Enolwen 5 mg/2,5 mg Depottablett

País: Suécia

Língua: sueco

Origem: Läkemedelsverket (Medical Products Agency)

Ingredientes ativos:

naloxonhydrokloriddihydrat; oxikodonhydroklorid

Disponível em:

Acino AG

Código ATC:

N02AA55

DCI (Denominação Comum Internacional):

naloxone hydrochloride dihydrate; oxycodone hydrochloride

Dosagem:

5 mg/2,5 mg

Forma farmacêutica:

Depottablett

Composição:

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

Tipo de prescrição:

Receptbelagt

Resumo do produto:

Förpacknings: Blister, 10 x 1 tabletter (endos); Burk, 20 tabletter; Burk, 50 tabletter; Burk, 100 tabletter; 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)

Status de autorização:

Avregistrerad

Data de autorização:

2016-06-22

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENOLWEN 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
ENOLWEN 10 MG/5 MG PROLONGED-RELEASE TABLETS
ENOLWEN 20 MG/10 MG PROLONGED-RELEASE TABLETS
ENOLWEN 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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 for the
treatment of severe pain, which can be
adequately managed only with opioid analgesics. Naloxone is added to
counteract constipation.
How works in pain relief
tablets contain oxycodone and naloxone as
active substances. Oxycodone is
responsible for the pain relieving effect of . 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 SYN

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enolwen 5 mg/2.5 mg prolonged-release tablets
Enolwen 10 mg/5 mg prolonged-release tablets
Enolwen 20 mg/10 mg prolonged-release tablets
Enolwen 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
5 mg/2.5 mg prolonged-release tablets
Light blue, round, convex, film-coated tablets with a nominal diameter
of 6.2 mm.
10 mg/5 mg prolonged-release tablets
White to off-white, oval, convex, film-coated tablets with a nominal
length of 13.2 mm.
20 mg/10 mg prolonged-release tablets
Pink, oval, convex, film-coated tablets with a nominal length of 10.2
mm.
40 mg/20 mg prolonged-release tabl