Iodopol

Leaflet accompanying the packaging: patient information

Iodopol

37-7400 MBq, hard capsules,

Sodium iodide (I)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, consult a nuclear medicine specialist doctor who is treating you.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform the nuclear medicine specialist doctor who is treating them. See section 4.

Table of contents of the leaflet

• 1. What is Iodopol and what is it used for
• 2. Important information before taking Iodopol
• 3. How to take Iodopol
• 4. Possible side effects
• 5. How to store Iodopol
• 6. Package contents and other information

1. What is Iodopol and what is it used for

Iodopol is a medicine used in adults, children, and adolescents to treat:

• thyroid tumors,
• hyperthyroidism,
• large thyroid goiter, when there is no other alternative therapeutic method.

This medicine contains sodium iodide (I), a radioactive substance that accumulates in certain organs such as the thyroid gland.
This medicine is radioactive; however, the doctor will consider whether its beneficial effect on the patient's condition outweighs the risk associated with radiation exposure.

2. Important information before taking Iodopol

When not to take Iodopol

Do not take this medicine in the following cases:

• if the patient is allergic to sodium iodide or any of the other ingredients of this medicine (listed in section 6),
• pregnancy or suspected pregnancy,
• breastfeeding,
• difficulty swallowing,
• esophageal obstruction,
• stomach disorders,
• slowed intestinal peristalsis.

If any of the above points apply to the patient, they should inform the nuclear medicine specialist doctor
who is treating them.

Warnings and precautions

Inform the nuclear medicine specialist doctor if:

• the patient has kidney function disorder,
• the patient has difficulty urinating,
• the patient has digestive or stomach disorders,
• among the symptoms of the disease, the patient has exophthalmos (eye disorder caused by Graves' disease). Small sodium concentrations in the blood have been observed in elderly patients after thyroid removal. This is most likely in women and patients taking diuretic medications (such as hydrochlorothiazide). If the patient belongs to one of these groups, the doctor may recommend regular blood tests to determine the electrolyte concentration (e.g., sodium) in the blood.

If any of the above points apply to the patient, they should inform the nuclear medicine specialist doctor

who is treating them. Iodopol may not be suitable for the patient.
The doctor will inform the patient if it is necessary to take special precautions after taking this medicine.
If the patient has any questions, they should consult a nuclear medicine doctor.

Before taking Iodopol, the patient should:

• follow a low-iodine diet,
• drink plenty of water before starting treatment to urinate as frequently as possible in the first hours after taking Iodopol,
• not eat on the day of administration.

Children and adolescents

Inform the nuclear medicine doctor if the patient is under 18 years old or if they cannot swallow the capsule.

Iodopol and other medicines

Inform the nuclear medicine specialist doctor about all medicines the patient is currently taking or has recently taken, including those that are available without a prescription, as well as any medicines the patient plans to take.
Inform the nuclear medicine specialist doctor if the patient is taking any of the following medicines, as they may affect the effectiveness of the treatment.
The doctor may recommend stopping the use of certain medicines before taking Iodopol:

• thyroid function inhibitorssuch as carbimazole, methimazole, propylthiouracil, perchlorates - discontinued for 1 week;
• salicylates: painkillers, antipyretics, or anti-inflammatory drugs such as aspirin
• discontinued for 1 week;
• cortisone: anti-inflammatory or anti-rejection medications - discontinued for 1 week;
• sodium nitroprusside: a medication that lowers blood pressure, also used during surgery
• discontinued for 1 week;
• bromsulfophthalein: a medication used in liver function tests - discontinued for 1 week; other medications that should be discontinued for 1 week:
• medicines that reduce blood clotting;
• medicines used to treat parasitic infections;
• antihistaminemedications: used to treat allergies;
• penicillins sulfonamides: antibiotics;
• tolutamide: a medication that lowers blood sugar levels;
• thiopental: an anesthetic medication used in operations to reduce intracranial pressure and treat severe seizures;
• phenylbutazone: a painkiller and anti-inflammatory medication - discontinued for 1-2 weeks;
• medicines containing iodine, administered to clear the airways of secretions
• discontinued for 2 weeks;
• medicines containing iodine, used topically - discontinued for 1-9 months;
• contrast agentscontaining iodine - discontinued for a period of up to 1 year;
• vitamin products, also containing iodine salts - discontinued for 2 weeks;
• medicines containing thyroid hormones, such as levothyroxine (discontinued for 6 weeks) or triiodothyronine (discontinued for 2 weeks);
• benzodiazepines: medications used to improve mood and help patients fall asleep and relax - discontinued for 4 weeks;
• lithium: a medication used to treat bipolar disorder - discontinued for 4 weeks;
• amiodarone: a medication used to treat arrhythmia - discontinued for 3-6 months.

Iodopol with food

Before starting treatment, the doctor may recommend a low-iodine diet and avoidance of foods such as shellfish.

Pregnancy and breastfeeding

This medicine should not be taken by pregnant women. Therefore, before taking Iodopol, the patient must inform the doctorif there is a possibility that she is pregnant, if she has not had her period at the expected time, if she suspects she may be pregnant, or if she plans to become pregnant.

If the woman is pregnant

Do nottake Iodopol during pregnancy. Pregnancy should be ruled out before taking this medicine.

Contraception in men and women

Women should not become pregnant for at least 6 months after taking Iodopol. It is recommended that women use contraception for a period of 6 months. As a precaution, men should not father a child for a period of 6 months after taking Iodopol, to allow the irradiated sperm to be replaced by non-irradiated sperm.

Fertility

Treatment with Iodopol may temporarily reduce fertility in men and women.
In men, high doses of sodium iodide (I) may temporarily affect sperm production.
If a man wants to become a father in the future, he should discuss sperm storage in a sperm bank with his doctor.

Breastfeeding

Inform the doctor if the patient is breastfeeding, as breastfeeding should be stopped before starting treatment. Do not resume breastfeeding after taking Iodopol.

Driving and operating machinery

It is unlikely that Iodopol will affect the ability to drive or operate machinery.

Iodopol contains sodium and quinoline yellow (E 104)

Iodopol contains up to 97 mg of sodium (the main component of table salt) in each capsule. This corresponds to 4.85% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients on a low-sodium diet.
Iodopol contains the dye quinoline yellow (E 104). It can cause allergic reactions.
It may have an adverse effect on activity and concentration in children.

3. How to take Iodopol

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products. Iodopol is administered only in special, controlled rooms and only by personnel trained in its safe use. These personnel will take special precautions to ensure safe administration of the medicine and will keep the patient informed about their actions.
The therapeutic activity (dose) will be determined individually for each patient by a nuclear medicine specialist doctor. This will be the minimum dose necessary to achieve the expected therapeutic effect.
Iodopol is administered in the form of a single capsule by a specialist who will also take all necessary precautions.
Recommended activity (dose) for adults:

• 200 – 800 MBq for the treatment of hyperthyroidism or large thyroid goiter,
• 1 850 - 3 700 MBq for partial or total thyroid gland removal and for the treatment of cancer cell spread (metastases),
• 3 700 - 11 100 MBq for further treatment of metastases.

MBq (megabecquerel) is a unit used to measure the radioactivity of the medicine dose.
Use in children and adolescents under 18 years of age
Children and adolescents are given smaller doses of the medicine.

How Iodopol is administered and what the procedure involves

Iodopol is administered in the form of a single capsule.
The capsule should be taken on an empty stomach.
The capsule should be swallowed with a large amount of water to get it into the stomach as quickly as possible.
Small children should take the capsule with crushed food.
Drink as much water as possible during the day after the procedure. This will help remove the active substance from the bladder more quickly.

Duration of the procedure

The nuclear medicine specialist doctor will inform the patient how long the procedure will take.

After taking Iodopol

The nuclear medicine doctor will inform the patient about the need to take special precautions after receiving the medicine. It is especially important:

• to avoid close contact with small children and pregnant women for a period of at least a few days. The nuclear medicine specialist doctor will inform the patient how long to do this;
• to drink plenty of fluids and urinate frequently to remove the medicine from the body,
• to flush the toilet and wash hands carefully, as body fluids will be radioactive for a few days;
• to drink beverages or eat sweets that contain citric acid, such as orange, lemon, or lime juice, to increase saliva production and prevent its accumulation in the salivary glands;
• to take laxatives to stimulate bowel movements if bowel movements are less frequent than once a day.

The patient's blood, stool, urine, or vomit may be radioactive for a few days and should not come into contact with other people.
If the patient has any questions, they should consult a nuclear medicine specialist doctor.

Overdose

Overdose is unlikely because the patient receives only one dose of Iodopol, which is strictly controlled by a nuclear medicine specialist doctor.
However, in case of overdose, the doctor will use an appropriate treatment method.
If you have any further doubts about taking Iodopol, consult a nuclear medicine specialist doctor.

4. Possible side effects

Like all medicines, Iodopol can cause side effects, although not everyone will experience them.
Common side effects include: hypothyroidism (underactive thyroid gland), transient hyperthyroidism (overactive thyroid gland), disorders of the lacrimal and salivary glands, local effects of radiation exposure. During cancer treatment, additional common side effects may include gastrointestinal disorders and decreased blood cell production due to bone marrow suppression.
If the patient experiences severe allergic reactions causing difficulty breathing or dizziness or if a severe exacerbation (crisis) of hyperthyroidism occurs, they should contact a doctor immediately.
All side effects of Iodopol are listed below. They are grouped according to the indications, as they depend on the activity (dose) used in different types of treatment.

Treatment of hyperthyroidism or large thyroid goiter

Very common(occurring in more than 1 in 10 people)

• hyperthyroidism

Common(occurring in no more than 1 in 10 people)

• a type of eye inflammation called thyroid ophthalmopathy (after treatment of Graves' disease)
• transient hyperthyroidism
• salivary gland inflammation

Very rare(occurring in no more than 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 exacerbation (crisis) of hyperthyroidism
• thyroid inflammation
• disorders of the lacrimal glands characterized by dry eyes
• decreased or discontinued production of parathyroid hormone, manifested as tingling in the hands, fingers, and around the mouth, and sometimes as a more severe form of muscle cramps
• hypothyroidism in offspring
• liver function disorders

Cancer treatment

Very common(occurring in more than 1 in 10 people)

• significant decrease in blood cell count, which can cause weakness, bruising, or increase the risk of infection
• anemia
• bone marrow failure with decreased production of red blood cells, white blood cells, or both
• disorders or loss of smell or taste
• nausea (vomiting)
• decreased appetite
• ovarian disorders
• flu-like illness
• headache, neck pain
• extreme fatigue or drowsiness
• eye inflammation causing redness, tearing, and itching
• salivary gland inflammation with symptoms such as dry mouth, nose, and eyes; tooth decay, tooth loss Common(occurring in no more than 1 in 10 people)
• abnormal, malignant increase in white blood cell count
• lack of white blood cells or platelets
• runny nose
• breathing difficulties
• vomiting
• local swelling of tissues Rare(occurring in no more than 1 in 1,000 people)
• severe or transient hyperthyroidism

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

• severe allergic reaction causing difficulty breathing or dizziness
• cancer, including bladder, colon, stomach cancer
• permanent or severe decrease in blood cell production in the bone marrow
• thyroid inflammation
• decreased or discontinued production of parathyroid hormone
• increased production of parathyroid hormones
• hypothyroidism
• inflammation of the trachea and (or) esophageal stricture
• connective tissue growth in the lungs
• breathing difficulties or wheezing
• pneumonia
• vocal cord paralysis, hoarseness, decreased ability to produce voice through the vocal cords
• mouth and throat pain
• fluid accumulation in the brain (edema)
• gastric mucosa inflammation
• swallowing difficulties
• urinary bladder inflammation
• menstrual cycle disorders
• decreased fertility in men, low sperm count, or absence of sperm
• hypothyroidism in offspring
• liver function disorders
• low sodium levels in the blood

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform the nuclear medicine specialist doctor who is treating them.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform the nuclear medicine specialist doctor who is treating you. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Iodopol

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 should be carried out in accordance with national regulations regarding radioactive substances.
The following information is intended only for medical personnel.
Do not use this medicine after the expiry date stated on the packaging after: "Expiry date".

6. Package contents and other information

What Iodopol contains

The active substance of the medicine is sodium iodide (I).
One capsule contains from 37 MBq to 7 400 MBq of sodium iodide (I).
The other ingredients are:

• sodium carbonate
• sodium bicarbonate
• sodium hydroxide
• disodium phosphate dihydrate
• sodium thiosulfate The composition of the gelatin capsule shell: quinoline yellow (E 104) erythrosine (E 127) titanium dioxide (E 171) gelatin

What Iodopol looks like and what the package contains

A polypropylene vial placed in a lead shielding container, closed with a lead plug, which contains a polypropylene insert with an iodine absorber. The package contains one capsule.
A polypropylene applicator for administering the capsule is attached to each package.

Marketing authorization holder and manufacturer

National Center for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Phone: 22 7180700
Fax: 22 7180350
e-mail: [email protected]

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Austria:
Iodopol 37‐7400 MBq hard capsules
Bulgaria:
Iodopol
Cyprus:
Iodopol
Czech Republic:
Iodopol
Denmark:
Sodium iodide (I-131) POLATOM
Estonia:
Iodopol
Finland:
Sodium iodide (I-131) POLATOM
Greece:
Iodopol
Lithuania:
Sodium iodide (131I) POLATOM 37‐7400 MBq hard capsules
Germany:
Iodopol
Norway:
Iodopol
Poland:
Iodopol
Portugal:
Iodopol
Slovakia:
Iodopol
Slovenia:
Sodium iodide (131I) POLATOM, 37‐7400 MBq hard capsules
Sweden:
Sodium iodide (I-131) POLATOM
Italy:
Sodium iodide (I-131) POLATOM
To obtain more detailed information on this medicine, consult a doctor or a representative of the marketing authorization holder.

Date of last revision of the leaflet: December 2024

Information intended only for healthcare professionals.
Instructions for opening the container with the radioactive product administered using an applicator:

• 1. Check the radioactivity and calibration date on the outer packaging.
• 2. Remove the top metal lid.
• 3. Remove the top part of the styrofoam insert.
• 4. Remove the shielding container with the capsule.
• 5. Tear the paper-foil packaging of the applicator and then remove the applicator.
• 6. Open the shielding container with the capsule. To do this, holding the bottom part of the container, pull the lid up. The vial with the capsule should remain in the shielding container.
• 7. Connect the vial to the applicator. To do this, screw the applicator onto the vial containing the capsule.
• 8. During administration of the capsule, it is recommended that the vial containing the capsule connected to the applicator remain 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 removed. The shielding container should be returned to the manufacturer.
• 10. To disconnect the applicator from the vial, place the vial with the applicator in the shielding container and then, holding the container with one hand, unscrew the applicator to disconnect it.
• 11. To perform a measurement of the capsule's activity, hold the applicator attached to the vial with the capsule using a gripping device and place it in an activity meter. After the measurement is complete, remove the vial with the applicator and place it back in the shielding container. If it is necessary to move the capsule to another room after measurement, disconnect the applicator from the vial according to the above instructions. After disconnecting the applicator, cover the container with the lid.

Any unused medicine or waste should be disposed of in accordance with local regulations.