What you need to know before you take ZALVISO®

Do not take ZALVISO®:

  • if you are allergic to sufentanil or any of the other ingredients of this medicine (listed in the ‘Contents of the pack and other information’ section).
  • if you have severe breathing problems.

Warnings and precautions

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 tumor;
  • 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 alcohol abuse;
  • 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

Children and adolescents

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

Other medicines and ZALVISO<sup>®</sup>

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<sup>®</sup> with alcohol

ZALVISO® with alcohol

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

Pregnancy and breast-feeding

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

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 has 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.

Read all of the ZALVISO® Package Leaflet carefully before you start taking ZALVISO® because it contains important information for you. If you have any further questions, ask your doctor or nurse. If you get any side effects, talk to your doctor or nurse.

For additional information, please download the entire Package Leaflet.