IOFLUPANE (123I) ROTOP

Package leaflet: Information for the patient

Ioflupane ( I) ROTOP 74 MBq/mL Solution for injection

ioflupane ( I)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine specialist responsible for performing the examination.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet:

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

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

This medicinal product is a radiopharmaceutical for diagnostic use only.
Ioflupane ( I) ROTOP contains the active substance ioflupane ( I), which is used to help identify (diagnose) brain disorders. It belongs to a group of medicines called "radiopharmaceuticals", which contain a small amount of radioactivity.

• When a radiopharmaceutical is injected, it accumulates in an organ or part of the body for a short period.
• Because it contains a small amount of radioactivity, its presence can be detected from outside the body using special imaging cameras.
• These can produce an image called a scan. The scan will show exactly where the radioactivity is located within the organ and body. This provides the doctor with valuable information about how that organ is functioning. When Ioflupane ( I) ROTOP is injected into an adult, it is carried by the blood throughout the body and accumulates in a small area of the brain. Changes in this area of the brain occur in the following conditions:
• Parkinsonism (including Parkinson's disease) and
• Dementia with Lewy bodies.

The scan allows the doctor to obtain information about the changes that have occurred in this area of the brain. The information obtained from the scan can help the doctor to diagnose the disease and decide on appropriate treatment.
During the use of Ioflupane ( I) ROTOP, you are exposed to a small amount of radioactivity. This exposure is lower than that expected for some types of X-rays. Your doctor and the nuclear medicine specialist have assessed that the clinical benefit of this examination performed with a radiopharmaceutical outweighs the risk associated with exposure to these small amounts of radiation.

2. What you should know before using Ioflupane ( I) ROTOP

Do not use Ioflupane ( I) ROTOP:

• if you are allergic to ioflupane ( I) or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.

Warnings and precautions
Talk to the nuclear medicine specialist before you are given Ioflupane ( I) ROTOP
if you have moderate or severe liver or kidney problems.
Before administration of Ioflupane ( I) ROTOP you must drink plenty of water prior to the start
of the examination, in order to urinate as frequently as possible during the first hours after the examination.
Children and adolescents
Ioflupane ( I) ROTOP is not recommended for children and adolescents aged between 0 and 18 years.
Other medicines and Ioflupane ( I) ROTOP
Inform the nuclear medicine specialist if you are taking or have recently taken any
other medicines. Some medicines and substances may affect how this medicine works, including:

• bupropion (used to treat depression (sadness))
• benzatropine (used to treat Parkinson's disease)
• mazindol (reduces appetite, used in the treatment of obesity)
• sertraline (used to treat depression (sadness))
• methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))
• phentermine (reduces appetite, used in the treatment of obesity)
• amphetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness); it is also a stimulant drug)
• cocaine (sometimes used as an anaesthetic for nasal surgery; it is also a stimulant drug)

Some medicines may reduce the quality of the images obtained. Your doctor may ask you
to stop taking them temporarily for a short period before administration of Ioflupane ( I)
ROTOP.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding,
please consult the nuclear medicine specialist before using this medicine.
You must inform the nuclear medicine specialist before administration of Ioflupane ( I) ROTOP
if there is any possibility that you are pregnant, if you have missed your menstrual period,
or if you are breastfeeding.
If you have any doubts, it is important to consult the nuclear medicine specialist
responsible for performing the examination.
If you are pregnant, do not use Ioflupane ( I) ROTOP, as the unborn child could be exposed
to radiation. The possibility of using alternative techniques that do not involve radiation
should always be considered.
If you are breastfeeding, the nuclear medicine specialist may delay the use of
Ioflupane ( I) ROTOP or ask you to stop breastfeeding. It is not known whether ioflupane ( I)
is excreted in breast milk.

• You must not breastfeed your baby for 3 days after administration of Ioflupane ( I) ROTOP.
• Replace breastfeeding with infant formula. Breast milk should be expressed at regular intervals and discarded.
• You must continue to follow this procedure for 3 days, until radioactivity is no longer present in your body.

Driving and using machines
Ioflupane ( I) ROTOP does not affect the ability to drive or operate machinery.
Ioflupane ( I) ROTOP contains alcohol (ethanol) 4% by volume. Each dose contains up to 79 mg of
alcohol, equivalent to less than 2 mL of beer or 0.8 mL of wine.
The small amount of alcohol in this medicine will not produce any significant effect.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
‘sodium-free’.

3. How to use Ioflupane (I) ROTOP

There are strict regulations regarding the use, handling, and disposal of radioactive materials.
Ioflupane (I) ROTOP must always be used in a hospital or similar facility. It must be handled and administered only by trained and qualified personnel capable of using it safely. The medical staff will provide you with all instructions to follow for the safe use of this medicinal product.
The nuclear medicine specialist performing the examination will determine the most appropriate dose of Ioflupane (I) ROTOP for you. This will be the minimum dose necessary to obtain the required diagnostic information.

Before receiving Ioflupane (I) ROTOP, the nuclear medicine specialist will ask you to take tablets or liquid containing iodine to prevent the accumulation of radioactivity in the thyroid gland. It is important that you take these tablets or liquid exactly as instructed by your doctor.

Administration of Ioflupane (I) ROTOP and performance of the examination
Ioflupane (I) ROTOP is administered by injection, usually into a vein in the arm. The recommended amount for an adult is typically between 111 and 185 MBq (megabecquerel, the unit used to measure radioactivity). A single injection is sufficient.

Duration of the examination
Imaging is usually performed between 3 and 6 hours after the injection of Ioflupane (I) ROTOP.
The nuclear medicine specialist will inform you about the expected duration of the examination.

After administration of Ioflupane (I) ROTOP, you should urinate frequently to rapidly eliminate the product from your body.
The nuclear medicine specialist will inform you of any special precautions to follow after administration of the medicinal product. If you have any questions, please consult your nuclear medicine specialist.

If you are given more Ioflupane (I) ROTOP than you should receive
Since Ioflupane (I) ROTOP is administered by a doctor under strict control, it is unlikely that you will receive an excessive dose. The nuclear medicine specialist will advise you to drink large amounts of fluid to help your body eliminate the medicinal product. You will need to pay particular attention when urinating; the doctor will give you specific instructions on this matter. This is a standard procedure with medicinal products such as Ioflupane (I) ROTOP. Any residual ioflupane (I) remaining in the body will naturally lose its radioactivity over time.

If you have any further questions about the use of this medicinal product, please consult the nuclear medicine specialist responsible for performing the examination.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone experiences them. The frequency of side effects 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 disturbance
• Nausea
• Dry mouth
• Vertigo
• Brief sensation of irritation similar to ants crawling on the skin (paraesthesia)
• Intense pain (or burning sensation) at the injection site. This has been reported in patients in whom the injection of Ioflupane (¹²³I) ROTOP was administered into a small vein.

Not known: frequency cannot be estimated from the available data

• Hypersensitivity (allergy)
• Difficulty breathing
• Skin redness
• Itching
• Rash
• Hives (urticaria)
• Excessive sweating
• Vomiting
• Low blood pressure
• Feeling of warmth

This radiopharmaceutical will release low doses of ionizing radiation, associated with a minimal risk of cancer and hereditary damage.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please contact your specialist in nuclear medicine. You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Ioflupane (I) ROTOP

You should not store this medicinal product. This medicine is stored under the responsibility of a specialist and in suitable premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended exclusively for the specialist:
Do not use this medicinal product after the expiry date stated on the label.
Hospital staff will ensure that the product is properly stored and disposed of, and that it is not used after the expiry date indicated on the label.

6. Package contents and other information

What Ioflupane ( I) ROTOP contains

• The active substance is ioflupane ( I). Each mL of solution contains ioflupane ( I) 74 MBq at the reference date and time (from 0.07 to 0.13 micrograms/mL of ioflupane).
• The excipients are acetic acid, sodium acetate, ethanol and water for injections.

Description of the appearance of Ioflupane ( I) ROTOP and contents of the pack
Ioflupane ( I) ROTOP is a 2.5 mL colourless injectable solution supplied in a single
10 mL colourless glass vial sealed with a butyl rubber closure and metal cap.
Marketing Authorisation Holder and Manufacturer
ROTOP Radiopharmacy GmbH
Bautzner Landstraße 400
01328 Dresden
Germany
Telephone: +49 (0)351 26 31 02 10
Fax: +49 (0)351 26 31 03 13
E-Mail: [email protected]
The following information is intended exclusively for physicians or healthcare professionals:
The complete Summary of Product Characteristics (SmPC) for Ioflupane ( I) ROTOP 74 MBq/mL
Injectable Solution is provided as a separate document within the medicinal product packaging, in order to
provide healthcare professionals with additional practical and scientific information on the administration and use
of this radiopharmaceutical. Refer to the SmPC.