Edronax 4 mg Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Reboxetine

Dostupné s:

Pfizer Healthcare Ireland

ATC kód:

N06AX; N06AX18

INN (Mezinárodní Name):

Reboxetine

Dávkování:

4 milligram(s)

Léková forma:

Tablet

Druh předpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Other antidepressants; reboxetine

Stav Autorizace:

Marketed

Datum autorizace:

1997-11-28

Informace pro uživatele

PAA205571
PAA205571
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, 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 had episodes of mania

Charakteristika produktu

Health Products Regulatory Authority
13 January 2023
CRN00CV5L
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Edronax 4 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 4 mg 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/day. 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
pr