Osmanil 12micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:

Fentanyl

Available from:

Zentiva Pharma UK Ltd

ATC code:

N02AB03

INN (International Name):

Fentanyl

Dosage:

12microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5000283653790

Patient Information leaflet

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
OSMANIL 12 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 12 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 PATCH
Osmanil transdermal patches 
                                
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Summary of Product characteristics

                                OBJECT 1
OSMANIL 12 MICROGRAMS/H TRANSDERMAL PATCH
Summary of Product Characteristics Updated 26-Feb-2015 | Zentiva
1. Name of the medicinal product
Osmanil 12 micrograms/h transdermal patch
2. Qualitative and quantitative composition
Each patch releases 12.5 micrograms fentanyl per hour. Each patch of
3.75 cm
2
contains 2.063 mg
fentanyl.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Transparent translucent patch with blue imprint “fentanyl 12 µ/h“
on the protective film.
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
For transdermal use
Osmanil should be applied to non-irritated and non-irradiated skin on
a flat surface of the torso or upper
arm. In young children, the upper back is the preferred location to
apply the patch, to minimise the
potential of the child removing the patch. A non-hairy area should be
selected. If this is not possible, hair
at the application site should be clipped (not shaved) prior to
application. If the site of Osmanil
application requires to be cleansed prior to application of the patch,
this should be done with water.
Soaps, oils, lotions or any other agent that might irritate the skin
or alter its characteristics should not be
used. The skin should be completely dry before the patch is applied.
Patches should be inspected prior to
use. Patches that are cut, divided, or damaged in any way should not
be used.
The Osmanil patch should be removed from the protective pouch by first
folding the notch (located close
to the tip of the arrow on the pouch label) and then carefully tearing
the pouch material. If scissors are
used to open the pouch, this should be done close to the sealed edge
so as not to damage the patch inside.
Osmanil should be appli
                                
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