Oxycodone/Naloxone Glenmark 5 mg/2,5 mg Depottablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

naloxonhydrokloriddihydrat; oxikodonhydroklorid

Available from:

Glenmark Arzneimittel GmbH

ATC code:

N02AA55

INN (International Name):

naloxone hydrochloride dihydrate; oxycodone hydrochloride

Dosage:

5 mg/2,5 mg

Pharmaceutical form:

Depottablett

Composition:

laktosmonohydrat Hjälpämne; stearylalkohol Hjälpämne; naloxonhydrokloriddihydrat 2,75 mg Aktiv substans; oxikodonhydroklorid 5 mg Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Burk, 10 tabletter; Burk, 20 tabletter; Burk, 28 tabletter; Burk, 30 tabletter; Burk, 50 tabletter; Burk, 56 tabletter; Burk, 60 tabletter; Burk, 98 tabletter; Burk, 100 tabletter; Blister, 10 x 1 tabletter (endos); Blister, 20 x 1 tabletter (endos); Blister, 28 x 1 tabletter (endos); Blister, 30 x 1 tabletter (endos); Blister, 50 x 1 tabletter (endos); Blister, 56 x 1 tabletter (endos); Blister, 60 x 1 tabletter (endos); Blister, 98 x 1 tabletter (endos); Blister, 100 x 1 tabletter (endos)

Authorization status:

Avregistrerad

Authorization date:

2016-09-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODONE/NALOXONE GLENMARK 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
OXYCODONE/NALOXONE GLENMARK 10 MG/5 MG PROLONGED-RELEASE TABLETS
OXYCODONE/NALOXONE GLENMARK 20 MG/10 MG PROLONGED-RELEASE TABLETS
OXYCODONE/NALOXONE GLENMARK 40 MG/20 MG PROLONGED-RELEASE TABLETS
oxycodone hydrochloride / naloxone 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 Oxycodone/Naloxone Glenmark is and what it is used for
2.
What you need to know before you take Oxycodone/Naloxone Glenmark
3.
How to take Oxycodone/Naloxone Glenmark
4.
Possible side effects
5.
How to store Oxycodone/Naloxone Glenmark
6.
Contents of the pack and other information
1.
WHAT OXYCODONE/NALOXONE GLENMARK IS AND WHAT IT IS USED FOR
Oxycodone/Naloxone Glenmark is a prolonged-release tablet, which means
that its active substances are
released over an extended period. Their action lasts for 12 hours.
PAIN RELIEF
You have been prescribed Oxycodone/Naloxone Glenmark for the treatment
of severe pain, which can be
adequately managed only with opioid analgesics. Naloxone is added to
counteract constipation.
How Oxycodone/Naloxone Glenmark works in pain relief
Oxycodone/Naloxone Glenmark tablets contain oxycodone and naloxone as
active substances. Oxycodone is
responsible for the pain relieving effect of Oxycodone/Naloxone
Glenmark. It is a strong analgesic
(“painkiller”) that belongs to a group of medicines called
opioids. Naloxone is intended to counteract
constipation. Constipation is a typic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oxycodone/Naloxone Glenmark 5 mg/2.5 mg prolonged-release tablets
Oxycodone/Naloxone Glenmark 10 mg/5 mg prolonged-release tablets
Oxycodone/Naloxone Glenmark 20 mg/10 mg prolonged-release tablets
Oxycodone/Naloxone Glenmark 40 mg/20 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg/2.5 mg prolonged-release tablets
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride
equivalent to 4.5 mg oxycodone
and naloxone hydrochloride dihydrate equivalent to 2.5 mg naloxone
hydrochloride and 2.25 mg naloxone.
Excipient with known effect: Each prolonged-release tablet contains
16.0 mg lactose.
10 mg/5 mg prolonged-release tablets
Each prolonged-release tablet contains 10 mg of oxycodone
hydrochloride equivalent to 9.0 mg oxycodone
and naloxone hydrochloride dihydrate equivalent to 5.0 mg naloxone
hydrochloride and 4.5 mg naloxone.
Excipient with known effect: Each prolonged-release tablet contains
32.0 mg lactose.
20 mg/10 mg prolonged-release tablets
Each prolonged-release tablet contains 20 mg of oxycodone
hydrochloride equivalent to 18.0 mg oxycodone
and naloxone hydrochloride dihydrate equivalent to 10.0 mg naloxone
hydrochloride and 9.0 mg naloxone.
< 40 mg/20 mg prolonged-release tablets
Each prolonged-release tablet contains 40 mg of oxycodone
hydrochloride equivalent to 36.0 mg
oxycodone and naloxone hydrochloride dihydrate equivalent to 20.0 mg
naloxone hydrochloride and 18.0
mg naloxone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
PROLONGED-RELEASE TABLET
Oxycodone/Naloxone Glenmark 5 mg/2.5 mg prolonged-release tablet
Light blue, round, convex, film-coated tablets with a nominal diameter
of 6.2 mm.
Oxycodone/Naloxone Glenmark 10 mg/5 mg prolonged-release tablet
White to off-white, oval, convex, film-coated tablets with a nominal
length of 13.2 mm.
Oxycodone/Naloxone Glenmark 20 mg/10 mg prolonged-release tablet
Pink, oval, convex, film-coated tablets with a nominal length o