Metadon 2care4 40 mg Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

metadonhydroklorid

Tillgänglig från:

2care4 Generics ApS

ATC-kod:

N07BC02

INN (International namn):

methadone hydrochloride

Dos:

40 mg

Läkemedelsform:

Tablett

Sammansättning:

laktosmonohydrat Hjälpämne; metadonhydroklorid 40 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Burk, 25 tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2018-09-13

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METADON 2CARE4 20 MG TABLETS
METADON 2CARE4 40 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.
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 therapy).
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 liver disease or impaired liver function (including
gallstones),
-
have impaired kidney function (including kidney stones),
-
have an underactive

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Metadon 2care4 20 mg tablets
Metadon 2care4 40 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg tablet contains 20 mg of methadone hydrochloride.
Each 40 mg tablet contains 40 mg of methadone hydrochloride.
Excipient with known effect
Each 20 mg tablet contains 142 mg lactose monohydrate.
Each 40 mg tablet contains 284 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
{Invented name} 20 mg tablets are white to almost white, round and
flat 8 mm in diameter tablets with
the marking ‘20’ on one side and score line on the other side.
The tablet can be divided into equal doses.
{Invented name} 40 mg tablets are white to almost white, round and
flat 10 mm diameter tablets with
the marking ’40’ on one side and score line on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symtomatic 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
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. {Invented name} 5 mg tablets are
also available. This is followed by
slow titration to effect. The titration should continue during several
weeks. The initial dose should be
carefully evaluated before increase of the dose is started.
3
Since the risk for ve