Edronax 4 mg Tablett

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

reboxetinmesilat

Dostępny od:

Ebb Medical AB

Kod ATC:

N06AX18

INN (International Nazwa):

reboxetinmesilat

Dawkowanie:

4 mg

Forma farmaceutyczna:

Tablett

Skład:

reboxetinmesilat 5,224 mg Aktiv substans

Typ recepty:

Receptbelagt

Status autoryzacji:

Avregistrerad

Data autoryzacji:

2017-09-20

Ulotka dla pacjenta

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
EDRONAX 4 MG TABLETS
reboxetine
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 Edronax
is and what it is used for
2.
What you need to know before you take Edronax
3.
How to take Edronax
4.
Possible side effects
5.
How to store Edronax
6.
Contents of the pack and other information
1.
WHAT EDRONAX IS AND WHAT IT IS USED FOR
The active substance in Edronax is reboxetine which is part of a group
of medicines called
antidepressants. Edronax is used in acute treatment of depressive
illness / major depression as well as
for maintaining the improvement of your symptoms when you have
initially responded to treatment
with reboxetine.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE EDRONAX
DO NOT TAKE EDRONAX
-
if you are allergic to reboxetine or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Edronax, if you:
•
suffer from convulsions or epilepsy. Treatment with reboxetine should
be stopped if seizures
occur.
•
have any signs of urinary problems, enlarged prostate or a history of
heart problems.
•
are taking medicines to lower your blood pressure.
•
have liver or kidney problems. Your doctor may need to adjust your
dosage.
•
are taking a medicine called a ‘monoamine oxidase inhibitor’
(MAOI) used for depression, or
have taken an MAOI in the last 2 weeks. Your doctor may need to stop
the MAOI at least 2
weeks before starting Edronax.
•
ever h

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EDRONAX 4 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 4 mg of reboxetine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round, convex tablet with a breakline on one side. A ‘P’ is
marked on the left
side of the breakline. A ‘U’ is marked on the right side of the
breakline. The side
opposite the breakline is marked ‘7671’. The tablet can be divided
into equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Reboxetine is indicated for the acute treatment of depressive
illness/major depression
and for maintaining the clinical improvement in patients initially
responding to
treatment.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended therapeutic dose is 4 mg twice a day (b.i.d.) i.e., 8
mg/day
administered orally. The full therapeutic dose can be given upon
starting treatment.
After 3-4 weeks, this dose can be increased to 10 mg/day in case of
incomplete clinical
response. The maximum daily dose should not exceed 12 mg/day. The
minimum
effective dose has not yet been established.
_Elderly_
Elderly patients have been studied in clinical trials at doses of 2 mg
b.i.d. However,
safety and efficacy have not been evaluated in placebo-controlled
conditions. Therefore,
as for other antidepressants that have not been studied in
placebo-controlled conditions,
reboxetine cannot be recommended.
_Paediatric population_
Reboxetine should not be used in the treatment of children and
adolescents under the
age of 18 years (see section 4.4).
_Renal or hepatic impairment_
The starting dose in patients with renal or hepatic impairment should
be 2 mg b.i.d
which can be increased based on patient tolerance.
3
Method of administration
Reboxetine is for oral use.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Paediatric population
Rebox