Label: information for the user

Gastrografin 370 mg Iodo/ml oral and rectal solution

Amidotrizoate sodium and amidotrizoate meglumine (DCI)

1. What is Gastrografin and how it is used.

2. What you need to know before starting to use Gastrografin.

3.How to use Gastrografin.

4.Possible adverse effects.

1. Storage of Gastrografin.
2. Contents of the package and additional information.

This medication is for diagnostic and therapeutic use.

Diagnostic use

• Gastrografin is a contrast medium used for X-ray exploration of the gastrointestinal tract. It can only be administered orally and rectally (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, colonic obstruction, and acute hemorrhage (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 indications mentioned, Gastrografin can be used for the same indications as barium sulfate, except for visualization of mucosal lesions.

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

Therapeutic use

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

No use Gastrografin

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

• In patients at risk of aspiration or esophageal bronchial fistula.
• If you have clinical hyperthyroidism (hyperfunction of the thyroid gland).

No use Gastrografin without diluting

• If you have lost a lot of body fluid or water (e.g., severe diarrhea, vomiting).
• In children under 10 years old.
• If it is possible for Gastrografin to pass (inadvertently) into your respiratory system.

Advertencias 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 (hyperactivity of the thyroid gland) or goiter (enlargement of the thyroid gland), as iodinated contrast media may interfere with thyroid function, exacerbate or induce hyperthyroidism, and thyroid crisis (a severe complication of an overactive thyroid).
• If you have severe cardiovascular disease,as it increases the risk of severe hypersensitivity reactions (allergies).
• If your health status has deteriorated significantly.

• If, in addition, you are to be administered barium sulfate. In this case, you should pay attention to the contraindications, precautions, and relevant possible 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 may occur.
• Interference with diagnostic tests: If you are to undergo a test for the diagnosis of thyroid-related diseases, inform your doctor, as it may alter the results. You should wait, at a minimum, 16 days after using Gastrografin.

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

Your doctor should examine the thyroid function of newborns who have been exposed to Gastrografin, either during pregnancy or after birth, as excessive iodine may cause hypothyroidism (underactive thyroid), which may require treatment.

Use of Gastrografin with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

- Beta-blockers (such as propanolol or atenolol): Allergic reactions to contrast media may be exacerbated, 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 bronchial dilation).

- Interleukin-2: If you are using this medication (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.

- Radioisotopes: If you are using this medication, you should know that the ability to capture radioisotopes, used in the diagnosis and treatment of thyroid diseases, may decrease for several weeks after administration of iodinated contrast media.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is no evidence that contrast media are safe for use in pregnant patients. Since, whenever possible, exposure to radiation during pregnancy should be avoided, the benefits of any radiological examination, with or without contrast media, should be carefully weighed against the possible risks.

The passage of Gastrografin into breast milk is unknown. Some data suggest that the risk to the infant is low in the event of administration of Gastrografin to the mother. Probably, breastfeeding is safe, especially due to the low intestinal absorption of Gastrografin.

Driving and operating machinery

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

Gastrografin contains sodium

This medication contains 3.76 mg of sodium (main component of table salt/for cooking) in each ml. This corresponds to 0.19% of the maximum daily sodium intake recommended for an adult.

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

Gastrografin is a contrast medium used for diagnostic testing, which should be performed in the presence of qualified personnel, preferably under the supervision of a doctor, who will indicate the instructions to follow at each moment.

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

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

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

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

Exploratory X-rays

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 administering 0.5-1.5 liters of Gastrografin solution at approximately 3% concentration (30 ml of Gastrografin in 1 liter of water).

*The oral and rectal routes can be combined.

In pediatric cases, the volumes should be adjusted. The maximum volumes to be administered of the Gastrografin solution 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 taken advantage of: the adjacent tissue is forced to release a significant 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 to 5 ml of the diluted solution is required, but in other cases, more quantity may be needed. 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 even more 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 prospectus.

If you use more Gastrografin than you should

The alterations of the hydroelectrolytic balance (state of balance inside the organism) by an excessive administration of Gastrografin should be corrected by parenteral route (any route other than digestive).

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent side effects(affect between 1 and 10 in every 100 patients):

• Vomiting, nausea, diarrhea.

Rare side effects(affect between 1 and 10 in every 10,000 patients):

- Anaphylactic shock, anaphylactoid or hypersensitivity reactions (allergic reactions that can be very severe).

• Thyroid crisis in patients with hyperthyroidism (excessive production of the thyroid gland).
• Hydroelectrolyte imbalance.
• Disorders of consciousness, headache, dizziness.
• Cardiac arrest, tachycardia (increased heart rate).
• Shock (general alteration of the organism), hypotension (low blood pressure).
• Bronchospasm (narrowing or obstruction of the bronchial muscle), dyspnea (difficulty breathing), aspiration of the medication, pulmonary edema after aspiration, aspiration pneumonia.
• Intestinal perforation, abdominal pain, formation of blisters in the oral mucosa.
• Toxic epidermal necrosis, urticaria, exanthema, irritation, skin rash, facial swelling (severe or mild skin reactions).
• Fever, sweating.

Side effects of unknown frequency(cannot be estimated from available data)

• Hypothyroidism (underactive thyroid)

As with all contrast agents, allergic reactions may occur, including severe reactions (shock) that may require immediate medical intervention. Moderate swelling of the face, lips, tongue, or throat, cough, pruritus (itching), nasal discharge, sneezing, and urticaria (like nettle rash) may be the first signs of a severe reaction.

After hours or days of Gastrografin administration, delayed reactions may occur. Inform your healthcare professional immediately if you experience any of these symptoms or have difficulty breathing.

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

Reporting side effects

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

Keep out of sight and reach of children.

This medication does not require any special temperature for conservation.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Gastrografin

• The active principles are sodium amidotrizoate and meglumine amidotrizoate.

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

• The other components are sodium saccharinate, edetate disodium-calcium dihydrate, and injection water.

Appearance of the product and contents of the package

Gastrografin is a nearly colorless to yellowish solution.

The contents of the package are 1 vial of 100 ml.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Berlimed S.A.

C/ Francisco Alonso, 7

Polígono industrial Santa Rosa

28806 Alcalá de Henares (Madrid)

Last review date of this leaflet: April 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 identified clearly with X-rays, the following test can be used as a diagnostic aid. After 30-60 minutes (later if the suspected lesion is 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 following 2 hours as a typical crystal formation in the precipitate.

Rectal administration

Treatment of uncomplicated meconium ileus

For rectal administration, a syringe and a soft rubber catheter are recommended. The return of the contrast medium is prevented by a adhesive strip that is pressed against the buttocks. A Foley catheter should not be used. The introduction should be made slowly and under constant radiological control.

The application is considered complete as soon as Gastrografin passes into the small intestine. To compensate for possible excessive fluid loss, a plasma infusion should be prepared before starting the application.

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

Appropriate time for taking radiographs:

Exposures of the stomach are made 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 shorter. When Gastrografin is used alone, the contrast medium usually reaches the rectum after 2 hours, while the combination of Gastrografin and barium sulfate may take up to 3 hours and, in isolated cases, even longer.

The most favorable time for taking radiographs of the colon is indicated by the feeling of needing to defecate experienced by all patients.

Special precautions

• Hydration and electrolyte balance

It is essential to ensure adequate hydration of the patient before and after administration of the contrast medium. This is particularly important in patients with multiple myeloma, diabetes mellitus with renal insufficiency, polyuria, oliguria, hyperuricemia, as well as in newborns, infants, small children, and elderly patients. Electrolyte imbalances should be corrected before the examination.

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

• Anxiety

States of excitement, anxiety, and intense pain can increase the risk of adverse reactions or intensify reactions related to contrast media. Sedatives can be administered to these patients.

• Hypersensitivity reactions

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

Pre-treatment with antihistamines and/or glucocorticoids may be considered.

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

• Thyroid dysfunction

A risk-benefit assessment is necessary in patients with suspected clinical hyperthyroidism, subclinical hyperthyroidism, or known or suspected goiter, as Gastrografin, like any iodinated contrast medium, can interfere with thyroid function, exacerbate or induce hyperthyroidism, and thyroid crisis.

In newborns, especially premature infants, who have been exposed to Gastrografin, either through the mother during pregnancy or in the neonatal period, thyroid function should be monitored, as excessive iodine exposure can cause hypothyroidism and may require treatment.

• Severe cardiovascular disease

Patients with cardiovascular disease who experience hypersensitivity reactions while taking beta-blockers may be refractory to beta-agonist treatment.

• Very poor health status

The need for the examination 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 bind iodine may be reduced for several weeks. PBI (iodine bound to proteins) and iodine uptake studies, which depend on iodine estimation, may not accurately reflect thyroid function for up to 16 days after contrast medium administration.

Warnings about excipients

Gastrografin contains sodium

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

Instructions for use/manipulation

If crystallization of the contrast medium occurs due to storage in a cold place, it can be redissolved by agitation and gentle warming to body temperature. This alteration does not affect 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 should be discarded 24 hours after opening the package.

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