Read all of this leaflet carefully before you start taking 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 doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

Do not take Zalviso:

• if you are allergic to sufentanil or any of the other ingredients of this medicine (listed in section 6).
• if you have severe breathing problems.

Warnings and precautions

Talk to your doctor or nurse before taking Zalviso.

Tell your doctor or nurse before treatment if you:

• are suffering from any condition that affects your breathing (such as asthma, wheezing, or shortness of breath). As Zalviso may affect your breathing, your doctor or nurse will check your breathing during treatment;
• have a head injury or brain tumour;
• have problems with your heart and circulation, especially slow heart rate, irregular heart beats, low blood volume or low blood pressure;
• have moderate to severe liver or severe kidney problems, as these organs have an effect on the way in which your body breaks down and eliminates the medicine;
• have a history of medicine or alcoholabuse;
• are regularly using a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone, oxycodone);
• have abnormally slow bowel movements;
• have a disease of the gall bladder or pancreas.

Taking the sublingual tablets with the device

Before you start using Zalviso, your doctor or nurse will show you how to use the Zalviso administration device. You will then be able to take a tablet as needed to relieve your pain. Follow the instructions carefully. Talk to your doctor or nurse if you did not fully understand the instructions or are unsure about the correct handling of the administration device.

Children and adolescents

Zalviso should not be used in children and adolescents below 18 years.

Other medicines and Zalviso

Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking any of the following:

• Any medicines that might have an effect on the way in which your body breaks down Zalviso e.g. ketoconazole, which is used for the treatment of fungal infections.
• Any medicines which might make you sleepy (have a sedative effect), such as sleeping pills, medicines to treat anxiety, tranquillisers or other opioid medicines, as they can increase the risk of severe breathing problems.
• Medicines for the treatment of severe depression (monoamine-oxidase (MAO) inhibitors), even if you have taken them in the last 2 weeks. The use of MAO inhibitors must be stopped for at least 2 weeks prior to use of Zalviso.
• Other medicines which are also taken sublingually (medicines that are placed under the tongue where they dissolve) or medicines which dilute or take effect in your mouth (e.g. nystatin, a liquid or pastilles you hold in your mouth to treat fungus infections), as the effect on Zalviso has not been studied.

Zalviso with alcohol

Do not drink alcohol while using Zalviso. It can increase the risk of experiencing severe breathing problems.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Zalviso should not be used during pregnancy or if you are a woman of childbearing potential not using contraception.

Sufentanil passes into breast milk and can cause side effects in the breast-fed child. Breastfeeding is not recommended when you take Zalviso.

Driving and using machines

Zalviso affects your ability to drive or use machines as it may cause sleepiness, dizziness or visual disturbances. You should not drive or operate machinery if you experience any of these symptoms whilst or after being treated with Zalviso. You should only drive and use machines if sufficient time as elapsed after your last dose of Zalviso.

Zalviso contains sunset yellow FCF Aluminium Lake (E110)

Zalviso contains the colouring agent sunset yellow FCF Aluminium Lake (E110), which may cause allergic reactions.

If you take more Zalviso than you should

The administration device will make you wait 20 minutes between doses to prevent you from taking more Zalviso than you should. However, symptoms of overdose include severe breathing problems like slow and shallow breathing, loss of conciousness, extreme low blood pressure, collapse and muscle rigidity. If these start to develop, tell a doctor or nurse immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below.

By reporting side effects, you can help provide more information on the safety of this medicine.

Ireland

United Kingdom

What Zalviso contains

• The active substance is sufentanil. Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
• The other ingredients are mannitol (E421), calcium hydrogen phosphate (anhydrous), hypromellose, croscarmellose sodium, stearic acid, magnesium stearate, sunset yellow FCF Aluminium Lake (E110) (see section 2 “What you need to know before you take Zalviso”)

What Zalviso looks like and contents of the pack

Zalviso sublingual tablets are orange-coloured flat-faced tablets with rounded edges. The sublingual tablets measure 3 mm in diameter.

The sublingual tablets are supplied in cartridges; each cartridge contains 40 sublingual tablets. One cartridge is packed in a sachet including an oxygen absorber.

Zalviso sublingual tablets are available in pack sizes of 1, 10 and 20 cartridges and in multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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