Gastrografin

Package Leaflet: Information for the User

Gastrografin,(660 mg + 100 mg)/ml, oral and rectal solution
Meglumine amidotrizoate + Sodium amidotrizoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this leaflet, you may need to read it again.
• Ask 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, please inform your doctor or pharmacist.

Table of Contents of the Leaflet:

1. What is Gastrografin and what is it 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 IS GASTROGRAFIN AND WHAT IS IT USED FOR

Gastrografin is a contrast agent used exclusively for diagnostic purposes in radiological examinations, including computed tomography of the gastrointestinal tract.
The medicine is in the form of an oral or rectal solution. It facilitates imaging of narrowing, leakage, dilation of the colon, foreign bodies, tumors, etc.
Gastrografin is often used when a barium enema or paste cannot be used. Sometimes the medicine is used in combination with barium to increase diagnostic efficacy.
Gastrografin may also be used to treat meconium ileus.
Gastrografin facilitates the distinction between the intestines and adjacent anatomical structures and allows for the evaluation of changes in the shape of the pancreas.

2. IMPORTANT INFORMATION BEFORE USING GASTROGRAFIN

When not to use Gastrografin in its undiluted form

• in patients with reduced blood volume (e.g., in patients who have become dehydrated due to severe diarrhea, vomiting, in newborns, infants, or children), as complications resulting from low blood volume can be particularly dangerous;
• in patients at risk of the medicine entering the respiratory tract, as entry of the medicine into the respiratory tract can cause serious respiratory complications, even with a fatal outcome.

Warnings and precautions

Before starting to use Gastrografin, consult your doctor:

• if you are allergic (hypersensitive) to Gastrografin or any other ingredient of the medicine (see section 6 "Contents of the pack and other information");
• if you have had an allergy (e.g., high fever, hives) or asthma;
• if you have had reactions to contrast agents containing iodine;
• if you have or are suspected of having hyperthyroidism or goiter

(enlargement of the thyroid gland), as iodine-containing contrast agents may induce hyperthyroidism and thyrotoxic crisis (a serious complication associated with hyperthyroidism) in such cases;

• if you have heart or circulatory system diseases;
• in patients in a very serious condition. You must inform your doctor if any of the above situations apply to you.The doctor will decide whether the examination can be performed. Before administering Gastrografin, the doctor may order a thyroid function test, and thyroid-inhibiting medications may also be given. The doctor will order a thyroid function test in newborns who have been exposed to Gastrografin, both in fetal life and after birth, as excessive iodine intake may cause hypothyroidism, which may require treatment. After administering Gastrografin, pseudoallergic reactions may occur, including severe ones, affecting the cardiovascular system, respiratory system, or skin. Delayed reactions may occur, appearing after several hours or days (see section 4 "Possible side effects").

Other medicines and Gastrografin

Tell your doctor about all the medicines you have taken recently, including those available without a prescription.
Be particularly careful when using Gastrografin with the following medicines:

• interleukins;
• radioactive substances used in the diagnosis and treatment of thyroid diseases. The doctor will decide on their use.

Gastrografin with food and drink

Before starting the examination, it is recommended to empty the intestines. The doctor will inform the patient of this necessity.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or think you may be pregnant, as Gastrografin should be used with caution in pregnant women.
Inform your doctor if you are breastfeedingor plan to breastfeed. The doctor will decide on the possibility of breastfeeding.

Driving and using machines

There is no information on the effect of Gastrografin on the ability to drive vehicles or operate machinery.
Additional information

Gastrografin contains sodium.

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

3. HOW TO USE GASTROGRAFIN

Gastrografin is intended for oral or rectal use. The dose of Gastrografin is determined by the doctor. It depends on the patient's age and the type of X-ray examination.
Gastrografin must not be administered by injection.
Detailed information on dosing and administration is presented at the end of this leaflet.

Using a higher dose of Gastrografin than recommended

Overdose of Gastrografin is unlikely. In case of overdose, the doctor will start treatment of the symptoms that occur. This may involve intravenous replenishment of water and electrolytes in the body.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gastrografin can cause side effects, although not everybody gets them.
Side effects are usually mild to moderate and are temporary. Severe and life-threatening reactions have also been reported, including death. The most common side effects are:
nausea, vomiting, diarrhea.
The following are possible side effects, grouped by frequency of occurrence:

• Common side effects: occurring in more than 1 in 100, but less than 1 in 10 patients,
• Rare side effects: occurring less frequently than 1 in 1000, but more frequently than 1 in 10,000 patients,
• Unknown: frequency cannot be estimated from available data. The following side effects have been observed:

As with other contrast agents, pseudoallergic reactionshave been reported, including severe reactions (anaphylaxis), which may require immediate medical intervention. The first symptoms of a severe reaction may be: mild facial swelling, lips, tongue, throat, coughing, itching, runny nose, sneezing, and hives.
Inform your doctor or medical staff if you experience any of the above symptoms or difficulty breathing.
Delayed reactionsmay occur several hours or days after administration of Gastrografin.
Gastrointestinal disorders:
Gastrografin may cause diarrhea, which resolves after bowel emptying. In patients with small intestine inflammation, temporary worsening of symptoms may occur. In case of constipation, prolonged contact with the intestinal mucosa may lead to ulceration and necrosis of the intestine.
If any of the symptoms worsen or other side effects occur,
including any not listed in this leaflet, inform your doctor or radiologist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products,
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE GASTROGRAFIN

Protect from light and X-ray radiation.
There are no special recommendations for the storage temperature of the medicinal product.
The medicine should be stored 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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Gastrografin contains

• The active substances of the medicine are: sodium amidotrizoate and meglumine amidotrizoate.
• The other ingredients are: sodium saccharin hydrate, sodium-calcium edetate hydrate, water for injections.

What Gastrografin looks like and what the pack contains

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

Marketing authorization holder and manufacturer

Marketing authorization 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
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
Bayer Sp. z o.o.
Jerozolimskie Avenue 158
02-326 Warsaw, Poland
tel.: (0-22) 572-35-00
Date of last revision of the leaflet: March 2025