SODIUM IODIDE (I131) CURIUM PHARMA SPAIN 37-7400 MBq CAPSULES

2. Before you use Sodium Iodide (131I) Curium Pharma Spain 37-7400 MBq hard capsule

Do not use Sodium Iodide (131I) if

• you are allergic to sodium iodide or any of the other components of this medicine (listed in section 6).
• you are pregnant.
• you are breast-feeding.
• you have:
• • difficulty swallowing.
  • a blockage in your throat.
  • stomach problems such as stomach inflammation (gastritis) and gastro-duodenal ulcer.
  • slow digestion or intestinal transit.

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

Warnings and precautions

Tell your nuclear medicine doctor in the following cases:

• if you have kidney function disorders.
• if you have problems emptying your bladder.
• if you have digestive or stomach problems.
• if you have exophthalmia (bulging eyes) among the symptoms of the disease you are suffering from (Graves' disease-induced orbitopathy).

Consult your nuclear medicine doctor if you are in any of the above situations. It is possible that Sodium Iodide (131I) may not be 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 elderly patients who have had their thyroid removed, low sodium levels in the blood have been observed. This phenomenon is more likely to occur in women and patients taking medications that increase the amount of water and sodium excreted in the urine (diuretics, such as hydrochlorothiazide). If you are in one of these groups, your doctor may perform periodic blood tests to check the amount of electrolytes (such as sodium) in your blood.

Before administration of Sodium Iodide (131I)you should:

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

Children and adolescents

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

Other medicines and Sodium Iodide (131I)

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

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

It is possible that your doctor may recommend stopping the use of the following medicines before treatment:

• medicines used to decrease thyroid functionsuch as carbimazole, methimazole, propylthiouracil, or perchlorate: 1 week before.
• salicylates: pain, fever, or inflammation-reducing medicines 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 lower high blood pressure, also used during surgery: 1 week before
• sodium sulfobromophthalein: a medicine used to evaluate liver function: 1 week before
• Other medicines: 1 week before
• • anticoagulants, to reduce blood clotting
  • antiparasitics, to treat parasitic infestations
  • antihistamines: used to treat allergies
  • penicillins and sulfonamides: antibiotics
  • tolutamide: a medicine used to reduce blood sugar levels
• thiopental: an anesthetic used to reduce cerebral pressure during surgery or used to treat severe epileptic convulsions: 1 week before
• phenylbutazone: a pain and inflammation-reducing medicine: 1 to 2 weeks before
• bronchial secretion fluidifierscontaining iodine: 2 weeks
• iodized antiseptic productsused only in a restricted area of the body: 1 to 9 months before
• iodinated contrast media: up to 1 year before
• vitamin preparationscontaining iodine: 2 weeks before
• medicines containing thyroid hormones, such as levothyroxine (4 weeks before) or triiodothyronine (2 weeks before)
• benzodiazepines: medicines that calm the mood, help with sleep, 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

Using Sodium Iodide (131I) with food

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

Pregnancy and breast-feeding

This medicine must not be used during pregnancy. Therefore, tell your nuclear medicine doctor before taking Sodium Iodide (131I)if you might be pregnant, if you have a delayed menstrual period, think you might be pregnant, or plan to become pregnant.

If you are pregnant

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

Contraception in men and women

Women should avoid becoming pregnant for at least 6 months after administration of Sodium Iodide (131I). Women are advised to use contraceptive methods for a period of 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) to allow for the replacement of irradiated sperm with non-irradiated sperm.

Fertility

Treatment with Sodium Iodide (131I) may temporarily reduce fertility in men and women.

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

If you are breast-feeding:

Tell your doctor if you are breast-feeding, as you should stop breast-feeding 8 weeks before treatment. Breast-feeding should not be resumed after treatment with Sodium Iodide (131I).

Driving and using machines

It is unlikely that Sodium Iodide (131I) will affect your ability to drive or use machines.

Sodium Iodide (131I) contains sodium and sugar

This medicine contains 63.5 mg of sodium (the main component of table/cooking salt) per capsule. This is equivalent to 3% of the maximum recommended daily intake of sodium for an adult. This should be taken into account if you are on 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 them before taking this medicine.

3. How to use Sodium Iodide (131I) Curium Pharma Spain 37-7400 MBq hard capsule

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

The nuclear medicine doctor supervising the procedure will decide the amount of Sodium Iodide (131I) you should take. 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 recommended doses for an adult are:

• 200-800 MBq to treat thyroid hyperactivity
• 1,850-3,700 MBq for partial or complete removal of the thyroid gland and 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 medicine.

Use in children and adolescents under 18 years

Lower doses are used for children and adolescents.

How Sodium Iodide (131I) is administered and what the procedure is

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

Your stomach should be empty when you take the capsule.

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

Young children should take the capsule with pureed food.

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

Duration of the procedure

Your nuclear medicine doctor will tell you the duration of the procedure.

After administration of Sodium Iodide (131I)

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. In particular, you should:

• avoid close contact with small children and pregnant women for a few days. Your nuclear medicine doctor will tell you the duration.
• drink plenty of fluids and urinate frequently to eliminate the medicine 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 sweets that contain 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 intestine if you have less than one bowel movement per day.

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

Consult your nuclear medicine doctor 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 receive only a single dose of Sodium Iodide (131I) under the strict control of the nuclear medicine doctor supervising the procedure.

However, if this happens, your doctor will administer the appropriate treatment.

If you have any further questions on the use of Sodium Iodide (131I), ask your nuclear medicine doctor supervising the procedure.

4. Possible Adverse Effects

Like other medications, this medication may produce adverse effects, although not all people suffer from them.

Frequent adverse reactions are: hypothyroidism (underactive thyroid gland), temporary hyperthyroidism (overactive thyroid gland), disorders of the salivary and lacrimal glands, and local radiation effects. In cancer treatment, frequent adverse effects on the stomach and intestines and a reduction in blood cell production in the bone marrow may also occur.

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

Below, all the adverse effects of Sodium Iodide (131I) are listed, grouped according to the indication for which it is used, as they depend on the doses used for the different treatments.

Treatment of Hyperactive Thyroid Gland

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

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

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

• temporarily hyperactive thyroid
• inflammation of the salivary glands

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

• vocal cord paralysis

Frequency Not Known(frequency cannot be estimated from available data):

• severe allergic reaction that causes difficulty breathing or dizziness
• severe hyperthyroid crisis
• thyroid inflammation
• reduction or loss of lacrimal gland function characterized by dry eyes
• reduction or loss of parathyroid hormone production with tingling in hands, fingers, and around the mouth to more severe forms of muscle cramps
• thyroid hormone deficiency in offspring
• abnormal liver function
• iodine acne (acne-like skin rash)
• local swelling

Cancer Treatment

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

• bone marrow disorder with severe reduction of red blood cells that can cause weakness, bruising, or make infections more likely
• lack of red blood cells
• bone marrow failure 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 failure
• alteration of menstrual cycle
• flu-like illness
• headache, neck pain
• extreme fatigue or drowsiness
• inflammation that causes redness, tearing, and itching in the eyes
• inflammation of the salivary glands with symptoms such as dry mouth, nose, and eyes; tooth decay, tooth loss

Common(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

Uncommon(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 temporarily hyperactive thyroid

Frequency Not Known(frequency cannot be estimated from available data):

• severe allergic reaction that causes difficulty breathing or dizziness
• cancer, including bladder, colon, stomach, and breast 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
• hypothyroidism
• inflammation of the trachea or narrowing of the throat or both
• Connective tissue proliferation in the lungs
• difficult or wheezing breathing
• pulmonary inflammation
• vocal cord paralysis, hoarseness, reduced ability to produce voice sounds
• mouth and throat pain
• fluid accumulation in the brain
• inflammation of the stomach lining
• difficulty swallowing
• bladder inflammation
• reduced male fertility, low sperm count, or loss of sperm
• thyroid hormone deficiency in offspring
• abnormal liver function

Reporting of Adverse Effects:

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

5. Storage of Sodium Iodide (131I) Curium Pharma Spain 37-7400 MBq Hard Capsule

You will not have to store this medication. This medication is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals must comply with national regulations for radioactive materials.

The following information is intended only for specialists.

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

Do not store above 25°C.

6. Package Contents and Additional Information

Composition of Sodium Iodide (131I)

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

Gelatin (in the capsule shell), disodium phosphate dihydrate, sodium thiosulfate, sodium hydrogencarbonate, sodium hydroxide, sucrose, sodium chloride, and water for injectable preparations.

Appearance of the Product and Package Contents

Sodium Iodide (131I) is a transparent capsule with a white to slightly brown powder, presented in packages containing one capsule.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa Nº 29

28100, Alcobendas, Madrid

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

This prospectus was approved in November 2021.

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for doctors or healthcare professionals:

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

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