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SODIUM IODIDE (131-L) DIAGNOSTIC CAPSULES 0.333-3.7 MBQ CAPSULES HARD

Active substance(s): SODIUM IODIDE I-131

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Read all of this leaflet carefully
before you receive this medicine.

PaCkage LeaFLeT:
InFoRMaTIon FoR The uSeR

Sodium Iodide (131I) Diagnostic
Capsules

Sodium Iodide (131I) Diagnostic
Capsules 0.333 to 3.7 MBq
Capsules, hard
Sodium [131I] Iodide
(called Sodium Iodide Diagnostic
Capsules in this leaflet)

• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor.
• 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 nurse.
In this leaflet:
1. What Sodium Iodide Diagnostic
Capsules are and what they are
used for
2. Before you are given Sodium
Iodide Diagnostic Capsules
3. How Sodium Iodide Diagnostic
Capsules are given
4. Possible side effects
5. How to store Sodium Iodide
Diagnostic Capsules
6. Further information

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1. What Sodium Iodide Diagnostic
1. Capsules are and what they are
1. used for
This medicine is used for diagnostic
use only. It is used only to help
identify illness.
Sodium Iodide Diagnostic Capsules
are a ‘radiopharmaceutical’ medicine.
• They contain an active ingredient
called ‘sodium iodide’.
• Once taken they can be seen
from outside your body by a
special camera used in the scan.
• The scan can help your doctor
see tumours in the thyroid glands,
and to see how well a tumour is
responding to treatment or if the
tumour has spread to other parts
of the body.

2. Before you are given Sodium
2. Iodide Diagnostic Capsules
You should not be given Sodium
Iodide Diagnostic Capsules:
• If you are allergic (hypersensitive)
to the active ingredient or any
other ingredient (listed in Section
6).
• If you are pregnant or think you
might be pregnant.
• If you are unable to swallow
normally.
• If you have digestive or stomach
problems
• If it is possible that you have slow
movement of food along your gut
(reduced gastrointestinal motility).
• For a scan of benign thyroid
tumours.
Do not have Sodium Iodide
Diagnostic Capsules if any of the

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above apply to you. If you are not
sure talk to your doctor or nurse.
Take special care with Sodium
Iodide Diagnostic Capsules
Check with your doctor or nurse
before having Sodium Iodide
Diagnostic Capsules:
• If the person who will be given this
medicine is a child or adolescent.
• If you have missed your last
period.
• If you are on a low sodium diet.

Taking other medicines
Please tell your doctor or nurse if you
are taking or have recently taken any
other medicines, including medicines
obtained without a prescription. This
includes herbal medicines. This is
because some medicines can affect
the way Sodium Iodide Diagnostic
Capsules work.
Before you are given Sodium Iodide
Diagnostic Capsules tell your doctor
or nurse if you are taking any of the
types of medicine below.
• Medicines used for an
overactive or underactive
thyroid such as carbimazole,
propylthiouracil, levothyroxine
sodium, sodium liothyronine or
thyroid extract.
• ‘Salicylates’ such as aspirin.
• Steroids such as prednisolone
or methylprednisolone.

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• Medicines used to thin the
blood such as warfarin or
heparin.
• Antihistamines such as
chlorpheniramine or cetirizine.
• Medicines used for parasite
infections such as
thiabendazole, rifampicin or
amphotericin B.
• Penicillins.
• Medicines called
‘sulphonamides’ such as
sulphasalazine (used for
rheumatoid arthritis and some
bowel problems), sumitriptan
(used for migraine) or
probenecid (used for gout).
• Medicines called
‘benzodiazepines’, which are
sedatives or are used to help
you sleep, such as temazepam,
nitrazepam or diazepam.

• ‘Expectorants’, used in cough
and cold remedies, such as
guaifenesin.
• Vitamins.
• Lithium, used for mental health
problems.
• Tolbutamide, used for diabetics.
• Thiopental, an anaesthetic used
in hospital.
• Phenylbutazone, used for pain
and arthritis.
• Amiodarone, used for an
uneven heart beat.
• Liquids or ointments that
contain iodine.
• Sodium nitroprusside, used in
hospital to lower blood pressure.
• Sodium sulfobromophthalein,
used in hospital to check how
well your liver is working.
• Perchlorate, a medicine given
before certain types of scan.

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• Medicines used in hospital for xrays or scans of the gallbladder.
• Medicines that contain iodine
used in hospitals for x-rays or
scans.
If you are not sure if any of the above
apply to you, talk to your doctor or
nurse before having Sodium Iodide
Diagnostic Capsules.
Pregnancy and breast-feeding
You should not be given Sodium
Iodide Diagnostic Capsules if you are
pregnant or think you might be
pregnant. This is because it may
affect the baby.
You will be told not to become
pregnant for 6 months after being
given Sodium Iodide Diagnostic
Capsules.

Do not breast-feed if you are given
Sodium Iodide Diagnostic Capsules.
This is because small amounts of
‘radioactivity’ will pass into the
mother’s milk. If you are breastfeeding, your doctor may wait until
you have finished breast-feeding
before giving you Sodium Iodide
Diagnostic Capsules. If it is not
possible to wait your doctor will ask
you to:
• stop breast-feeding, and
• use formula feed for your child,
and
• express (remove) breast milk and
throw away the milk.
Your doctor will let you know when
you can start breast-feeding again.

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Driving and using machines
Ask your doctor if you can drive or
use machines after you have been
given Sodium Iodide Diagnostic
Capsules.
Important information about
Sodium Iodide Diagnostic Capsules
When Sodium Iodide Diagnostic
Capsules are used you are exposed
to radioactivity.
• Your doctor will always consider
the possible risks and benefits
before you are given the medicine.
Ask your doctor if you have any
questions.

3. how Sodium Iodide
3. Diagnostic Capsules are given
Sodium Iodide Diagnostic Capsules
will be given to you by a specially
trained and qualified person.
• Sodium Iodide Diagnostic
Capsules will always be used in a
hospital or clinic.
• You will be asked to take Sodium
Iodide Diagnostic Capsules with
some liquid. It should be
swallowed whole.
• If it is possible that you have
problems with taking and
digesting food (gastrointestinal
disease) you may be asked to
take some other medicines, to
help the capsule get to your
stomach.
• They will tell you anything you
need to know for its safe use.

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Your doctor will decide on the dose
that is best for you.
The usual dose is:
• One single capsule. Scans are
usually taken at 4 hours and then
again at 18 to 24 hours. A further
scan may be necessary at 72
hours.
4. Possible side effects
Like all medicines, Sodium Iodide
Diagnostic Capsules can cause side
effects, although not everybody gets
them.
allergic reactions
If you have an allergic reaction when
you are in hospital or a clinic, tell the
doctor or nurse straightaway. The
signs may include:
• skin rash or itching or flushing
• swelling of the face

• difficulty in breathing.
If any of these side effects happen
after you leave the hospital or clinic
go straight to the casualty
department of your nearest hospital.
other side effects include
• feeling sick (nausea)
• being sick (vomiting).
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 nurse.
5. how to store Sodium Iodide
5. Diagnostic Capsules
Sodium Iodide Diagnostic Capsules
are kept out of the reach and sight of
children.
The product label includes the correct
storage conditions and the expiry

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date for the batch. Hospital staff will
ensure that the product is stored and
disposed of correctly and not used
after the expiry date stated on the
label.
6. Further information
What Sodium Iodide Diagnostic
Capsules contain
• The active ingredient is sodium
[131I] iodide. Each Sodium Iodide
(131I) Diagnostic Capsule contains
0.333 to 3.7 MBq (Megabecquerel
– the unit in which radioactivity is
measured) of sodium [131I] iodide.
• The other ingredients are sodium
thiosulphate, disodium hydrogen
orthophosphate, sodium hydroxide
and a gelatin capsule containing
gelatin, titanium dioxide (E171),
sodium laurilsulfate and acetic acid.

What Sodium Iodide Diagnostic
Capsules look like and contents of
the pack
Sodium Iodide Diagnostic Capsules
are supplied in a polystyrene
container containing hard capsules.
Marketing authorisation holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Germany
This leaflet was last approved in
May 2014

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Marketing authorisations
PL 00221/0112

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GE and the GE Monogram are
trademarks of General Electric
Company

1177816-49 /0514 /Oe 3000

PaCkage LeaFLeT:
InFoRMaTIon FoR The uSeR

12476522

IBS511-515P-GB0414-PIL

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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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