Patient leaflet - Gastromiro
1. What Gastromiro is and what it is used for
Gastromiro is an X-ray contrast medium. This is a special dye which is opaque to X-rays because it contains iodine.
X-ray radiation is used to obtain an image of the tissues of the body. The rays are directed on to the area of the body being investigated and pass through it to record an image on photographic film. If the doctor needs to highlight a particular area of the body to get better information, he/she will carry out a contrast X-ray. This means that a dye which absorbs X-rays will be used. Gastromiro is such a dye. It has been specially made into a drink for investigation of the digestive system. Because of its special formulation Gastromiro is used particularly in situations where it is possible that some dye could leak outside the digestive system. It is also particularly suited to babies and children.
Gastromiro may also be used if you are having a CAT scan (Computer Axial Tomography).
This medicine is for diagnostic use only.
2. What you need to know before you use Gastromiro
Gastromiro should only be given to you in a hospital or clinic where there are equipment and medically trained staff able to deal with allergic reactions.
Do not use Gastromiro
- Are allergic to Iopamidol, or to any other ingredients of Gastromiro (see list of ingredients in Section 6).
Warnings and precautions
Talk to your doctor before using Gastromiro if:
- you have had an allergic reaction to Gastromiro or any other contrast agents
- you have a history of asthma or any other allergic disorders
- you suffer from stomach problems
- you suffer from a liver or kidney problem
- you suffer from heart problems
- you suffer from myelomatosis (a tumor of the bone marrow) or a serious health problem
- you suffer from thyroid problems
- you are pregnant, or think you might be pregnant
- you are breast feeding
The radiologist will ask women the dates of menstrual periods, as it is not wise to perform this procedure during the pre-ovulation phase and pregnancy.
Other medicines and Gastromiro
There are no reports of reactions between Gastromiro and other medicines.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
This is particularly important for beta-blockers (medicines used to treat high blood pressure), as emergency medication which may be used to treat any side effects caused by Gastromiro may not be effective.
The Gastromiro solution should not be mixed with any other drugs before being given to you.
Pregnancy and breast-feeding
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby you should only be given Gastromiro if your doctor believes it is clearly necessary. Ask your doctor for advice before taking this medicine.
If you have been given this medicine during your pregnancy or this medicine has been given to your newborn baby, your doctor will check the thyroid gland function of your baby as it may be temporarily underactive.
Stopping breastfeeding is not necessary please consult your doctor before you are given this medicine.
Driving and using machines
There is no information about the effects of Gastromiro on driving, or using tools or machines. Ask your doctor if you can drive and if it is safe for you to use any tools or machines.
Gastromiro contains ethanol
Gastromiro is a sugar free, orange-flavoured solution.
Gastromiro contains small amounts of ethanol (alcohol), a 20ml dose contains the same amount of alcohol as a 24ml of beer or 10ml of wine. It can be harmful for those suffering from alcoholism. This should be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease, or epilepsy.
Gastromiro contains sodium
The sodium content of Gastromiro 20ml, 50ml and 100ml corresponds respectively to 0,22%, 0,55% and 1,12% of the recommended WHO maximum daily intake of 2 g of sodium for an adult.
3. How to use Gastromiro
Your doctor or radiographer will decide how much Gastromiro you should take depending on the area of your body which is being investigated. Usually you will be given Gastromiro as a drink to swallow, but sometimes Gastromiro is put into the rectum (an enema).
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, Gastromiro can cause side effects, although not everybody gets them. Most of the side effects that have been reported with Gastromiro were mild did not last long and got better on their own.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Package leaflet: Information for the patient
Gastromiro®
Iopamidol 61.2% w/v
CL116503 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 These are signs of an allergic reaction which can be serious and might require medical treatment.
Common (more than 1 out of 100 persons and less than 1 out of 10 persons)
- Vomiting
Uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons)
- Diarrhoea
- Abdominal discomfort
- Low blood pressure
Not known (which cannot be estimated with the available data)
- Hypersensitivity reactions
- Sudden shortness of breath or breathing difficulty
- Rash
Possible Side Effects in Children
Common (more than 1 out of 100 persons and less than 1 out of 10 persons)
- Diarrhoea
Uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons)
- Feeling sick (nausea)
- Vomiting
If you think you notice any side effects after receiving Gastromiro, immediately tell the medical staff supervising your X-ray procedure.
If you have any other questions not answered in this leaflet please ask the medical staff supervising your X-ray procedure.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme, website: 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 Gastromiro
- Keep out of the sight and reach of children.
- Gastromiro must be stored protected from light.
- Do not use Gastromiro after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Gastromiro contains
The active substance is iopamidol.
The other ingredients are: citric acid, disodium edetate dihydrate, orange flavour, red curaçao, sodium saccharinate, sodium cyclamate and purified water.
What GASTROMIRO looks like and contents of the pack
Gastromiro is a clear, colourless to pale yellow solution containing no undissolved solids.
If the solution is discoloured it should be thrown away.
Gastromiro solution is provided to hospitals in bottles of 20, 50 and 100 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bracco UK Ltd, Magdalen Centre, The Oxford Science Park, Oxford, OX4 4GA, United Kingdom
Manufacturer
Bracco UK Ltd, Magdalen Centre, The Oxford Science Park, Oxford, OX4 4GA, United Kingdom
Bracco Imaging S.p.A., Bioindustry Park - Via Ribes 5, 10010 Colleretto Giacosa (TO), Italy