Iodopol

Package leaflet: Information for the patient

Iodopol
37-7400 MBq, hard capsules,
Sodium iodide ( I)
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult the nuclear medicine specialist physician managing your treatment.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the nuclear medicine specialist physician managing your treatment. See section 4.

Table of contents

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

1. What Iodopol is and what it is used for

Iodopol is a medicinal product used in adults, children, and adolescents for the treatment of:

• thyroid nodules,
• hyperthyroidism,
• large goitre of the thyroid gland, when no other therapeutic alternative is available.

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

2. Important information before using Iodopol

When not to use Iodopol
This medicine should not be used 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 conditions apply to the patient, the patient must inform the doctor,
a nuclear medicine specialist.
Warnings and precautions
Inform the nuclear medicine specialist if:

• the patient has impaired kidney function,
• the patient has difficulty urinating,
• the patient has gastrointestinal or stomach disorders,
• the patient has bulging eyes (ophthalmopathy caused by Graves-Basedow disease) among disease symptoms.
  Low blood sodium levels have been observed in elderly patients after thyroidectomy. This is most likely to occur in women and in patients taking medications that increase water and sodium excretion in urine (diuretics such as hydrochlorothiazide). If the patient belongs to any of these groups, the doctor may recommend regular blood tests to monitor electrolyte levels (e.g. sodium). If any of the above conditions apply to the patient, the patient must inform the doctor, a nuclear medicine specialist. Iodopol may not be suitable for the patient. The doctor will inform the patient if special precautions are required after administration of this medicine. The patient should contact the nuclear medicine doctor if they have any questions.

Before taking Iodopol, the patient should:

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

Children and adolescents
Inform the nuclear medicine doctor if the patient is under 18 years of age or unable to swallow the capsule.

Iodopol and other medicines
Tell the nuclear medicine specialist about all medicines the patient is currently taking or has recently taken, including those available without a prescription, as well as any medicines the patient plans to take.
Inform the nuclear medicine specialist if the patient is taking any of the following medicines, as they may affect treatment efficacy. The doctor may recommend discontinuing certain medications before starting treatment:

• thyroid function-blocking drugs such as carbimazole, methimazole, propylthiouracil, perchlorates – discontinue for 1 week;
• salicylates: pain-relieving, antipyretic or anti-inflammatory drugs such as aspirin – discontinue for 1 week;
• cortisone: anti-inflammatory drugs or drugs preventing transplant rejection – discontinue for 1 week;
• sodium nitroprusside: a blood pressure-lowering drug also used during surgery – discontinue for 1 week;
• sulfobromophthalein: a drug used in liver function testing – discontinue for 1 week;
  other drugs that should be discontinued for 1 week:
• drugs reducing blood coagulation;
• drugs used in treatment of parasitic infections;
• antihistamines: used in allergy treatment;
• penicillins and sulfonamides: antibiotics;
• tolbutamide: a drug lowering blood glucose levels;
• thiopental: an anesthetic used in operations to reduce intracranial pressure and in treatment of severe epileptic seizures;
• phenylbutazone: a pain-relieving and anti-inflammatory drug – discontinue for 1–2 weeks;
• drugs containing iodine, administered to clear respiratory secretions – discontinue for 2 weeks;
• drugs containing iodine, applied topically – discontinue for 1–9 months;
• iodine-containing contrast agents – discontinue for up to 1 year;
• vitamin products containing iodine salts – discontinue for 2 weeks;
• drugs containing thyroid hormones, such as levothyroxine (discontinue for 6 weeks) or triiodothyronine (discontinue for 2 weeks);
• benzodiazepines: drugs used to improve mood and help patients relax and sleep – discontinue for 4 weeks;
• lithium: a drug used in treatment of bipolar disorder – discontinue for 4 weeks;
• amiodarone: a drug used in treatment of arrhythmia – discontinue for 3–6 months.

Iodopol and food
Before starting treatment, the doctor may recommend a low-iodine diet and avoiding foods such as shellfish.

Pregnancy and breastfeeding
This medicine must not be used in pregnant women. Therefore, before taking Iodopol, the patient must inform the doctor if there is any possibility of being pregnant, if her menstrual period is overdue, if she suspects she may be pregnant, or if she plans to become pregnant.
If a woman is pregnant
Do not take Iodopol during pregnancy. Pregnancy must be ruled out before administering this medicine.

Contraception in men and women
Women should not become pregnant for at least 6 months after administration of Iodopol. Use of contraception in women is recommended for 6 months. As a precautionary measure, men should not father a child within 6 months after receiving Iodopol to allow replacement of irradiated spermatozoa with non-irradiated ones.

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

Breastfeeding
Inform the doctor if the patient is breastfeeding, because breastfeeding must be discontinued before starting treatment. Breastfeeding must not be resumed after administration of Iodopol.

Driving and operating machinery
It is unlikely that Iodopol affects the ability to drive or operate machinery.

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

3. How to use Iodopol

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Iodopol is administered exclusively in specially designated, controlled areas and only by personnel appropriately trained in its safe use. These individuals take special precautionary measures to ensure the safe use of the drug and will keep the patient continuously informed about their actions.

The therapeutic activity (dose) will be individually determined for each patient by a nuclear medicine specialist. This will be the minimum dose necessary to achieve the desired therapeutic effect. The Iodopol medication is administered as a single capsule by a specialist, who will also take all necessary precautionary measures.

Recommended activity (dose) for adults:

• 200–800 MBq for the treatment of hyperthyroidism or large goitre,
• 1,850–3,700 MBq for partial or complete ablation of the thyroid gland and for treatment of metastatic spread (metastases),
• 3,700–11,100 MBq for further treatment of metastases.

MBq (megabecquerel) is the unit used to measure the radioactivity of the drug dose.

Use in children and adolescents under 18 years of age
Lower doses of the drug are used in children and adolescents.

How Iodopol is administered and what the procedure involves
Iodopol is administered as a single capsule.
The capsule should be taken on an empty stomach.
The capsule should be swallowed with a large amount of water to ensure it reaches the stomach as quickly as possible.
Young children should take the capsule together with crushed food.

Patients should drink as much water as possible during the day following the procedure. This helps ensure the active substance is eliminated more rapidly from the bladder.

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

After administration of Iodopol
The nuclear medicine physician will inform the patient about the need to take special precautionary measures after receiving the drug. These are especially important:

• Avoiding close contact with young children and pregnant women for at least several days. The nuclear medicine specialist will inform the patient how long this precaution should be maintained;
• Drinking large amounts of fluids and urinating frequently to eliminate the drug from the body;
• Thoroughly flushing the toilet and carefully washing hands, as body fluids will be radioactive for several days;
• Drinking beverages or eating sweets containing citric acid, e.g. orange, lemon, or lime juice, to stimulate saliva production and prevent its accumulation in the salivary glands;
• Taking laxatives if bowel movements occur less than once per day, to stimulate intestinal activity.

The patient's blood, faeces, urine, or vomit may be radioactive for several days, and other people must not come into contact with them.

In case of any questions, please consult the nuclear medicine specialist.

Use of a higher than recommended dose of the drug
Overdose is unlikely, as the patient receives only a single dose of Iodopol, strictly controlled by the nuclear medicine specialist. However, in the event of an overdose, the physician will apply appropriate treatment.

If you have any further doubts regarding the use of Iodopol, please consult your nuclear medicine specialist.

4. Possible adverse reactions

Like any medicine, Iodopol may cause adverse reactions, although not everyone experiences them.
Common adverse reactions include: hypothyroidism (underactive thyroid gland), transient hyperthyroidism (overactive thyroid gland), disturbances in tear and salivary gland function, and local effects of radiation exposure. During cancer treatment, additional common adverse reactions may include gastrointestinal disorders and reduced blood cell production due to suppressed bone marrow function.
If the patient experiences severe allergic reactions causing difficulty in breathing or dizziness, or if a severe exacerbation (thyroid storm) of hyperthyroidism occurs, immediate contact with a physician is required.
All adverse reactions associated with Iodopol are listed below, grouped according to indications, as they depend on the activity (dose) used in different types of treatment.

Treatment of hyperthyroidism or large multinodular goiter

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

• hyperthyroidism

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

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

Very rare (occur 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 in breathing or dizziness
• severe exacerbation (thyroid storm) of hyperthyroidism
• thyroiditis
• disturbances in tear gland function characterized by dry eyes
• decreased or ceased production of parathyroid hormone, manifesting as tingling in the hands, fingers, and around the mouth, and sometimes more severe muscle spasms
• thyroid hormone deficiency in offspring
• liver function disorders

Cancer treatment

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

• significant reduction in blood cell counts, which may cause weakness, bruising, or increased risk of infections
• absence of red blood cells
• bone marrow failure with reduced numbers of red blood cells, white blood cells, or both
• disturbances or loss of sense of smell or taste
• nausea
• decreased appetite
• ovarian dysfunction
• flu-like illness
• headache, neck pain
• excessive fatigue or drowsiness
• eye inflammation causing redness, tearing, and itching
• inflammation of the salivary glands with symptoms such as dryness of the mouth, nose, and eyes; dental caries, tooth loss

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

• abnormal, neoplastic increase in white blood cell count
• absence of white blood cells or platelets
• catarrh
• difficulty in breathing
• vomiting
• local tissue swelling

Rare (occur 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 in breathing or dizziness
• cancer, including bladder, colorectal, and stomach cancer
• permanent or serious reduction in blood cell production in the bone marrow
• thyroiditis
• decreased or ceased production of parathyroid hormone
• increased production of parathyroid hormones
• hypothyroidism
• tracheitis and/or esophageal narrowing
• connective tissue proliferation in the lungs
• difficulty in breathing or hoarse breathing
• pneumonia
• vocal cord paralysis, hoarseness, reduced voice production
• pain in the mouth and throat
• fluid accumulation in the brain (edema)
• inflammation of the gastric mucosa
• difficulty in swallowing
• bladder inflammation
• menstrual cycle disturbances
• reduced fertility in men, low sperm count or absence of sperm
• thyroid hormone deficiency in offspring
• liver function disorders
• low blood sodium levels

If any adverse symptoms occur in the patient, including any adverse reactions not listed in this leaflet, the patient should inform the nuclear medicine specialist supervising the treatment.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, they should be reported to the nuclear medicine specialist supervising the treatment. 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 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Iodopol

The patient will not be required to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate conditions.
Storage of radiopharmaceuticals should comply with national regulations concerning radioactive substances.
The following information is intended for medical personnel only.
Do not use this medicinal product after the expiry date stated on the packaging after: "Expiry date".

6. Contents of the packaging and other information

What Iodopol contains
The active substance is sodium iodide (I).
Each 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 thiosulphate

Composition of the gelatin capsule shell:
quinoline yellow (E 104), erythrosine (E 127), titanium dioxide (E 171), gelatin

What Iodopol looks like and contents of the pack
A polypropylene vial placed in a lead shielding container, sealed with a lead stopper containing a polypropylene insert with iodine absorbent. The packaging contains one capsule.
A polypropylene applicator for capsule administration is supplied with each pack.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel.: +48 22 7180700
Fax: +48 22 7180350
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Iodopol 37‐7400 MBq Hartkapseln
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 kietosios kapsulės
Germany: Iodopol
Norway: Iodopol
Poland: Iodopol
Portugal: Iodopol
Slovakia: Iodopol
Slovenia: Natrii iodidum (131I) POLATOM, 37‐7400 MBq trde kapsule
Sweden: Sodium iodide (I-131) POLATOM
Italy: Sodio ioduro (I-131) POLATOM

For further information about this medicinal product, please contact a physician or the representative of the Marketing Authorisation Holder.
Information intended exclusively for medical professionals.

Instructions for opening the container of the radioactive product administered using an applicator:

1. Check the radioactivity and calibration date indicated on the outer packaging.
2. Remove the upper metal lid.
3. Remove the upper part of the polystyrene insert.
4. Remove the shielded container with the capsule.
5. Open the paper-aluminum applicator packaging and remove the applicator.
6. Open the shielded container with the capsule. To do this, hold the bottom part of the container and pull the lid upwards. The vial with the capsule should remain inside the shielded container.
7. Connect the vial to the applicator. To do this, screw the applicator onto the vial containing the capsule.
8. During capsule administration, it is recommended that the vial containing the capsule, connected to the applicator, remains inside the shielded container. The patient, holding the shielded container in hand, places the upper part of the applicator into the mouth and then tilts it so that the capsule drops from the applicator into the mouth. In special cases, administration of the capsule without the shielded container is possible. In such a case, the patient grasps the applicator, removes the vial containing the capsule from the shielded container, places the upper part of the applicator into the mouth, and then tilts it so that the capsule drops from the applicator into the mouth.
9. After capsule administration, dispose of the applicator together with the vial. Return the shielded container to the manufacturer.
10. To disconnect the applicator from the vial, place the vial with the applicator into the shielded container, then, holding the container with one hand, unscrew the applicator to detach it.
11. To measure the capsule's activity, hold the applicator attached to the vial with the capsule using a handling device and place it into the dose calibrator. After measurement, remove the vial with the applicator and place it back into the shielded container. If it is necessary to transfer 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 medicinal product or waste material must be disposed of in accordance with local regulations.