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MICROPAQUE 1 G/ML ORAL OR RECTAL SUSPENSION

Active substance(s): BARIUM SULPHATE

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5031428 MPQ UK LEAFLET.qxp_148 x 295 mm_black 23/01/2015 16:42 Page1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Micropaque 1g/mL,
oral or rectal suspension
Barium sulphate
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
or pharmacist.
- 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 or pharmacist.

In this leaflet:
1. What Micropaque is and what it is used for
2. Before you use Micropaque
3. How to use Micropaque
4. Possible side effects
5. How to store Micropaque
6. Further information

1. WHAT MICROPAQUE IS AND WHAT IT IS
USED FOR
This medicine is for diagnostic use only.
Micropaque is an X-ray contrast media used to
highlight areas of your body. It is most commonly used
in X-ray or similar medical examinations to help the
doctor diagnose problems in your digestive system
(throat, stomach and bowels).
This medicine is for the use of children, adults and the
elderly.

2. BEFORE YOU USE MICROPAQUE
Do not use Micropaque
• if you are allergic (hypersensitive) to the active
substance (barium sulphate) or any of the other
ingredients (refer to the end of this leaflet);
• if you suffer from stomach ulcers, or any other
stomach or bowel problem (perforation, obstruction,
etc);
• if you have had a surgery or an examination
(endoscopy) of the digestive tract within the
7 previous days;
• if you have had a radiotherapy of the digestive tract
within the 4 previous weeks.
Tell your doctor if you are suffering from any of these
conditions.

Take special care with Micropaque
This medicinal product must not be injected.
Like with all products containing barium sulphate,
there is a risk of side effects; they are usually minor
but can also be life-threatening. Possible allergic-like
reactions may occur in the hours following
administration, up to 7 days after administration. They
are unforeseeable but the risk of occurrence is
increased if you have already had a reaction following
previous administration of product containing barium

sulphate (see section 4 “Possible side effects”). If this
is the case, you should inform your doctor.
Inform your doctor:
• if you have already experienced a reaction following
the administration of the same type of medicinal
product;
• if you suffer from asthma;
• in case of constipation or any other problem of the
digestive system;
• if you have any difficulty to swallow or to breath;
• if your kidneys do not work properly;
• in case of Hirschsprung’s disease (very rare bowel
problem affecting the children);
• if you are to undergo other radiological examination
in the next few days.

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

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, may become
pregnant, or are breast-feeding.
Ask your doctor of pharmacist for advice before taking
any medicine.

Important information about some of the
ingredients of Micropaque
This medicinal product contains:
• Glucose and sucrose in the vanilla/caramel flavour.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
• Sodium (1.76 g per 500 mL suspension). Please
take this into consideration if you are on a low salt
diet.
• Potassium (170 mg per 500 mL suspension). Please
take this into consideration if you have a reduced
kidney function or are on a controlled potassium
diet.
• ”Parahydroxybenzoate” and may cause allergic
reactions (possibly delayed).

3. HOW TO USE MICROPAQUE
Always use Micropaque exactly as your doctor has told
you. You should check with him/her if you are not sure.

Dosage
Adults:
The dose will be decided by the doctor depending on
the type of examination.
In the Elderly:
The dose will be decided by the doctor depending on
the type of examination. Special care should be taken
to follow the advice given in this leaflet.
In Children:
The dose will be decided by the doctor as such
investigations in children are rare and specialised. It
will therefore be tailored to suit the special
requirements in each case.

Method of administration
Depending on the part of the digestive system to be
examined, you may be given this medicine:
• rectally (into the back passage) as an enema,
• or orally (by mouth) as a drink.

5031428 MPQ UK LEAFLET.qxp_148 x 295 mm_black 23/01/2015 16:42 Page2

As an enema, the clinic/hospital staff will explain how
Micropaque will be used. The medical staff will take
care about a right positioning of the administration
device.
As a drink, you may need to swallow more than 1 Litre
(over 2 pints). It is particularly important to take this
medicine exactly as told to do so. You should finish all
that you have been given.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.
By reporting side effects you can help provide more
information on the safety of this medicine

5. HOW TO STORE MICROPAQUE
You should check with your doctor if you are not sure.
If you see other doctors, let them know what
medicines you have taken.

If you use more Micropaque than you should
Although you will be given Micropaque in a hospital,
and there will be little chance of an overdose, if you
think a child or anyone else has swallowed any of it,
let the emergency department or hospital staff know
immediately.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Side effects can occur at some frequencies which are
detailed below:
• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the
available data
Most side effects are not serious. Side effects reported
for Micropaque are mentioned below. Their frequency
is not known.
• sudden skin rash, breathing difficulties and fainting
(within minutes or days) due to allergic reactions;
• vomiting, diarrhoea, abdominal pain, constipation,
feeling bloated, flatulence;
• breathing difficulties;
• dizziness and feeling of imminent loss of
consciousness (presyncope);
• urticaria (patches of red skin, severely itching), rash.

Keep out of the reach and sight of children.
This medicine should be stored below 25°C. Do not
freeze it.
Do not use Micropaque after the expiry date which is
stated on the container. The expiry date refers to the
last day of that month. If you have any medicines that
are out of date, return them to your pharmacist or
hospital for safe disposal.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist or hospital
how to dispose of medicines no longer required. These
measures will help to protect the environment.

6.FURTHER INFORMATION
What Micropaque contains
• The active substance is barium sulphate (1 g/mL).
• The other ingredients are carmellose sodium,
sodium citrate dihydrate, xanthan gum, potassium
sorbate, sodium methyl parahydroxybenzoate,
sodium propyl parahydroxybenzoate, vanilla/caramel
flavour, saccharin sodium, sulphuric acid, and
purified water.

What Micropaque looks like and contents of
the pack
Micropaque is a white, thick liquid with a sweet vanilla
flavour.
Micropaque is available in bottles of 500 mL or
2,000 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Guerbet
B.P. 57400
95943 Roissy CdG Cedex
FRANCE

In very rare cases the administration of this type of
medicinal product can cause the formation of a plug
of faeces and barium in the bowel.

For any information about this medicine, please
contact the local representative of the Marketing
Authorisation Holder:

In case of perforation of the bowel, barium could leak
into the abdomen, and cause potentially abscesses,
inflammation or peritonitis. This could require surgery;
however, it is an extremely rare complication.

Guerbet Laboratories Ltd
Avon House
435 Stratford road
Shirley, Solihull
Birmingham B90 4AA
Phone: + 44 1217 338 542

The passage of barium into the blood may be
responsible for blockage of blood vessels, shock,
important difficulties to breathe and multiple formation
of clots in the blood vessels.
If you get any of the side effects, talk to your doctor or
health professional. This includes any side effects not
listed in this leaflet.

This leaflet was last approved in March 2015.

5031428

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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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