Skip to content
This is a text only leaflet, designed for the visually impaired. Please visit our electronic Medicines Compendium (eMC) website to view the original document which may contain images or tables.

You may be able to get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Leaflet line on 0800 198 5000 for more information.

The product code for this leaflet is: PL 00010/0537

 

Gastrografin

Company Details

Bayer plc


Bayer HouseStrawberry HillNewburyBerkshireRG14 1JA
Telephone:
Fax:
[view all information leaflets from this company]

Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.

If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

GASTROGRAFIN® SOLUTION

Sodium amidotrizoate and meglumine amidotrizoate

Read all of this leaflet carefully before you are given this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask the doctor giving you Gastrografin (the radiologist) or the X-ray department staff
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or the X-ray department staff/radiologist.

In this leaflet:

1. What Gastrografin is and what it is used for
2. Before you are given Gastrografin
3. How you will be given Gastrografin
4. Possible side effects
5. How to store Gastrografin
6. Further information

Go to top of the page

1. What Gastrografin is and what it is used for

Gastrografin is a contrast medium (a dye) which contains iodine. It is used to clearly show on X-rays the area of your body that your doctor wants to investigate. This will be your gullet (oesophagus), stomach or intestines (gastrointestinal tract). It may also be used to treat an intestinal obstruction in newborn babies (meconium ileus).

X-rays, like radio waves, can pass through objects and can be focused to make a picture. When you have an X-ray, the beam of rays goes through your body where it is absorbed to differing degrees by different tissues such as bones, muscles and organs. When the rays come out on the other side they make a pattern of light and shade on a film. Gastrografin helps to make this pattern clearer. The film is then examined by a specialist who will make a diagnosis.

This medicine is for diagnostic use only.

Go to top of the page

2. Before you are given Gastrografin

Do not use Gastrografin if:

  • you are, or suspect you are, allergic (hypersensitive) to iodine or iodine-containing contrast media or any of the other ingredients of Gastrografin (see Section 6: Further Information)
  • you have a condition caused by too much thyroid hormone (manifest hyperthyroidism).

Take special care with Gastrografin:

  • You must tell the X-ray department staff if you have any of the following:
    • any type of thyroid disease (e.g. hyperthyroidism).
    • a history of allergy or a tendency to develop hypersensitivity reactions (for example if you have hay fever, asthma or eczema)
    • heart or blood circulation problems, because in the rare event that you have an allergic reaction, it is more likely to be serious or fatal.

Gastrografin may affect the way the thyroid gland works for several weeks after being given it. If you are going to have an iodine test for thyroid disease, tell your doctor or the laboratory staff if you have received Gastrografin recently.

Taking or using other medicines

Please tell the radiologist or X-ray department staff if you are taking or have recently taken any other medicines, including medicines obtained without prescription. This is particularly important for:

  • beta-blockers (drugs used to treat heart or blood pressure), because they can make allergic reactions worse
  • if you have been treated with a drug called interleukin, because there is a higher chance of getting delayed reactions (e.g. fever flu-like symptoms, joint pain and pruritus (itching)).

Ask the X-ray department staff if you are not sure.

Using with food and drink

Before the examination the X-ray department staff should make sure that you have had enough to drink and that any imbalances in your body water and body salts are corrected.

Pregnancy and breast-feeding

Tell the X-ray department staff if you are pregnant or breast-feeding or think you may be pregnant.

Go to top of the page

3. How you will be given Gastrografin

The X-ray department staff will explain how everything works and what position you should lie in on the X-ray table.

The dose of Gastrografin and how it will be given will depend on the type of investigation. The dose range is usually from 2ml to 125 ml Gastrografin. This may be diluted depending on the type of investigation.

Gastrografin is either drunk as a solution or given as an enema, a liquid that is forced by low pressure into the anus. It must not be given by injection into the blood vessels.

If you receive more Gastrografin than you should

Overdosing is unlikely. If it does happen the radiologist will treat any symptoms that follow.

Go to top of the page

4. Possible side effects

Like all medicines, Gastrografin can cause side effects, although not everybody gets them.

If you notice:

  • itching of the skin, rash, wheals on the skin (urticaria)
  • difficulty breathing, gagging, feeling of suffocation
  • swelling of the face, neck or body
  • itchy or watery eyes, tickling in the throat or nose, hoarseness, coughing or sneezing
  • headache, dizziness, feeling faint
  • feeling particularly hot or cold, sweating
  • paleness or reddening of the skin
  • chest pain, cramp, tremor
  • feeling sick

Tell the radiologist or X-ray staff immediately as these may be the first signs of allergic reaction or shock. Your investigation will need to be stopped, and you may need further treatment.

Apart from the symptoms listed above the other side effects that you might experience are:

  • feeling sick or being sick
  • diarrhoea
  • anaphylactic shock (a very severe allergic reaction)
  • allergic-type skin reactions including itching, redness, wheals on the skin
  • overactive thyroid gland (hyperthyroidism)
  • disorder of your body water and body salts balance
  • fainting, dizziness, headache
  • fast heart beat, sudden stopping of the heart (cardiac arrest), low blood pressure, shock
  • difficulty breathing, swelling or fluid in the lungs. If Gastrografin gets into your lungs by accident it may cause fluid to collect in your lungs
  • abdominal pain, holes in the gut wall (intestinal perforation)
  • blistering inside the nose or mouth
  • severe skin disease (red, blistered, bleeding, painful skin, which may affect the lips, eyes, mouth, nose and genitals too)
  • rash, redness of the skin
  • swelling of the face
  • fever, sweating

If you currently have inflammation of the intestine or bowel (enteritis or colitis), this may temporarily get worse. If you currently have a blockage in your bowel, this can lead to Gastrografin staying in the bowel for longer than usual, which may damage the lining of the bowel.

Delayed reactions can occur, if you are concerned you should contact your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or the X-ray department staff/radiologist.

Go to top of the page

5. How to store Gastrografin

Keep out of the reach and sight of children.

Do not use Gastrografin after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Protect from light and X-rays. Do not store above 25°C.

Go to top of the page

6. Further Information

What Gastrografin contains

The active substances are sodium amidotrizoate and meglumine amidotrizoate.

1ml of solution contains 100mg sodium amidotrizoate and 660mg meglumine amidotrizoate.

The other ingredients are disodium edetate, sodium hydroxide, saccharin sodium, anise oil, polysorbate 80, and purified water.

What Gastrografin looks like and contents of the pack

Each pack of Gastrografin contains ten 100ml brown glass bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
UK

Manufacturer:

Bayer Pharma AG
Berlin
Germany

or

BerliMed S.A
Madrid
Spain
Go to top of the page

This leaflet was last revised in: December 2012

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Reference number

Gastrografin Solution 00010/0537

This is a service provided by the Royal National Institute of the Blind.

v8_0


Text size normal Text size at 110% Text size at 120%

CHANGE FORMAT

 

USEFUL INFO

 

QUICK LINKS