THERACAP 37 MBq/5550 MBq Hard capsule

Label: Information for the User

THERACAP 37 - 5550 MBq capsules

Sodium Iodide (131I)

Read this label carefully before starting to use the medication.

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

Information in this label:

1. What THERACAP is and what it is used for
2. What you need to know before starting to use THERACAP
3. How to use THERACAP
4. Possible adverse effects
5. Storage of THERACAP
6. Contents of the package and additional information

THERACAP is a medication from the group of radioisotopes used in adults, children, and adolescents to treat:

- thyroid cancer

- 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 specialist have considered that the beneficial effect of this medication on your health status outweighs the risk due to radiation.

Theracap should not be used

• If you are allergic (hypersensitive) to sodium iodide (131I) or to any of the components of this medication (including those listed in section 6).
• If you are or could be pregnant.
• If you are breastfeeding.
• If you have:
• • Difficulty swallowing.
  • Narrowing of the esophagus.
  • Stomach problems or have a slow bowel movement (reduced gastrointestinal motility).

If any of the above applies to you, inform your nuclear medicine doctor.

Warnings and precautions

Inform your nuclear medicine doctor.

• If you have kidney insufficiency.
• If you have problems urinating.
• If you have digestive or stomach problems.
• If you have exophthalmos as a symptom of the disease you have (Graves' disease-induced ophthalmopathy).
• In elderly patients who have had their thyroid gland removed, low sodium levels 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 level of electrolytes (such as sodium) in your blood.

Inform your nuclear medicine doctor if you are in any of these situations.Theracap may not be suitable for you. Your doctor will inform you if you need to take any special precautions after receiving this medication. Talk to your nuclear medicine doctor if you have any questions.

Before Theracap is administered to you, you must

• Follow a low-iodine diet.
• Drink plenty of water before starting the procedure to urinate as frequently as possible in the first hours after receiving Theracap.
• Be fasting on the day of administration.

Children and adolescents

Consult your nuclear medicine doctor if you are under 18 years old or if you are unable to swallow a capsule.

Use of THERACAP with other medications

Inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medication, as some medications may interfere with the treatment's functioning.

It is possible that your doctor will recommend stopping the following medications before treatment with Theracap:

• Medications that reduce thyroid gland functionsuch as carbimazole, methimazole, propylthiouracil, perchlorate, for 1 week.
• Salicylates: pain relievers, fever reducers, or anti-inflammatory medications, such as aspirin, for 1 week.
• Cortisone: medications to reduce inflammation or prevent organ rejection in transplant patients, for 1 week.
• Sodium nitroprusside: a medication to reduce high blood pressure and also used during procedures, for 1 week.
• Sulfobromophthalein sodium:a medication to evaluate liver function, for 1 week.
• Other medications to:reduce blood clotting, treat parasitic infections, treat allergies (antihistamines), antibiotics (penicillins and sulfonamides), reduce blood sugar levels (tolbutamide), anesthetics used in operations to reduce intracranial pressure and to treat severe epilepsy attacks (thiopental), for 1 week.
• Fenilbutazona:a medication to reduce pain and inflammation, for 1-2 weeks.
• Medicationscontaining iodineto help clear respiratory tract mucus,for 2 weeks.
• Medications that containiodineused only in a restricted area of the body, for 1-9 months.
• Contrast mediacontaining iodine, for up to 6 months.
• Vitaminscontaining iodine salts, for 2 weeks.
• Medications that containthyroid hormones,such as levothyroxine (for 4 weeks) or triiodothyronine (for 2 weeks).
• Benzodiazepines:medications that calm the mood and help patients sleep and relax their muscles, for 4 weeks.
• Lithium:a medication to treat bipolar disorders, for 4 weeks.
• Amiodarona: a medication to treat heart rhythm disorders, for 3-6 months.

Use of Theracap with food

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

Pregnancy, lactation, and fertility

This medication should not be administered during pregnancy. Therefore, you must inform your nuclear medicine doctor before administering Theracap if there is any possibility of pregnancy, if you have a delayed period, or if you think you may be pregnant or are planning to become pregnant.

If you are pregnant

Theracap should not be administered to you if you are pregnant. Any possibility of pregnancy should be ruled out before administering this medication.

Contraception in men and women

Women should not become pregnant for at least 6 months after treatment with Theracap. As a precaution, men should not father children for 6 months after treatment with Theracap to allow radiated sperm to be replaced by non-radiated sperm. It is recommended to use contraceptive methods for a period of 6 months.

Fertility

Treatment with Theracap may temporarily reduce fertility in men and women. In men, high doses of sodium iodide (131I) may temporarily affect sperm production. If you wish to have children in the future, you should talk to your doctor about the possibility of using a sperm bank.

If you are breastfeeding

Inform your doctor if you are breastfeeding because you should stop it before starting treatment. After treatment with Theracap, breastfeeding should not be resumed.

Driving and operating machinery

It is unlikely that Theracap will affect your ability to drive or operate machinery.

Theracap contains sodium

This medication contains 50 mg of sodium (main component of table salt/for cooking) in each capsule. This is equivalent to 2.5% of the maximum daily sodium intake recommended for an adult.

There are strict rules for the use, handling, and disposal of radioactive medications. Theracap will only be used in specialized and controlled healthcare centers. This product must be handled and administered by trained and qualified personnel to use it safely. Those people will take special care in the safe use of this product and will inform you of the procedure.

The nuclear physician who supervises the procedure will decide on the amount of Theracap to be used in your case. This will be the minimum amount necessary to achieve the desired effect.

Theracap is administered in an individual capsule by specialists who will take all necessary precautions.

The usual recommended doses for an adult are:

• 200-800 MBq to treat hyperactivity of the thyroid gland.
• 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 metastasis.

MBq (megabecquerel) is the unit of measurement for the amount of radioactivity of the medication.

Use in children and adolescents under 18 years old

In children and adolescents, lower doses are administered.

Administration of Theracap and procedure

Theracap is administered orally in an individual capsule.

Your stomach must be empty when the capsule is administered.

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

Smaller children should take the capsule mixed with puree.

Drink as much water as possible the day after treatment. This will help eliminate the active substance from your bladder.

Duration of the procedure

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

After administration of Theracap:

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

• Avoid direct contact with small children and pregnant women for some days. Your nuclear physician will tell you how long.
• Drink plenty of liquid and urinate frequently to eliminate the medication from your body.
• Flush the toilet carefully and wash your hands thoroughly since your bodily fluids will be radioactive for some days.
• Take beverages or sweets containing citric acid, such as orange, lime, or lemon juice to help you produce saliva and prevent it from accumulating in your salivary glands.
• Take laxatives that stimulate the intestine if you have less than one bowel movement per day.

Your blood, stool, urine, or possible vomit may be radioactive for a few days and should not come into contact with other people.

Consult your nuclear physician if you have any doubts.

If you have been administered more THERACAP than you should

A overdose is unlikely because you will receive a single, controlled dose of Theracap under the supervision of the nuclear physician who oversees the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

If you have any other doubts about the use of Theracap, ask the nuclear physician who oversees the procedure.

Like all medicines, THERACAP can cause side effects, although not everyone will experience them.

Some common 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 of the stomach and intestines and reduced production of blood cells in the bone marrow may appear.

If you have severe allergic reactions that cause difficulty breathing or dizziness, or if you have a severe thyroid hyperactivity crisis, contact your doctor immediately.

All possible side effects that may occur with Theracap are listed below, grouped according to the disease for which Theracap is being administered, as they depend on the doses used for each treatment.

Treatment of an overactive thyroid gland

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

• Underactive thyroid

Common(may affect up to 1 in 10 people)

• A type of eye inflammation called endocrine ophthalmopathy (after Graves' disease treatment)
• Temporary overactive thyroid
• Salivary gland inflammation

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

• Vocal cord paralysis

Frequency unknown(cannot be estimated from available data):

• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe thyroid hyperactivity crisis
• Thyroid inflammation
• Reduced tear gland function, characterized by dry eyes
• Reduced or lost parathyroid hormone production with hand tremors, fingers, and around the mouth, even in more severe muscle cramps.
• Thyroid hormone deficiency in offspring
• Abnormal liver function*

* not reported with Theracap but with other medications containing131I

Cancer treatment

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

• Severe reduction of blood cells that can cause weakness, bruising, or increase the risk of infections
• Anemia
• Bone marrow insufficiency with reduced red or white blood cells or both
• Disorder or loss of sense of smell or taste
• Nausea (discomfort)
• Loss of appetite
• Ovarian insufficiency
• Flu-like illnesses
• Headache, neck pain
• Extreme fatigue or drowsiness
• Eye inflammation that causes red, watery, or itchy eyes
• Salivary gland inflammation with symptoms such as dry mouth, nose, and eyes, tooth decay, or tooth loss

Common(may affect up to 1 in 10 people)

• Abnormal cancerous increase of white blood cells
• Anemia or low platelet count
• Runny nose
• Difficulty breathing
• Vomiting
• Areas of tissue inflammation

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

• Severe or temporary overactive thyroid

Frequency unknown(cannot be estimated from available data)

• Severe allergic reaction that causes difficulty breathing or dizziness
• Cancer, including bladder, colon, and stomach cancer
• Permanent or severe reduction of blood cell production in the bone marrow
• Thyroid inflammation
• Reduced or lost parathyroid hormone production
• Increased parathyroid hormone production
• Underactive thyroid
• Tracheal inflammation or narrowing of the throat or both
• Pulmonary fibrosis
• Difficulty breathing or wheezing
• Pneumonia
• Vocal cord paralysis, hoarseness, reduced ability to produce vocal sounds
• Mouth and throat pain
• Cerebral edema
• Stomach lining inflammation
• Dysphagia
• Urinary tract inflammation
• Menstrual cycle disorder
• Male infertility, low sperm count, or sperm loss
• Thyroid hormone deficiency in offspring
• Abnormal liver function

* not reported with Theracap but with other medications containing131I

If you experience side effects, consult your nuclear doctor even if it's side effects that don't appear in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it's possible side effects that don't appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use atwww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by you. This medication is stored under the responsibility of the specialist in appropriate facilities. Radioactive material storage will be performed in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use Theracap after the expiration date that appears on the label after CAD.

Store below 25°C. Do not freeze.

Composition of THERACAP

• The active principle is sodium iodide (131I). Each capsule contains between 37 and 5,550 MBq of sodium iodide (131I).
• The other components are sodium thiosulfate, anhydrous disodium phosphate, anhydrous colloidal silica, cornstarch, sodium hydroxide, and water for injection.

The capsule is a hard gelatin shell and is yellow in color and contains yellow iron oxide, titanium dioxide, sodium lauryl sulfate, acetic acid, printing ink, and gelatin.

Appearance of the product and contents of the packaging

THERACAP is a capsule presented inside a polycarbonate vial with a carbon disc to absorb the 131I. This vial is placed inside a lead container.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GE Healthcare Bio-Sciences, S.A.U

C/ Gobelas, 35-37

28023 Madrid

Spain

Responsible for manufacturing:

GE Healthcare Buchler GmbH & Co. KG

Gieselweg, 1

D-38110 Braunschweig

Germany

This prospectus was approved in March 2022

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for medical professionals or healthcare professionals:

The complete technical data sheet for THERACAP is included at the end of this prospectus, in order to facilitate medical professionals or healthcare professionals with scientific and practical information on the administration and use of this radiopharmaceutical.