PATIENT INFORMATION LEAFLET

Sodium Iodide (131I) Curium Pharma Spain 37-7400 MBq hard capsule

Sodium Iodide (131I)

6. Contents of the pack and additional information

Sodium Iodide (131I) is a medication used in adults, children, and adolescentsto treat:

• thyroid cancer and
• hyperthyroidism

This medication contains sodium iodide (131I), a radioactive element that accumulates in certain organs such as the thyroid gland.

This medication is radioactive, but your doctor and nuclear medicine physician have considered that the beneficial effect of this medication on your health status outweighs the risk due to radiation.

No use Ioduro (131I) de sodio

• if you are allergic to sodium iodide or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.
• if you are breastfeeding.
• if you have:
• • difficulty swallowing.
  • if you have a blockage in the throat.
  • if you have stomach problemssuch as stomach inflammation (gastritis) and gastric-duodenal ulcer.
  • if you have a slowdown of digestion or intestinal transit.

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

Warnings and precautions

Inform your nuclear medicine doctor in the following cases:

• if you have kidney function disorders.
• if you have problems emptying the bladder.
• if you have digestive or stomach problems.
• if you have exophthalmos (bulging eyes) among the symptoms of the disease you have (Graves' disease-induced ophthalmopathy).

Consult your nuclear medicine doctor if you are in any of the situations mentioned above.It may be that Sodium Iodide (131I) is not suitable for you. Your doctor will inform you if you need to take special precautions after using this medicine. Talk to your nuclear medicine doctor if you have any questions.

In patients of advanced age who have had their thyroid gland removed, low levels of sodium in the blood have been observed. This phenomenon is more likely to occur in women and in patients taking medications that increase the amount of water and sodium excreted in the urine (diuretics, such as hydrochlorothiazide). If you are included in any of these groups, your doctor may perform periodic blood tests to check the amount of electrolytes (such as sodium) in your blood.

Before the administration of Sodium Iodide (131I) of sodium, you must:

• follow a low-sodium diet
• drink plenty of water and urinate as frequently as possible during the first hours after the administration of Sodium Iodide (131I) of sodium
• be fasting on the day of treatment

Children and adolescents

Inform your nuclear medicine doctor if your child is under 18 years old or cannot swallow a capsule.

Other medicines andSodium Iodide (131I) of sodium

Inform your nuclear medicine doctor if you are taking, have taken recently or may need to take any other medicine, even those purchased without a prescription.

Inform your nuclear medicine doctor if you are taking or have taken recently any of the following medicines or products, as they may affect the effectiveness of this treatment.

You may be advised by your doctor to stop taking the following medicines before treatment:

• medicines used to reduce thyroid gland functionsuch as carbimazole, methimazole, propylthiouracil, or perchlorate: 1 week before.
• salicylates: medicines used to reduce pain, fever, or inflammation such as aspirin: 1 week before
• cortisone: anti-inflammatory medicines or used to prevent transplant rejection: 1 week before
• sodium nitroprusside: a medicine used to reduce high blood pressure, also used during surgery: 1 week before
• sulfobromophthalein sodium: a medicine used to evaluate liver function: 1 week before
• Other medicines: 1 week before
• • anticoagulants, to reduce blood clotting
  • antiparasitic medicines, to treat parasitic infestations
  • antihistamines: used to treat allergies
  • penicillins and sulfonamides: antibiotics
  • tolbutamide: a medicine used to reduce blood sugar levels
• thiopental: an anesthetic used to reduce intracranial pressure during surgery or used to treat severe epilepsy: 1 week before
• phenylbutazonea: a pain and anti-inflammatory medicine: 1 to 2 weeks before
• expectorants containing iodinethat are used only in a restricted area of the body: 2 weeks
• iodine-based antisepticsused only in a restricted area of the body: 1 to 9 months before
• iodine-based contrast media: up to 1 year before
• vitamin preparationscontaining iodine: 2 weeks before
• medicines containingthyroid hormones, such as levothyroxine (4 weeks before) or triiodothyronine (2 weeks before)
• benzodiazepines: medicines that calm the mood, help fall asleep, and relax muscles: 4 weeks before
• lithium: a medicine used to treat bipolar disorder: 4 weeks before
• amiodarone: a medicine used to treat heart rhythm disorders: 3 to 6 months before

Use ofSodium Iodide (131I) of sodium with food

Your doctor may recommend that you follow a low-iodine diet before treatment and avoid certain foods such as seafood and crustaceans.

Pregnancy and lactation

This medicine should not be used during pregnancy. Therefore,you must inform your nuclear medicine doctor before taking Sodium Iodide (131I) of sodiumif there is a possibility that you are pregnant, if you have a delayed menstrual period, think you may be pregnant, or plan to become pregnant.

If you are pregnant

Do not takeSodium Iodide (131I) of sodium if you are pregnant. Any possibility of pregnancy must be ruled out before using this medicine.

Birth control in men and women

Women should avoid pregnancy for at least 6 months after administration of Sodium Iodide (131I) of sodium. Women are recommended to use contraceptive methods for 6 months after treatment.

As a precaution, men should avoid fathering a child for a period of 6 months after treatment with Sodium Iodide (131I) of sodium to allow the substitution of irradiated sperm with non-irradiated sperm.

Fertility

The treatment with Sodium Iodide (131I) of sodium may temporarily reduce reproductive capacity in men and women.

In men, high doses of Sodium Iodide (131I) of sodium may temporarily affectsperm production. If you ever want to have a child, talk to your doctor about how to preserve your semen in a sperm bank.

If you are breastfeeding:

Inform your doctor if you are breastfeeding sinceyou must interrupt breastfeeding 8 weeks before treatment. Breastfeeding should not be resumed after treatment with Sodium Iodide (131I) of sodium.

Driving and operating machinery

It is unlikely that Sodium Iodide (131I) of sodium will affect your ability to drive or operate machinery.

Sodium Iodide (131I) of sodium contains sodium and sugar

This medicinecontains 63.5 mg of sodium (main component of table salt/for cooking) per capsule. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult. You should be aware if you follow a low-sodium diet.

This medicine contains sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

There are strict rules for the use, handling, and disposal of radioactive medications. Sodium Iodide (131I) will only be used in controlled special areas. This medication will only be handled and administered by properly trained and qualified individuals to use it safely. These individuals will take special safety measures for the safe use of this medication and will inform you properly about it.

The nuclear physician overseeing the procedure will decide on the amount of Sodium Iodide (131I) that should be taken. It will be the minimum amount necessary to achieve the desired effect.

Sodium Iodide (131I) is administered in a single capsule by specialists who will take the necessary precautions.

The generally recommended doses for an adult are:

• 200-800 MBq to treat hyperactivity of the thyroid gland
• 1,850-3,700 MBqfor partial or complete removal of the thyroid glandand to treat the spread of cancer cells, known as metastasis
• 3,700-11,100 MBq for follow-up treatment of metastases.

MBq (megabecquerel) is the unit used to measure the amount of radioactivity of the medication.

Use in children and adolescents under 18 years old

Lower doses are used for children and adolescents.

How Sodium Iodide (131I) is administered and what to do

You will be given a single capsule of Sodium Iodide (131I).

Your stomach must be empty when you take the capsule.

Take the capsule with plenty of water so that it reaches your stomach as quickly as possible.

Small children should take the capsule with purees.

Drink as much water as possible after taking the capsule and the day after the treatment. This will eliminate the active ingredient from your bladder.

Duration of the procedure

Your nuclear physician will inform you of the duration of the procedure.

After administration of Sodium Iodide (131I)

The nuclear physician will inform you if you need to take any special precautions after receiving this medication. In particular, you should:

• avoid close contact with small children and pregnant women for a few days. Your nuclear physician will inform you of the duration.
• drink plenty of liquids and urinate frequently to eliminate the medication from your body.
• flush the toilet carefully after using it and wash your hands thoroughly, as your bodily fluids will be radioactive for a few days.
• take drinks or candies containing citric acid, such as orange, lemon, or lime juice, to help produce saliva and prevent saliva from accumulating in your salivary glands.
• take laxatives to stimulate your intestines, in case you have less than one bowel movement per day.

Your blood, feces, urine, or possible vomiting may be radioactive for a few days and you should not be in contact with other people.

Consult your nuclear physician if you have any questions.

If you receive more Sodium Iodide (131I) than you should

It is very unlikely that an overdose will occur, as you will only receive a single dose of Sodium Iodide (131I) under the strict control of the nuclear physician overseeing the procedure.

However, if this were to happen, your physician will administer the necessary treatment.

If you have any other doubts about the use of this Sodium Iodide (131I), ask the nuclear physician overseeing the procedure.

Like other medications, this medication may cause side effects, although not everyone will experience them.

Frequent side effects are: hypothyroidism (underactive thyroid gland), temporary hyperthyroidism (overactive thyroid gland), salivary and lacrimal gland disorders, and local radiation effects. In cancer treatment, frequent side effects may also include gastrointestinal and intestinal problems, and a reduction in bone marrow blood cell production.

If you have a severe allergic reaction, which causes difficulty breathing or dizziness, or if you have a severe hyperthyroid crisis, contact your doctor immediately.

The following are all the side effects of Sodium Iodide (131I), grouped by indication, as they depend on the doses used for different treatments.

Treatment of an overactive thyroid gland

Very frequent(may affect more than 1 in 10 people):

• underactive thyroid
• a type of eye inflammation, called endocrine ophthalmopathy (after treatment for Graves' disease)

Frequent(may affect up to 1 in 10 people):

• temporarily overactive thyroid
• salivary gland inflammation

Very rare(may affect up to 1 in 10,000 people):

• voice cord paralysis

Frequency not known(the frequency cannot be estimated from the available data):

• severe allergic reaction causing difficulty breathing or dizziness
• severe hyperthyroid crisis
• thyroid inflammation
• characteristic lacrimal gland dysfunction with dry eyes
• reduction or loss of parathyroid hormone production with tingling in the hands, fingers, and around the mouth to more severe muscle cramps
• deficiency of thyroid hormone in offspring
• abnormal liver function
• iodine acne (acne as skin eruption)
• local swelling

Treatment of cancers

Very frequent(may affect more than 1 in 10 people):

• bone marrow disorder with severe reduction of red blood cells that may cause weakness, bruises, or make infections more likely
• lack of red blood cells
• bone marrow insufficiency with reduction of red blood cells, white blood cells, or both
• alteration or loss of sense of smell or taste
• nausea (feeling of discomfort)
• decreased appetite
• ovarian dysfunction
• menstrual cycle alteration
• illness similar to the flu
• headache, neck pain
• extreme fatigue or drowsiness
• inflammation causing redness, tearing, and itching in the eyes
• salivary gland inflammation with symptoms such as dry mouth, nose, and eyes; tooth decay, tooth loss

Frequent(may affect up to 1 in 10 people):

• lack of white blood cells or platelets
• nasal secretion
• difficulty breathing
• vomiting
• areas of inflammation in tissues.

Possibly frequent (may affect up to 1 in 100 people):

• abnormal and cancerous increase of white blood cells

Rare(may affect up to 1 in 1,000 people):

• severe or temporary overactive thyroid

Frequency not known(the frequency cannot be estimated from the available data):

• severe allergic reaction causing difficulty breathing or dizziness
• cancer, including bladder, colon, stomach, and lung cancer
• permanent or severe reduction of blood cell production in the bone marrow
• thyroid inflammation
• reduction or loss of parathyroid hormone production
• increase in parathyroid hormone production
• underactive thyroid
• tracheal or laryngeal inflammation or both
• Proliferation of connective tissue in the lungs
• difficult or wheezing breathing
• lung inflammation
• voice cord paralysis, hoarseness, reduction of voice production ability
• mouth and throat pain
• fluid accumulation in the brain.
• inflammation of the stomach lining
• difficulty swallowing
• bladder inflammation
• male infertility, low sperm count, or sperm loss
• thyroid hormone deficiency in offspring
• abnormal liver function

Reporting of side effects:

If you experience any type of side effect, consult your nuclear doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

You will not need to conserve this medication. This medication is conserved under the responsibility of the specialist in suitable facilities. Radioactive material storage must comply with national regulations.

The following information is intended solely for the specialist.

Sodium Iodide (131I) should not be used after the expiration date appearing on the label after "EXP".

Do not store above 25 °C.

Composition of Sodium Iodide (131I)

• The active principle is sodium iodide (131I). Each capsule contains between 37 and 7400 MBq.
• The other components are:

Gelatin (in the capsule coating), disodium phosphate dihydrate, sodium thiosulfate, sodium hydrogen carbonate, sodium hydroxide, sucrose, sodium chloride, and water for injection preparations.

Appearance of the product and contents of the packaging

Sodium Iodide (131I) is a transparent capsule with a powder that is white or slightly brown in color, presentedin packaging that contains a capsule.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa Nº 29

28100, Alcobendas, Madrid

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

This leaflet was approved in November 2021.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for doctors or healthcare professionals:

The complete technical data sheet ofSodium Iodide (131I) Curium Pharma Spain 37-7400 MBqhard capsule is included at the end of this leaflet, in order to facilitate doctors or healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical data sheet of Sodium Iodide (131I).