Metadon 2care4 5 mg Tablett

Ország: Svédország

Nyelv: svéd

Forrás: Läkemedelsverket (Medical Products Agency)

Aktív összetevők:

metadonhydroklorid

Beszerezhető a:

2care4 Generics ApS

ATC-kód:

N07BC02

INN (nemzetközi neve):

methadone hydrochloride

Adagolás:

5 mg

Gyógyszerészeti forma:

Tablett

Összetétel:

laktosmonohydrat Hjälpämne; metadonhydroklorid 5 mg Aktiv substans

Recept típusa:

Receptbelagt

Termék összefoglaló:

Förpacknings: Blister, 10 tabletter; Blister, 15 tabletter; Blister, 20 tabletter; Blister, 25 tabletter; Blister, 30 tabletter; Blister, 35 tabletter; Blister, 40 tabletter; Blister, 45 tabletter; Blister, 50 tabletter; Blister, 55 tabletter; Blister, 60 tabletter; Blister, 65 tabletter; Blister, 70 tabletter; Blister, 75 tabletter; Blister, 80 tabletter; Blister, 85 tabletter; Blister, 90 tabletter; Blister, 95 tabletter; Blister, 100 tabletter; Burk, 25 tabletter; Burk, 100 tabletter; Burk, 200 tabletter

Engedélyezési státusz:

Godkänd

Engedély dátuma:

2018-09-13

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METADON 2CARE4 5 MG TABLETS
METADON 2CARE4 10 MG TABLETS
methadone 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 {Invented name} is and what it is used for
2.
What you need to know before you take {Invented name}
3.
How to take {Invented name}
4.
Possible side effects
5.
How to store {Invented name}
6.
Contents of the pack and other information
1.
WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR
{Invented name} is a morphine-like medicinal product which is used in
adults for:
-
treating severe chronic pain which can be adequately managed only with
opioid analgesics.
-
substitution therapy in opiate dependent patients, given together with
medical and psychological
treatment and social rehabilitation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {INVENTED NAME}
DO NOT TAKE {INVENTED NAME}:
-
if you are allergic to methadone or any of the other ingredients of
this medicine (listed in
section 6).
-
if you use or have used a monoamino-oxidase inhibitor (MAO-inhibitor)
within the last two
weeks
(medicine used in the treatment of depression and Parkinson's
disease).
-
if you have respiratory depression with slow and shallow breathing, or
other acute breathing
difficulties (acute obstructive airway disease).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking {Invented name}, if
you:
-
get acute asthma attacks,
-
suffer from lung disease or breathing difficulties,
-
have a heart disorder or ischemic heart disease,
-
have a li

Termékjellemzők

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Metadon 2care4 5 mg tablets
Metadon 2care4 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg tablet contains 5 mg of methadone hydrochloride.
Each 10 mg tablet contains 10 mg of methadone hydrochloride.
Excipient with known effect
Each 5 mg tablet contains 157 mg lactose monohydrate per tablet.
Each 10 mg tablet contains 71 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
{Invented name} 5 mg tablets are white to almost white, round and flat
8 mm diameter tablets with the
marking ‘5’ on one side and score line on the other side.
The tablet can be divided into equal doses.
{Invented name} 10 mg tablets are white to almost white, round and
flat 6 mm diameter tablets with the
marking ‘10’ on one side and score line on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic
maintenance
treatment
of
opioid-dependent
patients
in
parallel
with
medical
and
psychological treatment and social rehabilitation. Symptomatic
treatment of severe chronic pain,
which can be adequately managed only with opioid analgesics.
{Invented name} is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Pain conditions
The dosage should be adjusted and evaluated based on the effect for
the individual patient.
The following dosage recommendations should only be considered as
suggested approaches when
treatment with {Invented name} is initiated and must be adjusted to
the individual need for pain
relief. In
order to more rapidly achieve a full analgesic effect {Invented name}
may initially be
dosed with shorter
dosage interval during a limited period.
_Dose in opioid naive patient_
When oral methadone is used in patients who have not already been
treated with opioids, the usual
initial dose is 5 mg 1-3 times/day. This is followed by slow