the breastfed infant is low in the event of Gastrografin administration to the mother. Breastfeeding is probably safe, especially due to the low intestinal absorption of Gastrografin.

Driving and Using Machines

No effects on the ability to drive and use machines have been reported after the administration of Gastrografin.

Gastrografin contains Sodium

This medicine contains 3.76 mg of sodium (main component of cooking/table salt) per ml. This is equivalent to 0.19% of the maximum recommended daily intake of sodium for an adult.

3. How to use Gastrografin

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

Gastrografin is a contrast medium used to perform a diagnostic test, which should be carried out in the presence of qualified personnel, preferably under the supervision of a doctor, who will indicate the instructions to follow at all times.

Gastrografin is supplied as a gastrointestinal solution, which can be administered orally or rectally.

Gastrografin should not be used intravascularly (injected directly into a vein or artery).

Before using Gastrografin, it is recommended to clean the intestine, as this facilitates the performance and validity of the diagnostic test.

The recommended dose may vary depending on the type of examination, the patient's age, the suspected/known pathology, the route of administration, and the region studied.

X-ray Examination

Depending on the area of the gastrointestinal tract to be studied, the oral or rectal route is used.

Computed Tomography (CT):

Depending on the area of the gastrointestinal tract to be studied, the oral or rectal route is used.

The examination can be performed after the administration of 0.5-1.5 liters of Gastrografin solution at approximately 3% concentration (30 ml of Gastrografin in 1 liter of water).

*Oral and rectal administration can be combined

In pediatric patients, the volumes should be adjusted. The maximum volumes to be administered of the Gastrografin dilution with water are specified in the table below.

Treatment of uncomplicated meconium ileus

Dose for rectal use

Gastrografin can be administered to newborns in the form of an enema for the non-surgical treatment of uncomplicated meconium ileus. The high osmotic pressure of the contrast medium is utilized: the adjacent tissue is forced to release a considerable amount of fluid, which then flows into the intestines and dissolves the thick meconium.

Gastrografin should be diluted 3-4 times its volume in water.

Normally, a dose of 2-5 ml of the diluted solution is required, but in other cases, more may be required. The solution should be administered under fluoroscopic control.

Gastrografin associated with barium sulfate

If necessary, the proportion of Gastrografin in the suspension can be increased further, in cases of pyloric spasm or pyloric stenosis (alterations of the pylorus, which is the final part of the stomach).

Your doctor will inform you about all the characteristics related to the administration of Gastrografin. Additional information regarding the administration and handling of Gastrografin is provided at the end of the package leaflet.

If you use more Gastrografin than you should

Alterations in hydroelectrolytic balance (state of balance inside the body) due to excessive administration of Gastrografin should be corrected parenterally (by any route other than the digestive tract).

In case of overdose or accidental ingestion, consult the Toxicology Information Service; Telephone 91 562 04 20, indicating the medicine and the amount used.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Frequent Adverse Effects(affect between 1 and 10 out of 100 patients):

• Vomiting, nausea, diarrhea.

Rare Adverse Effects(affect between 1 and 10 out of 10,000 patients):

• Anaphylactoid shock, anaphylactoid or hypersensitivity reactions (allergic reactions that can be very severe).
• Thyroid crisis in patients with hyperthyroidism (excessive production of the thyroid gland).
• Hydroelectrolytic imbalance.
• Disorders of consciousness, headache, dizziness.
• Cardiac arrest, tachycardia (increased heart rate).
• Shock (general alteration of the body), hypotension (low blood pressure).
• Bronchospasm (narrowing or obstruction of the bronchial musculature), dyspnea (difficulty breathing), aspiration of the medicine, pulmonary edema after aspiration, aspiration pneumonia.
• Intestinal perforation, abdominal pain, formation of blisters in the oral mucosa.
• Toxic epidermal necrolysis, urticaria, exanthema, irritation, skin rash, facial swelling (skin reactions of greater or lesser severity).
• Fever, sweating.

Adverse Effects with Unknown Frequency(cannot be estimated from available data)

• Hypothyroidism (underactive thyroid)

As with all contrast media, allergic reactions can occur, including severe reactions (shock) that may require immediate medical intervention. Moderate swelling of the face, lips, tongue, or throat, cough, pruritus (itching), nasal secretion, sneezing, and urticaria (of the type caused by nettles) may be the first symptoms of a severe reaction.

Delayed reactions can occur hours or days after administration of Gastrografin. Inform your healthcare professional immediately if you experience any of these symptoms or have difficulty breathing.

Gastrografin may cause diarrhea, but this stops as soon as the intestine is emptied. Existing enteritis (inflammation of the intestine) or colitis (inflammation of the colon) may temporarily worsen. In case of obstruction, prolonged contact with the intestinal mucosa can cause erosion, bleeding, and intestinal necrosis (death of intestinal cells).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gastrografin

Keep out of sight and reach of children.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light and ionizing radiation (X-rays).

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

Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Gastrografin Composition

• The active ingredients are sodium amidotrizoate and meglumine amidotrizoate.

1 vial with 100 ml contains 10 g of sodium amidotrizoate and 66 g of meglumine amidotrizoate (diatrizoate sodium and diatrizoate meglumine) in aqueous solution.

• The other components are sodium saccharin hydrate, sodium-calcium edetate hydrate, and water for injection.

Product Appearance and Package Contents

Gastrografin is a nearly colorless to yellowish solution.

The package contents are 1 vial of 100 ml.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Berlimed S.A.

C/ Francisco Alonso, 7

Polígono industrial Santa Rosa

28806 Alcalá de Henares (Madrid)

Date of Last Revision of this Prospectus: April 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals

Dosage and Administration

Oral Administration

For the early diagnosis of a perforation or anastomosis in the esophagus and/or gastrointestinal tract, the patient should ingest up to 100 ml of Gastrografin. If the suspected lesion cannot be clearly identified by X-ray, the following test can be used as a diagnostic aid. After 30-60 minutes (later if the lesion is suspected to be located in the distal intestine), a urine sample should be taken, mixing 5 ml with 5 drops of concentrated hydrochloric acid. The contrast medium that has undergone renal excretion will appear in the next 2 hours as a typical crystal formation in the precipitate.

Rectal Administration

Treatment of Uncomplicated Meconial Ileus

For application in the form of an enema, an irrigator and a soft rubber catheter are recommended. The return of the contrast medium is avoided by means of an adhesive tape with which the buttocks are pressed. A Foley catheter should not be used. The introduction should be done slowly and under constant radiological control.

The application is considered finished as soon as Gastrografin passes into the small intestine. In order to compensate for any excessive loss of fluid, an intravenous perfusion of plasma should be prepared before starting the application.

In case an hour after removing the catheter the contrast medium has not been evacuated again, it is necessary to ensure radiologically that the intestine has not been excessively dilated. In cases where immediate surgery is indicated, such as intestinal volvulus, gangrene, perforation, peritonitis, and atresias, this method should not be applied.

Suitable time for radiography:

Exposures of the stomach are performed in the usual way, whether Gastrografin is used alone or in combination with barium sulfate.

The time required for gastric emptying is the same as for barium sulfate, while the time required for intestinal filling is less. When Gastrografin is used alone, the contrast medium generally reaches the rectum after 2 hours, while the Gastrografin/barium sulfate combination may take up to 3 hours and, in isolated cases, even longer.

The most favorable time for radiological exposures of the colon is indicated by the sensation of need to defecate that all patients experience.

Special Precautions

• Hydration and hydroelectrolytic balance

Adequate hydration of the patient should be ensured before and after administration of the contrast medium. This is especially important in patients with multiple myeloma, diabetes mellitus with renal insufficiency, polyuria, oliguria, hyperuricemia, as well as in newborns, infants, young children, and elderly patients. Hydroelectrolytic imbalances should be corrected before exploration.

To compensate for possible clinically relevant electrolyte losses during rectal administration, when necessary, Ringer's lactate solution should be prepared for intravenous perfusion.

• Anxiety

States of excitement, anxiety, and intense pain can increase the risk of adverse reactions or intensify reactions related to contrast media. These patients may be given a sedative.

• Hypersensitivity reactions

A risk-benefit assessment should be performed, especially in patients with known hypersensitivity to Gastrografin or any of its components, due to a higher risk of hypersensitivity/anaphylactic reactions.

Pretreatment with antihistamines and/or glucocorticoids may be considered.

If hypersensitivity reactions occur, administration of the contrast medium should be suspended immediately and, if necessary, specific treatment should be initiated intravenously. To be able to act immediately in case of emergency, the appropriate medications, an endotracheal tube, and an artificial respirator should be readily available.

• Thyroid dysfunction

A risk-benefit assessment should be performed in patients with suspected clinical hyperthyroidism, patients with subclinical hyperthyroidism or known or suspected goiter, as Gastrografin, like any iodinated contrast medium, can interfere with thyroid function, worsen or induce hyperthyroidism and thyrotoxic crisis.

In newborns, especially premature infants, who have been exposed to Gastrografin, either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as excessive iodine exposure can cause hypothyroidism and possibly require treatment.

• Severe cardiovascular disease

If patients with cardiovascular disorders experience hypersensitivity reactions while taking beta-blockers, they may be refractory to treatment with beta-agonists.

• Severely impaired health status

The need for exploration should be carefully evaluated.

• Combined use with barium sulfate

Attention should be paid to the contraindications, precautions, and possible relevant side effects of barium sulfate.

• Gastrointestinal risks

Tissue damage, bleeding, necrosis, and intestinal perforation can occur.

• Interference with diagnostic tests

Iodinated contrast media can interfere with thyroid function tests, as the thyroid's ability to fix iodine may be reduced for several weeks. The results of PBI (protein-bound iodine) and radioactive iodine uptake studies, which depend on iodine estimation, may not accurately reflect thyroid function until 16 days after administration of iodinated contrast media.

Warnings about excipients

Gastrografin contains sodium

This medicine contains 3.76 mg of sodium per ml, equivalent to 0.19% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

Instructions for use/handling

In case of crystallization of the contrast medium due to storage in refrigerated areas, it can be dissolved again by shaking and gentle heating to body temperature. This alteration does not imply a detriment to the effectiveness and stability of the preparation.

This medicine should be visually inspected before administration for the presence of particles. It should only be used if the solution is transparent and free of particles.

The unused contrast medium within 24 hours after opening the packaging should be discarded.

Disposal of the unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.