Edronax 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Reboxetine mesilate

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N06AX18

INN (International Name):

Reboxetine mesilate

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EDRONAX
® 4MG TABLETS
(reboxetine methanesulphonate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.

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. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
IN THIS LEAFLET:
1.
What Edronax is and what it is used for
2.
Before you take Edronax
3.
How to take Edronax
4.
Possible side effects
5.
How to store Edronax
6.
Further 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.
BEFORE YOU TAKE EDRONAX
DO NOT TAKE EDRONAX

if you are allergic (hypersensitive) to reboxetine or any of
the other ingredients of Edronax. For a full list of excipients,
see section 6.
TAKE SPECIAL CARE WITH EDRONAX
Tell your doctor 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 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 “Taking other
medicines”).

ever had episodes of mania (overactive behaviour or
thoughts).

have eye problems, su

Summary of Product characteristics

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