Skip to Content

REBOXETINE 4MG TABLETS

Active substance(s): REBOXETINE / REBOXETINE METHANESULPHONATE / REBOXETINE / REBOXETINE METHANESULPHONATE / REBOXETINE / REBOXETINE METHANESULPHONATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Edronax ® 4mg Tablets / Reboxetine 4mg Tablets

Ref: 0533/110615/1/F

(reboxetine methanesulphate)
Patient Information Leaflet
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.
Your medicine is called Edronax 4mg Tablets/ Reboxetine 4mg Tablets but
will be referred to as Edronax throughout this leaflet.

Furthermore, if any of the symptoms listed above appear or worsen when a
patient under 18 is taking Edronax, you should inform your doctor.
Also, the long-term safety of Edronax in regard to growth, maturation and
cognitive and behavioural development in this age group has not yet been
demonstrated.
Taking other medicines
Given that Edronax may interact with other medicines, tell your doctor if you
are taking the following medicines:

1 What Edronax is and what it is used for

* Certain antifungals, e.g. ketoconazole
* Certain antibiotics, e.g. erythromycin, rifampicin.
* Medicines called ergot derivatives used to treat migraine or Parkinson’s

2 Before you take Edronax

* Certain antidepressants called MAO inhibitors, tricyclics, nefazodone,

In this leaflet:

3 How to take Edronax
4 Possible side effects
5 How to store Edronax
6 Further information

disease

SSRIs (such as fluvoxamine) or lithium

* Other MAO inhibitors such as linezolid (an antibiotic) and methylene blue
(used to treat high levels of methaemoglobin in the blood)

* Any potassium-losing diuretics (medicines for eliminating water), e.g
thiazides

* Medicines used to treat epilepsy e.g. phenobarbital, carbamazepine and
phenytoin

* Herbal medicines containing St. John’s Wort (Hypericum perforatum)
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

Your doctor will tell you whether you can take Edronax with other medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription,
herbal medicines, as well as vitamins and minerals.
Taking Edronax with food and drink
Edronax can be taken with or without food.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

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, such as certain kinds of glaucoma (increased
pressure in the eye).
Thoughts of suicide and worsening of your depression:
If you are depressed you can sometimes have thoughts of harming or
killing yourself. These may be increased when first starting
antidepressants, since these medicines all take time to work, usually about
two weeks but sometimes longer.
You may be more likely to think like this:
- If you have previously had thoughts about killing or harming yourself.
- If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are
depressed, and ask them to read this leaflet. You might ask them to tell you
if they think your depression is getting worse, or if they are worried about
changes in your behaviour.
Use in children and adolescents:
Edronax should not usually be used in children and adolescents less than 18
years old. Patients under 18 have an increased risk of undesirable effects,
such as suicide attempt, suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this
class of medicines. Nevertheless, it is possible that your doctor decides to
prescribe Edronax to a patient under 18 if it is in the patient's interest. If your
doctor has prescribed Edronax to a patient less than 18 years old and you
want to discuss this, please contact him/her.

Pregnancy
There are no adequate experiences from the use of Edronax in pregnant
women. Do not take Edronax if you are pregnant, unless your doctor
considers it absolutely necessary, following a careful clinical risk/benefit
consideration. Tell your doctor immediately if you are pregnant or are planning to become pregnant.
Breast-feeding
Edronax passes into the breast milk in small amounts. There is a risk of a
potential effect on the baby. Therefore, you should discuss the matter with
your doctor and he/she will decide whether you should stop breast-feeding
or stop the therapy with Edronax.
Driving and using machines
Caution is recommended when driving or using machines.
You should not drive or operate machinery until you know you are not
affected (i.e. feel drowsy) by Edronax, and that it is safe to do so.

3

How to take Edronax

* For adults the usual dose is 8 mg a day (one 4 mg tablet twice a day).

Based on how you respond to the medicine, after 3 to 4 weeks your doctor
may tell you to take up to 10 mg per day if necessary. The maximum daily
dose should not exceed 12 mg.
* In patients with poor kidney or liver function, the starting dose is 4 mg per
day. This may be increased depending on the individual response.
* The use of Edronax 4 mg tablets cannot be recommended for elderly
patients.
* Edronax should not be used in children and adolescents under 18 years.
The tablets should be taken in two divided doses, one dose in the morning
and one in the evening. You should swallow your tablet whole with a glass of
water. Do not chew the tablet.
To help you remember to take Edronax, you may find it easier to take your
tablets at the same time every day.
Always take Edronax exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
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.

Edronax® 4mg Tablets / Reboxetine 4mg Tablets

Ref: 0533/110615/1/B

(reboxetine methanesulphate)
Patient Information Leaflet (continued)
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 intend to stop 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.

4

Possible side effects

Like all medicines, Edronax can cause side effects, although not everybody
gets them. With Edronax most side effects are mild and usually go away
after the first few weeks of treatment.
If any of the side effects below gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Very common side effects (more than one in 10 patients)
* Difficulties to sleep (insomnia)
* Dizziness
* Dry mouth
* Constipation
* Nausea (feeling sick)
* Sweating
Common side effects (less than one in 10 patients)
* Headache
* Lack or loss of appetite
* Agitation, anxiety
* Paraesthesia (pins and needles), inability to sit or stand still, altered taste
sensation
* Lack of visual focus
* Increased heart rate, palpitation (heart pounding)
* Widened blood vessels, fall in blood pressure when standing up, increased
blood pressure
* Vomiting
* Rash
* Sensation of incomplete emptying or slowed emptying of the bladder,
urinary infection, painful urination, inability to completely empty the bladder
* Erectile dysfunction (impotence), ejaculatory pain, or ejaculatory delay
* Chills
Uncommon side effects (between 1 and 10 out of 1000 patients)
* Dilated pupils
* Spinning sensation
Rare side effects (between 1 and 10 out of 10000 patients)
* Glaucoma (a condition resulting in increased pressure in the eye)
After marketing reboxetine, the following side effects have been
reported:
* Hyponatremia (very low levels of sodium in the blood)
* Aggressive behaviour, hallucination
* Suicidal ideation, suicidal behaviour
Cases of suicidal ideation and suicidal behaviours have been reported
during reboxetine therapy or early after treatment discontinuation
(see section 2 “Take special care with Edronax”)
* Cold extremities, Raynaud’s phenomenon (poor blood circulation to the
extremities usually in the toes and fingers but could also affect nose and
ears, the skin turns pale and becomes cold and numb)
* Allergic skin inflammation
* Testicular pain
* Irritability
* Increased pressure in the eye

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard

5

How to store Edronax

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine, if your doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do.
Storing your medicine
* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
* Do not store above 25°C.
* Do not take your tablets out of the blister strip until it is time to take your
dose.
Important
This leaflet does not tell you everything about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist
(chemist). He/she will have additional information about this medicine and
will be able to advise you.

6

Further information

What this medicine contains:
Each tablet contains 4mg reboxetine (as methanesulphonate) as the active
ingredient.
Your medicine also contains the following inactive ingredients: Cellulose
microcrystalline, calcium hydrogen phosphate dihydrate, crospovidone,
colloidal hydrated silica and magnesium stearate.
What this medicine looks like and contents of the pack
Edronax is a white, round, convex tablets one side has '7671' impressed on
it and the other side has 'P' a break line and 'U' on the other side of the
break line. Edronax are available in blister strips in packs of 60.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer Italia S.r.I., Localita Marino del
Tronto - 63100 Ascoli Piceno, Italy and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0533

Edronax 4mg Tablets / Reboxetine 4mg Tablets

Edronax is a registered trademark of Pharmacia Italia S.p.A.
Revision date: 11/06/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide