Package leaflet: Information for the patient CAPSION 50 - 3700 MBq capsule, hard Sodium iodide (^,31l)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What CAPSION is and what it is used for

2.    What you need to know before CAPSION is used

3.    How CAPSION is used

4.    Possible side effects

5.    How CAPSION is stored

6.    Contents of the pack and other information

1. What CAPSION is and what it is used for

This medicine is a radiopharmaceutical product for therapy only.

Capsion is a capsule containing a radioactive element (iodine-131).

When taken by mouth, iodine-131 is rapidly absorbed from the stomach, into the blood stream and is taken up by the thyroid gland. The dose absorbed of iodine-131 destroys the thyroid cells.

Capsion can be used to treat

•    Overactive thyroid gland or

•    Tumour in the thyroid gland and its spread to other parts of your body.

In addition to Capsion, you may also need to have surgery or take other medicines to treat the thyroid disease.

The use of Capsion does involve exposure to amounts of radioactivity. Your doctor and the nuclear medicine doctor will have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before CAPSION is used Capsion must not be used:

•    If you are allergic to sodium iodide (^l3,l) or any of the other ingredients of this medicine (listed in section 6),

•    If you are pregnant or think you might be pregnant,

•    If you are breast feeding,

•    If you have gastrointestinal disorders like difficulty swallowing, an obstructed gullet, upset stomach or stomach ulcer,

•    If it is possible that you have slow movement of food through your gut (reduced gastrointestinal motility).

If any of these apply to you, tell your nuclear medicine doctor.

Warnings and precautions

Take special care with Capsion

•    If you have kidney problems, you could have difficulty eliminating the product from your body.

In this case, the dose you receive may need to be adjusted,

•    If you have bladder voiding problems,

•    If you have digestive or stomach problems,

•    If protruding eyes are part of the symptoms of the disease you are suffering from (Graves' disease-induced ophthalmopathy),

•    If you know you are allergic to gelatine.

If any of these apply to you, talk to your nuclear medicine doctor. Capsion may not be suitable for you. Your doctor / nuclear medicine doctor will advise you.

Before administration of Capsion:

•    In men, high doses of sodium iodide (^,3,l) may affect sperm production temporarily. If you would ever like to father a child, speak to your doctor about whether saving your sperm in a sperm bank should be considered.

•    If you are taking drugs, your doctor may also tell you to stop taking them some weeks or days before you receive Capsion. Please see subsection Others medicines and Capsion.

On the day of the administration you should:

•    Fast for at least 4 hours before the treatment.

•    Drink plenty of water to ensure you are well hydrated before the administration of Capsion. This will help ensure that you urinate as often as possible during the first few hours after the study.

Children and adolescents

Talk to your nuclear medicine doctor if you are under 18 years old, if you cannot swallow a capsule whole.

Other medicines and Capsion

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. These medicines may stop Capsion from working properly. Your nuclear medicine doctor / doctor may recommend that you stop the following medicines from one to several weeks before treatment, particular examples are:

« Medicines used for an overactive or underactive thyroid such as carbimazole, propylthiouracil, levothyroxine sodium, sodium liothyronine or thyroid extract.

•    Medicines used to reduce pain, fever or swelling (anti-inflammatory medicines iike aspirin, steroids, phenylbutazone),

•    Antibacterial and antibiotic medicines (sulphonamides, penicillins),

•    Medicines against cough (expectorants) containing iodine,

•    Vitamins containing iodine,

•    Medicines for mood management (lithium, benzodiazepines),

■    Medicines used to treat heart conditions (amiodarone, anticoagulants, sodium nitroprusside),

■    Diagnostic medicines used to perform radiography

•    Medicines used to treat allergy (anti-histamines),

•    Medicines used to treat parasitic diseases,

•    Medicines used to treat diabetes (tolbutamide),

•    Iodide antiseptic medicines for topical use,

•    Medicines used for anesthesia.

This is a long list, so always check with your nuclear medicine doctor about any medicine you are taking.

Capsion with food

Your doctor may recommend a low iodine diet prior to therapy and may ask you to avoid foods such as shellfish and crustaceans and food containing the colouring material E127 (Erythrosine).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.

You must inform the nuclear medicine doctor before the administration of Capsion if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.

If you are in any doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

You must not take Capsion if you are pregnant. It must be established that you are not pregnant before the use of this product.

You must tell your nuclear medicine doctor if you have missed a period or if there is any chance you may be pregnant.

If you are breast-feeding

Tell your nuclear medicine doctor if you are breast-feeding, as you should completely stop this before treatment for your health and your baby’s health. Moreover you must avoid close contact with your baby for a few days, depending on the dose administered. Your nuclear medicine doctor will inform you of the number of days.

Contraception in males and females

•    Women who have taken Capsion and who could get pregnant must use reliable contraception (e.g. Pill, implants, caps, condoms or Intra Uterine Devices (lUDs)) for 6-12 months after treatment.

•    In men, effective contraception must be implemented and maintained for 6 months after treatment.

Fertility

Reproduction capacity may be affected transiently in men and women after treatment with Capsion.

Driving and using machines

It is considered unlikely that Capsion will affect your ability to drive or to operate any tools or machines. But take care, and do not drive or operate machinery until you are sure you are not affected.

Capsion contains 110 mg of sodium per capsule which has to be taken into account if you are on low sodium diet.

Marketing Authorisation Holder and Manufacturer

CIS bio international B.P. 32

91192 Gif-sur-Yvette Cedex FRANCE

This leaflet was last revised in 04/2016.

Detailed information on this medicine is available on the web site of the MHRA.

The following information is intended for medical or healthcare professionals only:

The complete SmPC of Capsion is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please refer to the SmPC.

Any radioactive material may cause cancer or hereditary defects but your doctor / nuclear m edicine specialist will have ensured that the risks of the radiation are less than from your disease itself.

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.oov.uk/vellowcard.

By reporting side effects you can help provide information on the safety of this medicine.

5. How CAPSION is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.

6. Contents of the pack and other information What Capsion contains

•    The active substance is sodium iodide (^l3,l) with a radioactivity of 50 to 3700 MBq per capsule at the reference time set by the manufacturer.

•    The other ingredients are anhydrous sodium pyrophosphate and sodium thiosulphate.

•    The gelatine capsule is made of:

Upper part: green (titanium dioxide, yellow iron oxide, indigotine),

Lower part: orange (titanium dioxide, red iron oxide, yellow iron oxide).

What Capsion looks like and contents of the pack

You will not have to get this medicine or handle the packaging or the vial. The following data is for your information only.

Capsion is a green and orange capsule.

Packsize: One gelatine capsule packed in a glass vial.

3. How CAPSION is used

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Capsion will only be used In special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide on the quantity of Capsion to be used in your case. It will be the smallest quantity necessary to obtain the desired effect. The quantity to be administered depends on the condition to be treated. For the treatment of an overactive thyroid gland, the quantity usually recommended to be administered for an adult ranges from 200 to 800 MBq (megabecquerel, the unit used to express radioactivity).

For removal of the thyroid gland tumour or for treating its spread, the quantity usually recommended to be administered for an adult ranges from 1 850 to 3 700 MBq. The treatment may need to be repeated and doses can be up to 11 100 MBq for some conditions.

Use In children and adolescents

In children and adolescents, the quantity to be administered will be adapted.

Administration of Capsion and conduction of the procedure

Your stomach should be empty when taking this capsule.

You will be given a special container with the capsule in it. You will swallow the capsule from the container and be given a drink to help the capsule go down. The capsule must be swallowed whole.

Duration of the procedure

You will need to stay in hospital for a few days after taking the capsule. You should begin to feel the benefits of the treatment a few weeks later.

Your nuclear medicine doctor will inform you of the usual duration of the procedure.

After administration of Capsion

Directly after swallowing the capsule you will have radioactive material inside of you.

You must limit your contact with other people in order to reduce the amount of radiation that they may receive from you. You must avoid close contact with pregnant women or young children for a few days, depending on the dose administered. Your nuclear medicine doctor will inform you.

Also your stools, urine or possible vomit are considered radioactive and should not come into contact with other people.

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. These include:

•    Drinking plenty of fluids for at least 1 day after taking Capsion to ensure frequent urination in order to eliminate the product from your body

•    Flush the toilet carefully after use and wash your hands thoroughly as your bodily fluids will be radioactive

•    Having drinks or sweets that contain citric acid e.g. orange, lemon or lime juice to help produce saliva and stop swelling of your saliva glands.

•    Having specific laxatives that stimulate the bowel, if you have less than one bowel movement a day.

•    Regular follow-ups to check thyroid hormone levels and to identify possible late

complications.

Should you have any further question on the use of Capsion, please ask the nuclear medicine doctor who supervises the procedure.

If you have been given more Capsion than you should

An overdose is unlikely since Capsion is administered by a nuclear medicine doctor under strictly controlled conditions.

However, in the case of an overdose, you will receive the appropriate treatment. Radiation exposure can be reduced by inducing vomiting or the administration of a thyroid blocking agent and you will be asked to drink plenty of water to increase the elimination of the product from your body.

Should you have any further questions on the use of Capsion, please ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

Very common (may affect more than 1 in 10 patients)

•    Underactivity of the thyroid gland (6-12 weeks after treatment). If you feel very tired, or feel the cold, or gain weight, tell your doctor as this can be treated.

•    Inflammation of the thyroid gland

•    Ocular dryness or blocked tear ducts. The part of the eye that makes tears may not work properly. Normally these side effects are short lasting, but they may last longer in some patients.

•    Partial loss of taste, dry mouth, and some pain in the mouth due to inflammation of the saliva glands. This can be counteracted with anti inflammatory treatment and the problem reduced by sucking citrus fruit sweets and drinking plenty of water.

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Gastrointestinal disorders (diarrhoea)

Common (may affect up to 1 in 10 patients)

•    Temporary increase in the number of white cells in the blood

•    Overactivity of the thyroid gland and eye pain

Uncommon (may affect up to 1 in 100 patients)

•    Underactivity of the parathyroid gland. This causes a fall in the levels of calcium in the blood and muscle spasms.

•    Eye disorders

Not known (frequency cannot be estimated from the available data)

•    Allergic type reactions (e.g. itchy skin, rashes, sneezing)

•    Tooth loss

•    Reduction in the number of red blood cells and platelets in the blood. This may be fatal.

•    Local cerebral oedema

•    With higher doses, an increased risk of developing leukaemia (cancer of white blood cells) has been reported. There may also be a small increase in your risk of developing bladder, stomach and breast cancers.

•    Acute worsening of the overactivity of the thyroid

•    Pneumonia, respiratory distress, lung tissue scarring, respiratory distress, shortness of breath

•    Swelling of your windpipe (trachea), which may cause difficulty breathing

•    Effect on reproductive capacity in men, low sperm count

•    Effect on reproductive capacity in women, irregular menstruation, diminished fertility

•    Congenital underactivity of thyroid

•    Fatigue

•    Localised swelling

•    Local pain and discomfort

P3909pG

04/2016

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