GASTROLUX 370 mg/ml ORAL AND RECTAL SOLUTION

Introduction

Package Leaflet: Information for the User

Gastrolux 370 mg/ml Oral and Rectal Solution EFG.

Sodium Amidotrizoate and Meglumine Amidotrizoate.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Gastrolux and what is it used for

This medicine is for diagnostic use.

Gastrolux is a contrast medium used for X-ray examination 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.

Among the indications are:

• 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 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).
• Gastrolux is used with barium sulfate to accelerate gastrointestinal transit. In addition to the mentioned indications, Gastrolux can be used for the same indications as barium sulfate, except for the visualization of mucosal conditions.
• Gastrolux 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 (large intestine and rectum) as a diagnostic aid for pathologies in these organs.

2. What you need to know before you use Gastrolux

Do not use Gastrolux

• if you are allergic to the active substances or to any of the other components of this medicine (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 (overfunction of the thyroid gland)

Do not use Gastrolux 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 Gastrolux could inadvertently enter 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 bronchial asthma.
• If you have or are suspected to have hyperthyroidism (overactivity of the thyroid gland) or goiter (enlargement of the thyroid gland), since iodinated contrast media can interfere with thyroid function, worsen or induce hyperthyroidism and thyrotoxic crisis (serious complication of an overactive thyroid).
• 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 possible side effects relevant to 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 undergo any 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 tell your doctor if any of these 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-static medication (medication to reduce thyroid gland function).

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

Using Gastrolux 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 tell your doctor if you use any of the following medicines.

- Beta-blockers (such as propranolol or atenolol) allergic reactions due to contrast media can worsen, especially in the presence of bronchial asthma. Also, if you are being treated with beta-blockers, you may not respond to standard treatment for allergic reactions with beta-agonists (favoring 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 drug: If you are using this medicine, you should know that the uptake capacity of radioactive drugs used in the diagnosis and treatment of thyroid pathologies may decrease for several weeks after the administration of iodinated contrast media.

Gastrolux with food and drinks

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

Pregnancy, breastfeeding, 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 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 must be carefully weighed against the possible risks.

It is unknown if Gastrolux passes into breast milk. Some data suggest that the risk to the infant is low in case of administration of Gastrolux to the mother. Probably, breastfeeding is safe, especially due to the low intestinal absorption of Gastrolux.

Driving and using machines

No effect on the ability to drive and use machines after administration of Gastrolux is known.

Gastrolux contains sodium.

Gastrolux for oral use

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

Gastrolux in combination with barium sulfate

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

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3. How to use Gastrolux

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

Gastrolux 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.

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

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

Before using Gastrolux, it is recommended to clean the intestine, as it facilitates the realization 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 to be studied in the gastrointestinal tract, the oral or rectal route is used.

Computed Tomography (CT)

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

*Oral/rectal administration can be combined

In the case of pediatrics, the volumes should be adjusted. In the table below, the maximum volumes to be administered of the Gastrolux dilution with water are specified.

Gastrolux associated with barium sulfate

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

If you use more Gastrolux than you should

Alterations in hydroelectrolytic balance (state of balance inside the body) due to excessive administration of Gastrolux 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 administered.

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from 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 secretion, sneezing, itching, and urticaria (of the type caused by nettles) may be the first symptoms of a severe reaction.

Inform the healthcare staff immediately if you experience any of these symptoms or have difficulty breathing.

Delayed reactions may occur hours or days after administration of Gastrolux.

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

• Vomiting, nausea, diarrhea.

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

• Anaphylactoid shock, anaphylactoid or hypersensitivity reaction (allergic reactions that can be very severe)
• Thyroid crisis in patients with hyperthyroidism (excessive production of the thyroid gland).
• Hydroelectrolytic imbalance
• Consciousness disorders, 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) or dyspnea (feeling of 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)

Other possible adverse effects

• Inflammatory processes in the intestinal mucosa may be temporarily intensified.
• When administered rectally in the form of an enema, changes in the mucous membrane, bleeding, and destruction of intestinal tissue may occur in the case 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 (pruritus), nasal secretion, sneezing, and urticaria (of the type caused by nettles) may be the first symptoms of a severe reaction.

Delayed reactions may occur hours or days after administration of Gastrolux. Inform the healthcare professional immediately if you experience any of these symptoms or have difficulty breathing.

Gastrolux may cause diarrhea, but this ceases 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 may cause erosions, bleeding, and intestinal necrosis (death of intestinal cells).

Reporting of Adverse Effects

If you experience any other type of adverse effect, consult your doctor or nurse, 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. Conservation of Gastrolux

Keep this medicine out of 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 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 down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gastrolux

• The active ingredients 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, polysorbate 80, star anise oil, disodium edetate, citric acid, water for injectable preparations.

Appearance of the Product and Package ContentsGastrolux is available in packages containing:

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Juste Farma S.L.U

Avenida de San Pablo 27

28823, Coslada

(Madrid) Spain

Manufacturer:

Sanochemia Pharmazeutika GmbH,

Landegger Straße 7,

2491 Neufeld an der Leitha

Austria

Date of the Last Revision of this Prospectus: June 2023

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

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This information is intended only for healthcare professionals:

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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 Gastrolux. 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

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 Gastrolux passes into the small intestine. In order to be able 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 radiographs:

Stomach exposures 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 filling the intestine is shorter. When Gastrografin is used alone, the contrast medium usually 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 balance disorders should be corrected before the examination.

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

• Anxiety

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

• Hypersensitivity reactions

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

Prior 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 should be initiated intravenously. To be able to act immediately in case of an 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 Gastrolux, like any iodinated contrast medium, may interfere with thyroid function, worsen or induce hyperthyroidism and thyrotoxic crisis.

In newborns, especially premature babies, 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

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 the examination should be carefully evaluated.

• Combined use with barium sulfate

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

• Gastrointestinal risks

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

• Interference with diagnostic tests

Iodinated contrast media may 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 iodine uptake studies, which depend on iodine estimation, may not accurately reflect thyroid function until 16 days after the administration of iodinated contrast media.

• Warnings about excipients

Gastrolux 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 intake of 2 g of sodium recommended by the WHO for an adult.

Gastrolux 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 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.

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

The unused contrast medium in an examination should be discarded according to local regulations.