Label: information for the patient

Ioflupano (123I) ROTOP 74 MBq/ml injectable solution EFG

Ioflupano (123I)

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

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

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

3.How to use Ioflupano (123I) ROTOP

4.Possible adverse effects

5.Storage of Ioflupano (123I) ROTOP

6.Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Ioflupano (123I) ROTOP contains the active ingredient ioflupano (123I) which is used to help detect (diagnose) conditions in the brain. It belongs to a group of medications 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.
• As it contains a small amount of radioactivity, it can be detected from the outside of the body using special cameras.
• A picture, known as a gamma scan, can be taken. This gamma scan will show exactly where the radioactivity is located within the organ and the body, which can provide valuable information to the doctor about how the organ is functioning.

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

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

The image will provide the doctor with information about any changes in this area of the brain. This image will help the doctor to know more about the disease and decide on possible treatment.

When Ioflupano (123I) ROTOP is used, you are exposed to small amounts of radioactivity. This exposure is less than in some types of radiographic examinations. Your doctor and the 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.

No useIoflupano (123I) ROTOP

• if you are allergic to ioflupano (123I) or any of the other components of this medication (listed in section6).
• if you are pregnant.

Warnings and precautions

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

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

Children and adolescents

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

Other medications and Ioflupano (123I) ROTOP

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

• bupropion (used to treat depression (sadness))
• benzatropine (used to treat Parkinson's disease)
• mazindol (reduces appetite, used to treat obesity)
• sertraline (used to treat depression (sadness))
• methyphenidate (used to treat hyperactivity in children and narcolepsy (tendency to sleep))
• fentermine (reduces appetite, used to treat obesity)
• amphetamine (used to treat hyperactivity in children and narcolepsy (tendency to sleep); also a controlled substance)
• cocaine (sometimes used as an anesthetic for nasal surgery; also a controlled substance)

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your nuclear medicine doctor before this medication is administered.

You must inform your nuclear medicine doctor before administration of Ioflupano (123I) ROTOP if there is a possibility you are pregnant, if you experience a delay in your period, or if you are breastfeeding.

It is essential to consult your nuclear medicine doctor, who will oversee the procedure, in case of doubt.

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

If you are breastfeeding, your nuclear medicine doctor may delay the use of Ioflupano (123I) ROTOP or ask you to stop breastfeeding.The passage of ioflupano (123I) into breast milk is unknown.

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

Driving and operating machinery

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

Ioflupano (123I) ROTOPcontains4% ethanol (alcohol), which corresponds to a quantity 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 medication has no perceptible effects.

This medication containsless than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

There are strict laws regarding the use, handling, and disposal of radioactivity.Ioflupan (123I) ROTOPwill be used only in a hospital or a similar setting. Only trained and qualified personnel will handle and administer it safely. These individuals will inform you on how to use this medication safely.

The nuclear physician overseeing the procedure will decide the amount of Ioflupan (123I) ROTOP to be used in your case. This will be the minimum amount necessary to obtain the desired information.

Before receiving Ioflupan (123I) ROTOP, your nuclear physician will ask you to take some tablets or liquids containing iodine. These prevent the accumulation of radioactivity in the thyroid gland. It is essential that you take the tablets or liquid as instructed by your physician.

Administration of Ioflupan (123I) ROTOP and procedure

Ioflupan (123I) ROTOP is administered as an injection, usually into a vein in the arm. The recommended dose for an adult typically ranges from 111 to 185MBq (megabecquerel, the unit used to express radioactivity). A single injection is sufficient.

Procedure duration

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

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

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

Your nuclear physician will inform you if you need to take any special precautions after receiving this medication. If you have any questions, consult your nuclear physician.

If you have been administered more Ioflupan (123I) ROTOP than you should

Since Ioflupan (123I) ROTOP is administered by a physician in controlled conditions, it is unlikely that you will experience an overdose. Your nuclear physician will suggest that you drink plenty of liquids to help your body eliminate the medication. You should be careful with the urine you eliminate; your physician will tell you what to do. Any remaining ioflupan (123I) in your body will naturally lose its radioactivity.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them. The frequency of adverse effects is:

Frequent: may affect up to 1 in 10 people

• Headache

Infrequent: may affect up to 1 in 100 people

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

Unknown frequency: cannot be estimated from available data

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

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effects, consult your nuclear physician, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials

The following information is intended solely for healthcare professionals.

Do not use this medication after the expiration date that appears on the label.

Hospital staff will ensure that the product is properly stored and disposed of and that it is not used after the expiration date indicated on the label.

Composition of Ioflupano (123I) ROTOP

• The active principle 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 injectable preparations.

Appearance of the product and contents of the packaging

Ioflupano (123I) ROTOP is an colorless injectable solution. 2.5 ml or 5 ml of this solution are supplied in a single 10 ml colorless glass vial sealed with a butyl rubber stopper and a metal closure.

Holder of the marketing authorization and responsible manufacturer

ROTOP Radiopharmacy GmbH

Bautzner Landstrasse 400

01328 Dresden

Germany

Further information about this medication can be requested from the local representative of the marketing authorization holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas. Madrid

Spain

Last review date of this prospectus: March 2023

This information is intended solely for healthcare professionals:

The complete technical data sheet of Ioflupano (123I) ROTOP 74MBq/ml injectable solution EFG is included as a detachable section at the end of this prospectus 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. Consult the technical data sheet.