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Zalviso (sufentanil) – Package leaflet - N01AH03

Updated on site: 11-Oct-2017

Medication nameZalviso
ATC CodeN01AH03
Substancesufentanil
ManufacturerGrunenthal GmbH

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 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.

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 in Appendix V.

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

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

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

België/Belgique/Belgien

Lietuva

Luxemburg/Luxembourg

Grünenthal GmbH

S.A. Grünenthal N.V.

Lenneke Marelaan 8

 

1932 Sint-Stevens-Woluwe

 

België/Belgique/Belgien

 

Tél/Tel: + 32 (0)2 290 52 00 beinfo@grunenthal.com

България

Magyarország

Grünenthal GmbH

Grünenthal GmbH

Česká republika

Malta

Grünenthal GmbH

Grünenthal GmbH

Danmark

Nederland

Grünenthal Denmark ApS

Grünenthal B.V.

Arne Jacobsens Allé 7

De Corridor 21K

2300 København S

NL-3621 ZA Breukelen

Tlf: +45 88883200

Tel:+31 (0)30 6046370

 

info.nl@grunenthal.com

Deutschland

Norge

Grünenthal GmbH

Grünenthal Norway AS

Zieglerstr. 6

C.J. Hambros Plass 2C

DE-52078 Aachen

0164 Oslo

Tel: + 49 241 569-1111

Tlf: +47 22996054

service@grunenthal.com

 

Eesti

Österreich

Grünenthal GmbH

Grünenthal GmbH

Campus 21, Liebermannstraße A01/501

 

2345 Brunn am Gebirge

 

Ελλάδα

Polska

Grünenthal GmbH

Grünenthal GmbH

España

Portugal

Grünenthal Pharma, S.A.

Grünenthal, S.A.

C/Dr. Zamenhof, 36

Alameda Fernão Lopes, 12-8.º A

E-28027 Madrid

P-1495 - 190 Algés

Tel: +34 (91) 301 93 00

Tel: +351 / 214 72 63 00

France

România

Laboratoires Grünenthal SAS

Grünenthal GmbH

Immeuble Eurêka

19 rue Ernest Renan

 

CS 90001

 

F- 92024 Nanterre Cedex

 

Tél: + 33 (0)1 41 49 45 80

 

Hrvatska

Slovenija

Grünenthal GmbH

Grünenthal GmbH

Ireland

Slovenská republika

Grünenthal Pharma Ltd

Grünenthal GmbH

4045 Kingswood Road,

Citywest Business Park

 

IRL – Citywest Co., Dublin

Tel: +44 (0)870 351 8960 medicalinformationie@grunenthal.com

Ísland

Suomi/Finland

Grünenthal GmbH

Grünenthal GmbH

Italia

Sverige

Grünenthal Italia S.r.l.I

Grunenthal Sweden AB

Tel: +39 02 4305 1

Frösundaviks allé 15

 

169 70 Solna

 

Tel: +46 (0)86434060

Κύπρος

United Kingdom

Grünenthal GmbH

Grünenthal Ltd

1 Stokenchurch Business Park

 

Ibstone Road, HP14 3FE – UK

 

Tel: +44 (0)870 351 8960

 

medicalinformationuk@grunenthal.com

Latvija

 

Grünenthal GmbH

 

 

This leaflet was last revised in

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

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