Vizamyl

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

VIZAMYL 400 MBq/ml solution for injection

flutemetamol (F)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist responsible for performing the examination.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet:

1. What VIZAMYL is and what it is used for
2. What you need to know before using VIZAMYL
3. How to use VIZAMYL
4. Possible side effects
5. How to store VIZAMYL
6. Contents of the pack and other information

1. What VIZAMYL is and what it is used for

VIZAMYL contains the active substance flutemetanol (F) and is used to assist in the diagnosis of Alzheimer's disease and other causes of memory loss.
This medicinal product is a radiopharmaceutical intended solely for diagnostic use.
VIZAMYL is used to assist in the diagnosis of Alzheimer's disease and other causes of memory loss. It is administered to adults with memory problems prior to undergoing a type of brain scan called a PET scan (positron emission tomography). This scan, together with other tests evaluating brain function, can help your doctor determine whether or not you have beta-amyloid plaques in the brain. Beta-amyloid plaques are deposits that are sometimes found in the brains of people with dementia (such as in Alzheimer's disease). You should discuss the results of the scan with the doctor who requested the examination.
Use of VIZAMYL involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist have determined that the clinical benefit of this procedure performed with a radiopharmaceutical outweighs the risk associated with exposure to these small amounts of radiation.

2. What you need to know before using VIZAMYL

Do not use VIZAMYL:

• If you are allergic to flutemetamol ( F) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Please consult the nuclear medicine specialist before being administered VIZAMYL if:

• you have kidney problems
• you have liver problems
• you are pregnant or suspect you may be pregnant
• you are breastfeeding.

Children and adolescents
VIZAMYL is not intended for use in children and adolescents under 18 years of age.
Other medicines and VIZAMYL
Inform the nuclear medicine specialist if you are taking or have recently taken any other medicines, as these may interfere with the images obtained from the brain scan.
Pregnancy and breastfeeding
You must inform the nuclear medicine specialist before administration of VIZAMYL if there is any possibility that you are pregnant, if you have missed a menstrual period, or if you are breastfeeding.
In case of doubt, it is important to consult the nuclear medicine specialist responsible for performing the examination.
If you are pregnant
The nuclear medicine specialist will administer the medicine during pregnancy only if they consider that the benefit outweighs the risks.
If you are breastfeeding
You must stop breastfeeding for 24 hours after the injection. During this period, you should express milk and discard it. Resumption of breastfeeding should be discussed with the nuclear medicine specialist responsible for performing the examination.
Avoid close contact with children within 24 hours after injection.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, please seek advice from the nuclear medicine specialist before being administered this medicine.
Driving and using machines
VIZAMYL may cause transient dizziness and vertigo, impairing your ability to drive vehicles and operate machinery.
You should not drive, operate machinery, or perform potentially hazardous activities until these effects have completely subsided.
VIZAMYL contains alcohol (ethanol) and sodium
VIZAMYL contains alcohol (ethanol). Each dose contains up to 552 mg of alcohol. This amount corresponds to approximately 14 ml of beer or 6 ml of wine. This could be harmful for individuals with alcoholism and should be considered in pregnant women, women who are breastfeeding, and patients with liver problems or epilepsy.
VIZAMYL contains up to 41 mg of sodium (a main component of table salt) per dose. This equals 2% of the maximum daily recommended dietary intake for an adult. This amount may need to be taken into account in patients on a low-sodium diet.

3. How to use VIZAMYL

There are strict regulations governing the use, handling, and disposal of
radiopharmaceuticals.
VIZAMYL will only be used in designated controlled areas. This medicinal product will be handled and
administered exclusively by trained and qualified personnel competent in its safe use.
Such personnel will provide you with all necessary information regarding the procedure.
The nuclear medicine specialist may ask you to drink plenty of water before the examination and during the 24 hours following the scan, so as to urinate as frequently as possible and thereby promote faster elimination of the medicinal product from the body.
Dose
The nuclear medicine specialist responsible for performing the examination will determine the dose of VIZAMYL to be used in your case. The physician will select the minimum amount necessary.
The normally recommended quantity for an adult is 185 MBq. The megabecquerel (MBq) is the unit of measurement used to express radioactivity.
Administration of VIZAMYL and performance of the examination
VIZAMYL is administered by intravenous injection, followed by a flush with sodium chloride solution, which ensures complete delivery of the administered dose.
A single injection is sufficient to perform the scan required by the physician.
Duration of the examination
Generally, the brain scan is performed 90 minutes after administration of VIZAMYL. The nuclear medicine specialist will inform you about the usual duration of the examination.
After administration of VIZAMYL
Avoid any close contact with children and pregnant women during the 24 hours following the injection.
The nuclear medicine specialist will inform you of any special precautions to be observed after administration of the medicinal product. Contact the nuclear medicine specialist for any doubts or questions.
If you have been administered an excessive dose of VIZAMYL:
It is unlikely that you will receive an excessive dose of the medicinal product, as you will receive a single, accurately measured and controlled dose of VIZAMYL from the nuclear medicine specialist.
However, in the event of an overdose, you will receive appropriate treatment. This treatment consists of increasing urinary and faecal elimination to promote the removal of radioactivity from the body.
If you have any further doubts about the use of this medicinal product, please consult the nuclear medicine specialist responsible for performing the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with this medicine:

Serious side effects
Contact your doctor immediately if you experience one or more of the following side effects;
you may require urgent medical treatment:

• Allergic reactions: signs may include swelling of the face and eyes, pallor, itching, skin tightness, skin rash, shortness of breath, chest tightness, throat irritation, and general malaise. These side effects are not common and may occur in 1 out of 100 people.

If you experience any of the side effects listed above, seek immediate medical advice.

Other possible side effects

Common: may occur in 1 out of 10 people

• sensation of warmth
• increased blood pressure

Uncommon: may occur in 1 out of 100 people. You may experience the following uncommon side effects:

• headache
• dizziness
• anxiety
• general malaise (nausea)
• chest discomfort
• low blood sugar levels (symptoms: hunger, headache)
• back pain
• sensation of warmth or cold
• increased respiratory rate
• pain at injection site
• increased heart rate (palpitations)
• muscle or bone pain
• tremor
• skin swelling
• fever
• hyperventilation
• altered taste sensation
• sensation of dizziness
• reduced sense of touch
• fatigue or weakness
• inability to achieve or maintain erection
• indigestion, stomach ache, or bitter taste in mouth
• vomiting
• decreased sensitivity, especially of the skin and face
• increased levels of “lactate dehydrogenase in blood” or “neutrophils” as indicated in blood tests
• skin tightness

This radiopharmaceutical will emit low levels of ionizing radiation, which are associated with a minimal risk of developing cancer and hereditary abnormalities (transmission of defective genes).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your nuclear medicine specialist. You may also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VIZAMYL

You should not store this medicinal product. This medicinal product is stored under the responsibility of a specialist and in suitable premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended exclusively for the specialist.
Do not use this medicinal product after the expiry date and time stated on the label after 'EXP'.
Do not use this medicinal product if you notice that the vial is damaged or if the solution contains particles or appears yellowed.

6. Package contents and other information

Contents of VIZAMYL

• The active substance is flutemetamol (F). Each ml of solution contains 400 MBq flutemetamol (F) at the reference date and time (calibration date and time).
• The other components are sodium chloride and anhydrous ethanol, polysorbate 80, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injectable preparations, see section 2.

Appearance of VIZAMYL and pack contents

• VIZAMYL is a clear, colourless to pale yellow injectable solution.
• VIZAMYL is supplied in a 10 ml or 15 ml glass vial. Each vial is contained within a shielded container.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway

Manufacturers
Advanced Accelerator Applications Molecular Advanced Accelerator Applications Molecular
Imaging Italy S.r.l. Imaging France SAS
Via Piero Maroncelli 40 Technopole de l’Aube
47014 Meldola (FO) 14 Rue Gustave Eiffel
Italy 10430 Rosières-Près-Troyes
France
Seibersdorf Labor GmbH Curium Pharma Spain, S.A.
Grundstuck. Nr. 482/2 EZ98 KG C/Manuel Bartolome Cossio 10
2444 Seibersdorf 28040 Madrid
Austria Spain
Curium PET France Curium Italy S.R.L.
Parc scientifique Georges Besse Via Ripamonti 435
180 allee Von Neumann 20141 Milano (MI)
30000 Nîmes Italy
France
Advanced Accelerator Applications Molecular Advanced Accelerator Applications Molecular
Imaging Iberica, S.L.U. Imaging Italy S.R.L.
Josep Anselm Clavé 100 Via Dell’Industria
Esplugues de Llobregat 86077 Pozzilli (IS)
Barcelona, 08950 Italy
Spain
Curium Finland Oy Nucleis SA
Saukonpaadenranta 2 Allée du Six-Août, 8
Helsinki, FI-00180 4000 Liège
Finland Belgium
Helmholtz-Zentrum Dresden-Rossendorf e.V. ITEL Telecomunicazioni S.r.l.
Zentrum für Radiopharmazeutische Via Antonio Labriola Zona Industriale SNC,
Tumorforschung 70037, Ruvo di Puglia (BA)
Bautzner Landstraβe 400 Italy
01328 Dresden
Germany

Advanced Accelerator Applications Molecular
Imaging Iberica S.L.U.
Hospital Clinico Universitario Virgen de la
Arrixaca, Ctra. Madrid-Cartagena, sn, El Palmar,
30120 Murcia
Spain

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
The following information is intended exclusively for healthcare professionals:
The full product characteristics (SmPC) of VIZAMYL is provided as a separate document in the product packaging. This provides healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.
Refer to the SmPC {the SmPC must be included in the package}.