Patient Information Leaflet

VIZAMYL 400 MBq/ml injectable solution

flutemetamol (18F)

Read this leaflet carefully before you receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, consult your nuclear medicine doctor who is supervising the procedure.

• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

VIZAMYL contains the active ingredient flutemetamol (18F) and is used to help diagnose Alzheimer's disease and other causes of memory loss. This medication is a diagnostic radiopharmaceutical only.

VIZAMYL is used to help diagnose Alzheimer's disease and other causes of memory loss. It is administered to adults with memory problems before undergoing a type of brain scan, known as a positron emission tomography (PET) study. This study, along with other brain function tests, may help your doctor determine if you may or may not have β-amloid plaques in your brain. β-amloid plaques are deposits that are sometimes present in the brain of people with dementia (such as Alzheimer's disease)

You should discuss the test results with the doctor who requested the study.

The administration of Vizamyl involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of being exposed to small amounts of radiation.

Do not use VIZAMYL:

• If you are allergic to flutemetamol (18F) or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your nuclear medicine doctor before administering VIZAMYL if:

• You have kidney problems
• You have liver problems
• You are pregnant or think you may be pregnant

• You are breastfeeding

Children and adolescents

VIZAMYL is not indicated for children or adolescents under 18 years of age.

Use of VIZAMYL with other medications

Inform your nuclear medicine doctor if you are using, have used recently, or may need to use any other medication, as some medications may interfere with the images obtained from the brain scan.

Pregnancy and breastfeeding

You must inform the nuclear medicine doctor before administering VIZAMYL if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding. In case of doubt, it is essential to consult the nuclear medicine doctor supervising the procedure.

If you are pregnant

The nuclear medicine doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

You must suspend breastfeeding for 24 hours after the injection. Express and discard the milk produced during this period. Breastfeeding may be resumed when instructed by the nuclear medicine doctor supervising the procedure.

You should avoid close contact with small children for 24 hours after the injection.

If you are pregnant, breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your nuclear medicine doctor before receiving this medication.

Driving and operating machinery

VIZAMYL may cause transient dizziness or vertigo, which may affect your ability to drive or operate machinery.

You should not drive, operate complex machines, or engage in other potentially hazardous activities until the effects have completely disappeared.

VIZAMYL contains alcohol (ethanol) and sodium

VIZAMYL contains 7% of its volume of alcohol (ethanol); this is up to 552 mg of alcohol, equivalent to 14 ml of beer or 6 ml of wine. This amount may be detrimental to patients with alcoholism and should be taken into account in pregnant women and breastfeeding women, as well as in individuals with liver problems or epilepsy.

Vizamyl contains a maximum of 41 mg of sodium (main component of table salt/for cooking) in each dose. This is equivalent to 2% of the maximum daily sodium intake recommended for an adult. Patients with low-sodium diets should be aware that this medication contains a maximum of 41 mg of sodium per dose.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals.

VIZAMYL will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified professionals who will use it safely. They will provide you with the necessary information about the procedure.

Your nuclear medicine doctor may instruct you to drink plenty of liquid before starting the exam and during the 24 hours after the exam to urinate frequently and help eliminate the product from your body more quickly.

Dose

The nuclear medicine doctor supervising the procedure will decide the amount of VIZAMYL to be used in your case. The doctor will use the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is 185 MBq (MegaBecquerel, the unit used to measure radioactivity).

Administration of VIZAMYL and procedure performance

VIZAMYL is administered as an injection into your vein (intravenous injection), followed by a wash with sodium chloride solution to ensure complete administration of the dose.

One injection is sufficient to perform the procedure your doctor needs.

Procedure duration

The brain study is usually performed 90 minutes after the administration of VIZAMYL. Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After VIZAMYL administration

You should avoid close contact with small children and pregnant women during the 24 hours after the injection.

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medication. Consult your nuclear medicine doctor if you have any doubts.

If more VIZAMYL has been administered than necessary

A overdose is unlikely, as you will receive a single dose of VIZAMYL from the nuclear medicine doctor in controlled conditions.

However, in case of overdose, you will receive the appropriate treatment. The treatment consists of increasing urine and feces elimination to help eliminate radioactivity from the body.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine:

Severe side effects

Inform your doctor immediately if you observe any of the following symptoms, as you may need urgent medical treatment:

• Allergic reactions: symptoms may include facial swelling or eye swelling, paleness, skin itching or skin tightness, skin rash, feeling of lack of air, chest rigidity, throat irritation or general discomfort. These effects are rare and may affect 1 in 100 people.

Inform your doctor immediately if you experience any of the above symptoms.

Other side effects include

Frequent:may affect up to 1 in 10 people

• flushing of the face
• increase in blood pressure

Rare:may affect up to 1 in 100 people. You may experience the followingside effects:

• headache
• dizziness
• anxiety
• general discomfort (nausea)
• chest discomfort

• low blood sugar (symptoms: hunger, headache)
• back pain
• sensation of cold or heat
• increased respiratory rate
• pain at the injection site
• palpitations
• muscle or bone pain
• tremors
• swollen and inflamed skin
• fever
• hyperventilation
• change in the taste of things (alteration of taste)
• sensation of spinning (dizziness)
• reduction of sensations or sense of touch
• sensation of fatigue or weakness
• inability to achieve or maintain an erection
• indigestion, stomach pain or mouth pain
• vomiting
• reduction of sensations or sensitivity, especially in the skin or face
• increase in lactate dehydrogenase level in the blood or neutrophil count in blood analysis
• skin tightness

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation, which is associated with a very low risk of developing cancer and genetic defects.

Reporting of side effects

If you experience any type of side effect, consult your nuclear doctor, even if it is a side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAnnex V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not need to be stored. This medication is stored under the responsibility of the specialist in suitable facilities. Radioactive pharmaceutical storage will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use this medication after the expiration date and time, which are specified on the label after "CAD".

Do not use this medication if you observe that the vial is damaged, if the solution contains suspended particles, or if it is discolored.

Composition of VIZAMYL

• The active principle is flutemetamol (18F). Each ml of solution contains 400 MBq of

flutemetamol (18F) at the time and date of calibration.

• The other components are: sodium chloride, anhydrous ethanol, polisorbate 80, sodium dihydrogen phosphate dihydrate, dodecahydrate of disodium hydrogen phosphate and water for injection, see section 2.

Appearance of the product and contents of the pack

• VIZAMYL is a transparent, colourless to slightly yellowish injectable solution.
• VIZAMYL is supplied in a 10 ml or 15 ml glass vial. Each vial is stored in a container.

• Only some pack sizes may be marketed.

Marketing authorisation holder

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo

Norway

Responsible person

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics{month year}.

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.

This information is intended for healthcare professionals only:

The full product information of VIZAMYL is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the product information[the product information must be included in the box].