Oral Sodium Iodide 131 I Solution
Package leaflet: Information for the patient
Sodium iodide (,3,l) CIS bio international 1110 MBq/mL oral solution
Sodium iodide (131l)
Reference: I-131-S-1
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 Sodium iodide (,31l) CIS bio international is and what it is used for
2. What you need to know before Sodium iodide (13,l) CIS bio international is used
3. How Sodium iodide (131l) CIS bio international is used
4. Possible side effects
5. How Sodium iodide(13,l) CIS bio international is stored
6. Contents of the pack and other information
CIS Dio international, Member of IBA Molecular group of companies
1. What Sodium iodide (131l) CIS bio international is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic and therapeutic use.
When taken by mouth, the radioactive element (iodine-131) in the solution is rapidly absorbed from the stomach, into the blood stream and is taken up by the thyroid gland. Because of the radioactivity, it can be detected outside the body using a special camera, and pictures, known as scans. These scans give valuable information about the structure and/or the functioning of your thyroid gland.
Depending of the dose absorbed from iodine-131, it can also destroy the thyroid cells.
Sodium iodide (13,l) CIS bio international can be used for the management of thyroid diseases therapy or to treat thyroid diseases.
In addition to Sodium iodide (131l) CIS bio international, you may also need to have surgery or take other medicines to treat the thyroid disease.
The use of Sodium iodide (,31l) CIS bio international does involve exposure to amounts of radioactivity. Your doctor and the nuclear medicine doctor 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 Sodium iodide (131l) CIS bio international is used
Sodium iodide (131l) CIS bio international must not be used:
• If you are allergic to sodium iodide (,3,l) or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or believe you may be pregnant (see section “Pregnancy, breast-feeding and fertility").
• If you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”).
• If your child is the patient and is under 10 years old, she/he should not be given Sodium iodide (131l) CIS bio international if she/he is only having an examination to find out what is wrong with her/his thyroid.
• If you have gastrointestinal disorders like difficulty to swallow, upset stomach or stomach ulcer.
• If you have a reduced abdominal or bowel movement.
If this applies to you, tell your doctor / nuclear medicine doctor.
P45G9pG
12/2014
Warnings and precautions
Take special care with Sodium iodide (,3,l) CIS bio international
• If you have kidney problems, you could have difficulty to eliminate the product from your body. In this case, the dose you should receive may need to be adjusted.
• If you have bladder voiding problems, you may have a urinary catheter implemented after having received a high dose.
• If you have a stomach disease, you could be prescribed medicines to treat ulcer disease and gastritis (H2 antagonists or proton pump inhibitors).
• If you have less than one bowel movement a day, you may have specific laxatives which stimulate the bowel.
• If the protruding eyes are among the symptoms of your illness (Graves' ophthalmopathy). In this case, you will receive a simultaneous treatment to reduce inflammation (corticosteroids).
Please talk to your doctor / nuclear medicine doctor if any of the above applies to
you. Sodium iodide (,3,l) CIS bio international may not be suitable for you. Your doctor /
nuclear medicine doctor will advise you.
Before administration of Sodium iodide (!3,l) CIS bio international:
• If you are planning to have a child, talk to your doctor because you do not have to create or conceive a child during the months following the administration of this medicine (see section “Pregnancy, breast-feeding and fertility”)
• Women must avoid pregnancy by using effective contraception which should be continued for several months after treatment, (see section “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding, the breast-feeding must be discontinued for 6 -8 weeks
before treatment (see section “Pregnancy, breast-feeding and fertility”).
• 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 wether saving your sperm in a sperm bank should be considered.
• If you are taking thyroid hormones (e.g. triiodothyronine or thyroxine), or antithyroid drugs (e.g. carbimazole or propylthiouracil) your doctor will tell you to stop taking it some weeks or days before you receive Oral sodium iodide (131l) solution. Your doctor will also tell you when you can resume your treatment.
- You may be asked to follow a low iodine diet before treatment to increase the uptake in the thyroid gland (See section Oral sodium iodide (,31l) solution with food).
Children and adolescents
Talk to your nuclear medicine doctor if you are under 18 years old.
Other medicines and Sodium iodide (131l) CIS bio international Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may stop Sodium iodide(,31l) CIS bio international from working properly. Your doctor may recommend that you stop the following medicines from one to several weeks before treatment. Particular examples are:
• Medicines reducing thyroid gland function (antithyroid medicines e.g. carbimazole, imidazole, methimazole or propylthiouracil, perchlorate),
• Thyroid hormone preparations (such as thyroxine,triiodothyronine)
• Medicines used to reduce pain, fever or swelling (anti-inflammatory medicines like aspirin, corticosteroids, phenylbutazone),
• Antibacterial and antibiotic medicines (sulphonamides, penicillins),
• Medicines against cough (expectorants) containing iodine,
• Vitamins containing iodine,
• Medicines for mood (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.
Sodium iodide (,3’l) CIS bio international with food
A low iodine diet prior to therapy will enhance uptake into functioning thyroid tissue.
Your doctor will give you full information, but this will involve avoiding certain foods such as shellfish and crustaceans and foods containing the colouring material E127 (Erythrosine).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 Sodium iodide (l3'l) CIS bio international if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
P45Q9pG
12/2014
6. Contents of the pack and other information What Sodium iodide (,3,l) CIS bio international contains
• The active substance is sodium iodide (l3'l) with an activity of 1110 MBq/mL at the reference time set by the manufacturer.
• The other ingredients are sodium carbonate, sodium bicarbonate, sodium thiosulfate, sodium hydroxide, water for injection.
What Sodium iodide (,31l) CIS bio international looks like and contents of the pack
Sodium iodide (131l) is a clear, colourless solution.
Each multidose vial contains 1 to 10 mL of the oral solution.
Marketing Authorisation Holder and Manufacturer
CIS bio international B.P. 32
91192 Gif-sur-Yvette Cedex FRANCE
This leaflet was last revised in December 2014.
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 Sodium iodide (13,l) CIS bio international 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.
Uncommon (may affect less than one out of 100 patients and more than one out of 1,000 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 has occurred.
• Local cerebral oedema, in the treatment of thyroid carcinoma with metastasis - Temporary worsening of your existing thyroid disease
• 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 bladder and breast cancers.
• Higher frequency of stomach cancer
• Inflam m ation of the windpipe
• Pulmonary fibrosis, pneumonia, respiratory distress, dyspnoea
• Reduced fertility in men and women
• Hereditary defects, congenital hypothyroidism
• Local pain and discomfort
• Fatigue
• Localised swelling
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.qov.uk/yellowcard.
By reporting side effects you can help provide information on the safety of this medicine.
5. How Sodium iodide (131l) CIS bio international 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.
If you are pregnant
You must not take Sodium iodide (,31l) CIS bio international it you are pregnant. It
must be established that you are not pregnant before the use of this product.
So, 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. It may be possible to delay treatment until your baby is weaned.
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.
Contraception in males and females
• Women who have taken Sodium iodide (,31l) CIS bio international and who could get pregnant must use reliable contraception (e.g. Pill, implants, caps, condoms or Intrauterine Devices (lUDs)) for a time period of 6 -12 months after treatment.
• In a man, effective contraception must be implemented and maintained until 6 months after administration of the radiopharmaceutical to allow the replacement of irradiated by non-irradiated spermatozoa.
Fertility
Reproduction capacity may be affected transiently in men and women after treatment with Sodium iodide (13,l) CIS bio international.
Driving and using machines
It is considered unlikely that Sodium iodide (13,l) CIS bio international will affect your ability to drive or to operate any tools or machines. But take care, and do not try to drive or operate machines until you are sure you are not affected.
3. How Sodium iodide (13,l) CIS bio international is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. Sodium iodide (,3,l) CIS bio international 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 Sodium iodide (13,l) CIS bio international to be used in your case. It will be the smallest quantity necessary to get the desired information/effect.
Doses required depend on the indication:
• for diagnostic use, the maximum recommended dose for an adult is 400 MBq (megabecquerel, the unit used to express radioactivity).
• for therapeutic use, the dose for an adult ranges from 200 MBq up to a maximum of 3,700 MBq.
The treatment may need to be repeated and doses can be up to 11,100 MBq for repeat doses with some conditions.
Use in children
In children and adolescents, the quantity to be administered will be determined after performing a preliminary testing.
Administration of Sodium iodide (13,l) CIS bio international and conduct of the procedure
Sodium iodide (,3II) is administered orally in a drink through a straw.
Duration of the procedure
In diagnostic indications, images are usually performed between 18 and 24 hours after administration.
In therapeutic indications, you should be asked to stay in hospital during a few days after administration. You should begin to feel the benefits of the treatment a few months later.
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
After administration of Sodium iodide (,3,l) CIS bio international
Because you will receive some radioactive material, you will have to 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 doctor will inform you.
Also your stools, urine or possible vomit are considered radioactive and should be disposed of with care so they will not come into contact with other people.
The nuclear medicine doctor will tell you if you need to take any other special precautions after receiving this medicine. These involve to:
• Drink plenty of fluids for at least 1 day after taking Oral sodium iodide (13,l) solution. This will prevent active substance gathering in the bladder.
• Urinate frequently 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.
• Have drinks or sweets that contain citric acid e.g. orange, lemon or lime juice which will stimulate the saliva flow.
• Use contraception for a time period of 6-12 months for women and of 6 months for men.
• Have specific laxatives that stimulate the bowel if you have less than one bowel movement a day.
• Be followed up regularly to check thyroid hormone levels and identify possible late complications.
Contact your nuclear medicine doctor if you have any questions.
If you have been given more Sodium iodide (,31l) CIS bio than you should
An overdose in unlikely, since you will be given Sodium iodide (131l) CIS bio by a doctor under strictly controlled conditions.
However, in the case of an overdose, you will receive the appropriate treatment. Radiation exposure can be reduced by means of administration of emetic substances or 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 question on the use of Sodium iodide (t31l) CIS bio international, 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 patient over 10)
• Underactivity of the thyroid gland (6-12 weeks after treatment). If you become unduly sensitive to cold, feel very tired or gain a lot of weight tell your doctor as this can be treated.
• Inflammation of the thyroid gland
• Ocular dryness or block 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.
• Feeling sick (nausea)
• Vomiting
• Partial loss of taste, dry mouth, and some pain in the mouth due to inflammation of the salivary glands. This can be counteracted with anti inflammatory treatment and the problem reduced by sucking citrus fruit sweets and drinking plenty of water.
• Gastrointestinal disorders
Common (may affect less than one out of 10 patients and more than one out of 100
patients)
• Temporary increase in the number of white cells in the blood
• Graves’ disease
• Eyes pain
P4509pG
f 2/2014
7