Label: information for the user

Gastrolux 370 mg/ml oral and rectal solution EFG.

Sodium amidotrizoate and meglumine amidotrizoate.

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

This medication is for diagnostic use.

Gastrolux is a contrast medium used for X-ray exploration of the gastrointestinal tract. It can only be administered orally and rectally (enema), and is primarily 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), small intestine obstruction, colon obstruction, and acute hemorrhage (acute bleeding).
• Megacolon (marked and pathological dilation of the colon).
• Visualization of a foreign body or a tumor before performing an endoscopy.
• Visualization of a gastrointestinal fistula (pathological tract that communicates two different areas of the digestive tube).
• Gastrolux is used with barium sulfate to accelerate gastrointestinal transit. In addition to the indications mentioned, Gastrolux can be used for the same indications as barium sulfate, except for visualization of mucosal lesions.
• Gastrolux 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.

Do not use Gastrolux

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

Do not use Gastrolux without dilution

• If you have lost a lot of body fluid or water (e.g., severe diarrhea, vomiting).
• In children under 10 years old.
• If Gastrolux could possibly pass (inadvertently) into your respiratory system.

Warnings and precautions

Consult your doctor or nurse before starting to use Gastrolux.

• If you have alterations in hydration and electrolyte balance.
• If you have states of excitement, anxiety, or intense pain.
• If you have had any allergic reaction (e.g., shellfish allergy, hay fever/acute seasonal allergic rhinitis, hives).
• If you have asthma bronchial.
• If you have or suspect you 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 you have a significant deterioration in your health status.
• If you are also going 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 Gastrolux in the gastrointestinal tract (e.g., obstruction, stasis), tissue damage, bleeding, necrosis, and intestinal perforation may occur.
• Interference with diagnostic tests: If you are going to have a test 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 Gastrolux.

Before you receive Gastrolux, inform your doctor if any of the following cases apply to you.Your doctor will decide if the planned diagnostic test is or is not possible. Your thyroid function may be examined before receiving Gastrolux, and you may be administered a thyroid-stimulating medication (medication to reduce thyroid function).

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

Use of Gastrolux 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 propranolol or atenolol): Allergic reactions to contrast media may worsen, especially in the presence of asthma bronchial. 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.

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

Gastrolux with food and drinks

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

The safety of contrast media for use in pregnant patients has not been demonstrated. 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 Gastrolux into breast milk is unknown. Some data suggest that the risk to the infant is low in the case of administration of Gastrolux to the mother. Breastfeeding is probably safe, especially due to the low intestinal absorption of Gastrolux.

Driving and operating machines

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

Gastrolux contains sodium.

Gastrolux for oral use

This medication contains 231.84 to 386.4 mg of sodium (main component of table salt/for cooking) in each dose (60-100 ml). This is equivalent to 11.59-19.32% of the maximum daily sodium intake recommended for an adult.

Gastrolux in combination with barium sulfate

This medication contains 115.92 mg of sodium (main component of table salt/for cooking) in each dose (30 ml). This is equivalent to 5.79% of the maximum daily sodium intake recommended for an adult.

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

Gastrolux is a contrast medium used for diagnostic testing, which must 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.

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

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

Before using Gastrolux, 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.

Exploration by X-rays

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

Computed Tomography (CT)

Depending on the area to be studied of the gastrointestinal tract, the oral or rectal route is used. The examination can be performed after administering 0.5-1.5 liters of Gastrolux solution at approximately 3% concentration (30 ml of Gastrolux in 1 liter of water).

*May combine oral/rectal administration

In pediatric cases, volumes should be adjusted. The maximum volumes to administer of the Gastrolux dilution with water are specified in the table below.

Gastrolux associated with barium sulfate

If necessary, the proportion of Gastrolux 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 Gastrolux. Additional information regarding the administration and handling of Gastrolux is provided at the end of the prospectus.

If you use more Gastrolux than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91.562.04.20, indicating the medication and the amount administered.

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

Inform medical personnel immediately if you experience any of these symptoms or have difficulty breathing.

After hours or days of Gastrolux administration, delayed reactions may occur.

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

• nausea, vomiting, diarrhea.

Rare side effects(affect between 1 and 10 of 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
• Altered 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 muscle) or dyspnea (sensation of difficulty breathing), aspiration of the medication, pulmonary edema after aspiration, aspiration pneumonia.
• Intestinal perforation, abdominal pain, formation of blisters on the oral mucosa.
• Toxic epidermal necrosis, urticaria, exanthema, irritation, skin rash, facial swelling (cutaneous reactions of varying severity)
• Fever, sweating

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

• Hypothyroidism (underactive thyroid)

Other possible side effects

• Inflammatory processes in the intestinal mucosa may be temporarily intensified.
• By rectal administration in the form of an enema, changes in the mucous membrane, bleeding, and intestinal tissue destruction may occur in cases of constipation.

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

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

Gastrolux may cause diarrhea, but this stops as soon as the intestine is emptied. An existing enteritis (inflammation of the intestine) or colitis (inflammation of the colon) may temporarily worsen. In cases of obstruction, prolonged contact with the intestinal mucosa may cause erosions, bleeding, and intestinal necrosis (death of intestinal cells).

Reporting of side effects

If you experience any other type of side effect, consult your doctor or nurse, even if it is a side effect that does not appear in this prospectus.You can also report them directly through the Spanish System of 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 medication.

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

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

Do not store at a temperature above 30 °C.

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 in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Gastrolux

• The active principles are sodium amidotrizoate and meglumine amidotrizoate
• 1 bottle of 100 ml contains 66 g of meglumine amidotrizoate and 10 g of sodium amidotrizoate.

• The other components are:sodium hydroxide, sodium saccharin, polisorbate 80, star anise oil, disodium edetate, citric acid, water for injectable preparations.

Appearance of the product and contents of the packagingGastrolux is available in packaging that contains:

• 1 bottle of 100 ml of solution.
• 10 bottles 100 ml of solution each.
• 20 bottles 100 ml of solution each.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Juste Farma S.L.U

Avenida de San Pablo 27

28823, Coslada

(Madrid) Spain

Responsible for manufacturing:

Sanochemia Pharmazeutika GmbH,

Landegger Straße 7,

2491 Neufeld an der Leitha

Austria

Last review date of this prospectus: June 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Deviceshttp://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

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Dosage andform of administration

Oral administration

To diagnose early perforation or anastomosis in the esophagus and/or gastrointestinal tract, the patient should ingest up to 100 ml of Gastrolux. 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 suspected that the lesion is located in the distal intestine), a urine sample should be taken, mixing 5 ml with 5 drops of concentrated hydrochloric acid. The medium that has undergone renal excretion will appear in the following 2 hours as a typical crystal formation in the precipitate.

Rectal administration

For rectal application, a syringe and a soft rubber catheter are recommended. The return of the medium is avoided by a adhesive tape that presses 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 Gastrolux passes into the small intestine. In order 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 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 atresias, this method should not be applied.

Appropriate time for performing radiographs:

Exposures of the stomach are performed in the usual way, whether Gastrolux 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 Gastrolux is used alone, the medium generally reaches the rectum after 2 hours, while the combination of Gastrolux/barium sulfate may take up to 3 hours and, in isolated cases, even longer.

The most favorable time for performing radiological exposures of the colon is indicated by the sensation of the need 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 especially 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. Alterations in electrolyte balance should be corrected before the examination.

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

• Anxiety

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

• Hypersensitivity reactions

A risk-benefit assessment is necessary, especially in patients with known hypersensitivity to Gastrolux 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 suspended immediately and, if necessary, specific treatment initiated intravenously. In order to act immediately in case of an emergency, it should be easily available to have the appropriate medications, an endotracheal tube, and a respirator.

• Thyroid dysfunction

A risk-benefit assessment is necessary in patients with suspected clinical hyperthyroidism, patients with subclinical hyperthyroidism, or known or suspected goiter, as Gastrolux, 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 Gastrolux, 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

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 contraindications, precautions, and relevant possible side effects of barium sulfate.

• Gastrointestinal risks

It may cause tissue damage, bleeding, necrosis, and intestinal perforation.

• 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, cannot accurately reflect thyroid function for up to 16 days after administration of iodinated contrast media.

• Warnings about excipients

Gastrogralux for oral use

This medicine contains 231.84 to 386.4 mg of sodium per dose (60-100 ml), equivalent to 11.59-19.32% of the maximum daily sodium intake of 2 g recommended by the WHO for an adult.

Gastrogralux in combination with barium sulfate

This medicine contains 115.92 mg of sodium per dose (30 ml), equivalent to 5.79% 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 refrigerated places, it can be redissolved by agitation and gentle warming to body temperature. This alteration does not imply a detriment to the effectiveness and stability of the preparation.

The unused contrast medium should be discarded 72 hours after opening the packaging.

The unused contrast medium from an examination should be discarded in accordance with local regulations.