What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 00010/0568 , PL00010/0569.


Urografin 150

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 patient

UROGRAFIN®

Sodium amidotrizoate (sodium diatrizoate) and meglumine amidotrizoate (meglumine diatrizoate)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask the doctor giving you Urografin (the radiologist) or the X-ray department staff.
  • If you get any side effects, talk to your doctor or the X-ray department staff/radiologist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Urografin is and what it is used for
2. What you need to know before you are given Urografin
3. How you will be given Urografin
4. Possible side effects
5. How to store Urografin
6. Contents of the pack and other information

1. What Urografin is and what it is used for

Urografin is an injectable 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.

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. Urografin 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.

2. What you need to know before you are given Urografin

Do not use Urografin

  • if you are allergic to sodium amidotrizoate, meglumine amidotrizoate, iodine or iodine-containing contrast media or any of the other ingredients of this medicine (listed in section 6)
  • if you have a condition caused by too much thyroid hormone (uncontrolled thyrotoxicosis)
  • if you have severe heart insufficiency (causing oedema (swelling of areas of your body e.g. ankles) or shortness of breath)
  • if you are pregnant or have inflammation of the pelvic cavity (symptoms include stomach pain and tenderness, fever and irregular menstrual periods): you must not have your uterus (womb) investigated with Urografin.

Warnings and precautions

Talk to your doctor or the X-ray department staff/radiologist before receiving Urografin

You must tell the X-ray department staff if you have any of the following:

  • reduced liver or kidney function
  • epilepsy or a history of seizures
  • a disease of blood vessels in the brain (cerebral arteriosclerosis)
  • diabetes mellitus requiring treatment and/or associated with diabetic complications
  • damaged lungs (pulmonary emphysema)
  • poor general health
  • or are suspected to have an overactive thyroid gland (hyperthyroidism) or a swollen neck due to an enlarged thyroid gland (benign nodular goitre) as iodinated contrast media may in this situation induce hyperthyroidism and thyrotoxic crisis (severe complication of an overactive thyroid)
  • a disease of the bone marrow (multiple myeloma)
  • a history of allergy or a tendency to develop hypersensitivity reactions (for example if you have hay fever, asthma or eczema), especially if you have taken a medicine like Urografin (a contrast medium) before
  • poor heart function or blood circulation
  • previously had a reaction to any contrast media.

If any of these apply to you, you may be at a higher risk of having an allergic reaction or becoming unconscious/fainting.

If you have a phaeochromocytoma (tumour of the adrenal gland) you may be given a medicine called an alpha-receptor blocker before the investigation to prevent your blood pressure from rising.

Your thyroid function may be tested before receiving Urografin and you may be given thyreostatic medication (medication to reduce thyroid gland function).

Your doctor will test the thyroid function of newborns who have been exposed to Urografin either during pregnancy or after birth, because too much iodine can cause hypothyroidism (underactive thyroid gland), possibly requiring treatment.

Other medicines and Urografin

Tell your doctor or the X-ray department staff/radiologist if you are taking, have recently taken or might take any other medicines. 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))
  • if you have kidney disease due to diabetes (diabetic nephropathy) and are taking a type of medicine called biguanides (metformin). You should inform your doctor who will probably stop the biguanides 48 hours before the examination.

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

Urografin with food and drink

If the procedure is to look at your abdomen, kidneys or bladder you may be asked to avoid foods that cause flatulence (wind) for two days beforehand. These foods include:

  • peas, beans, lentils, salads, fruit
  • brown or granary bread
  • all kinds of uncooked vegetables.

You will be told not to eat after 6pm on the day before the examination, but you can still drink. Babies and young children, however, must not fast. If you have a disorder of your body water and body salts balance this will be corrected before the examination.

Do not reduce the amount you normally drink before the investigation, especially if you have any of the following:

  • multiple myeloma (disease of the bone marrow)
  • diabetes mellitus
  • polyuria (production of large amounts of urine which is pale in colour)
  • oliguria (production of small amounts of urine)
  • gout.

Also, fluid intake must not be reduced in babies, young children, or in someone who is in a very poor general state of health where their body tissues are wasting away.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask the doctor or X-ray department staff /radiologist for advice before receiving this medicine.

Driving and using machines

You should not drive or operate machinery for 24 hours after the examination as you may have a delayed reaction to Urografin.

Urografin contains sodium

This medicine contains 362.50 mg of sodium (main component of cooking salt) in each dose (250 ml). This is equivalent to 18.1% of the recommended maximum daily dietary intake of sodium for an adult.

3. How you will be given Urografin

The X-ray department staff will decide how much Urografin is needed for your particular investigation. They will explain how everything works and what position you should lie in on the X-ray table.

The dose of Urografin varies depending on the investigation and your weight. The dose range is normally between 1 and 500 ml.

Once you lie down the Urografin will be injected into a vein. Sometimes, Urografin will be injected into your muscles or anus (back passage). The staff in the X-ray department will observe you for 30 minutes after the injection just in case you have any side effects.

If you receive more Urografin than you should

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

If you have any further questions on the use of this medicine, ask your doctor or the X-ray department staff/radiologist for advice before receiving this medicine.

4. Possible side effects

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

Side effects you may get after being given a contrast medium like Urografin are usually mild and do not last long.

However, as with similar contrast media, severe and life-threatening reactions, as well as deaths, have been reported.

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 possible side effects of Urografin are:

  • feeling sick or being sick
  • a sensation of pain and a general feeling of warmth
  • in rare cases your kidneys temporarily stop working
  • reddening or other reactions at the injection site if Urografin is not injected properly.

Very rarely severe or even life-threatening side-effects may occur and in some cases have been fatal. These include:

lowered blood pressure

fainting (collapse)

circulatory failure

an irregular, rapid heart beat which may cause the heart to suddenly stop beating altogether (cardiac arrest)

fits or other brain related symptoms

a build-up of water in the air spaces of the lung

anaphylactic shock (a very severe allergic reaction).

If you are having a procedure where Urografin will reach the brain, you may have complications such as:

  • coma, temporary confusion and drowsiness
  • temporary weakness of the muscles
  • disturbed vision or weakness of the facial muscles
  • epileptic fits, especially in someone with epilepsy or brain damage.

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

Reporting of side effects

If you get any side effects, talk to your doctor, radiologist or X-ray department staff. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Urografin

Keep this medicine out of the sight and reach of children.

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

Protect from light and secondary X-rays.

6. Contents of the pack and other information

What Urografin contains

  • The active substances are sodium amidotrizoate and meglumine amidotrizoate.
    1 ml Urografin 150 contains 40 mg sodium amidotrizoate and 260 mg meglumine amidotrizoate.
    1 ml Urografin 150 for infusion contains 40 mg sodium amidotrizoate and 260 mg meglumine amidotrizoate.
  • The other ingredients are sodium calcium edetate (E 385) and water for injections.

What Urografin looks like and contents of the pack

Urografin 150 is available in packs of ten 10 ml ampoules or packs of ten 20 ml ampoules.

Urografin 150 for infusion is available in 250 ml or 500 ml bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bayer plc
400 South Oak Way
Reading
RG2 6AD

Manufacturer:

BerliMed S.A
Madrid
Spain

This leaflet was last revised in October 2018.

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

Urografin 150 00010/0569

Urografin 150 for Infusion 00010/0568

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

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