LUMIREM SUSPENSION

Active substance: FERUMOXSIL

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216601_175x210 mm 27/03/13 07:08 Page1

LUMIREM

Take special care with LUMIREM
You should inform your doctor if you suffer of asthma, since
LUMIREM may aggravate symptoms of the existing disease.

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.
• 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.

Remove all metallic objects you may be wearing before the
examination. Inform your doctor if you have:
• a pacemaker
• a clip on a blood vessel
• an infusion pump
• a nerve stimulator
• a cochlear implant (implant in the inner ear)
• any suspected metallic foreign bodies, particularly in the eye.
This is important as these can result in serious problems,
as magnetic resonance imaging devices use very strong
magnetics fields.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oral suspension
suspension of siloxane-coated superparamagnetic
iron oxide crystals

In this leaflet:
1. What LUMIREM is and what it is used for
2. Before you use LUMIREM
3. How to use LUMIREM
4. Possible side effects
5. How to store LUMIREM
6. Further information
1. WHAT LUMIREM IS AND WHAT IT IS USED FOR
LUMIREM is a diagnostic agent. It belongs to the group of
contrast agents used for magnetic resonance imaging (MRI)
and it contains iron.
LUMIREM is used to enhance the contrast of the images
obtained during MRI examinations of the stomach and
bowels.
This medicine is for diagnostic use only.
2. BEFORE YOU USE LUMIREM
You should read the information in this section carefully.
You and your doctor should take into consideration the
information given before you take LUMIREM
Do not use LUMIREM if
• you are allergic to iron or any of the other ingredients of
LUMIREM
• you have a pacemaker
• you have a clip on a blood vessel
• you have an infusion pump
• you have a nerve stimulator
• you have a cochlear implant (implant in the inner ear)
• you have any suspected metallic foreign bodies, particularly
in the eye.

Inform your doctor of any recent examination you may have
had with LUMIREM if he/she wants you to have a laboratory
test for iron done.

Taking other medicines
Please inform your doctor or pharmacist of any disease you
might have and if you are taking or have recently taken any
other medicines, even those not subject to medical
prescription. Be particularly careful if you take medicines for
high blood pressure.
Taking LUMIREM with food and drink
There are no known interactions between LUMIREM and food
and drinks. However, please check with your doctor or pharmacist
if it is required not to eat or drink before the examination.
Pregnancy and breast-feeding
Inform your doctor if you are pregnant, might be pregnant,
or if your period is late.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
LUMIREM is unlikely to affect your ability to drive or use
machines. If you feel unwell after the examination, you should
not drive or use machines.
Important information about some of the ingredients
of LUMIREM
List of the ingredients with a known effect: methyl
parahydroxybenzoate (E 218), propyl parahydroxybenzoate
(E 216), sunset yellow colouring agent (E 110), sorbitol
(E 420) and sodium.

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3. HOW TO USE LUMIREM
LUMIREM is an oral suspension.
The recommended dose in adults is 900 ml. This dose may be
adjusted by your doctor, but at least 600 ml is generally necessary.
The dose is administered in three portions during the hour
before examination.
4. POSSIBLE SIDE EFFECTS
Like all medicines, LUMIREM can cause side effects, although
not everybody gets them.
LUMIREM contains 26g of sorbitol per 300 mL, which can be
expected to cause gastric upsets:
The side effects most commonly occurring during
administration of LUMIREM are gastrointestinal disorders and
transient prickling sensations in the mouth. Allergic reactions
are possible.
The side effects reported for LUMIREM are mentioned below
and their frequency is unknown:
• allergic reactions (hypersensitivity) can be serious in nature
occurring within 60 min after the administration such as
anaphylactic reaction or delayed occurring up to 7 days after
administration of product, recognizable by spots, itching,
sudden swelling of the face and neck that can cause
breathing difficulties,
• prickling sensation
• diarrhoea, abdominal pain, nausea, abdominal distension,
flatulence, pain in the upper abdomen
• cold sensation
Side effects in children:
The side effects of Lumirem in children are the same as those
in adults.
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.

5. HOW TO STORE LUMIREM
Keep out of the reach and sight of children.
LUMIREM must be stored below 25°C
Do not use LUMIREM after the expiry date which is stated on
the bottle and on the carton, after the abbreviation “Exp”.
The expiry date refers to the last day of that month.
It is unlikely that you will be asked to dispose of any left over
LUMIREM. If this happens ask your pharmacist what you
should do. These measures will help to protect the
environment.

Guerbet
Guerbet

6. FURTHER INFORMATION

16-24 rue Jean Chaptal - 93600 Aulnay-sous-Bois - France
For any information about this medicine, please contact the
local representative of the Marketing Authorisation Holder:
Guerbet Laboratories Ltd
435 Stratford road - Shirley - Solihull B90 4AA - UK
Phone: + 44 1217 338 542

What LUMIREM contains
• The active substance is a suspension of siloxane-coated
superparamagnetic iron oxide crystals.
• The other ingredients are methylparahydroxybenzoate
(E 218), propylparahydroxybenzoate (E 216), carmellose
sodium, sunset yellow colouring agent (E 110), orange
flavour, ammonium glycyrrhizinate, sodium saccharin, 70%
crystallisable sorbitol, sodium chloride, sodium hydroxide,
purified water. (see also section 2 ‘Important information
about some of the ingredients of LUMIREM’)
What LUMIREM looks like and contents of the pack
LUMIREM is a orange-brown to orange oral solution for oral
administration.
The LUMIREM pack contains 1 or 3 bottles with 300 ml of
suspension.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:

BP 57400 - 95943 Roissy CdG cedex - France
Manufacturer:

216601

Sodium diet
This medicinal product contains 100 mg of sodium (salt) per
100 mL. Take this into account in case you are on a low
sodium diet.
Intolerance to sorbitol
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.
Allergy to dye yellow-orange S (E110)
This product may cause allergic reactions.

This leaflet was last approved in 12 February 2013

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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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