Gastrografin

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

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 digestive system.
The medicine is in the form of a solution for drinking or rectal infusion. 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 together with barium to increase diagnostic efficacy.
Gastrografin may also be used to treat meconium ileus.
Gastrografin facilitates the distinction of the intestines and adjacent anatomical structures and allows for the assessment 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 dehydration due to severe diarrhea, vomiting, in newborns, infants, or children), as complications resulting from low blood volume may be particularly dangerous;
• in patients who are at risk of the medicine entering the respiratory tract, as the entry of the medicine into the respiratory tract may cause serious respiratory complications, even with a fatal outcome.

Warnings and precautions

Before starting to use Gastrografin, you should consult a 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 who are in a very serious condition.

You should 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, pseudo-allergic reactions may occur, including severe cases (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.
If any of the above symptoms occur or if you experience difficulty breathing, you should inform your doctor or medical staff.
Delayed reactions may occur several hours or days after administering Gastrografin.
Gastrointestinal disorders
Gastrografin may cause diarrhea, which subsides after bowel emptying. In patients with small intestine inflammation, there may be a temporary worsening of symptoms. In the 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 if you experience any other side effects, including any possible side effects not listed in the leaflet, you should consult your doctor or radiologist.

Other medicines and Gastrografin

You should tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.
You should exercise special caution when using Gastrografin together with the following medicines:

• interleukins;
• radioactive substances used in the diagnosis and treatment of thyroid disorders.

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

You should inform your doctor if you are pregnant or suspect you are pregnant, as Gastrografin should be used with caution in pregnant women.
You should inform your doctor if you are breastfeedingor plan to breastfeed. The doctor will decide whether breastfeeding is possible.

Driving and using machines

There is no information on the effect of Gastrografin on the ability to drive vehicles or operate machinery.
Gastrografin containsfrom 224.40 to 374.00 mg of sodium (the main component of table salt) in each dose (60-100 ml). This corresponds to 11.2-18.7% of the maximum recommended daily intake of sodium in the diet for adults.
Gastrografin in combination with barium sulfate contains112.20 mg of sodium (the main component of table salt) in each dose (30 ml). This corresponds to 5.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. HOW TO USE GASTROGRAFIN

Gastrografin is intended for drinking or rectal infusion. The dose of Gastrografin is determined by the doctor. It depends on the patient's age and the type of X-ray examination.
Gastrografin should not be administered by injection.
For detailed information on dosing and administration, see 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 for 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 commonly reported side effects are:
vomiting, nausea, diarrhea.
The following possible side effects are listed in groups according to their 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 the available data.

The following side effects have been observed:

As with other contrast agents, pseudo-allergic reactions have 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.
You should inform your doctor or medical staff if you experience any of the above symptoms or difficulty breathing.
Delayed reactions may occur several hours or days after administering Gastrografin.
Gastrointestinal disorders
Gastrografin may cause diarrhea, which subsides after bowel emptying. In patients with small intestine inflammation, there may be a temporary worsening of symptoms. In the 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 if you experience any other side effects, including any possible side effects not listed in the leaflet, you should consult your doctor or radiologist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of the medicine.

5. HOW TO STORE GASTROGRAFIN

Do not store above 25°C.
Protect from light and X-ray radiation.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
The contents of the bottle should be used within 72 hours of opening.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

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 hydroxide, disodium edetate, sodium saccharin, polysorbate 80, star anise essential oil, purified water.

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.

For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Bayer Hellas ABEE
Sorou 18-20
15 125 Marousi
Athens, Greece

Manufacturer:

Berlimed S.A.
Calle Francisco Alonso (Pg Ind Santa Rosa) 7
28806 Alcala De Henares
Spain

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Greece, the country of export:
26988/14-7-1995
29753/13-05-2005
41340/05/06-09-2006
65584/30-9-2010

Parallel import authorization number: 906/12 Date of approval of the leaflet: 19.12.2022

[Information on the trademark]
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Information intended exclusively for healthcare professionals:

Medicines for the treatment of hypersensitivity reactions, as well as for rescue operations, should be available.
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In newborns, especially premature infants, who have been exposed to Gastrografin, both in fetal life and in the neonatal period, it is recommended to monitor thyroid function, as excessive iodine intake may cause hypothyroidism, which may require treatment.

• Barium sulfate If Gastrografin is used together with barium preparations, the contraindications, warnings, and possible side effects of these medicines should be taken into account.
• Gastrointestinal tract In the event of prolonged retention of Gastrografin in the digestive tract (e.g., constipation, stasis), the following may occur: tissue damage, bleeding, intestinal necrosis.
• Hydration Due to the hyperosmolarity of Gastrografin, which may cause dehydration and electrolyte disturbances, it is necessary to ensure and maintain adequate hydration and electrolyte balance in patients.
• Interactions
• Medicines Previous treatment (even up to several weeks) with interleukin-2 is associated with an increased risk of delayed reactions after administering Gastrografin.
• Effect on laboratory test results Diagnosis and treatment of thyroid disorders with thyrotropic radioisotopes may be impaired for several weeks after administering iodine-containing contrast agents, due to reduced uptake of the radioisotope.
• Preclinical safety data Preclinical data, obtained from conventional studies of systemic toxicity, genotoxicity, reproductive toxicity, local tolerance, and contact sensitization, did not reveal any special hazard for humans.
• Method of administration Gastrografin should not be administered intravenously due to the presence of auxiliary substances (flavorings, lubricant).

Due to the high osmotic pressure and the tendency to absorb in the intestines, Gastrografin should not be administered to newborns, infants, and young children in doses higher than recommended. In newborns and infants, it is safer to use contrast agents with low osmolality rather than Gastrografin with high osmolality.

Oral administration

The dose of the contrast agent depends on the type of examination and the patient's age.
Adults and children over 10 years of age:
Stomach imaging: 60 ml
Serial gastrointestinal examinations: 100 ml
In the case of elderly and debilitated patients, it is recommended to dilute the medicine with an equal volume of water.
Children:
Children (up to 10 years of age): from 15 ml to 30 ml of the solution (may be diluted with twice the volume of water).
Newborns, infants, and young children: from 15 ml to 30 ml of the solution (diluted with three times the volume of water).
Computed tomography (CT):
From 0.5 liters to 1.5 liters of Gastrografin solution at a concentration of approximately 3% (30 ml of Gastrografin solution per 1 liter of water).
Rectal administration(including treatment of uncomplicated meconium ileus)
Adults:
Up to 500 ml of diluted Gastrografin solution (diluted with 3- to 4-fold volume of water).
Children:
Children (up to 5 years of age): up to 500 ml of Gastrografin solution (diluted with 5-fold volume of water).
Children (over 5 years of age): up to 500 ml of Gastrografin solution (diluted with 4- to 5-fold volume of water).

Dose in combination with barium sulfate

Adults and children over 10 years of age:
Adding 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 of age): from 2 ml to 5 ml of Gastrografin per 100 ml of barium sulfate suspension,
• children (from 5 to 10 years of age): 10 ml of Gastrografin per 100 ml of barium sulfate suspension.

If necessary (in case of pyloric spasm or pyloric stenosis), the dose of Gastrografin can be further increased.

Instructions for use

Gastrografin has a tendency to crystallize at a temperature of 7°C. This phenomenon is reversible after gentle heating and shaking, and it does not affect the efficacy or stability of the medicine.
Any unused product or waste should be disposed of in accordance with local regulations, within 72 hours of first opening.
Additional information on the use of Gastrografin can be found in section 3 of the leaflet.