DaTSCAN 74 MBq/ml solution for injection

DaTSCAN 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 DaTSCAN 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 Parkinsons 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 DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than in some types of X-ray investigation. Your doctor will always consider the possible risks and benefits of DaTSCAN.

This medicine is used for diagnostic use only. It is used only to identify illness.

Do not use DaTSCAN if:

you are allergic hypersensitive to ioflupane or any of the other ingredients of DaTSCAN see Section 6 Further Information.

you are pregnant

Take special care with DaTSCAN

DaTSCAN is not recommended for:
- people with moderate or severe problems with their kidneys or liver

Use in Children

DaTSCAN is not recommended for:
- children aged 0 to 18 years

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines or substances can affect the way that DaTSCAN works. These include buproprion used to treat depression sadness benzatropine used to treat Parkinsons 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 amfetamine used to treat hyperactivity in children and narcolepsy excessive sleepinessalso 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 DaTSCAN.

Pregnancy and breast-feeding

Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant. This is because the child may receive some of the radioactivity. Tell your doctor if you think you might be pregnant. Alternative techniques which do not involve radioactivity should be considered.

If you are breast-feeding, your doctor may delay the use of DaTSCAN, 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 DaTSCAN 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

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

Important information about some of the ingredients of DaTSCAN

DaTSCAN contains alcohol (ethanol) 5 % by volume. Each dose contains up to 197 mg alcohol. This is about the same as 5 ml beer, or 2 ml wine. This is harmful for those suffering from alcoholism. To 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 any of these apply to you.

There are strict laws on the use, handling and disposal of radioactivity. DaTSCAN 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.

Your doctor will decide the dose that is best for you.

Before you receive DaTSCAN, your 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.

DaTSCAN is given to you as an injection, usually into a vein in your arm. The recommended radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to measure radioactivity). A single injection is enough. The camera pictures are usually taken 3 to 6 hours after the injection of DaTSCAN.

If you get more DaTSCAN than you should

Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an overdose. Your 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 DaTSCAN. Any ioflupane ( 123I) which remains in your body will naturally lose its radioactivity.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, DaTSCAN can cause side effects, although not everybody gets them.

The frequency of side effects is:

Common: affects 1 to 10 users in 100

• Headache

Uncommon: affects 1 to 10 users in 1,000

• Increased appetite
• Dizziness
• Taste disturbance
• Nausea
• Dry mouth
• Vertigo
• A brief irritating feeling similar to ants crawling over your skin (formication)
• Intense pain on injection. This has been reported among patients receiving DaTSCAN into a small vein

Not known: frequency cannot be estimated from the available data.

• Hypersensitivity (allergic)

The amount of radioactivity in the body from DaTSCAN is very small. It will be passed out of the body in a few days without need for you to take special precautions.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Do not use DaTSCAN after the expiry date, which is stated on the carton and vial after EXP. Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.

What DaTSCAN contains

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

What DaTSCAN looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GE Healthcare Limited
Little Chalfont
Bucks HP7 9NA
United Kingdom

Manufacturer:

GE Healthcare B.V.
Den Dolech 2
NL-5612 AZ, Eindhoven
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem TélTel 32 0 2 719 7410 Lietuva GE Healthcare co Nycomed Lithuania Seimyniskiu 3 LT-2005 Vilnius Tel. 370 68 726 753

LuxembourgLuxemburg GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem BelgiëBelgiqueBelgien TélTel 32 0 2 719 7410 GE Healthcare South Central Europe Handels GmbH Representative Office Bulgaria 36 Dragan Tsankov blvd, World Trade Centre, Office B405-406, Sofia 1040 . 3592 973 3174

eská republika Magyarország GE Healthcare South Central Europe Handels GE Healthcare South Central Europe GmbH Branch Office Czech Republic Vyskocilova 14221a CZ 140 28 Praha 4 Tel 420 224 446 179 Handels GmbH Representative Office Hungary Akron u. 2 H-2040 Budaörs Tel 36 23 410 412

Danmark GE Healthcare AS Huginsvej 8 DK-3400 Hillerød Tlf 45 70 2222 03 Malta Pharma-Cos Ltd. Pharma-Cos House Triq C. Portanier MT Santa Venera HMR 11 Tel 356 21441 870

Deutschland GE Healthcare Buchler GmbH Co. KG Gieselweg 1 D-38110 Braunschweig Tel 49 0 5 307 93 00 Norge GE Healthcare AS Nycoveien 1-2 NO-0401 Oslo Tlf 47 23 18 50 50

Eesti GE Healthcare Estonia OÜ Mustamäe tee 46 EE - 10621 Tallinn Tel 372 6260 061 Nederland GE Healthcare B.V. De Rondom 8 NL-5612 AP, Eindhoven Tel 31 0 40 299 10 00

GE Healthcare A.E. 139 GR 141 21 . 30 210 805 08 64 Österreich GE Healthcare Handels GmbH Europlaza Gebäude E Wienerbergstrasse 41 Technologiestrasse 10 A-1120 Wien Tel 43 0 1 97272-0

España GE Healthcare Bio-Sciences, S.A. Polska GE Healthcare South Central Europe

C Gobelas, 35-37 28023 Madrid Tel 34 91 663 25 00 Handels GmbH Representative Office Poland 2, Stawki PL-00 193 Warszawa Tel. 48 22 6356886611

France GE Healthcare SA 11 avenue Morane Saulnier F-78140 Vélizy Villacoublay Tél 33 1 34 49 54 54 Portugal Satis GE Healthcare Edifico Ramazzotti Av. Do Forte n 6-6A 2790-072 Carnaxide Tel 351 214251352

Ireland GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel 44 0 1494 54 40 00 România GE Healthcare South Central Europe Handels GmbH Representative Office Str.Navodari No.42 Sc.2 et.2 014108 Bucharest Tel 0040 21 2321153

Ísland Icepharma Lynghálsi 13 IS-110 Reykjavik Sími 354 540 8000 Slovenija Higiea d.o.o Blatnica 10 SI-1236 Trzin Tel 386 1 589 722125

Italia GE Healthcare S.r.l. Via Galeno 36 I-20126 Milano Tel 39 02 26001 111 Slovenská republika GE Healthcare South Central Europe Handels GmbH Branch Office Slovakia Florianske nám 2 SK-811 07 Bratislava Tel 421 2 5542 5948

Phadisco Ltd 185 CY-2235 357 22 715000 SuomiFinland Oy GE Healthcare Bio-Sciences Ab Kuortaneenkatu 2 FIN-00510 Helsinki PuhTel 358 10 39411

Latvija General Electric International Inc. Meza Str.4 Riga, LV-1048 Tel 371 780 7086 Sverige GE Healthcare AB Solna Strandväg 98 S-171 54 Solna Tel 46 0 8 559 504 00

United Kingdom

GE Healthcare Limited Amersham Place
Little Chalfont HP7 9NA-UK Tel: +44 (0) 1494 54 40 00

This leaflet was last approved in MM/YYYY