Ioflupane (123I) Rotop 74 MBq/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ioflupane (123I) ROTOP 74 MBq/ml solution for injection EFG

Ioflupane (123I)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician, who will supervise the procedure.
• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine is a radiopharmaceutical intended for diagnostic use only.

Ioflupano (123I) ROTOP contains the active substance ioflupano (123I), which is used to help detect (diagnose) conditions in the brain. It belongs to a group of medicines called "radiopharmaceuticals", which contain a small amount of radioactivity.

• When a radiopharmaceutical is injected, it accumulates in a specific organ or area of the body for a short period of time.
• Because it contains a small amount of radioactivity, it can be detected from outside the body using special cameras.
• An image can be taken, known as a scintigraphy. This scintigraphy will show exactly where the radioactivity is located within the organ and the body, providing the doctor with valuable information about how that organ is functioning.

When Ioflupano (123I) ROTOP is injected into an adult, it is distributed throughout the body via the bloodstream. It accumulates in a specific area of the brain. Changes in this area of the brain occur in:

• Parkinsonism (including Parkinson's disease) and
• Dementia with Lewy bodies.

The image will provide your doctor with information about any changes in this area of your brain. This image will help your doctor learn more about your condition and decide on appropriate treatment.

When Ioflupano (123I) ROTOP is used, you are exposed to small amounts of radiation. This exposure is less than that of some types of X-ray scans. Your doctor and the nuclear medicine physician have determined that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk associated with exposure to these small amounts of radiation.

2. What you need to know before using Ioflupano (123I) ROTOP

Do not use Ioflupano (123I) ROTOP

• if you are allergic to ioflupano (123I) or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.

Warnings and precautions

Consult your nuclear medicine physician before using Ioflupano (123I) ROTOP if you have moderate or severe kidney or liver problems.

Before administration of Ioflupano (123I) ) ROTOP, you must drink plenty of water before and after the procedure to urinate as frequently as possible during the first 48 hours following completion.

Children and adolescents

Ioflupano (123I) ROTOP is not recommended for children and adolescents between 0 and 18 years of age.

Other medicines and Ioflupano (123I) ROTOP

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines. Some medicines and substances may affect how Ioflupano (123I) ROTOP works.

These medicines include:

• bupropion (used to treat depression or to stop smoking)
• sertraline, paroxetine, citalopram, escitalopram, fluoxetine, fluvoxamine (used to treat depression)
• methylphenidate, methamphetamine (used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (excessive sleepiness))
• phentermine (appetite suppressant, used as a means to treat obesity)
• amphetamine
• cocaine (sometimes used as an anesthetic for nasal surgery)
• modafinil (used to treat narcolepsy [excessive sleepiness] and other sleep disorders)
• codeine (used to relieve mild to moderate pain and to suppress dry cough)

Some medicines may reduce the quality of the resulting image. Your doctor may ask you to stop taking them for a short period before receiving Ioflupano (123I) ROTOP.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

You must inform the nuclear medicine physician before administration of Ioflupano (123I) ROTOP if there is any possibility that you are pregnant, if you have missed your period, or if you are breastfeeding.

If in doubt, it is important that you consult your nuclear medicine physician, who will supervise the procedure.

If you are pregnant, do not use Ioflupano (123I) ROTOP. This is because the fetus may be exposed to some of the radioactivity. In such cases, alternative techniques not involving radioactivity should be considered.

If you are breastfeeding, your nuclear medicine physician may delay the use of Ioflupano (123I) ROTOP or ask you to interrupt breastfeeding. It is not known whether ioflupano (123I) passes into breast milk.

• Do not breastfeed your baby for 3 days after administration of Ioflupano (123I) ROTOP.
• Use infant formula to feed your child. Express breast milk regularly and discard the milk you express.
• You must continue doing this for 3 days, until the radioactivity is no longer in your body.

Driving and using machines

Ioflupano (123I) ROTOP has no known influence on the ability to drive and use machines.

Ioflupano (123I) ROTOP contains 4% ethanol (alcohol), corresponding to an amount of 158 mg per dose, equivalent to less than 4 ml of beer or 1.6 ml of wine.

The small amount of alcohol in this medicine has no perceptible effects.

This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., it is essentially "sodium-free".

3. How to use Ioflupano (123I) ROTOP

There are strict regulations regarding the use, handling, and disposal of radioactive substances. Ioflupano (123I) ROTOP will always be used in a hospital or similar facility. Only trained and qualified personnel will handle and administer it, ensuring its safe use. These individuals will inform you about the necessary precautions for the safe use of this medicine.

The nuclear medicine physician supervising the procedure will determine the amount of Ioflupano (123I) ROTOP to be used in your case. This will be the smallest amount necessary to obtain the required diagnostic information.

Before receiving Ioflupano (123I) ROTOP, your nuclear medicine physician will ask you to take certain tablets or liquid containing iodine. These are used to prevent the accumulation of radioactivity in the thyroid gland. It is important that you take the tablets or liquid exactly as directed by your physician.

Administration of Ioflupano (123I) ROTOP and performance of the procedure

Ioflupano (123I) ROTOP is administered by injection, usually into a vein in the arm. The recommended amount for an adult typically ranges from 111 to 185 MBq (megabecquerels, a unit used to measure radioactivity). A single injection is sufficient.

Duration of the procedure

In general, imaging with the camera is performed between 3 and 6 hours after the injection of Ioflupano (123I) ROTOP.

Your nuclear medicine physician will inform you about the usual duration of the procedure.

After administration of Ioflupano (123I) ROTOP, you should urinate frequently to help eliminate the product from your body quickly.

The nuclear medicine physician will inform you whether you need to take any special precautions after receiving this medicine. If you have any questions, consult your nuclear medicine physician.

If you have been given more Ioflupano (123I) ROTOP than you should

Since Ioflupano (123I) ROTOP is administered by a physician under controlled conditions, it is unlikely that you will experience an overdose. Your nuclear medicine physician may advise you to drink plenty of fluids to help your body eliminate the medicine. You should take care when disposing of your urine; your physician will instruct you on the necessary precautions. This is standard practice with radiopharmaceuticals such as Ioflupano (123I) ROTOP. Any residual ioflupano (123I) remaining in your body will naturally lose its radioactivity over time.

If you have any doubts about the use of this medicine, consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The frequency of adverse effects is:

Frequent: 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
• A brief sensation of irritation similar to ants crawling on the skin (tingling)
• Severe pain (or burning sensation) at the injection site. This has been reported among patients who received Ioflupano (123I) ROTOP into a small vein.

Frequency not known: cannot be estimated from the available data

• Hypersensitivity (allergic reaction)
• Shortness of breath
• Skin redness
• Itching
• Rash
• Skin welts (urticaria)
• Excessive sweating
• Vomiting
• Low blood pressure
• Feeling of warmth

The amount of radioactivity in the body as a result of the injection of Ioflupano (123I) ROTOP is very small and will be eliminated from the body within a few days without requiring special precautions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ioflupane (123I) ROTOP

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will comply with national regulations concerning radioactive materials.

The following information is intended for healthcare professionals only.

Do not use this medicine 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. Contents of the container and other information

Composition of Ioflupano (123I) ROTOP

• The active substance is ioflupano (123I). Each ml of solution contains 74 MBq of ioflupano (123I) at the reference time (0.07 to 0.13 micrograms/ml of ioflupano).
• The other components are acetic acid, sodium acetate, ethanol, and water for injections.

Presentation of the product and contents of the container

Ioflupano (123I) ROTOP is a colourless injectable solution. It is supplied in 2.5 ml or 5 ml of this solution in a single 10 ml colourless glass vial, sealed with a butyl rubber stopper and a metal crimp cap.

Marketing Authorization Holder and Manufacturer

ROTOP Radiopharmacy GmbH
Bautzner Landstrasse 400
01328 Dresden
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Curium Pharma Spain S.A.
Avda. Doctor Severo Ochoa, 29
28100 Alcobendas, Madrid
Spain

Date of the most recent review of this leaflet: October 2025

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics for Ioflupano (123I) ROTOP 74 MBq/ml solution for injection EFG is included as a detachable section at the end of this leaflet within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. Please consult the Summary of Product Characteristics.