Leveraxo 80mg modified-release tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Oxycodone hydrochloride

Tillgänglig från:

Viatris UK Healthcare Ltd

ATC-kod:

N02AA05

INN (International namn):

Oxycodone hydrochloride

Dos:

80mg

Läkemedelsform:

Modified-release tablet

Administreringssätt:

Oral

Klass:

Schedule 2 (CD)

Receptbelagda typ:

Caution - AMP level prescribing advised

Produktsammanfattning:

BNF: 04070200; GTIN: 5016695007243

Bipacksedel

Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Leveraxo 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg
prolonged-release tablets
oxycodone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Leveraxo is and what it is used for
2.
What you need to know before you take Leveraxo
3.
How to take Leveraxo
4.
Possible side effects
5.
How to store Leveraxo
6.
Contents of the pack and other information
1.
WHAT LEVERAXO IS AND WHAT IT IS USED FOR
Leveraxo is a centrally acting, strong painkiller from the group of
opioids.
Leveraxo is used to treat severe pain in adults and adolescents aged
12 years and older, which can be
adequately managed only with opioid analgesics.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVERAXO
DO NOT TAKE LEVERAXO
-
if you are allergic to oxycodone hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
-
if you suffer from severely depressed breathing (respiratory
depression) with too little oxygen in
the blood (hypoxia) and/or too much carbon dioxide (hypercapnia) in
the blood
-
if you suffer from severe chronic obstructive lung disease, cor
pulmonale (cardiac changes due to
chronic overload of lung circulation) or acute, severe bronchial
asthma
-
if you suffer from intestinal paralysis (paralytic ileus)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Leveraxo if you:
-
are older or debilitated
-
have severely impaired lung, liver or kidney function (see also
section 3 “Risk patients”_)_
-
suffer from myxoedem

Produktens egenskaper

OBJECT 1
LEVERAXO 5 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 04-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Leveraxo 5 mg prolonged-release tablets
Leveraxo 10 mg prolonged-release tablets
Leveraxo 20 mg prolonged-release tablets
Leveraxo 30 mg prolonged-release tablets
Leveraxo 40 mg prolonged-release tablets
Leveraxo 60 mg prolonged-release tablets
Leveraxo 80 mg prolonged-release tablets
2. Qualitative and quantitative composition
_Leveraxo 5 mg prolonged-release tablets_
Each prolonged-release tablet contains 5 mg oxycodone hydrochloride
equivalent to 4.5 mg oxycodone.
_Leveraxo 10 mg prolonged-release tablets_
Each prolonged-release tablet contains 10 mg oxycodone hydrochloride
equivalent to 9 mg oxycodone.
_Leveraxo 20 mg prolonged-release tablets_
Each prolonged-release tablet contains 20 mg oxycodone hydrochloride
equivalent to 17.9 mg
oxycodone.
_Leveraxo 30 mg prolonged-release tablets_
Each prolonged-release tablet contains 30 mg oxycodone hydrochloride
equivalent to 26.9 mg
oxycodone.
_Leveraxo 40 mg prolonged-release tablets_
Each prolonged-release tablet contains 40 mg oxycodone hydrochloride
equivalent to 36 mg oxycodone.
_Leveraxo 60 mg prolonged-release tablets_
Each prolonged-release tablet contains 60 mg oxycodone hydrochloride
equivalent to 53.8 mg
oxycodone.
_Leveraxo 80 mg prolonged-release tablets_
Each prolonged-release tablet contains 80 mg oxycodone hydrochloride
equivalent to 72 mg oxycodone.
Excipient with known effect:
_Leveraxo 5 mg prolonged-release tablets_
Each prolonged-release tablet contains a maximum of 15 mg sucrose.
_Leveraxo 10 mg prolonged-release tablets_
Each prolonged-release tablet contains a maximum of 30 mg sucrose.
_Leveraxo 20 mg prolonged-release tablets_
Each prolonged-release tablet contains a maximum of 12 mg sucrose.
_Leveraxo 30 mg prolonged-release tablets_
Each prolonged-release tablet contains a maximum of 18 mg sucrose.
_Leveraxo 40 mg prolonged-release tablets_
Each prolonged-release tablet contains a