Sevodyne 20micrograms/hour transdermal patches

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buprenorphine

Available from:

Aspire Pharma Ltd

ATC code:

N02AE01

INN (International Name):

Buprenorphine

Dosage:

20microgram/1hour

Pharmaceutical form:

Transdermal patch

Administration route:

Transdermal

Class:

Schedule 3 (CD No Register)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5060209731476

Patient Information leaflet

If you are affected (e.g. feel dizzy, drowsy or have blurred vision),
you should not drive or operate machinery whilst using
Sevodyne, or for 24 hours after removing the patch.
This medicine can affect your ability to drive as it may make you
sleepy or dizzy.
•
Do not drive while taking this medicine until you know how it affects
you.
•
It is an offence to drive if this medicine affects your ability to
drive.
•
However you would not be committing an offence if:
•
The medicine has been prescribed to treat a medical or dental problem;
and
•
You have taken it according to the instructions given by the
prescriber or in the information provided with
the medicine.
•
It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
3. How to use Sevodyne
Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.
Different strengths of Sevodyne are available. Your doctor will decide
which strength of Sevodyne will suit you best.
When people first start using Sevodyne, they often experience some
nausea and vomiting (see section 4). This usually
passes after the first week of treatment. It’s a good idea to book a
follow-up appointment with your doctor a week or
two after you first start using Sevodyne patches to ensure that you
are taking the correct dose and to manage any
side effects.
During treatment, your doctor may change the patch you use to a
smaller or larger one if necessary or tell you to use a
combination of up to two patches. Do not cut or divide the patch or
use a higher dose than recommended. YOU SHOULD
NOT APPLY MORE THAN TWO PATCHES AT THE SAME TIME UP TO A MAXIMUM TOTAL
DOSE OF 40 MICROGRAMS/HOUR.
If you feel that the effect of the Sevodyne is too weak or too strong,
talk to your doctor or pharmacist.
Adults and elderly patients
Unless your doctor has told you differently, attach one Sevodyne patch
(as described in de

Summary of Product characteristics

OBJECT 1
SEVODYNE 20 MICROGRAM/HOUR TRANSDERMAL PATCH
Summary of Product Characteristics Updated 24-Apr-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Sevodyne 20 microgram/hour transdermal patch
2. Qualitative and quantitative composition
Each transdermal patch contains 20 mg of buprenorphine in a 25 cm
2
area releasing a nominal 20
micrograms of buprenorphine per hour over a period of 7 days.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
Rectangular beige coloured patch with rounded edges and imprinted with
“Buprenorphin” and “20 μg/h ”
in blue colour.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of non-malignant pain of moderate intensity when an opioid
is necessary for obtaining
adequate analgesia.
Sevodyne is not suitable for the treatment of acute pain.
Sevodyne is indicated in adults.
4.2 Posology and method of administration
Posology
_Patients aged 18 years and over:_
The lowest Sevodyne dose (Sevodyne 5 microgram/hour transdermal patch)
should be used as the initial
dose. Consideration should be given to the previous opioid history of
the patient (see section 4.5) as well
as to the current general condition and medical status of the patient.
_Titration_
During initiation of treatment with Sevodyne, short-acting
supplemental analgesics may be required (see
section 4.5) as needed until analgesic efficacy with Sevodyne is
attained.
The dose of Sevodyne may be titrated upwards as indicated after 3
days, when the maximum effect of a
given dose is established. Subsequent dose increases may then be
titrated based on the need for
supplemental pain relief and the patient's analgesic response to the
patch.
To increase the dose, a larger patch should replace the patch that is
currently being worn, or a
combination of patches should be applied in different places to
achieve the desired dose. It is
recommended that no more than two patches are applied at the same
time, up to a maximum total dose of
40 microgram/hour buprenorphine. A new