Osmanil 100micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl

Available from:

Zentiva Pharma UK Ltd

ATC code:

N02AB03

INN (International Name):

Fentanyl

Dosage:

100microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5000283653066

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OSMANIL 25, 50, 75 AND 100
MICROGRAMS/H TRANSDERMAL PATCH
(FENTANYL)
IMPORTANT THINGS YOU NEED TO KNOW ABOUT OSMANIL TRANSDERMAL PATCH
• These patches contain a strong pain killer.
• Ensure that old patches are removed before applying a new one.
• Patches must not be cut
• Do not expose the patches to a heat source (such as a hot water
bottle).
• If you develop a fever tell your doctor immediately.
• Follow the dosage instructions carefully and only change your
patch every
3 days (72 hours).
• If your breathing becomes shallow and weak take the patch off and
seek
medical help.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, nurse or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their signs of illness are the same as
yours.
•
If you get any side effects talk to your doctor, nurse or pharmacist.
This
includes any possible side effects not listed in this leaflet. See
section 4
WHAT IS IN THIS LEAFLET:
1. What Osmanil transdermal patch is and what it is used for
2. What you need to know before you use Osmanil transdermal patch
3. How to use Osmanil transdermal patch
4. Possible side effects
5. How to store Osmanil transdermal patch
6. Contents of the pack and other information 1. WHAT OSMANIL TRANSDERMAL PATCH_ _IS AND WHAT IT IS USED FOR
The name of your medicine is Osmanil 25, 50, 75 and 100 micrograms/h
transdermal
patch. It is called Osmanil transdermal patch or just ‘patch’ in
this leaflet.
The patches help relieve pain that is very bad and long-lasting.
Osmanil transdermal patch contains a medicine called fentanyl. It
belongs to a
group of strong painkillers called opioids.
The medicine passes slowly into your body through your skin.. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OSMANIL
TRANSDERMAL PAT

Summary of Product characteristics

OBJECT 1
OSMANIL 100MCG/HR TRANSDERMAL PATCHES
Summary of Product Characteristics Updated 06-Nov-2014 | Zentiva
1. Name of the medicinal product
Osmanil 100 micrograms/h transdermal patch
2. Qualitative and quantitative composition
Each patch release 100 micrograms fentanyl per hour. Each patch of
30cm
2
contains 16.5mg fentanyl.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Transparent and colourless patch with blue imprint on the backing
foil: “fentanyl 100 µg/h“.
4. Clinical particulars
4.1 Therapeutic indications
Fentanyl transdermal patch is indicated
Adults
• in severe chronic pain which can be adequately managed only with
opioid analgesics.
Children
• long term management of severe chronic pain in children receiving
opioid therapy from 2 years of age.
4.2 Posology and method of administration
_POSOLOGY_
Initial dose selection
The appropriate initiating dose of Osmanil transdermal patch should be
based on the patient's current
opioid use. It is recommended that Osmanil transdermal patch be used
in patients who have demonstrated
opioid tolerance. Other factors to be considered are the current
general condition and medical status of the
patient, including body size, age and extent of debilitation as well
as degree of opioid tolerance.
_ADULTS_:
Opioid-tolerant patients
To convert opioid-tolerant patients from oral or parenteral opioids to
Osmanil transdermal patch refer to
_Equianalgesic potency conversion_
_ _
_ _ below. The dosage may subsequently be titrated upwards or
_ _
_ _
downwards, if required, in increments of either 12.5 or 25
micrograms/hr to achieve the lowest
appropriate dose of Osmanil transdermal patch depending on response
and supplementary analgesic
requirements.
Opioid-naïve patients
In strong opioid-naive patients, the normal initial Osmanil
transdermal patch dosage should not exceed 25
micrograms/h.
Clinical experience with Osmanil transdermal patch is limited in
opioid-naive patients. In the
circumstances in which therapy with Osmanil