IOFLUPANE (123I) ROTOP 74 MBQ/ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you are given 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 supervise the procedure.

• If you get any side effects, talk to your nuclear medicine doctor.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

• 2. What you need to know before Ioflupane (123 I) Rotop is used

• 3. How Ioflupane (123 I) Rotop is used

• 4. Possible side effects

• 5. How Ioflupane (123 I) Rotop is stored

• 6. Contents of the pack and other information

1. what ioflupane (123 i) rotop is and what it is used for

This medicine is a radiopharmaceutical product for diagnostic use only.

Ioflupane (123 I) Rotop contains the active substance ioflupane (123I) which is used to help identify (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 collects in a specific organ or area of the body for a short time.
• Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras.
• A picture, known as a scan, can be taken. This scan will show exactly where the radioactivity is inside the organ and the body. This can give the doctor valuable information about how that organ is working.

When Ioflupane (123I) Rotop is injected into an adult, it is carried around the body in the blood. It collects in a small area of your brain. Changes in this area of the brain occur in:

• Parkinsonism (including Parkinson’s di­sease) and
• dementia with Lewy bodies.

A scan will give your doctor information about any changes in this area of your brain. Your doctor may feel that the scan would help in finding out more about your condition and deciding on possible treatment.

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

2. what you need to know before ioflupane (123 i) rotop is used

Ioflupane (123 I) Rotop must not be used

• 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 problems with your kidneys or liver.

Before administration of Ioflupane (123 I) Rotop you should drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study.

Children and adolescents

Ioflupane (123I) Rotop is not recommended for children aged 0 to 18 years.

Other medicines and Ioflupane (123 I) Rotop

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

• bupropion (used to treat depression (sadness))
• benzatropine (used to treat Parkinson’s di­sease)
• mazindol (reduces appetite, as a means to treat obesity)
• sertraline (used to treat depression (sadness))
• methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))
• phentermine (reduces appetite, as a means to treat obesity)
• amphetamine (used to treat hyperactivity in children and

narcolepsy (excessive sleepiness); also, a drug of abuse)

• cocaine (sometimes used as an anaesthetic for nose surgery; also, a drug of abuse)

Some medicines may reduce the quality of the picture obtained. The doctor may ask you to stop taking them for a short time before you receive 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 for advice before you are given this medicine.

You must inform the nuclear medicine doctor before the administration of Ioflupane (123I) Rotop if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.

When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant, do not use Ioflupane (123I) Rotop. This is because the child may receive some of the radioactivity. Alternative techniques which 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 stop breast-feeding. It is not known whether ioflupane (123I) is passed into breast milk.

• You should not breast-feed your child for 3 days after Ioflupane (123I) Rotop is given.
• Instead use formula feed for your child. Express your breast milk regularly and throw away any breast milk you have expressed.
• You will need to continue to do 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 (123 I) Rotop contains alcohol (ethanol) 4% by volume.

Each dose contains up to 158 mg of alcohol. This is equivalent to less than 4 ml beer or 1.6 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

3. How Ioflupane (123 I) Rotop is used

There are strict laws on the use, handling and disposal of radioactivity. Ioflupane (123I) Rotop will always be used in a hospital or a similar place. It will only be handled and given to you by people who are trained and qualified to use it safely. They should tell you anything you need to do for the safe use of this medicine.

The nuclear medicine doctor supervising the procedure will decide on the quantity of Ioflupane (123I) Rotop to be used in your case. It will be the smallest quantity necessary to get the desired information.

Before you receive Ioflupane (123I) Rotop, your nuclear medicine doctor will ask you to take some tablets or liquid that contain iodine. These stop the radioactivity building-up in your thyroid gland. It is important that you take the tablets or liquid as the doctor tells you.

Administration of Ioflupane (123 I) Rotop and conduct of the procedure

Ioflupane (123I) Rotop is given to you as an injection, usually into a vein in your arm. The quantity to be administered usually recommended for an adult ranges from 111 to 185 MBq (megabecquerel, the unit used to express radioactivity). A single injection is enough.

Duration of the procedure

The camera pictures are usually taken 3 to 6 hours after the injection of Ioflupane (123I) Rotop.

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

After administration of Ioflupane (123 I) Rotop, you should urinate frequently in order to eliminate the product from your body quickly.

The Nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

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

Since Ioflupane (123I) Rotop is given by a doctor under controlled conditions, it is unlikely that you will get an overdose. Your nuclear medicine doctor will suggest that you drink plenty of fluids to help the body get rid of the medicine. You will need to be careful with the water (urine) that you pass – your doctor will tell you what to do. This is normal practice with medicines like Ioflupane (123I) Rotop. Any ioflupane (123I) which remains in your body will naturally lose its radioactivity.

If you have any further question on the use of this medicine, please ask the nuclear medicine doctor who supervises 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
• Taste disturbance
• Nausea
• Dry mouth
• Vertigo
• A brief irritating feeling similar to ants crawling over your skin

(formication)

• Intense pain (or burning sensation) at the site of injection. This

has been reported among patients receiving Ioflupane (123I) Rotop into a small vein.

Not known: frequency cannot be estimated from the available data

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

This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. How Ioflupane (123 I) Rotop is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmace­uticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only.

Do not use this medicine after the expiry date which is stated on the label.

Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.

6. contents of the pack and other information the active substance is ioflupane (123i). each ml of solution contains ioflupane (123i) 74 mbq at reference time (0.07 to 0.13 pg/ml of ioflupane).

• The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.

What Ioflupane (123 I) Rotop looks like and contents of the pack

Ioflupane (123I) Rotop is a colourless solution for injection. 2.5 ml or 5 ml of this solution are supplied in a single colourless 10 ml glass vial sealed with a butyl rubber stopper and metal overseal.

Marketing Authorisation Holder and Manufacturer

ROTOP Radiopharmacy GmbH

Bautzner Landstralie 400

01328 Dresden, Germany

Telephone: +49 (0)351 26 31 02 10

Fax: +49 (0)351 26 31 03 13

E-Mail:

This leaflet was last revised in September 2021.

The following information is intended for healthcare professionals only:

The complete Summary of Product Characteristics (SmPC) of Ioflupane (123I) Rotop 74 MBq/ml Solution for injection is provided as a separate document in the product packaging, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmace­utical. Please refer to the SmPc.