IOFLUPANO (123I) ROTOP 74 MBq/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Ioflupane (123I) ROTOP 74 MBq/ml Solution for Injection EFG

Ioflupane (123I)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor, who will be supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

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

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

This medicine is a radiopharmaceutical for diagnostic use only.

Ioflupane (123I) ROTOP contains the active substance ioflupane (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 scintigram. This scintigram will show exactly where the radioactivity is in the organ and the body, which can provide the doctor with valuable information about how that organ is working.

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

• Parkinson's disease (including Parkinson's disease) and
• Lewy body dementia.

The image will give your doctor information about any changes in this area of your brain. This image will help your doctor learn more about your disease and decide on possible treatment.

When using Ioflupane (123I) ROTOP, you are exposed to small amounts of radioactivity. This exposure is less than in some types of X-ray examinations. Your doctor and nuclear medicine doctor have decided that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of exposure to these small amounts of radiation.

2. What you need to know before you use Ioflupane (123I) ROTOP

Do not use Ioflupane (123I) ROTOP

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

Warnings and precautions

Talk to your nuclear medicine doctor before using Ioflupane (123I) ROTOP if you have moderate or severe kidney or liver problems.

Before administration of Ioflupane (123I) ROTOP, you mustdrink plenty of water before the start of the examination to urinate as frequently as possible during the first few hours after the study.

Children and adolescents

Ioflupane (123I) ROTOP is not recommended in children from 0 to 18 years.

Other medicines and Ioflupane (123I) ROTOP

Tell your nuclear medicine doctor if you are taking or have recently taken any other medicines. Some medicines or substances may affect how this medicine works. These include:

• bupropion (used to treat depression)
• benzatropine (used to treat Parkinson's disease)
• mazindol (reduces appetite, used to treat obesity)
• sertraline (used to treat depression)
• methylphenidate (used to treat hyperactivity in children and narcolepsy)
• phentermine (reduces appetite, used to treat obesity)
• amphetamine (used to treat hyperactivity in children and narcolepsy; also a drug of abuse)
• cocaine (sometimes used as an anesthetic for nose surgery; also a drug of abuse)

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor before this medicine is administered to you.

You must inform your nuclear medicine doctor before administration of Ioflupane (123I) ROTOP if you might be pregnant, if you have a delayed period, or if you are breast-feeding.

In case of doubt, it is important that you talk to your nuclear medicine doctor, who will be supervising the procedure.

If you are pregnant, do not use Ioflupane (123I) ROTOP. This is because the fetus may receive some of the radioactivity. In this case, alternative techniques that do not involve radioactivity should be considered.

If you are breast-feeding, your nuclear medicine doctor may delay the use of Ioflupane (123I) ROTOP or ask you to interrupt breast-feeding. It is not known if ioflupane (123I) passes into breast milk.

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

Driving and using machines

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

Ioflupane (123I) ROTOPcontains 4% ethanol (alcohol), which corresponds 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 noticeable effects.

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

3. How to use Ioflupane (123I) ROTOP

There are strict laws on the use, handling, and disposal of radioactivity. Ioflupane (123I) ROTOP will always be used in a hospital or similar setting. It will only be handled and administered by trained and qualified personnel who are able to use it safely. These personnel will inform you about what you need to do for the safe use of this medicine.

The nuclear medicine doctor supervising the procedure will decide on the amount of Ioflupane (123I) ROTOP to be used in your case. This will be the smallest amount necessary to obtain the desired information.

Before receiving Ioflupane (123I) ROTOP, your nuclear medicine doctor will ask you to take some tablets or liquids containing iodine. These stop the accumulation of radioactivity in the thyroid gland. It is important that you take the tablets or liquid as directed by your doctor.

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

Ioflupane (123I) ROTOP is administered by injection, usually into a vein in the arm. The recommended amount to be administered to an adult varies from 111 to 185 MBq (megabecquerel, the unit used to express radioactivity). A single injection is sufficient.

Duration of the procedure

Images are usually taken with the camera between 3 and 6 hours after injection of Ioflupane (123I) ROTOP.

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

After administration of Ioflupane (123I) ROTOP, you musturinate frequently to quickly eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. If you have any questions, talk to your nuclear medicine doctor.

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

Since Ioflupane (123I) ROTOP is administered by a doctor under controlled conditions, it is unlikely that you will experience an overdose. Your nuclear medicine doctor will suggest that you drink plenty of fluids to help your body eliminate the medicine. You should be careful with the urine you eliminate; your doctor will tell you what to do. This is a normal practice with medicines like Ioflupane (123I) ROTOP. Any remaining ioflupane (123I) in your body will naturally lose its radioactivity.

If you have any further questions on the use of this medicine, ask your nuclear medicine doctor, who will be supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects is:

Common: may affect up to 1 in 10 people

• Headache

Uncommon: may affect up to 1 in 100 people

• Increased appetite
• Dizziness
• Altered taste
• Nausea
• Dry mouth
• Vertigo
• A brief sensation of irritation like ants walking on your skin (tingling)
• Severe pain (or burning sensation) at the injection site. This has been reported in patients who received Ioflupane (123I) ROTOP in a small vein.

Frequency not known: cannot be estimated from the available data

• Hypersensitivity (allergic reaction)
• Shortness of breath
• Redness of the skin
• Itching
• Rash
• Hives on the skin (urticaria)
• Excessive sweating
• Vomiting
• Low blood pressure
• Feeling of heat

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ioflupane (123I) ROTOP

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on 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 stored and disposed of correctly and not used after the expiry date stated on the label.

6. Contents of the pack and further information

Composition of Ioflupane (123I) ROTOP

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

Appearance of the product and pack contents

Ioflupane (123I) ROTOP is a clear, colorless solution for injection. 2.5 ml or 5 ml of this solution are supplied in a single 10 ml glass vial sealed with a butyl rubber stopper and a metal cap.

Marketing authorisation holder and manufacturer

ROTOP Radiopharmacy GmbH

Bautzner Landstrasse 400

01328 Dresden

Germany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas, Madrid

Spain

Date of last revision of this leaflet: March 2023

This information is intended for healthcare professionals only:

The full summary of product characteristics of Ioflupane (123I) ROTOP 74 MBq/ml solution for injection EFG is included as a tear-off section at the end of this leaflet in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. See the summary of product characteristics.