Iodek sodu, Na 131 I Polatom do terapii

PATIENT INFORMATION LEAFLET: USER INFORMATION

SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY, HARD CAPSULES,

activity from 37 to 5500 MBq
Sodium Iodide (I-131) capsules for therapeutic use

You should read the contents of the leaflet before using the medicine.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your nuclear medicine specialist doctor.
• If you experience any side effects, including any not listed in this leaflet, you should tell your nuclear medicine specialist doctor.

Table of contents of the leaflet:

What Sodium Iodide Na I POLATOM capsules for therapy are and what they are used for
Important information before using Sodium Iodide Na I POLATOM capsules for therapy
How to use Sodium Iodide Na I POLATOM capsules for therapy

• 4. Possible side effects How to store Sodium Iodide Na I POLATOM capsules for therapy
• 6. Package contents and other information

WHAT SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY ARE AND WHAT THEY ARE USED FOR

WHAT THEY ARE USED FOR

Sodium Iodide Na I POLATOM capsules for therapy are a medicinal product (radio-pharmaceutical) intended exclusively for therapy. The capsules contain a varying amount (activity) of radioactive sodium iodide, administered orally, and are used to treat thyroid diseases.
Sodium Iodide Na I is used to treat benign thyroid diseases: nodular goiter without thyroid dysfunction, hyperthyroidism in the course of Graves' and Basedow's disease, single nodule and multinodular goiter. It is also used to treat differentiated thyroid cancer: after surgical treatment to destroy remaining thyroid tissue, to destroy remaining cancer foci, and to treat iodine-uptake metastases of thyroid cancer.
Due to the content of the radioactive isotope iodine-131, the use of this medicine is associated with exposure to ionizing radiation. Your doctor has determined that the benefits of the therapy outweigh the potential risks associated with ionizing radiation.

IMPORTANT INFORMATION BEFORE USING SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY

WHEN NOT TO USE SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY

The medicine must not be used:

• in pregnant or suspected pregnant women (or when pregnancy has not been ruled out),
• in breastfeeding women,
• if the patient is hypersensitive to the active substance or any of the other ingredients of the medicine.

WARNINGS AND PRECAUTIONS

Great caution should be exercised when using Sodium Iodide Na I POLATOM capsules for therapy in the treatment of patients:

• with uncontrolled hyperthyroidism, with swallowing disorders or gastrointestinal diseases causing regurgitation or vomiting (due to the risk of improper absorption of the medicine and radioactive contamination, consideration should be given to administering iodine-131 in a different pharmaceutical form or by a different route than oral). Due to the risk of radioactive contamination, caution should be exercised when treating patients with radioactive iodine who:
• may not follow medical staff's instructions,
• have urinary incontinence.

Some patients receiving therapeutic activities of iodine-131 isotope may need to be hospitalized due to the need to comply with radiological protection regulations.
Administering medicines containing radioactive isotopes poses a risk of exposure to external ionizing radiation or contamination caused by urine stains, vomit, etc. For this reason, basic hygiene rules should be observed.
In order to reduce the radiation dose absorbed by the bladder, it is recommended to drink a slightly larger amount of fluids than usual (about 1-1.5 liters per day more) and to urinate more frequently after taking the medicine.
A low sodium concentration in the blood has been observed in elderly patients after thyroid removal surgery. The occurrence of this phenomenon is most likely in women and in patients taking diuretics that increase water and sodium excretion in the urine (such as hydrochlorothiazide). If the patient belongs to one of the above-mentioned groups, the doctor may recommend regular blood tests to determine the electrolyte concentration (e.g. sodium) in the blood.

BEFORE ADMINISTERING SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY, YOUR DOCTOR MAY RECOMMEND:

• a low-iodine diet (especially limiting the consumption of seafood products), avoiding medicines containing iodine (e.g. vitamins with iodine, some disinfectants, some eye drops, some expectorants, amiodarone preparations, some contrast agents used in radiological examinations),
• in the case of thyroid cancer treatment, temporary withdrawal of thyroid hormones to increase iodine uptake by the tumor tissue,
• in the case of hyperthyroidism treatment, withdrawal of anti-thyroid medicines, e.g. containing thiamazole or propylthiouracil.

SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY AND OTHER MEDICINES

You should tell your nuclear medicine specialist doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines you plan to take.
Many substances interact with iodides in various ways. They affect the binding of iodides to proteins, their behavior in the body, or modify the effects of radioactive iodine. This means that the doctor needs to be aware of all the medicines taken by the patient and decide whether to discontinue some of them before administering Sodium Iodide Na I.

SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY WITH FOOD AND DRINK

Before treatment with Sodium Iodide Na I, a low-iodine diet should be followed, which increases its uptake by the thyroid tissue. It is recommended that the patient fast for about 2 hours before and after swallowing the capsule containing Sodium Iodide Na I to ensure good absorption of the medicine.

PREGNANCY AND BREASTFEEDING

Sodium Iodide Na I POLATOM capsules for therapy must not be used in pregnant or breastfeeding women.
Before taking the medicine, you should inform your nuclear medicine specialist doctor if:

• you suspect you are pregnant,
• you have not had your menstrual period at the expected time,
• you are breastfeeding. In case of doubts, consultation with a nuclear medicine specialist doctor who will be treating you is necessary. If you are pregnant, it is essential to inform your doctor.

In the case of both sexes, it is recommended to use contraception for at least 4 months after treatment with Sodium Iodide Na I.
In the case of necessity to use Sodium Iodide Na I in a breastfeeding woman, breastfeeding should be discontinued.

DRIVING AND USING MACHINES

No data available

SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY CONTAIN SODIUM

The product contains from 80 to 96 mg of sodium in one capsule. This should be taken into account in patients on a low-sodium diet.

HOW TO USE SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY

There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical products. Sodium Iodide Na I POLATOM capsules for therapy are administered only in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure safe use of the product and will keep you informed about their actions.
Sodium Iodide Na I POLATOM capsules for therapy are an oral medicine with varying radioactive activity.
The therapeutic activity (dose) is determined by your nuclear medicine specialist doctor. This activity should be determined individually for each patient. It will be the minimum dose necessary to achieve the expected therapeutic effect.
Depending on the type of disease, the recommended radioactive activity of the capsules ranges from:

• Treatment of hyperthyroidism and indifferent goiter: 200-800 MBq
• Destruction of thyroid tissue after surgery for thyroid cancer: 1850-3700 MBq
• Treatment of thyroid cancer metastases: 3700-11,100 MBq (MBq = megabecquerel - unit of radioactivity measurement)

USE IN CHILDREN

The use of Sodium Iodide Na I POLATOM capsules for therapy in children must be carefully analyzed by a nuclear medicine specialist doctor, taking into account clinical indications and the assessment of the risk-benefit ratio in this patient group. The therapeutic dose is calculated in a similar way to that used in adults, but it may be considered to be reduced depending on the age and weight of the child.

AFTER ADMINISTERING SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY, YOU SHOULD:

• urinate frequently to remove the radiopharmaceutical from the body,
• in the case of both sexes, use contraception for at least 4 months after treatment.

Administering medicines containing radioactive isotopes poses a risk of exposure to external ionizing radiation or contamination caused by the isotope contained in urine stains, vomit, sweat, etc. In connection with this, after administering Sodium Iodide Na I, you should:

• avoid close contact with other people, especially small children and pregnant women, for a period of time recommended by your doctor,
• carefully dispose of urine, stool, and sweat for a period of time recommended by your doctor.

OVERDOSE

Overdose is almost impossible, as the dose of the product administered to the patient is strictly controlled by the nuclear medicine specialist doctor.
The medicine is supplied in capsules with known activity, which makes it easier for the doctor to control the dose to be administered to the patient.
In case of overdose, the doctor may administer medicines that block the uptake of iodine-131 by the thyroid gland or induce vomiting and recommend drinking more fluids and urinating frequently to remove the radiopharmaceutical from the body.
In case of any further doubts related to the use of the medicine, you should consult your nuclear medicine specialist doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Iodide Na I POLATOM capsules for therapy can cause side effects, although not everybody gets them.

EARLY SIDE EFFECTS

Early side effects that occur very frequently (in more than 1 in 10 patients) in the first hours or days after taking the medicine (especially in high doses) include: radiation-induced thyroiditis (manifested by discomfort, rarely severe pain in the neck; swelling in the neck), radiation-induced sialadenitis (manifested by swelling, discomfort, rarely severe pain in the salivary gland area), dry mouth, nausea, vomiting, tracheal stenosis.
In patients treated for thyroid cancer metastases to the lungs (usually multiple, high activities of iodine-131), radiation-induced pneumonitis or fibrosis may occur.
It is necessary to consider the possibility of local brain edema and/or exacerbation of existing brain edema in patients with thyroid cancer metastases to the central nervous system.

LATE SIDE EFFECTS

A very common (occurring in more than 1 in 10 patients) late side effect of Sodium Iodide Na I therapy for benign thyroid diseases is hypothyroidism, which requires compensation with thyroid hormones.
All the following side effects occur with an unknown frequency, which cannot be estimated from the available data.
In some patients, after administration of radioactive iodine, there is an increase in thyroid hormone levels in the blood (usually 7-10 days after treatment). In patients with poorly controlled thyroid function, this may lead to the occurrence of hyperthyroidism symptoms (similar to those at the beginning of thyroid disease), and in extreme cases, it may lead to a life-threatening thyroid crisis. In a small percentage of patients with nodular goiter, administration of iodine-131 may cause symptoms of Graves' and Basedow's disease.
A late side effect is also the occurrence of reversible or, in very rare cases (in patients treated with high doses of iodine-131), irreversible impairment of bone marrow function.
This may manifest as a decrease in the number of platelets or white blood cells, and rarely red blood cells.
A rare consequence of treatment with iodine-131 in patients with Graves' and Basedow's disease (especially in smokers) may be the exacerbation or occurrence of exophthalmos (thyroid ophthalmopathy). Similarly, in patients treated with iodine-131 for thyroid nodules, thyroiditis of immunological origin may occur, which is usually transient but may manifest as hyperthyroidism requiring treatment.
Treatment of thyroid cancer with Sodium Iodide Na I may cause transient (or exceptionally permanent) impairment of fertility in women and men.
As a result of administering Sodium Iodide Na I, permanent damage to the salivary glands may occur, with dry mouth, taste disorders, and smell disorders (more frequent after repeated administration of iodine-131), and rarely permanent impairment of tear secretion (dry eye syndrome) or their outflow from the eye (due to narrowing of the tear ducts).
In a small number of patients after treatment with iodine-131, disorders of parathyroid function have occurred - their hyperfunction or hypofunction.
Exposure to ionizing radiation may lead to an increased incidence of tumors (in the case of using high activities of radioactive isotopes) or may lead to the occurrence of genetic defects. Epidemiological data indicate an increased incidence of stomach, bladder, breast, and leukemia tumors in patients treated with Sodium Iodide Na I.

REPORTING SIDE EFFECTS

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or nuclear medicine specialist doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides
Jerusalem Avenue 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

HOW TO STORE SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY

The patient will not need to store this medicinal product.
Radiopharmaceutical products are stored only by authorized personnel in appropriate conditions. The storage of radiopharmaceuticals is carried out in accordance with the regulations for the storage of radioactive substances.
The following information is intended only for medical personnel.
Do not use the product after the expiry date stated on the packaging.

6. PACKAGE CONTENTS AND OTHER INFORMATION

WHAT SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY CONTAIN

The active substance of the medicine is Sodium Iodide I with an activity of 37 MBq to 5500 MBq

• Other ingredients are: Sodium carbonate, Sodium bicarbonate, Disodium phosphate dihydrate, Sodium thiosulfate pentahydrate, Hard gelatin capsule

WHAT SODIUM IODIDE Na I POLATOM CAPSULES FOR THERAPY LOOK LIKE AND WHAT THE PACKAGE CONTAINS

The product is supplied in the form of a capsule in a vial.
The vial is made of polyethylene and is closed with a polyethylene plug equipped with an iodine absorber and placed in a lead shielding container. The package contains one capsule.
A polypropylene applicator (type A) for administering the capsule and a radiopharmaceutical certificate are attached to each package.

MARKETING AUTHORIZATION HOLDER AND MANUFACTURER

National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel.: 22 7180700
Fax: 22 7180350
e-mail: polatom@polatom.pl
To obtain more detailed information, you should contact your doctor or the marketing authorization holder's representative.

DATE OF LAST UPDATE OF THE LEAFLET: 08.02.2018

INFORMATION INTENDED ONLY FOR MEDICAL PROFESSIONALS.

Procedure for administering the capsule using the type A applicator:

• 1. Check the radioactivity and calibration date on the outer packaging.
• 2. Remove the metal can from the cardboard box and tear off its top cover.
• 3. Remove the top part of the styrofoam insert.
• 4. Remove the shielding container with the capsule.
• 5. Tear off the paper-foil packaging of the applicator and then remove the applicator.
• 6. Open the shielding container with the capsule. To do this, unscrew the container cap, holding its bottom part. The vial with the capsule should remain in the shielding container.
• 7. Connect the vial to the applicator. To do this, push the applicator into the vial containing the capsule.
• 8. During administration of the capsule, it is recommended that the vial containing the capsule connected to the applicator be placed in the shielding container. The patient, holding the shielding container in their hand, places the top part of the applicator in their mouth and then tilts it so that the capsule falls out of the applicator into the mouth. In special cases, it is possible to administer the capsule without the shielding container. In this case, the patient, holding the applicator, removes the vial containing the capsule from the shielding container, places the top part of the applicator in their mouth, and then tilts it so that the capsule falls out of the applicator into the mouth.
• 9. After administering the capsule, the applicator with the vial should be disposed of in the trash. The shielding container should be returned to the manufacturer.

In case of necessity to disconnect the vial from the applicator, the vial with the applicator should be placed in the shielding container, and then, holding the container with your hand, tilt the applicator to release the connection.
To perform a measurement of the capsule's activity, place the top part of the applicator in the activity meter clamp and then remove the applicator connected to the vial containing the capsule. The whole should be placed in the activity meter. After the measurement is completed, the vial with the applicator should be placed in the shielding container. If it is necessary to move the capsule to another room after measurement, the applicator should be disconnected from the vial in the manner described above. After disconnecting the applicator, the container should be covered with a cap.
Any unused remnants of the medicine or its waste should be disposed of in accordance with local regulations.