Sodium iodide (I131) Curium Pharma Spain 37-7400 MBq capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Sodium Iodide (131I)

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician, who will supervise the procedure.
• If you experience any adverse effects, contact your nuclear medicine physician, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Sodium Iodide (131I) Curium Pharma Spain 37-7400 MBq hard capsule is and what it is used for

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

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

4. Possible adverse effects

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

6. Package contents and additional information

1. What Ioduro (131I) de sodio Curium Pharma Spain 37-7400 MBq hard capsule is and what it is used for

Sodium iodide (131I) is a medicine used in adults, children, and adolescents to treat:

• thyroid cancer and
• overactive thyroid (hyperthyroidism)

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

This medicine is radioactive; however, your doctor and your nuclear medicine physician have determined that the beneficial effect of this medicine on your health condition outweighs the risks associated with radiation exposure.

2. Before using 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).
• if you are pregnant.
• if you are breastfeeding.
• if you have:
  • difficulty swallowing.
  • a blockage in your throat.
  • stomach problems such as inflammation of the stomach (gastritis) or gastro-duodenal ulcer.
  • delayed digestion or intestinal transit.

If any of these situations apply to you, inform your nuclear medicine physician.

Warnings and precautions

Inform your nuclear medicine physician 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 exophthalmos (protruding eyes) among the symptoms of your disease (ophthalmopathy associated with Graves' disease).

Consult your nuclear medicine physician if you are in any of the above situations. Sodium Iodide (131I) may not be suitable for you. Your doctor will advise you whether special precautions are needed after using this medicine. Speak with your nuclear medicine physician if you have any questions.

In elderly patients 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 excretion of water and sodium in the urine (diuretics, such as hydrochlorothiazide). If you belong to any of these groups, your doctor may perform periodic blood tests to monitor the levels of electrolytes (e.g., sodium) in your blood.

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

• 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)
• remain fasting on the day of treatment

Children and adolescents

Inform the nuclear medicine physician if your child is under 18 years of age or unable to swallow a capsule.

Other medicines and Sodium Iodide (131I)

Inform your nuclear medicine physician if you are currently taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

Your doctor may recommend that you stop taking the following medications before treatment:

• medications used to reduce thyroid gland function, such as carbimazole, methimazole, propylthiouracil, or perchlorate: 1 week before
• salicylates: medications used to reduce pain, fever, or inflammation such as aspirin: 1 week before
• cortisone: anti-inflammatory medications or those used to prevent transplant rejection: 1 week before
• sodium nitroprusside: medication used to lower high blood pressure, also used during surgery: 1 week before
• sodium sulfobromophthalein: medication used to assess liver function: 1 week before
• Other medications: 1 week before
  • anticoagulants, to reduce blood clotting
  • antiparasitics, to treat parasitic infestations
  • antihistamines: used to treat allergies
  • penicillins and sulfonamides: antibiotics
  • tolbutamide: medication used to reduce blood sugar levels
• thiopental: anesthetic used to reduce intracranial pressure during surgery or to treat severe epileptic seizures: 1 week before
• phenylbutazone: medication for pain and inflammation: 1–2 weeks before
• iodine-containing bronchial secretion fluidifiers: 2 weeks before
• iodinated antiseptic products used only on a limited area of the body: 1 to 9 months before
• iodinated contrast media: up to 1 year before
• vitamin preparations containing iodine: 2 weeks before
• medications containing thyroid hormones, such as levothyroxine (4 weeks before) or triiodothyronine (2 weeks before)
• benzodiazepines: medications that calm mood, aid sleep, and relax muscles: 4 weeks before
• lithium: a medication used to treat bipolar disorder: 4 weeks before
• amiodarone: a medication used to treat heart rhythm disorders: 3 to 6 months before

Use of 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 breastfeeding

This medicine must not be used during pregnancy. Therefore, you must inform your nuclear medicine physician before taking Sodium Iodide (131I) if there is any possibility you are pregnant, if you have missed a menstrual period, think you might be pregnant, or plan to become pregnant.

If you are pregnant

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

Contraception in men and women

Women must avoid pregnancy for at least 6 months following administration of Sodium Iodide (131I). It is recommended that women 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 replacement of irradiated spermatozoa with non-irradiated ones.

Fertility

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

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

If you are breastfeeding:

Inform your doctor if you are breastfeeding, as you must stop breastfeeding 8 weeks before treatment. Breastfeeding must not be resumed after treatment with Sodium Iodide (131I).

Driving and use of machines

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

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 corresponds to 3% of the maximum daily sodium intake recommended 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Sodium iodide (131I) will only be used in specially controlled areas. This medicine will only be handled and administered by properly trained and qualified personnel who are competent in its safe use. These individuals will take special safety measures for the safe use of this medicine and will provide you with appropriate information about it.

The nuclear medicine physician supervising the procedure will determine the amount of sodium iodide (131I) you should receive. This will be the minimum quantity necessary to achieve the desired effect.

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

The generally recommended doses for adults are:

• 200–800 MBq for the treatment of overactivity of the thyroid gland
• 1,850–3,700 MBq for partial or complete removal of the thyroid gland and for treatment of cancer cell spread, known as metastases
• 3,700–11,100 MBq for follow-up treatment of metastases.

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

Use in children and adolescents under 18 years of age

Lower doses are used for children and adolescents.

How sodium iodide (131I) is administered and the procedure to follow

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 to ensure it reaches your stomach as quickly as possible.

Young children should take the capsule mixed with purées.

Drink as much fluid as possible after taking the capsule and on the day following treatment. This will help eliminate the active substance from your bladder.

Duration of the procedure

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

After administration of sodium iodide (131I)

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

• avoid close contact with young children and pregnant women for a few days. Your nuclear medicine physician will advise you on the duration.
• drink plenty of fluids and urinate frequently to eliminate the medicine from your body.
• flush the toilet carefully after use and wash your hands thoroughly, as your bodily fluids will be radioactive for a few days.
• consume drinks or candies containing citric acid, such as orange, lemon, or lime juice, to help stimulate saliva production and prevent accumulation of saliva in your salivary glands.
• take laxatives to stimulate your bowel if you have fewer than one bowel movement per day.

Your blood, faeces, urine, or any possible vomit may be radioactive for a few days, and you should avoid contact with other people.

Consult your nuclear medicine physician if you have any questions.

If you receive more sodium iodide (131I) than you should

It is highly unlikely that an overdose will occur, as you will receive only a single dose of sodium iodide (131I) under strict supervision by the nuclear medicine physician overseeing the procedure.

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

If you have any further questions about the use of this sodium iodide (131I), ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like other medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent adverse reactions are: hypothyroidism (underactive thyroid gland), transient hyperthyroidism (overactive thyroid gland), disorders of the salivary and lacrimal glands, and effects of local radiation. In cancer treatment, gastrointestinal and intestinal side effects and reduced blood cell production in the bone marrow may also occur frequently.

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

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

Treatment of hyperactive thyroid gland

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

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

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

• transient overactivity of the 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 causing difficulty breathing or dizziness
• severe hyperthyroid crisis
• inflammation of the thyroid gland
• reduced function of the lacrimal glands characterized by dry eyes
• reduced or loss of parathyroid hormone production with tingling in the hands, fingers, and around the mouth progressing to more severe forms of muscle cramps
• deficiency of thyroid hormone in offspring
• abnormal liver function
• iodo 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 in red blood cells, which may cause weakness, bruising, or increased likelihood of infections
• lack of red blood cells
• bone marrow failure with reduction in red blood cells, white blood cells, or both
• altered or loss of sense of smell or taste
• nausea (feeling of discomfort)
• decreased appetite
• ovarian dysfunction
• menstrual cycle disturbances
• flu-like illness
• headache, neck pain
• extreme fatigue or drowsiness
• inflammation causing redness, tearing, and itching of the eyes
• inflammation of the salivary glands with symptoms such as dry mouth, nose, and eyes; dental caries, tooth loss

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

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

Uncommon (may affect up to 1 in 100 people):

• abnormal and cancerous increase in white blood cells

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

• severe or transient overactivity of the thyroid

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

• severe allergic reaction causing difficulty breathing or dizziness
• cancer, including of the bladder, colon, stomach, and breast
• permanent or severe reduction in blood cell production in the bone marrow
• inflammation of the thyroid gland
• reduced or loss of parathyroid hormone production
• increased production of parathyroid hormones
• underactive thyroid
• inflammation of the trachea or narrowing of the throat or both
• proliferation of connective tissue in the lungs
• difficult or wheezing breathing
• lung inflammation
• vocal cord paralysis, hoarseness, reduced ability to produce voice sounds
• mouth and throat pain
• accumulation of fluid in the brain
• inflammation of the stomach lining
• difficulty swallowing
• inflammation of the bladder
• reduced male fertility, low sperm count, or absence of sperm
• deficiency of thyroid hormone in offspring
• abnormal liver function

Reporting of adverse effects:

If you experience any type of adverse effect, consult your nuclear medicine physician, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

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

The following information is intended solely for the specialist.

Do not use Sodium Iodide (131I) after the expiry date stated on the label following "EXP".

Do not store above 25 °C.

6. Contents of the container and other information

Composition of Sodium Iodide (131I)

• The active substance 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 hydrogen carbonate, sodium hydroxide, sucrose, sodium chloride, and water for injections.

Appearance of the medicinal product and contents of the container

Sodium Iodide (131I) is a transparent capsule containing a white to slightly brownish powder, supplied in containers 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
The Netherlands

This summary of product characteristics was approved in November 2021.

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

This information is intended only for doctors or healthcare professionals:

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

Please consult the package leaflet for Sodium Iodide (131I).