Edronax 4mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Reboxetine mesilate

Dostupné z:

Pfizer Ltd

ATC kód:

N06AX18

INN (Medzinárodný Name):

Reboxetine mesilate

Dávkovanie:

4mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04030400; GTIN: 5013457025903

Príbalový leták

PAA187450
PAA187450
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
• 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 any other medicine for depression such as MAO
inhibitors, tricyclics, nefazodone, SSRIs (such as
fluvoxamine) or lithium.
• are taking other MAO inhibitors such as linezolid (an antibiotic)
or methylene blue (see section “Other
medicines and

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
EDRONAX 4 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 4mg of reboxetine
For 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
Reboxetine is for oral use.
Use in 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. The minimum effective dose has not yet been established.
Use in the 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.
Use in children and adolescents under the age of 18 years
Reboxetine should not be used in the treatment of children and
adolescents
under the age of 18 years (see section 4.4).
Use in patients with renal or hepatic insufficiency
The starting dose in patients with renal or hepatic insufficiency
should be 2 mg
b.i.d which can be increased based on patient tolerance.
4.3
CONTRAINDICATIONS
Known hypersensitivity to reboxetine or any of the components of the
product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
USE IN CHILDREN AND ADOLESC