Zalviso 15microgram sublingual tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sufentanil citrate

Available from:

Grunenthal Ltd

INN (International Name):

Sufentanil citrate

Dosage:

15microgram

Pharmaceutical form:

Sublingual tablet

Administration route:

Sublingual

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 4032129057814

Patient Information leaflet

1
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 b

Summary of Product characteristics

OBJECT 1
ZALVISO 15 MICROGRAMS SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 04-Apr-2016 | Grunenthal
Ltd
1. Name of the medicinal product
Zalviso 15 micrograms sublingual tablets
2. Qualitative and quantitative composition
Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
Excipient(s) with known effect:
Each sublingual tablet contains 0.074 mg sunset yellow FCF Aluminium
Lake (E110).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sublingual tablet.
Zalviso sublingual tablets of 3 mm diameter are orange-coloured
flat-faced tablets with rounded edges.
4. Clinical particulars
4.1 Therapeutic indications
Zalviso is indicated for the management of acute moderate to severe
post-operative pain in adult patients.
4.2 Posology and method of administration
Zalviso is to be administered in a hospital setting only. Zalviso
should only be prescribed by physicians
who are experienced in the management of opioid therapy, particularly
opioid adverse reactions such as
respiratory depression (see section 4.4).
Posology
Zalviso sublingual tablets are to be self-administered by the patient
in response to pain using the Zalviso
administration device. The Zalviso administration device is designed
to deliver a single sufentanil 15
micrograms sublingual tablet, on a patient-controlled as needed basis,
with a minimum of 20 minutes
(lockout interval) between doses, over a period of up to 72 hours,
which is the maximum recommended
treatment duration. See section “Method of administration“.
_Elderly _
No special population studies were performed using sufentanil
sublingual tablets in elderly patients. In
clinical trials approximately 30 % of enrolled patients were 65 to 75
years of age. The safety and efficacy
in elderly patients was similar to that observed in younger adults
(see section 5.2).
_Hepatic or renal impairment_
No special population studies were performed using sufentanil
sublingual tablets in hepatic and renal
impaired patients. Only limited data are available f