What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/1042/004, EU/1/15/1042/006, EU/1/15/1042/003, EU/1/15/1042/002, EU/1/15/1042/005, EU/1/15/1042/001.


Zalviso 15 micrograms sublingual tablets

Package leaflet: Information for the patient

Zalviso 15 micrograms sublingual tablets

Sufentanil

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

1. What Zalviso is and what it is used for

The active substance of Zalviso is sufentanil, which belongs to a group of strong pain-relieving medicines called opioids.

Zalviso is used to treat acute moderate to severe pain after an operation in adults.

2. 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 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 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.

Concomitant use of Zalviso and sedating medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor prescribes Zalviso together with sedating medicines the duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedating medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

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.

Zalviso contains sodium

Zalviso contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

3. 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” above).

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 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.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. 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.

Very common side effects (may affect more than 1 in 10 people): nausea, vomiting, fever.

Common side effects (may affect up to 1 in 10 people):

confusion, dizziness, headache, drowsiness, increased heart rate, high blood pressure, low blood pressure, constipation, indigestion, itching of the skin, involuntary muscle cramps, muscle twitching, difficulty passing urine.

Uncommon side effects (may affect up to 1 in 100 people): allergic reactions, lack of interest or emotion, nervousness, sleepiness, abnormal sensation of the skin, problems coordinating muscle movements, muscle contractions, exaggeration of reflexes, vision disturbances, decreased heart rate, dry mouth, excessive sweating, rash, dry skin, chills, weakness.

Frequency not known (frequency cannot be estimated from the available data): severe allergic reactions (anaphylactic shock), convulsion (fits), coma, small pupil size, redness of the skin, withdrawal syndrome.

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

HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. 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.

6. 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. 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

Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
Tel.: +49-241-569-0

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

United Kingdom
Grünenthal Ltd
1 Stokenchurch Business Park
Ibstone Road
HP14 3FE
UK
Tel: +44 (0)870 351 8960

This leaflet was last revised in 07/2019

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