Fentanyl Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fentanyl 6.3mg;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Fentanyl 6.3 mg

Dosage:

37 mcg/h

Pharmaceutical form:

Transdermal patch

Composition:

Active: Fentanyl 6.3mg   Excipient: Durotak 87-4287 Pegoterate  

Prescription type:

Class B1 Controlled Drug

Manufactured by:

Mallinckrodt Chemical Inc

Therapeutic indications:

The management of chronic cancer pain. The management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. For use in accordance with NZMA guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.

Product summary:

Package - Contents - Shelf Life: Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 1 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 2 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 3 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 4 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 5 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 7 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 8 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 10 patches - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2013-06-26

Patient Information leaflet

190725-fentanyl-sandoz-cmi
Page 1
FENTANYL SANDOZ
®
_fentanyl transdermal patches _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Fentanyl Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FENTANYL
SANDOZ IS USED
FOR
This medicine is used to relieve
chronic or long-lasting pain, which
requires strong painkillers.
It contains the active ingredient
fentanyl.
Fentanyl belongs to a group of
medicines called opioid analgesics.
It works by blocking the nerves that
recognise pain messages from the
body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine may be addictive.
This medicine is available only with
a doctor's prescription.
WARNING
Fentanyl Sandoz patches may be
retrieved and abused by addicts.
Please ensure that used patches are
concealed and disposed of carefully.
Return unused patches to the
pharmacy (see Disposal at the end of
this leaflet).
Keep used and unused patches where
children cannot reach them.
BEFORE YOU USE
FENTANYL SANDOZ
_WHEN YOU MUST NOT USE IT _
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
fentanyl, the active ingredient, or
to any of the other ingredients
listed at the end of this leaflet
under Product description.
•
any other similar medicines.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the
skin.
DO NOT USE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF TH

Summary of Product characteristics

NEW ZEALAND DATA SHEET
230522-fentanyl-sandoz-ds
Page 1 of 26
WARNINGS
_LIMITATIONS OF USE_
Because of the risks associated with the use of opioids, Fentanyl
Sandoz should only be used
in patients for whom other treatment options, including non-opioid
analgesics, are ineffective,
not tolerated or otherwise inadequate to provide appropriate
management of pain (see
_section _
_4.4 Special Warnings and Precautions for Use_
).
_HAZARDOUS AND HARMFUL USE_
Fentanyl Sandoz poses risks of hazardous and harmful use which can
lead to overdose and
death. Assess the patient's risk of hazardous and harmful use before
prescribing and monitor
the patient regularly during treatment (see
_section 4.4. Special Warnings and Precautions for _
_Use_
).
_LIFE THREATENING RESPIRATORY DEPRESSION_
Serious, life-threatening or fatal respiratory depression may occur
with the use of Fentanyl
Sandoz. Be aware of situations which increase the risk of respiratory
depression, modify
dosing in patients at risk and monitor patients closely, especially on
initiation or following a
dose increase (see
_section 4.4 Special Warnings and Precautions for Use_
).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, _
_INCLUDING ALCOHOL_
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor
patients for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
taking Fentanyl Sandoz.
1 PRODUCT NAME
FENTANYL SANDOZ,
_12micrograms/hour, 25 micrograms/hour, 37micrograms/hour, 50 _
_micrograms/hour, 75 micrograms/hour, 100 micrograms/hour; Transdermal
Patch _
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fentanyl Sandoz 12
*
: Each patch contains 2.1mg fentanyl in a patch size 5.25 cm
2
, releasing
a