GASTROGRAFIN

Package leaflet: Information for the user

Gastrografin 370 mg iodine/ml gastro-intestinal solution

sodium amidotrizoate + meglumine amidotrizoate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Gastrografin is and what it is used for

Gastrografin belongs to the category of water-soluble, nephrotropic, high-osmolar radiological contrast agents.
This medicinal product is for diagnostic use only, administered orally or rectally.
Gastrografin is a radiographic contrast medium used to visualize the gastrointestinal tract (also in combination with barium sulfate). Gastrografin is primarily indicated when the use of barium sulfate is inadequate or contraindicated, or when results obtained with barium sulfate are unsatisfactory.

Specifically, Gastrografin is used in the following cases:

• when partial or complete stenosis is suspected (narrowing of the digestive tract);
• in the presence of acute bleeding;
• when there is a risk of perforation (peptic ulcer, diverticula);
• in the presence of other acute conditions that are highly likely to require surgical intervention;
• when disturbances occur following stomach or intestinal surgery (risk of perforation or suture dehiscence);
• in patients with megacolon (dilation of the final portion of the intestine);
• for visualization of foreign bodies or tumors prior to endoscopy;
• for visualization of gastrointestinal fistulas (abnormal connections between organs or parts of organs that normally do not communicate).

In addition to these cases, Gastrografin may naturally be used for all the indications for which barium sulfate is indicated.
In combination with barium sulfate, Gastrografin allows for significant improvement, both diagnostically and procedurally, in routine gastrointestinal transit examinations. Gastrografin is not limited solely to the diagnosis of enteritis (inflammation of the intestine).

2. What you need to know before using Gastrografin

Do not use Gastrografin

• if you are allergic to sodium amidotrizoate or meglumine amidotrizoate, iodinated contrast media, or any of the other ingredients of this medicine (listed in section 6);
• if you have Waldenström's macroglobulinemia or multiple myeloma (diseases characterized by the presence of abnormal proteins in the blood);
• in cases of severe hepatic or renal insufficiency (severe reduction in liver or kidney function);
• undiluted, if you have reduced plasma volume, a broncho-esophageal fistula, or suspected risk of aspiration (see section "How to use Gastrografin").

Warnings and precautions
Talk to your doctor or nurse before using Gastrografin.
During administration of contrast media, including Gastrografin, you may experience anaphylactoid/allergic reactions or other idiosyncratic reactions characterized by cutaneous, respiratory, or cardiovascular manifestations, up to and including severe reactions such as shock.
These risks are greater with intravascular (directly into blood vessels) administration of iodinated contrast media, but are also relevant for enteral (oral or rectal) contrast media such as Gastrografin.
Delayed reactions (after several hours or days) may occur (see "Undesired effects").
If you experience reactions such as nausea, vomiting, mild angioedema, conjunctivitis, cough, itching, rhinitis, sneezing, or urticaria, inform your doctor or nurse immediately, as these may be early signs of impending shock. These reactions may occur regardless of dose and route of administration (see "Undesired effects").
If any of the following conditions apply to you, inform your doctor, who will decide whether or not the examination should proceed:

• if you have a history of allergic disorders,
• if you have a history of bronchial asthma,
• if you have previously experienced anaphylactoid/allergic reactions to iodinated contrast media,
• if you have cardiovascular disorders (heart diseases). Patients with cardiovascular disorders are at higher risk of severe or even fatal outcomes from severe anaphylactoid/allergic reactions. In such cases, the risk of anaphylactoid/allergic reactions is increased, and premedication with antihistamines and/or glucocorticoids may be considered.

If allergic reactions occur (see "Undesired effects"), administration of the contrast agent must be stopped immediately and, if necessary, specific therapy initiated via an intravenous access. You may also be treated with medications prepared for managing allergic reactions.

Thyroid dysfunction
If you suffer from, or are suspected of suffering from, hyperthyroidism (overactivity of the thyroid gland) or goiter (enlargement of the thyroid), your doctor will carefully evaluate the risks and benefits of using Gastrografin, since iodinated contrast media may interfere with thyroid function and may worsen or induce hyperthyroidism and thyrotoxic crisis (a serious complication of hyperthyroidism).
Before receiving Gastrografin, your doctor may perform tests to assess thyroid function and may prescribe antithyroid treatment (medications to reduce thyroid gland activity).
Your doctor will perform thyroid function tests in newborns who have been exposed to Gastrografin during pregnancy or in the neonatal period, because exposure to excessive iodine may cause hypothyroidism (reduced thyroid function), which may require treatment.

Gastrointestinal system
Prolonged retention of Gastrografin in the gastrointestinal tract (e.g., in case of obstruction, stasis) may cause tissue damage, bleeding, necrosis (tissue death), and intestinal perforation.

Children
Gastrografin should only be administered in diluted form in patients with reduced plasma volume, such as neonates, infants, and children.

Other medicines and Gastrografin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exercise particular caution if you are being treated with:

• Beta-blockers (medicines used for high blood pressure or rapid heart rate), as allergic reactions may be worsened if you are taking beta-blockers, especially if you have bronchial asthma.
• The drugs normally used to treat allergic or anaphylactoid reactions (i.e., beta-agonists) may be ineffective if you are taking beta-blockers.
• Interleukin-2 (a medicine that modulates the immune system), as previous treatment (up to several weeks) with Interleukin-2 is associated with an increased risk of delayed reactions to Gastrografin.

INTERFERENCE WITH DIAGNOSTIC TESTS - RADIOISOTOPES: THE DIAGNOSIS AND TREATMENT
OF THYROID DISORDERS USING THYROTROPIC RADIOISOTOPES MAY BE IMPAIRED FOR
SEVERAL WEEKS AFTER ADMINISTRATION OF IODINATED CONTRAST AGENTS DUE TO
REDUCED UPTAKE OF RADIOISOTOPES.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or nurse before using this medicine.

Pregnancy
Adequate and well-controlled studies in pregnant women have not been conducted.
Caution is required when administering Gastrografin during pregnancy.
Since exposure to radiation should be avoided during pregnancy whenever possible, your doctor will carefully evaluate the benefits and potential risks of an X-ray diagnostic procedure, with or without contrast medium.

Breastfeeding
After intravascular use, diatrizoic acid salts are excreted in breast milk. However, at the recommended doses of Gastrografin, effects on the breastfed infant are not expected. You are likely to be able to breastfeed safely, particularly considering the low gastrointestinal absorption of Gastrografin.

Gastrografin contains sodium
Gastrografin contains 3.76 mg of sodium (the main component of table salt) per ml.
This corresponds to 0.19% of the maximum daily dietary intake recommended for an adult.

3. How to use Gastrografin

Use this medicine exactly as instructed by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
The use of this medicinal product is restricted to hospitals, clinics, healthcare facilities, and specialist radiological practices, and must be administered under medical supervision.
Gastrografin will be administered diluted in patients with reduced plasma volume, such as neonates, infants, children, and dehydrated patients, since hypovolemic complications may be particularly severe in these individuals.
Gastrografin will be administered diluted in patients with suspected risk of aspiration or bronchoesophageal fistula, since its hyperosmolarity may cause acute pulmonary edema, chemical pneumonia, respiratory collapse, and death.

Dietary recommendations and hydration
To enhance diagnostic accuracy, a prior bowel cleansing may be required.
If you suffer from multiple myeloma (a tumor affecting the bone marrow), diabetes mellitus with kidney complications, polyuria or oliguria (increased or decreased urine volume), hyperuricemia (elevated blood uric acid levels), if you are elderly, or if the medicine is used in neonates, infants, or young children, adequate monitoring of hydration status is necessary both before and after administration of the contrast agent.

The recommended doses are:

• Pure Gastrografin

Oral use
The dose should be adjusted according to your age and the type of examination.
Adults and children aged 10 years and older:
You will be given 60 ml for stomach examination and up to 100 ml for serial imaging of the gastrointestinal tract.
Elderly patients and debilitated patients
The contrast agent will be administered after dilution with water in a 1:1 ratio.

Rectal use
Adults
The contrast agent will be administered in diluted form, using a volume of water 3–4 times greater than the volume of Gastrografin. A volume of 500 ml of this diluted solution is sufficient.

• Gastrografin combined with barium sulfate

Adults and children aged 10 years and older:
You will be given a mixture of approximately 30 ml of Gastrografin combined with the usual amount of barium sulfate suspension.
In cases of pylorospasm or pyloric stenosis (spasm or narrowing of the valve at the lower end of the stomach), your doctor may further increase the amount of Gastrografin in the suspension, without affecting the contrast intensity. X-rays of the stomach can be performed using standard techniques, either with Gastrografin alone or in combination with barium sulfate. Gastric emptying times are identical to those observed with barium sulfate suspension.
However, intestinal filling is accelerated. When Gastrografin is administered alone, the contrast medium generally reaches the rectum within 2 hours, whereas when combined with barium sulfate, transit may last up to three hours or longer, depending on the individual case.
The optimal time to take X-rays of the colon is when you feel the urge to defecate, which invariably occurs.

Use in children
Neonates (up to 1 month), infants (1 month–2 years), and children (2–11 years)
Infants under one year of age, and especially neonates, may be at risk of electrolyte imbalances and circulatory disturbances. Therefore, particular attention must be paid to the dose of contrast agent administered, the technical performance of the radiological procedure, and the patient’s overall health status.

• Pure Gastrografin

Oral use
In children under 10 years of age, a dose of Gastrografin up to 15–30 ml will be administered, possibly diluted with water in a 1:2 ratio.
In neonates, infants, and frail children, the contrast agent will be diluted with water in a 1:3 ratio.

Rectal use
In children over 5 years of age, a dose of up to 500 ml of diluted solution (prepared by diluting Gastrografin with 4–5 times its volume of water) will be administered.
In children up to 5 years of age, a dose of up to 500 ml of diluted solution (prepared by diluting Gastrografin with 5 times its volume of water) will be administered.

• Gastrografin combined with barium sulfate

In children aged 5 to 10 years, a dose of 10 ml of Gastrografin per 100 ml of barium sulfate suspension will be administered.
In children up to 5 years of age, a dose of 2–5 ml of Gastrografin per 100 ml of barium sulfate suspension will be administered.

If you have received more Gastrografin than you should
In case of overdose, your doctor will attempt to correct disturbances in fluid and electrolyte balance (maintenance of water and electrolytes in the body at a constant proportion).
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects you may experience with iodinated contrast media are usually mild to moderate and transient in nature. However, severe and potentially life-threatening reactions have been reported, including cases of death.
Some of the following side effects may occur with the frequencies listed below:

Common side effects (may affect up to 1 in 10 people)

• vomiting,
• nausea,
• diarrhoea.

Rare side effects (may affect up to 1 in 1,000 people)

• anaphylactic shock,
• anaphylactic/allergic reaction,
• hyperthyroidism (overactivity of the thyroid gland),
• fluid and electrolyte imbalance (of body fluids and salts),
• altered consciousness,
• headache,
• dizziness,
• cardiac arrest,
• tachycardia (increased heart rate),
• shock (drop in blood pressure and reduction of all physical and mental functions due to severe circulatory failure),
• hypotension (low blood pressure),
• bronchospasm (spasm of the bronchi),
• dyspnoea (shortness of breath),
• aspiration of the medicinal product,
• pulmonary oedema (fluid in the lungs) following aspiration,
• aspiration pneumonia,
• intestinal perforation,
• abdominal pain,
• blister formation at the level of the mouth and mucous membranes,
• toxic epidermal necrolysis (a severe skin disorder),
• urticaria (skin rash and itching),
• skin rash,
• pruritus (itching),
• erythema (redness of the skin),
• facial oedema (swelling of the face),
• fever,
• sweating.

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

• hypothyroidism (reduced function of the thyroid gland).

Immune system disorders, anaphylactic/allergic reaction: Generalized allergy is rare and mostly mild, usually presenting as skin reactions. However, a severe hypersensitivity reaction cannot be completely ruled out, characterized by symptoms affecting the skin, respiratory system, or cardiovascular system, including severe reactions such as shock, which may require medical intervention (see section “Warnings and precautions”).

If you experience reactions such as mild swelling of the face, lips, tongue, or throat, cough, itching, rhinitis, sneezing, or urticaria, inform your doctor or nurse immediately, as these may be the first signs of a serious reaction, even delayed (occurring several hours or days after administration) (see section “Warnings and precautions”).

Gastrointestinal disorders:
The hypertonic solution of Gastrografin may cause diarrhoea, which resolves once your bowel has emptied. If you suffer from colitis or enteritis at the time of administration, these conditions may temporarily worsen. In case of obstruction, prolonged contact with the intestinal mucosa may lead to erosions and intestinal necrosis (destruction and death of intestinal tissue) (see “Warnings and precautions”).

If you experience any of these symptoms or have difficulty breathing, inform medical staff immediately.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gastrografin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle after "Expiry". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging and properly stored.
This medicine does not require any special storage temperature conditions.
Keep the bottle in the outer packaging to protect the medicine from light. Protect from X-rays.
Any unused contrast medium solution must be discarded within 1 day after opening the bottle.
At temperatures below 7°C, Gastrografin may tend to crystallize; this phenomenon is reversible upon warming and shaking. This does not affect the efficacy or stability of the preparation.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gastrografin contains

• The active substances are sodium amidotrizoate and meglumine amidotrizoate. 100 ml of gastroenteric solution contain 10 g of sodium amidotrizoate and 66 g of meglumine amidotrizoate.
• The other components are: sodium saccharin hydrate, sodium calcium edetate hydrate, water for injections.

Description of the appearance of Gastrografin and package contents
Gastroenteric solution
100 ml bottle
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 – 20156 Milan, Italy
Manufacturer
Berlimed SA c/ Francisco Alonso s/n 28806 Alcalá de Henares - Madrid/Spain

The following information is intended exclusively for healthcare professionals:

Gastrografin is a medicinal product for diagnostic use only, administered orally or rectally.
Due to the presence of additives (flavoring agents and a humectant), Gastrografin must not be
used intravascularly.
It is recommended to ensure and maintain adequate hydration and proper electrolyte balance (blood salts) in patients, as the hyperosmolarity (high concentration) of Gastrografin may cause dehydration and electrolyte imbalance. Fluid and electrolyte disturbances should be corrected before diagnostic procedures.
Gastrografin must not be administered undiluted in patients with reduced plasma volume, such as neonates, infants, children, and dehydrated patients, because hypovolemic complications (reduction in blood volume) may be particularly severe in these patients.
Due to its high osmotic pressure and tendency to be absorbed through the intestinal wall, Gastrografin should not be administered at doses higher than recommended in neonates, infants, and young children. In neonates and infants, low-osmolarity contrast media are often safer to use than high-osmolarity Gastrografin.
Gastrografin must not be administered undiluted in patients with suspected risk of aspiration or bronchoesophageal fistula, as hyperosmolarity may cause acute pulmonary edema, chemical pneumonia, respiratory collapse, and death.
In patients with a predisposition to allergy, known hypersensitivity to iodinated contrast media, or a history of asthma, premedication with antihistamines and/or glucocorticoids should be considered.
If hypersensitivity reactions occur (see "Possible adverse effects"), administration of the contrast agent must be immediately discontinued and, if necessary, specific therapy initiated via intravenous access.
Immediate availability of emergency measures and medications for the treatment of hypersensitivity reactions is recommended.
The use of the medicinal product in patients with a previous anaphylactoid/hypersensitivity reaction to any other iodinated contrast medium should be carefully evaluated in terms of risk-benefit ratio, due to the increased risk of anaphylactoid/hypersensitivity reactions in such patients.
Patients receiving beta-blockers who experience such reactions may be resistant to beta-agonists (see "Other medicines and Gastrografin").
Thyroid dysfunction
In patients with confirmed or suspected hyperthyroidism, assessment of thyroid function tests prior to administration of Gastrografin and/or preventive antithyroid treatment (to block thyroid activity) should be considered.
In neonates, especially premature neonates, who have been exposed to Gastrografin via the mother during pregnancy or in the neonatal period, monitoring of thyroid function is recommended, as excessive iodine exposure may cause hypothyroidism, which may require treatment.
Poor general health condition
The necessity of the examination must be carefully evaluated in patients with poor general health.
Barium sulfate
If Gastrografin is used in combination with barium sulfate preparations, particular attention must be paid to the contraindications, warnings, and potential side effects associated with such preparations.