DATSCAN 74 MBq/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

DaTSCAN 74 MBq/ml solution for injection

Ioflupane (123I)

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 is 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.

What is in this leaflet

1. What DaTSCAN is and what it is used for

1. What you need to know before you are given DaTSCAN
   1. How to use DaTSCAN
   2. Possible side effects
   3. Storing DaTSCAN

1. Contents of the pack and other information

1. What DaTSCAN is and what it is used for

DaTSCAN contains the active substance ioflupane (123I) which is used to help diagnose diseases 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 a special medical device called a gamma camera.
• An image, known as a scintigraphy, can be obtained. This scintigraphy will show exactly the distribution of the radiopharmaceutical in a specific organ and in the body. This can give your doctor valuable information about the structure of that organ.

When DaTSCAN 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:

• Parkinsonism (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 DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than in some types of radiographic examinations. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of being exposed to small amounts of radiation.

This medicine is used only for diagnostic purposes. It is used only to identify the disease.

2. What you need to know before you are given DaTSCAN

DaTSCAN must not be used

• if you are allergic to ioflupane 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 you are given DaTSCAN if you have moderate or severe kidney or liver problems.

Children and adolescents

DaTSCAN is not recommended for children from 0 to 18 years.

Other medicines and DaTSCAN

Tell your nuclear medicine doctor if you are using or have recently used other medicines. Some medicines and substances can affect how DaTSCAN works. These medicines include:

• bupropion (used to treat depression)
• benzatropine (used to treat Parkinson's disease)
• mazindol (decreases 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 used as a recreational drug)
• cocaine (sometimes used as an anesthetic for nose surgery; also used as a recreational drug)

Some medicines may reduce the quality of the image obtained. Your doctor may ask you to stop using them for a short period before you are given DaTSCAN.

Pregnancy and breastfeeding

Do not use DaTSCAN if you are pregnant or think you may be pregnant. This is because the baby may receive some radioactivity. Tell your nuclear medicine doctor if you think you may be pregnant. Alternative techniques that do not involve radioactivity should be considered.

If you are breastfeeding, your nuclear medicine doctor may postpone the use of DaTSCAN, or ask you to interrupt breastfeeding. It is not known if ioflupane (123I) passes into breast milk.

• Do not breastfeed your child for 3 days after receiving DaTSCAN.

• Use artificial milk to feed your child. Express breast milk periodically and discard it.
• You will have to do this for 3 days, until there is no radioactivity in your body.

Driving and using machines

DaTSCAN has no known influence on the ability to drive and use machines.

DaTSCAN containsalcohol (ethanol) at 5% by volume. Each dose contains up to 197 mg of alcohol, almost the same as 5 ml of beer or 2 ml of wine. This is harmful to people with alcoholism and should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy. Tell your doctor if this applies to you.

3. How to use DaTSCAN

There are strict laws regarding the use, handling, and disposal of radioactivity. DaTSCAN will always be used in a hospital or similar setting. It will only be handled and administered by trained and qualified personnel. These personnel will inform you about what you need to do for the safe use of this medicine. Your nuclear medicine doctor will decide what the best dose is for you.

Before you receive DaTSCAN, your nuclear medicine doctor will ask you to take some tablets or liquids that contain iodine. This slows down the accumulation of radioactivity in your thyroid gland. It is important that you take the tablets or liquids that your doctor tells you to.

DaTSCAN is administered as an injection, usually into a vein in the arm. The recommended radioactivity administered by injection is between 111 and 185 MBq (megabecquerels or MBq is a unit used to measure radioactivity). A single injection is sufficient. Images with the camera are usually taken between 3 and 6 hours after the injection of DaTSCAN.

If you are given more DaTSCAN than you should

Since DaTSCAN is administered by a doctor in strictly controlled conditions, it is unlikely that you will receive an overdose. Your nuclear medicine doctor will recommend that you drink plenty of fluids to speed up the elimination of the medicine from your body. You will need to be careful with the urine you pass: the doctor will tell you what to do. This is routine with medicines like DaTSCAN. Any remaining ioflupane (123I) that is retained in your body will naturally lose its radioactivity.

If you have any other questions about the use of this medicine, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

Like all medicines, DaTSCAN 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 sense of taste
• Nausea
• Dry mouth
• Vertigo
• A brief sensation of irritation similar to that of ants on the skin (tingling)
• Severe pain (or burning sensation) at the injection site. This has been reported in patients who received DaTSCAN in a small vein

Frequency not known: cannot be estimated from the available data

• Hypersensitivity (allergic)
• Shortness of breath
• Redness of the skin
• Itching
• Rash
• Hives on the skin (urticaria)
• Excessive sweating

• Vomiting
• Low blood pressure
• Feeling of heat

The amount of radioactivity in the body as a result of the injection of DaTSCAN is very small and will be eliminated from the body in a few days without the need for special precautions.

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing DaTSCAN

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 only for the specialist:

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not freeze.

Do not use this medicine after the expiry date which is stated on the packaging and vial after EXP. The expiry date refers to the last day of the month stated. 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 other information

Composition of DaTSCAN

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

Appearance and packaging

DaTSCAN is a clear, colourless solution for injection of 2.5 or 5 ml, supplied in a single 10 ml glass vial sealed with a rubber stopper and a metal overseal.

Marketing authorisation holder and manufacturer

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

Netherlands

You can obtain more information about this medicine by contacting the local representative of the marketing authorisation holder.

This leaflet was last revised in <{MM/AAAA}>

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.