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GASTROMIRO

Active substance(s): IOPAMIDOL

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Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy

Impianto di proprietà della:

Prodotto:

GASTROMIRO (UK)

SPECIFICA
RIFERIMENTO:
Dimensioni:
Color i n°:

Codice Bracco:

Codice Bracco superato:

Codice Terzista:

Codice Terzista superato:

Istruzione

CI00QV05

CI00QV04

31011873-06

31011873-05

Fustella

150 X 280 mm
Black

Traduzione braille:

Materiale:

Pantone Green 347

Eurolaser

2154ZD

Pantone Rosso 185

Pantone Rosso 185

CODICE LAETUS

2154ZD

Pantone Rosso 185

Pantone Rosso 185

Pantone Rosso 185

Vernice

106

1
Modifica rispetto la versione precedente:

TRANSFER OF MAH FROM BRACCO UK LTD TO BRACCO IMAGING S.P.A.

Quality Assurance
P. Packaging M. Development

Data Emissione

CROM
in FOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

Data Obsolescenza

Archiviare almeno fino a:

I colori su questa prova sono approssimativi,
questa è una stampa a 600 dpi ottenuta con colori
a base acqua CMYK. Definizione e colori non
riflettono il risultato finale della produzione stampata.

11 MAG 2016
FCI00QV05-PIL-GASTRO
Versione interna: 05

Via G. Tartini, 2- 2 0 15 8

- MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

Status

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

FRONTE - Font size heading c.19.5 - Font size subheading c.10 - Font size main text c.09 - Font size line-spacing 9

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Package leaflet: Information for the patient

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GASTROMIRO®

Iopamidol 61.2% w/v
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Read all of this leaflet carefully before you start using 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 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 you get any side effects, talk to your doctor. This includes any possible side effects not listed in this
leaflet. See section 4.

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In this leaflet:
1. What Gastromiro is and what it is used for
2. What you need to know before you use Gastromiro
3. How to use Gastromiro
4. Possible side effects
5. How to store Gastromiro
6. Contents of the pack and o information

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1. What Gastromiro is and what it is used for

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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).

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This medicine is for diagnostic use only.
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2. What you need to know before you use Gastromiro

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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).

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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.

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

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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.

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The Gastromiro solution should not be mixed with any other drugs before being given to you.

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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.

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Stopping breastfeeding is not necessary please consult your doctor before you are given this medicine.

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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.

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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

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Bracco s.p.a. via E. Folli, 50 - 20134 Milano - Italy

Impianto di proprietà della:

Prodotto:

GASTROMIRO (UK)

SPECIFICA
RIFERIMENTO:
Dimensioni:
Color i n°:

Codice Bracco:

Codice Bracco superato:

Codice Terzista:

Codice Terzista superato:

Istruzione

CI00QV05

CI00QV04

31011873-06

31011873-05

Fustella

150 X 280 mm
Black

Traduzione braille:

Materiale:

Pantone Green 347

Eurolaser

2154ZD

Pantone Rosso 185

Pantone Rosso 185

CODICE LAETUS

2154ZD

Pantone Rosso 185

Pantone Rosso 185

Pantone Rosso 185

Vernice

106

1
Modifica rispetto la versione precedente:

TRANSFER OF MAH FROM BRACCO UK LTD TO BRACCO IMAGING S.P.A.

Quality Assurance
P. Packaging M. Development

Data Emissione

CROM
in FOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

Data Obsolescenza

Archiviare almeno fino a:

I colori su questa prova sono approssimativi,
questa è una stampa a 600 dpi ottenuta con colori
a base acqua CMYK. Definizione e colori non
riflettono il risultato finale della produzione stampata.

11 MAG 2016
FCI00QV05-PIL-GASTRO
Versione interna: 05

Via G. Tartini, 2- 2 0 15 8

- MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

Status

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

RETRO - Font size heading c.19.5 - Font size subheading c.10 - Font size main text c.09 - Font size line-spacing 9

0
1

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.

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3. How to use Gastromiro

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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.

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4. Possible side effects

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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.

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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.

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Common (more than 1 out of 100 persons and less than 1 out of 10 persons)
• Vomiting

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Uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons)
• Diarrhoea
• Abdominal discomfort
• Low blood pressure

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Not known (which cannot be estimated with the available data)
• Hypersensitivity reactions
• Sudden shortness of breath or breathing difficulty
• Rash

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Possible Side Effects in Children
Common (more than 1 out of 100 persons and less than 1 out of 10 persons)
• Diarrhoea

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Uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons)
• Feeling sick (nausea)
• Vomiting

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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.

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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.

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

5. How to store Gastromiro

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• 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.

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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.

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6. Contents of the pack and other information

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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 water.

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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.

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Marketing Authorisation Holder
Bracco Imaging spa, Via Egidio Folli 50, 20134 Milano, Italy

Date of granting approval of latest variation: July 2016

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31011873-06
CI00QV05

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Manufacturers
Famar S.A.,63 Ag. Dimitriou Avenue, 17456 Alimos (Athens), Greece
Bracco s.p.a., via Caduti di Marcinelle 13, 20134 Milano, Italy

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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