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SODIUM IODIDE (I131) CAPSULES T

Active substance(s): SODIUM IODIDE I 131 SOLUTION

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DRN 5302

Sodium Iodide (I-131) Capsule T United Kingdom

Page 1 of 2

Package leaflet: Information for the user

Sodium Iodide I131 Capsule T
131I

as sodium iodide

Read all of this leaflet carefully before you start taking 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. See section 4.
In this leaflet:
1. What Sodium Iodide I131 is and what it is used for
2. Before you take Sodium Iodide I131
3. How to take Sodium Iodide I131
4. Possible side effects
5. How to store Sodium Iodide I131
6. Further information

1.

What Sodium Iodide I131 is and what it
is used for

Sodium Iodide I131 is used to treat:
thyroid gland tumours and
overactivity of the thyroid gland.
This medicine contains a radioactive substance which when taken, collects in
certain organs such as, the thyroid gland.
The radioactive substance can be photographed from outside the body,
using special cameras which take a scan. This scan shows the distribution of
radioactivity within the organ and body. This also gives the doctor valuable
information about the structure and function of that organ.

2.

Before you take Sodium Iodide I131

Do not take Sodium Iodide I131
if you have/are
swallowing problems
obstructed gullet
abdominal diseases
reduced abdominal or bowel movement
pregnant

Take special care with Sodium Iodide I131
Inform your doctor if you have
reduced kidney function
This medicine does involve treatment with radioactivity. Your doctor
will only give you this medicine if the benefit outweighs the risk.
Sodium Iodide I131 is given in one single dose by specialists, who will
take responsibility for any necessary precautions.
Your doctor will inform you if you need to take any special precautions
after using this medicine. Contact your doctor if you have any
questions.

Other medicines and Sodium Iodide (I-131)
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Your doctor may recommend that you stop the following medicines
before treatment:
a) medicines to reduce thyroid gland function such as:
- carbimazole, thiamazole, propylthiouracil
- perchlorate
b) salicylates: medicines to reduce pain, fever or inflammation such
as acetylsalicylic acid
c) cortisone, medicines to reduce inflammation or prevent organ
transplant rejection
d) sodium nitroprusside: a medicine to reduce high blood pressure,
and also used during an operation
e) sodium sulfobromophtalein: a medicine to test liver function
f) certain medicines
- to reduce blood coagulation
- to treat parasitic infestation
- antihistamines: used to treat allergies
- penicillins and sulphonamides: antibiotics
- tolbutamide: a medicine to reduce the blood sugar
- thiopentone: used while under anaesthetic to reduce brain
pressure, and also to treat extreme epileptic seizures
g) phenylbutazone: a medicine to reduce pain and inflammation
h) medicines to help free the airways of sputum
i) vitamins
j) medicines containing thyroid hormones such as, thyroxine,
liothyronine, thyroid extract
k) amiodarone: a medicine to treat heart rhythm disorders
l) benzodiazepines: medicines which calm and initiate sleep or relax
muscles
m) lithium: a medicine to treat depression
n) iodide containing medicines which are used only on a restricted
area of the body
o) contrast mediums given into the vein to make inner body parts
visible
p) orally taken contrast mediums used to make the gall bladder
visible
q) contrast mediums containing iodine.
Before using Sodium Iodide I131, stop using the medicines listed
previously as follows:
a-f): 1 week
g): 1-2 weeks
h-i): 2 weeks
j): 2-6 weeks
k-m): 4 weeks
n): 1-9 months
o-q): 1 year

05302006BYS07b / 21 CON 5302 United Kingdom SPC 13012015 / 24 CON 5302 United Kingdom PIL 13012015

DRN 5302

Sodium Iodide (I-131) Capsule T United Kingdom

Pregnancy and breast-feeding
Pregnancy
Do not take Sodium Iodide I131 if you are pregnant. Any
possibility of pregnancy must be ruled out before using this
medicine.
Women should not become pregnant until at least 4 months after
using Sodium Iodide I131.
Breast-feeding
Tell your doctor if you are breast-feeding as he may delay
treatment until breast-feeding is finished. He may also ask you to
stop breast-feeding until the radioactivity is no longer in your
body.
Ask your doctor or pharmacist for advice before taking any medicine .

Driving and using machines
It is considered unlikely that Sodium Iodide (I-131) will affect your
ability to drive or to use machines.

Sodium Iodide I131 contains sucrose (sugar) and sodium
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3.

How to take Sodium Iodide I131

Always take Sodium Iodide I131 exactly as your doctor has told you. You
should check with your doctor if you are not sure.
Sodium Iodide I131 will always be used in a hospital or similar setting. It
will only be administered to you by qualified people trained to safe
handle radioactive material.
Your doctor will decide the Sodium Iodide I131 amount to be used.
You may receive a small dose of 20 to 40 MBq before treatment. This
allows your doctor to calculate the necessary radioactive dose.
The dose administered depends also on the disease and your body
weight.

The usual dose is :
One capsule which is individually produced for you.
Approximate doses for adults are:
200-800 MBq to treat overactive thyroid gland
1850-3700 MBq for partial or complete removal of the thyroid
gland and for treating the spread of cancer cells, known as
metastases
3700-11100 MBq for follow up treatment of metastases.
MBq is the unit used to measure radioactivity, and defines the activity
of a quantity of radioactive material.

Children under 18 years
Lower doses are used for children.

Method of use
In an upright body position, swallow the capsule whole with one glass
of water at least 2 hours after a meal.
Young children should take the capsule together with mashed food.

4.

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Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Side effects can occur with the following frequencies:
very common, occurs in more than 1 of 10 users
underactive thyroid
stomach and intestine disturbances after the first days of high dose
treatment
swelling and pain in the salivary glands related to this may occur:
dry mouth and eyes
partial loss of taste
very rarely tooth loss
Stimulate the salivary glands by eating or drinking acidic foods. This will
reduce the frequency of the last four side effects.
Frequency unknown, from the data available
worsening of existing overactive thyroid gland
brief thyroid inflammation
inflamed trachea which may become narrowed
local pain, discomfort, fluid accumulation in the brain and swelling in the
tissue which takes up the active substance
nausea, vomiting
symptoms of allergic reactions
acne like rash (pimples and pustules)
reduction or loss of parathyroid hormone production
at high concentrations used in cancer treatment, a small increase in:
- solid cancers such as bladder, stomach and colon cancers
- leukaemia, a blood cancer in which too many or abnormal white blood
cells are produced
- reduced blood cell production in the bone marrow
reduction in the blood platelets
reduction in red blood cells
Reporting of side effects
If you get any side effects, talk to your Nuclear medicine doctor who
supervises the procedure. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
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 Sodium Iodide I131

Do not use Sodium Iodide I131 after the expiry date stated on the label.
Hospital staff will ensure correct storage temperature, between 15 25°C as stated on the label.

6.

Further information

What Sodium Iodide I131 contains
The active substance is 131I as sodium iodide.
Each vial contains 1 capsule with 37 to 7400 MBq iodide-131.
The other ingredients are: disodium hydrogen phosphate dihydrate,
sodium thiosulphate pentahydrate, sodium hydrogen carbonate, sodium
hydroxide, saccharose, sodium chloride, water for injections and gelatin

Drink as much as possible the day after treatmen t. This will
prevent active substance gathering in the bladder.

What Sodium Iodide I131 looks like and contents of the pack

Ongoing check ups

Sodium Iodide I131 Capsule T is a transparent capsule filled with white to
light brown powder and is available in packages containing one capsule.

Your doctor will check your blood for up to a month after
administration. Scans may be taken throughout the entire period of
treatment.

If you take more Sodium Iodide I131 than you should

It is unlikely that overdose will occur as this medicine is given under control
by a doctor. However, if this happens you will receive appropriate treatment
from your doctor.
If you have any further questions on the use of this product, ask your
doctor.

Marketing Authorisation Holder
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands
PL 12288/0010
Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands

This leaflet was last approved in 01/2015.
05302006BYS07b / 21 CON 5302 United Kingdom SPC 13012015 / 24 CON 5302 United Kingdom PIL 13012015

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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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