Gastrolux 370 mg/ml oral and rectal solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gastrolux 370 mg/ml oral and rectal solution EFG.

Sodium amidotrizoate and meglumine amidotrizoate.

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Leaflet contents:

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

1. What Gastrolux is and what it is 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 or rectally (enema), and is primarily indicated when the use of barium sulfate is unsatisfactory, undesirable, or contraindicated.

Indications include:

• Early diagnosis of perforation (opening in a viscus or organ) or anastomotic defect (defective connection), radiologically undetectable, in the esophagus and/or gastrointestinal tract, as well as acute perforations (peptic ulcer, diverticulum (herniation of the digestive tube in a sac-like form), following total or partial removal of the stomach or intestine (risk of perforation or leakage).

• Suspected partial or complete stenosis (narrowing), small bowel obstruction, colonic obstruction, and acute hemorrhage (acute bleeding).

• Megacolon (marked and pathological dilation of the colon).

• Visualization of a foreign body or tumor prior to endoscopy.

• Visualization of a gastrointestinal fistula (abnormal tract connecting two different regions of the digestive tube).

• Gastrolux is used with barium sulfate to accelerate gastrointestinal transit. In addition to the indications listed above, Gastrolux may be used for the same indications as barium sulfate, except for the visualization of mucosal abnormalities.

• Gastrolux is used in computed tomography (CT, imaging of cross-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 an aid in the diagnosis of pathologies affecting these organs.

2. What you need to know before using 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 (overactive thyroid gland).

Do not use undiluted Gastrolux

• If you have lost a significant amount of body fluid or water (e.g., severe diarrhea, vomiting).
• In children under 10 years of age.
• If there is a possibility that Gastrolux could inadvertently enter your respiratory system.

Warnings and precautions

Talk to your doctor or nurse before using Gastrolux

• If you have disturbances in hydration and electrolyte balance.
• If you suffer from states of excitement, anxiety, or severe pain.
• If you have or have had any allergic reaction (e.g., allergy to shellfish, hay fever/acute seasonal allergic rhinitis, hives).
• If you have bronchial asthma.
• If you have or are suspected of having hyperthyroidism (overactive thyroid gland) or goiter (enlargement of the thyroid gland), as iodinated contrast media may interfere with thyroid function, worsen or induce hyperthyroidism, and trigger a thyrotoxic crisis (a serious complication of an overactive thyroid).
• If you have severe cardiovascular disease, as this increases the risk of experiencing a severe hypersensitivity (allergic) reaction.
• If you are experiencing a significant deterioration in your general health.
• If you are also to receive barium sulfate. In this case, pay attention to the contraindications, precautions, and potential side effects relevant to that 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 to undergo any test for diagnosing thyroid-related diseases, inform your doctor, as this may alter test results. A minimum of 16 days should elapse after using Gastrolux before such tests.

Before you receive Gastrolux, inform your doctor if any of these situations apply to you. Your doctor will decide whether the planned diagnostic procedure can or cannot be performed. Your thyroid function may be evaluated before receiving Gastrolux, and you may be given a thyrostatic medication (a drug to reduce thyroid gland function).

The doctor should evaluate thyroid function in newborns who have been exposed to Gastrolux, either during pregnancy or after birth, because excess iodine may cause hypothyroidism (underactive thyroid gland), which might require treatment.

Use of Gastrolux with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you inform your doctor if you are taking any of the following medicines.

• Beta-blockers (such as propranolol or atenolol): allergic reactions due to contrast media may 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 of 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 taking diuretics, you should know that saline rehydration is necessary to minimize the risk of acute renal failure.

• Radiopharmaceuticals: If you are using this medicine, you should know that the uptake capacity of radiopharmaceuticals used in the diagnosis and treatment of thyroid disorders may be reduced for several weeks after administration of iodinated contrast media.

Gastrolux with food and drink

Before using Gastrolux, bowel cleansing is recommended, as it facilitates the performance and validity of the diagnostic test.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 exposure to radiation should be avoided during pregnancy whenever possible, the benefits of any radiological examination, with or without contrast medium, must be carefully weighed against potential risks.

It is unknown whether Gastrolux passes into breast milk. Some data suggest that the risk to the infant is low if Gastrolux is administered to the mother. Breastfeeding is likely safe, particularly due to the low intestinal absorption of Gastrolux.

Driving and using machines

No known effects on the ability to drive or operate machinery have been reported after administration of Gastrolux.

Gastrolux contains sodium.

Gastrolux for oral use

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

Gastrolux in combination with barium sulfate

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

3. How to use Gastrolux

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Gastrolux is a contrast medium used to perform a diagnostic test, which must be carried out in the presence of qualified personnel, preferably under the supervision of a physician who will provide you with specific instructions throughout the procedure.

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

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

Prior to using Gastrolux, bowel cleansing is recommended, as it facilitates the performance and validity of the diagnostic test.

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

X-ray examination

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

Target organ	Route of administration	Dose/Preparation/Dilution	Concentration	Age
Esophagus	Oral	15–30 mL diluted with 3 times its volume of water	25% solution	Neonates and infants
15–30 mL diluted with 2 times its volume of water	33% solution	Children up to 10 years
60 mL Undiluted	Undiluted	Adults and children from 10 years
Stomach	Oral	15–30 mL diluted with 3 times its volume of water	25% solution	Neonates and infants
15–30 mL diluted with 2 times its volume of water	33% solution	Children up to 10 years
60 mL Undiluted	Undiluted	Adults and children from 10 years
Dynamic examination of gastrointestinal tract	Oral	15–30 mL diluted with 3 times its volume of water	25% solution	Neonates and infants
15–30 mL diluted with 2 times its volume of water	33% solution	Children up to 10 years
Maximum 100 mL of Gastrolux	Undiluted	Adults and children from 10 years
Large intestine	Rectal	Up to 500 mL of dilution. Diluted with 5 times its volume	16.7% solution	Children under 5 years
Up to 500 mL of dilution. Diluted with 4–5 times its volume of water	16.7% to 20% solution	Children 5 to 18 years
Up to 500 mL of dilution. Diluted with 3–4 times its volume of water	20% to 25% solution	Adults

Computed tomography (CT)

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

Target organ	Route and technique of administration	Preparation/Dilution	Concentration	Dose
Esophagus	Oral	9 to 15 ml of Gastrolux diluted with 0.3 to 0.5 liters of water	3% solution	Patients should drink 300 to 500 ml of this solution
Stomach	Oral	9 to 15 ml of Gastrolux diluted with 0.3 to 0.5 liters of water	3% solution	Patients should drink 300 to 500 ml of this solution
Small intestine	Oral	9 to 15 ml of Gastrolux diluted with 0.3 to 0.5 liters of water	3% solution	Patients should drink 300 to 500 ml of this solution
Distal GI tract/Entire intestine	Oral*	30 ml of Gastrolux diluted with 1 liter of water, or 45 ml of Gastrolux in 1.5 liters of water	3% solution	Up to 1500 ml of prepared solution may be administered
Large intestine/Rectum	Rectal	15 ml of Gastrolux in 0.5 liters of water	3% solution	Up to 500 ml may be administered

*oral/rectal administration may be combined

In the case of pediatric use, volumes should be adjusted. The table below specifies the maximum volumes to be administered of the Gastrolux dilution with water.

	Oral	Enema/rectal
Age	Gastrolux	Water	Gastrolux	Water
6 months	3 ml	100 ml	1 ml	50 ml
2 years	6 ml	200 ml	2 ml	100 ml
5 years	9 ml	300 ml	3 ml	150 ml
10 years	15 ml	500 ml	4 ml	200 ml
>10 years	15 -30 ml	500 - 1000 ml	500 ml	1500 -2000 ml

Gastrolux associated with barium sulfate

Age	Gastrolux	Barium sulfate
From 0 to 5 years	2–5 ml	100 ml
From 5 to 10 years	10 ml	100 ml
From 11 to 18 years	30 ml	Usual dose according to organ being studied
Adults	30 ml	Usual dose according to organ being studied

If necessary, the proportion of Gastrolux in the suspension can be further increased 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 characteristics related to the administration of Gastrolux. Additional information regarding the administration and handling of Gastrolux is provided at the end of this leaflet.

If you use more Gastrolux than you should

Disturbances in the hydroelectrolytic balance (the body's internal equilibrium) due to excessive administration of Gastrolux should be corrected by parenteral route (any route other than the digestive tract).

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91.562.04.20, indicating the medication and the amount administered.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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, pruritus (itching), and urticaria (of the type caused by nettles) may be the first signs of a serious reaction developing.

Inform healthcare personnel 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 (affect between 1 and 10 out of every 100 patients):

• Vomiting, nausea, diarrhoea.

Rare adverse effects (affect between 1 and 10 out of every 10,000 patients):

• Anaphylactoid shock, anaphylactoid or hypersensitivity reactions (allergic reactions that may become very severe)
• Thyrotoxic crisis in patients with hyperthyroidism (excessive production by the thyroid gland)
• Hydroelectrolytic imbalance
• Disorders of consciousness, headache, dizziness
• Cardiac arrest, tachycardia (increased heart rate)
• Shock (generalized disturbance in the body), hypotension (low blood pressure)
• Bronchospasm (narrowing or obstruction of bronchial muscles) or dyspnoea (feeling of breathlessness), medication aspiration, pulmonary oedema 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 varying severity)
• Fever, sweating

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

• Underactivity of the thyroid gland (hypothyroidism)

Other possible adverse effects:

• Inflammatory processes in the intestinal mucosa may be temporarily intensified.
• When administered rectally as an enema, changes in the mucosal membrane, bleeding, and destruction of intestinal tissue may occur, especially 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, pruritus (itching), nasal discharge, sneezing, and urticaria (of the type caused by nettles) may be the first signs of a serious reaction developing.

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

Gastrolux may cause diarrhoea, but this stops as soon as the intestine is emptied. Pre-existing enteritis (inflammation of the intestine) or colitis (inflammation of the colon) may worsen temporarily. In cases 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 adverse effect, consult your doctor or nurse, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 above 30 °C.

Do not use this medicine after the expiry date stated on the container after EXP.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Gastrolux

• The active substances 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 injections.

Presentation of the product and contents of the container Gastrolux is available in containers 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 most recent revision of this leaflet: June 2023

Detailed information on this medicinal product 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 for healthcare professionals only:

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Dosage and method of administration

Oral administration

For the early diagnosis of a perforation or anastomosis in the oesophagus 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 may be used as a diagnostic aid. After 30-60 minutes (longer if a lesion in the distal intestine is suspected), a urine sample should be taken and mixed with 5 drops of concentrated hydrochloric acid. Any contrast medium that has undergone renal excretion will appear within the following 2 hours as a typical crystal formation in the precipitate.

Rectal Administration

For administration as an enema, a rectal irrigator and a soft rubber catheter are recommended. To prevent backflow of the contrast medium, the buttocks should be held together using adhesive tape. A Foley catheter must not be used. The contrast medium should be introduced slowly and under continuous radiological monitoring.

Administration is considered complete as soon as Gastrolux passes into the small intestine. In order to compensate for potential excessive fluid loss, an intravenous plasma infusion should be prepared prior to beginning administration.

If, one hour after catheter removal, the contrast medium has not yet been evacuated, radiological confirmation must be obtained to ensure that excessive intestinal distension has not occurred. This method must not be used in cases requiring immediate surgery, such as intestinal volvulus, gangrene, perforation, peritonitis, or atresia.

Optimal Timing for Radiographic Imaging

Radiographic exposures of the stomach are performed in the usual manner, whether Gastrolux is used alone or in combination with barium sulfate.

Gastric emptying time is similar to that of barium sulfate, whereas intestinal filling occurs more rapidly. When Gastrografin is used alone, the contrast medium generally reaches the rectum within 2 hours, while the combination of Gastrografin/barium sulfate may take up to 3 hours, and in isolated cases even longer.

The optimal time for radiographic imaging of the colon is indicated by the patient's sensation of needing to defecate.

Special Precautions

• Hydration and Electrolyte Balance

Adequate patient hydration must be ensured 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, and in newborns, infants, young children, and elderly patients. Electrolyte imbalances should be corrected prior to the examination.

To compensate for potentially clinically relevant electrolyte losses during rectal administration, lactated Ringer's solution should be prepared and ready for intravenous infusion if necessary.

• Anxiety

States of excitement, anxiety, and severe pain may increase the risk of adverse reactions or intensify contrast medium-related reactions. Sedatives may be administered to such patients.

• Hypersensitivity Reactions

A risk-benefit assessment must be performed, especially in patients with known hypersensitivity to Gastrolux or any of its components, due to an increased risk of hypersensitivity or anaphylactic reactions.

Premedication with antihistamines and/or glucocorticoids may be considered.

If hypersensitivity reactions occur, administration of the contrast medium must be stopped immediately, and specific intravenous treatment initiated if necessary. To ensure immediate response in emergencies, appropriate medications, an endotracheal tube, and an artificial respirator must be readily available.

• Thyroid Dysfunction

A risk-benefit assessment is necessary in patients with suspected clinical hyperthyroidism, subclinical hyperthyroidism, or known or suspected goiter, since, like any iodinated contrast medium, Gastrolux may interfere with thyroid function, exacerbate or induce hyperthyroidism, or trigger a thyrotoxic crisis.

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

• Severe Cardiovascular Disease

Patients with cardiovascular disorders who experience hypersensitivity reactions while taking beta-blockers may be unresponsive to treatment with beta-agonists.

• Poor General Health Status

The necessity of the examination must be carefully evaluated.

• Combined Use with Barium Sulfate

Attention must be paid to the contraindications, precautions, and potential adverse effects relevant to 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 gland's ability to bind iodine may be reduced for several weeks. PBI (protein-bound iodine) results and radioactive iodine uptake studies, which depend on iodine measurement, cannot accurately reflect thyroid function for up to 16 days after administration of iodinated contrast media.

• Warnings Regarding Excipients

Gastrogralux for Oral Use

This medicinal product 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.

Gastrogralux in Combination with Barium Sulfate

This medicinal product 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

If crystallization of the contrast medium occurs due to storage in refrigerated conditions, it can be redissolved by gentle agitation and warming to body temperature. This change does not impair the efficacy or stability of the preparation.

The contrast medium must be discarded if not used within 72 hours after opening the container.

Any unused contrast medium remaining after an examination must be disposed of in accordance with local regulations.