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How to take ZALVISO®
and possible side effects

 

How to take ZALVISO®

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The sublingual tablets are taken using the ZALVISO® administration device, which is a system that delivers a single dose upon activation. After receiving a dose you will not be able to release another dose for 20 minutes and you will not be able to take more than 3 doses in one hour.

The device will work for 3 days (72 hours), which is also the maximum recommended duration of your treatment.

ZALVISO® is placed under the tongue using the ZALVISO® administration device. You can control your treatment and should only activate the device when in need of pain relief.

The tablets dissolve under your tongue and should not be crushed, chewed, or swallowed. You should not eat or drink and should talk as little as possible for 10 minutes after each dose.

ZALVISO® is only to be taken in a hospital setting. It is only prescribed by physicians who are experienced in the use of strong pain killers like ZALVISO® and know the effects it may have on you, in particular on your breathing (see ‘Warnings and precautions’ in the ‘What you need to know before you take Zalviso®’ section).

Do not use the device if any component is visibly damaged.

After your treatment the medical staff will take the ZALVISO® administration device and dispose of any unused tablets accordingly. The device is constructed so that you will not be able to open it.

 
 

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 or adverse events may include severe breathing problems like slow and shallow breathing, loss of consciousness, extreme low blood pressure, collapse and muscle rigidity. If these start to develop, tell a doctor or nurse immediately. If you have any further questions on the use of this medicine, ask your doctor or nurse.

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.

 
 

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most serious side effects are severe breathing problems like slow and shallow breathing, which may even lead to stopping breathing or inability to breathe. In case you experience any of the above mentioned side effects, stop taking ZALVISO®and tell your 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 and on the Grünenthal website

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

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.

 
 

How to store ZALVISO®

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

Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask the medical staff how to throw away medicines you no longer use. These measures will help protect the environment.


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.

 
 

Contents of the pack and other information


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.


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.