Denephor 10 mg/5 mg Depottablett

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

naloxonhydrokloriddihydrat; oxikodonhydroklorid

Dostępny od:

Hormosan Pharma GmbH

Kod ATC:

N02AA55

INN (International Nazwa):

naloxone hydrochloride dihydrate; oxycodone hydrochloride

Dawkowanie:

10 mg/5 mg

Forma farmaceutyczna:

Depottablett

Skład:

laktosmonohydrat Hjälpämne; stearylalkohol Hjälpämne; naloxonhydrokloriddihydrat 5,5 mg Aktiv substans; oxikodonhydroklorid 10 mg Aktiv substans

Typ recepty:

Receptbelagt

Status autoryzacji:

Avregistrerad

Data autoryzacji:

2016-06-22

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
DENEPHOR 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
DENEPHOR 10 MG/5 MG PROLONGED-RELEASE TABLETS
DENEPHOR 20 MG/10 MG PROLONGED-RELEASE TABLETS
DENEPHOR 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 Denephor is and what it is used for
2.
What you need to know before you take Denephor
3.
How to take Denephor
4.
Possible side effects
5.
How to store Denephor
6.
Contents of the pack and other information
1.
WHAT DENEPHOR IS AND WHAT IT IS USED FOR
Denephor 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 Denephor for the treatment of severe pain,
which can be adequately managed only
with opioid analgesics. Naloxone is added to counteract constipation.
How Denephor works in pain relief
Denephor tablets contain oxycodone and naloxone as active substances.
Oxycodone is responsible for the
painrelieving effect of Denephor. It is a strong analgesic
(“painkiller”) that belongs to a group of medicines
called opioids. Naloxone is intended to counteract constipation.
Constipation is a typical side effect of
treatment with opioid painkillers.
RESTLESS LEGS SYNDROME
You have been prescribed Denephor for the second line symptomatic
treatment of severe to very severe
restless legs syndrome in people who can’t be treated with dopamine
medicines. People wi

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Denephor 5 mg/2.5 mg prolonged-release tablets
Denephor 10 mg/5 mg prolonged-release tablets
Denephor 20 mg/10 mg prolonged-release tablets
Denephor 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
Denephor 5 mg/2.5 mg prolonged-release tablet
Light blue, round, convex, film-coated tablets with a nominal diameter
of 7.2 mm.
Denephor 10 mg/5 mg prolonged-release tablet
White to off-white, oval, convex, film-coated tablets with a nominal
length of 13.2 mm.
Denephor 20 mg/10 mg prolonged-release tablet
Pink, oval, convex, film-coated tablets with a nominal length of 10.2
mm.
Denephor 40 mg/20 mg prolonged-release tablet
Light orange to ochre, oval, convex, film-coated tablets with a
nominal