1. What Sodium Iodide Diagnostic Capsules are and what they are 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 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

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.

•    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.

•    Medicines used in hospital for x-rays 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.

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 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.

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 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

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

Marketing Authorisations

PL 00221/0112

PACKAGE LEAFLET: INFORMATION FOR THE USER

GE and the GE Monogram are trademarks of General Electric Company

12476522 IBS511-515P-GB0414-PIL