Ioflupane (123i) rotop

Package leaflet: Information for the patient

Ioflupane (123I) ROTOP, 74 MBq/ml, solution for
injection
Ioflupane (123I)
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult the nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, including any not listed in this leaflet, tell your nuclear medicine physician. See section 4.

Table of contents

1. What Ioflupane (123I) ROTOP is and what it is used for
2. Important information before using Ioflupane (123I) ROTOP
3. How to use Ioflupane (123I) ROTOP
4. Possible side effects
5. How to store Ioflupane (123I) ROTOP
6. Contents of the pack and other information

1. What Ioflupane (123I) ROTOP is and what it is used for

This medicine is a radiopharmaceutical product intended solely for diagnostic use.
Ioflupane (123I) ROTOP contains the active substance ioflupane (123I), used to assist in diagnosing certain brain disorders. This medicine belongs to a group of slightly radioactive substances known as radiopharmaceuticals.

• After injection, this radiopharmaceutical temporarily accumulates in specific organs or areas of the body.
• Because it contains a small amount of radioactive substance, it can be detected externally using special cameras.
• An image, known as a "scan", can be obtained. The scan shows precisely the location of radioactivity within the organ and the body. This enables the physician to obtain valuable information about the organ's function. After administration to an adult patient, Ioflupane (123I) ROTOP is distributed throughout the body via the bloodstream. It accumulates in a small area of the brain. Changes in this brain region occur in the following disorders:
• Parkinsonism (including Parkinson's disease) and
• Dementia with Lewy bodies.

The scan will provide the physician with information about any abnormalities in this area of the patient's brain. The treating physician may determine that the information obtained from the scan will be helpful in better understanding the patient's condition and in making decisions regarding potential treatment.
After administration of Ioflupane (123I) ROTOP, the patient is exposed to a small radiation dose.
This dose is lower than that received during certain X-ray examinations. The patient's treating physician and the nuclear medicine physician have determined that the benefits of this radiopharmaceutical procedure outweigh the risks associated with exposure to these small amounts of radiation.

2. Important information before using Ioflupane (123I) ROTOP

When not to use Ioflupane (123I) ROTOP

• if the patient is allergic to ioflupane (123I) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant.

Warnings and precautions
Before starting treatment with Ioflupane (123I) ROTOP, discuss with the nuclear medicine physician if the patient has moderate or severe kidney or liver disease.
Before administration of Ioflupane (123I) ROTOP and before starting the examination, the patient should drink plenty of water to ensure adequate hydration before and after the examination and to urinate as frequently as possible during the first 48 hours following the examination.

Children and adolescents
Administration of Ioflupane (123I) ROTOP is not recommended for children and adolescents aged 0 to 18 years.

Ioflupane (123I) ROTOP and other medicines
Inform the nuclear medicine physician about all medicines recently taken. Some medicines or substances may affect the action of Ioflupane (123I) ROTOP.
This includes:

• bupropion (used in the treatment of depression or to stop smoking),
• sertraline, paroxetine, citalopram, escitalopram, fluoxetine, fluvoxamine (used in the treatment of depression),
• methylphenidate, dexamphetamine (used in the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy (excessive sleepiness)),
• phentermine (appetite suppressant, used in the treatment of obesity),
• amphetamines,
• cocaine (sometimes used as a local anaesthetic in nasal surgery),
• modafinil (used in the treatment of narcolepsy (excessive sleepiness) and other sleep disorders),
• codeine (used to relieve mild to moderate pain and suppress dry cough).

Some medicines may reduce the quality of the images obtained. The physician may advise the patient to temporarily discontinue such medicines shortly before administration of Ioflupane (123I) ROTOP.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her nuclear medicine physician before using this medicine.
If there is any possibility that the patient is pregnant, if her menstrual period is delayed, or if she is breastfeeding, she must inform the nuclear medicine physician before administration of Ioflupane (123I) ROTOP.
In case of any doubts, consult the nuclear medicine physician supervising the examination.
If the patient is pregnant, Ioflupane (123I) ROTOP must not be used. Otherwise, the unborn child may be exposed to some radiation. Consider using alternative diagnostic techniques that do not involve ionising radiation.
If the patient is breastfeeding, the nuclear medicine physician may delay administration of Ioflupane (123I) ROTOP or recommend temporary discontinuation of breastfeeding. It is not known whether ioflupane (123I) passes into human breast milk.

• The patient should not breastfeed for 3 days after administration of Ioflupane (123I) ROTOP.
• During this time, the infant should be fed with infant formula. Breast milk should be expressed and discarded at regular intervals.
• This should be continued for 3 days, until there is no longer any radioactivity in the patient's body.

Driving and using machines
The effect of Ioflupane (123I) ROTOP on the ability to drive and operate machinery is unknown.

Ioflupane (123I) ROTOP contains 4% v/v alcohol (ethanol).
This medicine contains up to 158 mg of alcohol per dose. The amount of alcohol in a single dose is equivalent to less than 4 ml of beer or 1.6 ml of wine.
The small amount of alcohol in this medicine will not produce noticeable effects.

The medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Ioflupane (123I) ROTOP

There are strict regulations regarding the handling, transfer, and disposal of radiopharmaceuticals. Ioflupane (123I) ROTOP will always be administered in a hospital or similar facility. This medicine will be prepared and administered to patients only by trained and authorized personnel qualified to use it safely. These individuals will inform the patient of all necessary steps to ensure safe use of this medicine.

The nuclear medicine physician supervising the procedure will determine the appropriate dose of Ioflupane (123I) ROTOP for the individual patient. This will be the smallest dose necessary to obtain the required diagnostic information.

Before administration of Ioflupane (123I) ROTOP, the physician will instruct the patient to take tablets or liquid containing iodine. This will prevent accumulation of radioactivity in the thyroid gland. It is important to take the tablets or liquid exactly as directed by the physician.

Administration of Ioflupane (123I) ROTOP and performance of the scan
Ioflupane (123I) ROTOP is administered by injection, usually into a vein in the arm. The usual recommended dose for adults is between 111 and 185 MBq (megabecquerel; MBq is a unit of measurement used to quantify radioactivity). A single injection is sufficient.

Duration of the scan
The scan, performed using a special camera, is usually carried out 3 to 6 hours after injection of Ioflupane (123I) ROTOP.
The nuclear medicine physician will inform the patient how long the scan usually takes.

After receiving Ioflupane (123I) ROTOP, the patient should urinate frequently to help eliminate the medicine from the body quickly.

The nuclear medicine physician will inform the patient whether any special precautions are necessary after receiving this medicine. If there are any questions, the patient should consult the nuclear medicine physician.

Administration of a higher than recommended dose of Ioflupane (123I) ROTOP
Because Ioflupane (123I) ROTOP is administered by a physician under controlled conditions, it is unlikely that the patient will receive an overdose. The nuclear medicine physician will advise the patient to drink large amounts of fluids to facilitate elimination of the medicine from the body. Appropriate precautions must be taken during urination—the physician will explain what needs to be done. This is standard practice for radiopharmaceuticals such as Ioflupane (123I) ROTOP. Any residual Ioflupane (123I) ROTOP in the patient's body will lose its radioactivity spontaneously over time.

If there are any further doubts regarding the use of this medicine, the patient should consult the nuclear medicine physician supervising the procedure.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them. The frequency of adverse reactions is as follows:

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• increased appetite
• dizziness
• taste disturbances
• nausea
• dry mouth
• sensation of spinning
• brief, bothersome tingling sensation
• severe pain (or burning sensation) at the injection site. This reaction has been observed in patients who received Ioflupane (123I) ROTOP administered into a small vein.

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

• hypersensitivity (allergy)
• shortness of breath
• skin redness
• itching
• rash
• urticaria
• excessive sweating
• vomiting
• low blood pressure
• feeling of warmth

The amount of radioactivity in the body after administration of Ioflupane (123I) ROTOP is very small. It will be eliminated from the body within a few days without the need for special precautionary measures.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your nuclear medicine physician. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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 can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicinal product Ioflupane (123I) ROTOP

The patient must not store this medicinal product. This medicinal product will be stored by medical professionals in appropriate facilities. Radiopharmaceuticals must be stored in accordance with local regulations concerning radioactive substances.
The following information is intended exclusively for medical professionals. Do not use this medicinal product after the expiry date stated on the label.
Hospital staff must ensure proper storage and disposal of the product, and must not use it after the expiry date indicated on the label.

6. Contents of the pack and other information What Ioflupane (123I) ROTOP contains

• The active substance is ioflupane (123I). Each millilitre of solution contains 74 MBq of ioflupane (123I) at the reference date and time (equivalent to 0.07–0.13 μg/ml of ioflupane).
• The other components are: glacial acetic acid, sodium acetate trihydrate, anhydrous ethanol, and water for injections.

What Ioflupane (123I) ROTOP looks like and contents of the pack
Ioflupane (123I) ROTOP is a colourless solution for injection. 2.5 ml or 5 ml of the solution is supplied in a 10 ml vial made of colourless type I glass, with a chlorobutyl rubber stopper type I, sealed with an aluminium flip-off cap, and placed in a lead container.

Marketing Authorisation Holder and Manufacturer
ROTOP Radiopharmacy GmbH
Bautzner Landstrasse 400
01328 Dresden
Germany
Telephone: +49 351 - 26 310 100
E-mail: [email protected]

Information intended exclusively for healthcare professionals:
The complete Summary of Product Characteristics (SmPC) for Ioflupane (123I) ROTOP is provided as a detachable section at the end of the printed leaflet included in the product pack, to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical product. See SmPC.