S's,    GASTROMIRO®

BRACCO    lopamidol 61.2% w/v

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Gastromiro is and what it is used for

2.    Before you use Gastromiro

3.    How to use Gastromiro

4.    Possible side effects

5.    How to store Gastromiro

6.    Further information

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. 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

•    If you are allergic (hypersensitive) to X-ray dyes containing iodine

•    If you have had any allergic reaction (hypersensitivity reaction) in the past such as rash, itching, urticaria (hives) or difficulty in breathing following injection or oral/rectal administration of any special dye or contrast agent for an X-ray procedure

•    If you require administration of contrast agent other than by oral administration or by rectal administration (for example, if you require an injection by needle of contrast agent into a vein or artery). Gastromiro is only to be used for oral administration as a drink or for rectal administration (an enema)

Tell your doctor if you think any of the points in this section apply to you.

Take special care with GASTROMIRO

Before treatment with Gastromiro tell your doctor if:

•    you have had an allergic reaction to Gastromiro or any other contrast agents

•    you have a history of astma 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.

Using other medicines

There are no reports of reactions between Gastromiro and other medicines.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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

Gastromiro should not be used during pregnancy or breast-feeding unless clearly necessary. Ask your doctor for advice before being given this medicine.

Ask your doctor or pharmacist for advice before taking any 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.

Important information about some of the ingredients of Gastromiro

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. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease, or epilepsy.

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). 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

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.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE GASTROMIRO

•    Keep out of the reach and sight 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.

6. FURTHER INFORMATION

What GASTROMIRO contains

Gastromiro contains a substance called iopamidol as its active ingredient. The particular quantity of iopamidol in Gastromiro means that it has an iodine content of 300 milligrams per millilitre. It also contains citric acid, disodium edetate dihydrate, orange flavour, red curagao, sodium saccharinate, sodium cyclamate and 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 U.K. Ltd, Bracco House, Mercury Park, Wycombe Lane,

Wooburn Green, Buckinghamshire HP10 OHH Tel. +44 (0) 1628 851500 Fax +44 (0) 1628 819317

Manufacturer    CO

Bracco S.p.A. via E. Folli 50, 20134 Milano (Italy) and Famar S.A.,

63 Ag. Dimitriou Avenue, 17456 Alimos (Athens) Greece.

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Date of granting approval of latest variation: September 2013    - §