Hapoctasin 35micrograms/hour transdermal patches

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Buprenorphine

Disponible desde:

Accord-UK Ltd

Código ATC:

N02AE01

Designación común internacional (DCI):

Buprenorphine

Dosis:

35microgram/1hour

formulario farmacéutico:

Transdermal patch

Vía de administración:

Transdermal

clase:

Schedule 3 (CD No Register)

tipo de receta:

Caution - AMP level prescribing advised

Resumen del producto:

BNF: 04070200; GTIN: 5012617023612

Información para el usuario

HAPOCTASIN 35MICROGRAM/H, 52.5MICROGRAM/H
AND 70MICROGRAM/H TRANSDERMAL PATCHES
Buprenorphine
_continued over page_
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 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 or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT HAPOCTASIN IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU USE HAPOCTASIN
3
HOW TO USE HAPOCTASIN
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE HAPOCTASIN
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT HAPOCTASIN IS AND WHAT IT IS USED FOR
Hapoctasin is an analgesic (a pain-relieving medicine) intended to
relieve
moderate to severe cancer pain and severe pain that has not responded
to other
types of painkillers.
Hapoctasin acts through the skin. When the transdermal patch is
applied to the
skin, the active substance buprenorphine passes through the skin into
the blood.
Buprenorphine is an opioid (strong pain reliever), which reduces pain
by acting
on the central nervous system (specific nerve cells in the spinal cord
and in the
brain). The effect of the transdermal patch lasts for up to three
days. Hapoctasin is
not suitable for the treatment of acute (short-lasting) pain.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE HAPOCTASIN
DO NOT USE HAPOCTASIN IF YOU:
•
are ALLERGIC to buprenorphine, soya, peanuts or any of the other
ingredients of
this medicine (listed in section 6)
•
are dependent on STRONG PAIN RELIEVERS (opiods)
•
suffer from a disease in which you have or may have GREAT DIFFICULTY
BREATHING
•
are taking MONOAMINE OXIDASE (MAO) inhibitors (certain medicines used
to treat depression) or you have taken this

Ficha técnica

OBJECT 1
HAPOCTASIN 35 MICROGRAM/H, TRANSDERMAL PATCHES
Summary of Product Characteristics Updated 02-Aug-2016 | Accord-UK Ltd
1. Name of the medicinal product
Hapoctasin 35 microgram/h, transdermal patches
2. Qualitative and quantitative composition
Hapoctasin 35 microgram/h
Each transdermal patch contains 20 mg buprenorphine.
Area containing the active substance: 25 cm
2
Nominal release rate: 35 micrograms of buprenorphine per hour.
Excipient with known effect: soya oil 16 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal patch
The patches are tan coloured, rectangular with four rounded edges and
topped off corners and labelled
with Buprenorphin 35 µg/h.
Each patch is packed in single sealed sachets.
4. Clinical particulars
4.1 Therapeutic indications
Moderate to severe cancer pain and severe pain which does not respond
to non-opioid analgesics
Hapoctasin is not suitable for the treatment of acute pain.
4.2 Posology and method of administration
Posology
Patients over 18 years of age
The Hapoctasin dosage should be adapted to the condition of the
individual patient (pain intensity,
suffering, individual reaction). The lowest possible dosage providing
adequate pain relief should be
given. Three transdermal patch strengths are available to provide such
adaptive treatment: Hapoctasin 35
microgram/h, Hapoctasin 52.5 microgram/h and Hapoctasin 70
microgram/h.
Initial dose selection:
Patients who have previously not received any analgesics should
startwith the lowest transdermal patch
strength Hapoctasin 35 microgram/h
Patients previously given a WHO step-I analgesic (non-opioid) or a
step-II analgesic (weak opioid)
should also begin with Hapoctasin 35 microgram/h. According to the WHO
recommendations, the
administration of a non-opioid analgesic can be continued, depending
on the patient's overall medical
condition.
When switching from a step-III analgesic (strong opioid) to Hapoctasin
and choosing the initial
transdermal patch strength, the nature of the previous medicinal
prod