Iodopol diagnostic

Iodopol Diagnostic
1-37 MBq, hard capsules
Sodium iodide ( I)
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult the nuclear medicine specialist supervising your examination.
• If you experience any adverse reactions, including any not listed in this leaflet, inform the nuclear medicine specialist supervising your examination. See section 4.

Contents of the leaflet:

1. What Iodopol Diagnostic is and what it is used for
2. Important information before taking Iodopol Diagnostic
3. How to take Iodopol Diagnostic
4. Possible side effects
5. How to store Iodopol Diagnostic
6. Contents of the package and other information

1. What Iodopol Diagnostic is and what it is used for

Iodopol Diagnostic is a medicinal product (radiopharmaceutical) intended exclusively for diagnostic purposes. The capsules are administered orally and are used in the diagnosis of thyroid disorders. Iodopol Diagnostic is indicated for performing isotopic examinations in thyroid diseases. It is used to assess thyroid function disorders (hyperthyroidism and hypothyroidism), to locate the thyroid gland, to evaluate its size and shape, and to assess the function of thyroid lesions: “cold” nodules (which do not accumulate iodine), “warm” nodules (which accumulate iodine to a similar extent as normal thyroid tissue), and “hot” nodules (which accumulate iodine more intensely than normal thyroid tissue). Iodopol Diagnostic may be used to study the behavior of radioiodine in the thyroid gland. Assessment of thyroid iodine uptake and its half-life in the thyroid may be used for dosimetric calculations of therapeutic radioiodine doses. Iodopol Diagnostic is used in patients treated for differentiated thyroid cancer to identify residual thyroid tissue and to diagnose metastases. Due to the presence of radioactive iodine-131, administration of this medicinal product involves exposure to ionizing radiation. The physician has determined that the benefits of the examination outweigh the potential risks associated with ionizing radiation.

2. Important information before taking Iodopol Diagnostic

When not to use Iodopol Diagnostic

• If the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of the medicine (listed in section 6).
• In women with confirmed or suspected pregnancy (or when pregnancy has not been ruled out),
• In breastfeeding women,
• For diagnostic use in children under 10 years of age,
• For scintigraphic examination of the thyroid, except in cases of thyroid cancer or when iodine-123 or technetium-99m are not available,
• In patients with dysphagia (swallowing disorders), esophageal stricture, esophageal stenosis, esophageal diverticula, active gastritis, gastric erosions, or peptic ulcers,
• In patients with suspected slowed gastrointestinal motility.

Warnings and precautions

Extreme caution should be exercised when administering Iodopol Diagnostic to patients with swallowing disorders or gastrointestinal diseases causing regurgitation or vomiting (due to the risk of improper drug intake and radioactive contamination; consider administering iodine-131 in a pharmaceutical form other than capsules or via a route other than oral).
Administration of radiopharmaceuticals poses a risk of exposure to ionizing radiation for other individuals, as well as potential contamination from urine, vomit, sweat, etc. Therefore, basic hygiene principles must be strictly observed.
To reduce radiation dose absorbed by the urinary bladder, increased fluid intake and frequent bladder emptying are recommended after administration of the medicinal product.

Prior to administration of Iodopol Diagnostic, the physician may recommend:

• A low-iodine diet (especially limiting consumption of seafood),
• Avoidance of iodine-containing medications (e.g. iodine-containing vitamins, certain antiseptics, certain drugs for cataract prevention, certain expectorants, amiodarone preparations, and certain contrast agents used in radiological examinations),
• Temporary discontinuation of natural or synthetic thyroid hormones to enhance iodine uptake by thyroid tissue,
• Temporary discontinuation of antithyroid drugs, such as those containing thiamazole or propylthiouracil.

Iodopol Diagnostic and other medicines

Inform the nuclear medicine specialist about all medicines currently taken or recently taken, including those available without a prescription, as well as any medicines you plan to take. Many substances interact with iodides, affecting their protein binding and behavior in the body. Therefore, the physician must review all medications taken by the patient and decide whether any should be discontinued prior to administration of sodium iodide (I).

The physician may recommend temporarily stopping certain medications before administration:

• Antithyroid drugs such as carbimazole, methimazole, propylthiouracil, perchlorates – discontinue 2–5 days before the examination;
• Salicylates: analgesic, antipyretic, or anti-inflammatory drugs such as aspirin – discontinue 1 week before;
• Cortisone: anti-inflammatory or immunosuppressive drugs – discontinue 1 week before;
• Sodium nitroprusside: antihypertensive drug, also used during surgery – discontinue 1 week before;
• Nitrates: drugs used in coronary heart disease – discontinue 1 week before;
• Sulfobromophthalein: drug used in liver function tests – discontinue 1 week before;
• Anticoagulant drugs – discontinue 1 week before;
• Antiparasitic drugs – discontinue 1 week before;
• Antihistamines: used in allergy treatment – discontinue 1 week before;
• Penicillins and sulfonamides: antibiotics – discontinue 1 week before;
• Tolbutamide: blood glucose-lowering drug – discontinue 1 week before;
• Thiopental: anesthetic used in operations to reduce intracranial pressure and treat severe epileptic seizures – discontinue 1 week before;
• Phenylbutazone: analgesic and anti-inflammatory drug – discontinue 1–2 weeks before;
• Iodine-containing drugs used to clear respiratory secretions – discontinue 4 weeks before;
• Vitamin preparations containing iodide salts – discontinue 4 weeks before;
• Thyroid hormone drugs, such as levothyroxine (discontinue 4 weeks before) or liothyronine (discontinue 2 weeks before);
• Benzodiazepines: drugs used to improve mood and help patients sleep and relax – discontinue 4 weeks before;
• Lithium: drug used in bipolar disorder treatment – discontinue 4 weeks before;
• Amiodarone: drug used in the treatment of arrhythmias – discontinue 3–6 months before;
• Topically applied iodine-containing drugs – discontinue 1–9 months before;
• Water-soluble contrast agents – discontinue 1–2 months before;
• Water-insoluble contrast agents – discontinue 3–6 months before.

Taking Iodopol Diagnostic with food and drink

Before administration of sodium iodide (I), the physician may recommend a low-iodine diet to enhance iodine uptake by thyroid tissue. The patient should remain fasting for approximately 2 hours before and after swallowing the capsule containing sodium iodide (I) to ensure proper drug absorption.

Pregnancy and breastfeeding

Iodopol Diagnostic must not be used in pregnant women or in women who are breastfeeding.

Before taking the medicine, inform the nuclear medicine specialist if:

• There is suspicion of pregnancy,
• Menstruation has not occurred at the expected time,
• The woman is breastfeeding.

In case of doubt, consultation with the nuclear medicine specialist supervising the examination is required. If the patient is pregnant, the physician must be informed before the capsule is administered. If administration of sodium iodide (I) is necessary in a breastfeeding woman, breastfeeding must be discontinued.

Driving and operating machinery

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

Iodopol Diagnostic contains sodium

The medicinal product contains up to 99 mg of sodium per capsule. This should be taken into account in patients on a low-sodium diet.
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3. How to use Iodopol Diagnostic

There are strict regulations regarding the handling, transfer, and disposal of radiopharmaceuticals.
Iodopol Diagnostic is administered only under appropriate conditions and exclusively by appropriately qualified personnel.
These individuals take special precautionary measures to ensure safe use of the medicinal product and will keep you informed about their procedures.
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Iodopol Diagnostic is a medicinal product for oral administration, with variable radioactive activity doses.
The activity (dose) of the medicinal product is determined by a nuclear medicine specialist. This will be the minimum dose necessary to obtain the desired diagnostic information.
Depending on the type of examination, the recommended radioactive activity of the capsules is as follows:

• for isotopic examinations performed in patients with benign thyroid diseases, a dose of 0.15 - 4 MBq of sodium iodide ( I) is recommended.
• for examinations in patients being treated for differentiated thyroid cancer, a dose of 37 - 240 MBq (usually 37 - 74 MBq) of sodium iodide ( I) is recommended. MBq (megabecquerel) is the unit used to measure the radioactive dose of the medicinal product.

Use in children
The use of Iodopol Diagnostic in children must be carefully evaluated by a nuclear medicine specialist, taking into account clinical indications and a benefit-risk assessment in this patient group.
It should be noted that long-term potential adverse effects associated with the administration of iodine ( I) in children (especially under 10 years of age) and adolescents are more likely than in adults.
The diagnostic activity for children should be a fraction of the adult dose and may be calculated by adjusting the adult activity based on the child's body weight and/or body surface area.

After administration of Iodopol Diagnostic, the following should be observed:

• to reduce radiation dose absorbed by the urinary bladder, drink larger amounts of fluids (approximately 1 - 1.5 liters more than usual),

• urinate frequently to eliminate residual radiopharmaceutical from the body.
  The administration of radiopharmaceuticals poses a risk of external ionizing radiation exposure or contamination from isotopes present in urine, vomit, sweat, etc., to other individuals. Therefore, after administration of sodium iodide Na I, the following precautions should be taken:

• avoid close contact with other people, and especially with young children and pregnant women, for the period recommended by the physician,

• carefully clean up any bodily excretions and sweat for the period recommended by the physician.

Administration of a higher than recommended dose of the medicinal product
Overdose is almost impossible because the dose administered to the patient is strictly controlled by the nuclear medicine specialist.
The medicinal product is supplied in capsules of known activity, which facilitates accurate dose control for the patient.
In the event of an overdose, the physician may administer drugs blocking the uptake of iodine-131 by the thyroid gland, or induce vomiting, and recommend increased fluid intake and frequent urination to eliminate residual radiopharmaceutical from the body.
If there are any doubts regarding the use of the medicinal product, consult a nuclear medicine specialist.

4. Possible adverse reactions

Like all medicinal products, this medicinal product can cause adverse reactions, although not everyone will experience them.
Adverse reactions following administration of Iodopol Diagnostic have been reported in single cases
(exact frequency cannot be estimated based on available data).
Possible adverse reactions are listed below:
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Frequency unknown (frequency cannot be determined from available data)

• hypersensitivity reactions
• nausea and vomiting
• congenital thyroid dysfunction disorders. Exposure to ionizing radiation may lead to an increased incidence of cancer or may cause hereditary defects. However, current evidence indicates a low risk of such adverse effects occurring in diagnostic procedures in nuclear medicine. If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform the nuclear medicine specialist supervising the examination.

Reporting of adverse reactions
If any adverse reactions occur, including adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the Marketing Authorisation Holder. Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Iodopol Diagnostic

The patient will not be required to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel,
under appropriate conditions and in compliance with regulations concerning radioactive substances.
The following information is intended solely for medical staff.
Do not use the medicinal product after the expiry date stated on the packaging.

6. Contents of the packaging and other information

What Iodopol Diagnostic contains
The active substance is sodium iodide ( I).
Each capsule contains from 1 to 37 MBq of sodium iodide ( I).
Other components are:
Sodium carbonate
Sodium hydrogen carbonate
Disodium phosphate dihydrate
Sodium thiosulfate pentahydrate
Water for injections

Composition of the gelatin capsule shell:
Indigotine (E 132)
Titanium dioxide (E 171)
Gelatin
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What Iodopol Diagnostic looks like and contents of the pack
Polypropylene vial closed with a polyethylene stopper and placed in a lead shielding container.
Up to 10 capsules of equal activity can be placed in one vial. A radiopharmaceutical certificate is attached to each package.

Marketing authorisation holder and manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: [email protected]

For further information, please contact your doctor or representative of the marketing authorisation holder.

Information intended exclusively for medical professionals

The radiopharmaceutical is supplied in capsules with activity according to the order
(activity is determined at 12:00 on the calibration date).
When handling and administering the medicinal product, the principles of radiation safety
under ionizing radiation conditions must be strictly observed.
Instructions for opening the packaging containing the radioactive product:

1. Check the radioactivity and the calibration date indicated on the outer packaging.
2. Remove the metal container from the cardboard box and tear off its upper lid.
3. Remove the upper part of the polystyrene insert.
4. Remove the shielded container with the capsule.
5. Remove the upper lid of the lead shielded container.
6. Remove the plastic cap from the polypropylene vial placed inside the lead container.
7. Remove capsules individually from the vial using tweezers.

Any unused medicinal product or waste material must be disposed of in accordance
with local regulations.
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