Gastrografin

Patient Information Leaflet

Gastrografin, (660 mg + 100 mg)/ml, oral and rectal solution
Meglumine amidotrizoate + Sodium amidotrizoate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you

• Keep this leaflet, as you may need to read it again.
• Speak to your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Leaflet contents:
1. What Gastrografin is and what it is used for
2. Important information 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 is a contrast agent used exclusively for diagnostic imaging in radiological examinations, including computed tomography (CT) of the gastrointestinal tract.

The medicine is a solution for oral intake or rectal administration. It helps visualize narrowing, leakage, distension of the colon, foreign bodies, tumors, etc.

Gastrografin is often used when barium enema or barium paste cannot be administered. Sometimes it is used together with barium to increase diagnostic effectiveness.

Gastrografin may also be used in the treatment of fecal impaction (intestinal obstruction due to hardened stool).

Gastrografin facilitates differentiation between the intestines and adjacent anatomical structures and enables assessment of changes in the shape of the pancreas.

2. IMPORTANT INFORMATION BEFORE USING GASTROGRAFIN

When not to use undiluted Gastrografin

• In patients with reduced blood volume (e.g., patients who are dehydrated due to severe diarrhea or vomiting, newborns, infants, or children), because complications related to low blood volume may be particularly dangerous;
• In patients at risk of the solution entering the respiratory tract, as aspiration into the airways may cause serious respiratory complications, even fatal outcomes.

Warnings and precautions

Before using Gastrografin, speak to your doctor if:

• You are allergic (hypersensitive) to Gastrografin or to any other ingredient of this medicine (see section 6, "Contents of the pack and other information");
• You have or have had allergic reactions (e.g., high fever, urticaria) or asthma;
• You have previously experienced reactions to iodine-containing contrast agents;
• You have or suspect hyperthyroidism or goiter (enlarged thyroid gland), because iodine-containing contrast agents may in such cases induce hyperthyroidism or trigger a thyroid storm (a severe complication associated with hyperthyroidism);
• You have heart or circulatory diseases;
• You are in a very poor general health condition.

You must inform your doctor if any of the above situations apply to you.
Your doctor will decide whether the examination can be performed. Before administering Gastrografin, your doctor may order tests to assess thyroid function. Antithyroid drugs (thyrostatics) may also be prescribed.

Your doctor will order thyroid function tests in newborns who have been exposed to Gastrografin, both during fetal life and after birth, because excessive iodine intake may cause hypothyroidism, which may require treatment.

After administration of Gastrografin, pseudoallergic reactions may occur, including severe reactions affecting the cardiovascular system, respiratory system, or skin. Delayed reactions occurring several hours or days after administration are also possible (see section 4, "Possible side effects").

Other medicines and Gastrografin

Tell your doctor about all medicines you are currently taking, including those obtained without a prescription. Exercise particular caution when using Gastrografin together with the following medicines:

• Interleukins;
• Radioactive substances used in the diagnosis and treatment of thyroid disorders.

Your doctor will decide on the use of these medicines.

Gastrografin with food and drink

Before starting the examination, it is recommended to empty the bowels. Your doctor will inform you if this is necessary.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or suspect you may be pregnant, because Gastrografin should be used with caution in pregnant women.

Inform your doctor if you are breastfeeding or planning to breastfeed.
Your doctor will decide whether breastfeeding can continue.

Driving and using machines

There is no information available on the effects of Gastrografin on the ability to drive or operate machinery.

Additional information

Gastrografin contains sodium.
Gastrografin contains 3.76 mg of sodium (main component of table salt) in each 1 ml, which corresponds to 0.19% of the maximum daily sodium intake recommended by WHO for an adult.

3. HOW TO USE GASTROGRAFIN

Gastrografin is intended for oral administration or rectal enema use. The Gastrografin dosage is determined by the physician and depends on the patient's age and the type of X-ray examination.
Gastrografin must not be administered by injection.
Detailed information regarding dosage and administration is provided at the end of this leaflet.
Administration of a higher than recommended dose of Gastrografin
Overdose with Gastrografin is unlikely. In case of overdose, the physician will initiate treatment of the symptoms, which may include intravenous rehydration and electrolyte replacement.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, Gastrografin may cause adverse reactions, although not everyone experiences them.
Adverse reactions are usually mild to moderate and transient. Severe and life-threatening reactions, including fatal outcomes, have also been reported. The most commonly reported adverse reactions are: vomiting, nausea, diarrhoea.
The following adverse reactions are listed below by frequency categories:

• Common adverse reactions: occurring in more than 1 in 100 but less than 1 in 10 patients,
• Rare adverse reactions: occurring in less than 1 in 1,000 but more than 1 in 10,000 patients,
• Not known: frequency cannot be estimated from the available data. The following adverse reactions have been observed:

As with other contrast agents, hypersensitivity-like reactions have been reported, including
severe reactions (shock), which may require immediate medical intervention. Early signs of a
severe reaction may include: mild swelling of the face, lips, tongue, throat, cough, itching,
rhinorrhea, sneezing, and urticaria.
Inform the physician or medical personnel immediately if any of the above symptoms occur or if
difficulty breathing develops.
Delayed reactions may occur several hours or days after administration of Gastrografin.
Gastrointestinal disorders:
Gastrografin may cause diarrhea, which resolves after intestinal evacuation. In patients with
inflammation of the small intestine, transient worsening of symptoms may occur. In cases of
constipation, prolonged contact with the intestinal mucosa may lead to erosion and intestinal
necrosis.
If any of the symptoms worsen or if any other adverse effects occur , including any possible
adverse effects not listed in this leaflet, consult a physician or radiologist.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your
physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring
Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and
Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorization Holder.
Reporting of adverse reactions enables further monitoring of the safety of the medicinal product.

5. HOW TO STORE GASTROGRAFIN

Protect from light and X-ray radiation.
No special temperature storage requirements for the medicinal product.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The contents of the bottle should be used within 72 hours of opening.

6. PACK CONTENTS AND OTHER INFORMATION

What Gastrografin contains

• The active substances in this medicine are: sodium amidotrizoate and meglumine amidotrizoate.
• Other components are: sodium saccharin monohydrate, calcium sodium edetate monohydrate, water for injections.

What Gastrografin looks like and contents of the pack

• Gastrografin is a clear, colourless or slightly yellow solution.
• Available pack sizes: 1 bottle of 100 ml; 5 bottles of 100 ml; 10 bottles of 100 ml. Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer
Berlimed S.A.
Poligono Industrial Santa Rosa
c/ Francisco Alonso s/n
E-28806 Alcalá de Henares, Madrid
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw, Poland
tel.: (0-22) 572-35-00

Information intended exclusively for medical professionals:

Medications for the treatment of hypersensitivity reactions, as well as emergency resuscitation measures, should be readily available.

• Thyroid dysfunction In patients with diagnosed or suspected hyperthyroidism, thyroid function tests and/or antithyroid drugs should be considered prior to administration of Gastrografin, as iodine-containing contrast agents may impair thyroid function, exacerbate or induce hyperthyroidism, or trigger a thyroid storm. In newborns, especially preterm infants, who have been exposed to Gastrografin both in utero and in the neonatal period, thyroid function should be monitored, since excess iodine exposure may cause hypothyroidism, which may require treatment.

• Barium sulfate If Gastrografin is used in combination with barium sulfate preparations, consider the contraindications, warnings, and potential adverse effects associated with these agents.

• Gastrointestinal system Prolonged retention of Gastrografin in the gastrointestinal tract (e.g., due to constipation or intestinal stasis) may lead to tissue damage, bleeding, or intestinal necrosis.

• Hydration Due to the hyperosmolality of Gastrografin, which may cause dehydration and electrolyte imbalances, adequate hydration and electrolyte balance should be ensured and maintained in patients.

• Interactions

• Drugs Prior treatment (even up to several weeks) with interleukin-2 is associated with an increased risk of delayed reactions following administration of Gastrografin.

• Effect on laboratory tests Diagnosis and treatment of thyroid disorders using radioactive isotopes may be impaired for up to several weeks after administration of iodine-containing contrast agents, due to reduced uptake of the radioisotope.

• Preclinical safety data Preclinical data from conventional systemic toxicity, genotoxicity, reproductive toxicity, local tolerance, and contact sensitization studies revealed no special hazard for humans.

• Method of administration Gastrografin must not be administered intravenously due to the presence of excipients (flavoring agents, lubricants). Because of its high osmotic pressure and tendency to be absorbed in the intestines, Gastrografin should not be administered to newborns, infants, and young children in doses higher than recommended. In newborns and infants, low-osmolality contrast agents are safer than the high-osmolality Gastrografin.

Oral administration
The contrast dose depends on the type of examination and patient age.
Adults and children aged 10 years and older:

• Gastric imaging: 60 mL
• Serial gastrointestinal studies: 100 mL

In elderly or debilitated patients, dilute the preparation with an equal volume of water.

Children:

• Newborns, infants, younger children: 15 mL to 30 mL of solution (diluted with 3 times the volume of water).
• Children (up to 10 years of age): 15 mL to 30 mL of solution (may be diluted with 2 times the volume of water).

Computed tomography (CT):
0.5 L to 1.5 L of Gastrografin solution at a concentration of approximately 3% (30 mL of Gastrografin solution per 1 L of water).

Rectal administration (including treatment of uncomplicated meconium ileus)
Adults:
Up to 500 mL of diluted Gastrografin solution (diluted with 3 to 4 times the volume of water).

Children:

• Children (up to 5 years): up to 500 mL of Gastrografin solution (diluted with 5 times the volume of water).
• Children (over 5 years): up to 500 mL of Gastrografin solution (diluted with 4 to 5 times the volume of water).

Dosage in combination with barium sulfate
Adults and children aged 10 years and older:
Add approximately 30 mL of Gastrografin to the usual dose of barium sulfate.

Children:
In addition to the usual dose of barium sulfate:

• Children (up to 5 years): 2 mL to 5 mL of Gastrografin per 100 mL of barium sulfate suspension,
• Children (5 to 10 years): 10 mL of Gastrografin per 100 mL of barium sulfate suspension.
  If necessary (e.g., in case of pyloric spasm or stenosis), the dose of Gastrografin may be further increased.

Instructions for use
Gastrografin has a tendency to crystallize at temperatures of 7°C. This phenomenon is reversible upon gentle warming and shaking and does not affect the efficacy or stability of the medicinal product. Any unused product or waste material should be disposed of in accordance with local regulations within 72 hours of first opening. Additional information on the use of Gastrografin is provided in section 3 of the package leaflet.