Edronax 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Reboxetine mesilate

Available from:

DE Pharmaceuticals

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

Page 1 of 6
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

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 sec

Summary of Product characteristics

OBJECT 1
EDRONAX 4MG TABLETS
Summary of Product Characteristics Updated 23-Oct-2015 | Pfizer
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
•
11. Legal status
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.