Edronax 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Reboxetine mesilate

Available from:

Waymade Healthcare 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

evening. You should swallow your tablet with a glass of water. The
tablet can be divided
into equal doses. Do not chew the tablet.
To help you remember to take Edronax, you may fi nd it easier to take
your tablets at the
same time every day.
Like other drugs Edronax will not relieve your symptoms immediately.
You should start to
feel better within a few weeks.
It is important that you continue to take your tablets, even though
you feel better, until
your doctor advises you to stop. Please be patient, if you stop taking
your tablets too early,
your symptoms might come back.
IF YOU TAKE MORE EDRONAX THAN YOU SHOULD
You should never take more tablets than your doctor recommends. If you
take too many
tablets, contact your doctor or local hospital immediately. If you
take more Edronax than
you should, you may experience symptoms of overdose including low
blood pressure,
anxiety and hypertension.
IF YOU FORGET TO TAKE EDRONAX
If you forget to take Edronax, take your next dose at the normal time.
Do not take a double
dose to make up for a forgotten tablet.
IF YOU STOP TAKING EDRONAX
You should not stop your medicine without talking to your doctor, as
your symptoms
may come back.
There have been a few reports of withdrawal symptoms including
headache, dizziness,
nervousness and nausea (feeling sick), when patients stopped treatment
with Edronax.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets
them. With Edronax most side effects are mild and usually go away
after the fi rst few
weeks of treatment.
If any of the side effects below gets serious, or if you notice any
side effects not listed in
this leafl et, please tell your doctor or pharmacist.
VERY COMMON SIDE EFFECTS (more than one in 10 patients)
• Diffi culties to sleep (insomnia)
• Dizziness
• Dry mouth
• Constipation
• Nausea (feeling sick)
• Sweating
COMMON SIDE EFFECTS (less than one in 10 patients

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