Vizamyl (flutemetamol (18F)) – Package leaflet - V09AX04

Package leaflet: Information for the patient

VIZAMYL 400 MBq/mL solution for injection

Flutemetamol (18F)

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 your 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 VIZAMYL is and what it is used for

2.What you need to know before VIZAMYL is used

3.How VIZAMYL is used

4.Possible side effects

5.How VIZAMYL is stored

6.Contents of the pack and other information

1.What VIZAMYL is and what it is used for

VIZAMYL contains the active substance flutemetamol (18F) and is used to help diagnose Alzheimer’s disease and other causes of memory loss.

VIZAMYL is given to adults with memory problems before they undergo a type of brain scan called a positron-emission tomography (PET) scan. This scan, along with other brain function tests, can help your doctor determine whether or not you may have β-amyloid plaques in your brain. β-Amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer’s disease).

You should discuss the results of the test with the doctor that requested the scan.

VIZAMYL belongs to a group of medicines called ‘radiopharmaceuticals’ and its use involves exposure to small amounts of radioactivity.

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 VIZAMYL is used

VIZAMYL must not be used:

-If you are allergic to flutemetamol (18F) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your nuclear medicine doctor before you are given VIZAMYL if you:

-have kidney problems

-have liver problems

-are pregnant or think you may be pregnant

-are breast-feeding

Children and adolescents

VIZAMYL is not intended for use in children and adolescents below the age of 18 years old.

Other medicines and VIZAMYL

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the images obtained from the brain scan.

Pregnancy and breast-feeding

You must inform the nuclear medicine doctor before you are given VIZAMYL 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 the nuclear medicine doctor who will supervise the procedure.

If you are pregnant

The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.

If you are breast-feeding

You must stop breast-feeding for 24 hours after the injection. Express the breast milk during this period and discard any breast milk you have expressed. Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.

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.

Driving and using machines

VIZAMYL may cause transient dizziness or vertigo, which may affect your ability to drive or use machines. You should not drive, use machines or engage in other potentially hazardous activities until these effects have completely disappeared.

VIZAMYL contains alcohol (ethanol) and sodium

VIZAMYL contains alcohol (ethanol). Each dose contains up to 552 mg alcohol. This is about the same as 14 mL of beer or 6 mL of wine. This could be harmful for people with alcoholism and needs to be taken into account in pregnant or breast-feeding women and people with liver problems or epilepsy.

VIZAMYL contains a maximum of 41 mg of sodium per dose. These amounts may need to be considered for people on a low sodium diet.

3.How VIZAMYL will be used

There are strict laws on the use, handling and disposal of radiopharmaceutical products.

VIZAMYL will only be used in special controlled areas. This product will only be handled and given to you by professionals who are trained and qualified to use it safely. They will provide you with the necessary information on the procedure.

Dose

The nuclear medicine doctor supervising the procedure will decide on the amount of VIZAMYL to be used in your case. The doctor will choose the smallest amount necessary.

The usual amount recommended for an adult is 185 MBq. Megabecquerel (MBq) is the unit used to measure radioactivity.

Administration of VIZAMYL and conduct of the procedure

VIZAMYL is given as an injection into your vein (intravenous injection) followed by a flush of sodium chloride solution to ensure full delivery of the dose.

One injection is sufficient to carry out the scan that your doctor needs.

Duration of the procedure

A brain scan is usually taken 90 minutes after VIZAMYL is given. Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of VIZAMYL

You should avoid any close contact with young children and pregnant women for 24 hours following the injection.

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 received more VIZAMYL than you should

An overdose is unlikely since you will only receive a single dose of VIZAMYL from the nuclear medicine doctor under controlled conditions.

However, in the case of an overdose, you would receive the appropriate treatment. Treatment consists of increasing the passing of urine and stools in order to help remove radioactivity from your body.

If you have any further questions on the use of this medicine, please ask your 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 following side effects may happen with this medicine:

Serious side effects

Tell your doctor straight away, if you notice any of the following, as you may need urgent medical treatment:

-Allergic reactions - the signs may include swelling of your face or eyes, having pale, itchy or tight skin or having a rash, feeling short of breath, tightness in the chest, irritation in your throat or being sick. These are uncommon side effects and may affect up to 1 in 100 people.

Tell your doctor straight away if you notice any of the signs above.

Other side effects include

Common - may affect up to 1 in 10 people

-looking flushed

-increased blood pressure

Uncommon - may affect up to 1 in 100 people. You may experience the following uncommon side effects:

-headache

-feeling dizzy

-feeling anxious

-feeling sick (nausea)

-chest discomfort

-low blood sugar (symptoms: hunger, headache)

-back pain

-feeling hot or cold

-increased breathing rate

-pain at the injection site

-heart pounding (palpitations)

-pain in muscles or bones

-shaking movements (tremor)

-puffy and swollen skin

-fever

-over breathing (hyperventilation)

-change in the way you taste things

-a spinning feeling (vertigo)

-reduced sense of touch or sensation

-feeling tired or weak

-inability to get or maintain an erection

-indigestion, stomach ache or sore mouth

-vomiting

-decreased feeling or sensitivity especially in your skin or your face

-increase in “blood lactate dehydrogenase” or “neutrophils” in blood tests

-skin tightness

This radiopharmaceutical will deliver low amounts of ionising radiation, which is associated with very low risk of cancer and hereditary abnormalities (passing on faulty genes).

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 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.How VIZAMYL 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.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date and time, which are stated on the label after ‘EXP’.

Do not use this medicine if you notice that the vial is damaged or the solution contains particulate matter or appears discoloured.

6. Contents of the pack and other information

What VIZAMYL contains

-The active substance is flutemetamol (18F). Each mL of solution contains flutemetamol (18F) 400 MBq at reference time.

-The other ingredients are sodium chloride and ethanol anhydrous, polysorbate 80, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate and water for injections.

What VIZAMYL looks like and contents of the pack

-VIZAMYL is a clear, colourless to slightly yellow solution for injection.

-VIZAMYL is supplied in a 10-mL or 15-mL glass vial. Each vial is stored in a container.

Advanced Accelerator Applications S.r.l.

Via Ribes 5

10010 Colleretto Giacosa (TO)

Italy

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

This leaflet was last revised in {month YYYY}.

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

The following information is intended for medical or healthcare professionals only:

The complete SmPC of VIZAMYL is provided as a separate document in the product package, 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 {SmPC should be included in the box}.