Sodium Iodide (I131) Capsules T

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

IWhat Sodium Iodide I131 is and what it . is used for

Sodium Iodide 1131 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


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


p)    orally taken contrast mediums used to make the gall bladder


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

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 1131.

•    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.

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

Ongoing check ups

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.

4.    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 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 1131 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

What Sodium Iodide I131 looks like and contents of the pack

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

•    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