EDRONAX 4 MG TABLETS
Active substance(s): REBOXETINE / REBOXETINE METHANESULPHONATE
Edronax® 4 mg Tablets / Reboxetine 4 mg Tablets
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
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.
Your medicine is available using either of the above names but will be
referred to as Edronax throughout the remainder of this leaflet.
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
are taking medicines to lower your blood pressure.
have liver or kidney problems. Your doctor may need to adjust your
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 “Other medicines and Edronax”).
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.
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
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
Other medicines and Edronax
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Edronax may affect or be affected by other medicines. These include:
Certain antifungals, e.g. ketoconazole
Certain antibiotics, e.g. erythromycin, rifampicin
Medicines called ergot derivatives used to treat migraine or
Certain antidepressants called MAO inhibitors, tricyclics, nefazodone,
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),
Medicines used to treat epilepsy e.g. phenobarbital, carbamazepine
Herbal medicines containing St. John’s Wort (Hypericum perforatum)
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.
Edronax with food and drink
Edronax can be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
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.
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
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The recommended dose in adults 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
Edronax should not be used in children and adolescents under
The tablets should be taken in two divided doses, one dose in the
morning and one in the evening. You should swallow your tablet with a
glass of water. The tablet can be divided into equal doses. Do not chew
To help you remember to take Edronax, you may find 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
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 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)
Nausea (feeling sick)
Common side effects (less than one in 10 patients)
Lack or loss of appetite
Paraesthesia (pins and needles), inability to sit or stand still, altered
Lack of visual focus
Increased heart rate, palpitation (heart pounding)
Widened blood vessels, fall in blood pressure when standing up,
increased blood pressure
Sensation of incomplete emptying or slowed emptying of the bladder,
urinary infection, painful urination, inability to completely empty the
Erectile dysfunction (impotence), ejaculatory pain or ejaculatory delay
Uncommon side effects (between 1 and 10 out of 1000 patients)
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
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 “Warnings and precautions”)
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
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 via the Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the
safety of this medicine.
5) HOW TO STORE EDRONAX
Keep out of the sight and reach of children.
Do not store above 25oC.
Do not use Edronax after the expiry date which is stated on the carton
or the blister. The expiry date refers to the last day of that month.
If the tablets become discoloured or show any sign of deterioration
return them to your pharmacist.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Edronax contains:
The active ingredient is reboxetine. Each tablet contains 4mg reboxetine.
The other ingredients are:
Microcrystalline cellulose, calcium hydrogen phosphate dihydrate,
crospovidone, hydrated colloidal silica, and magnesium stearate.
What Edronax looks like and contents of the pack:
Edronax 4 mg Tablets are white, round, convex tablets with a breakline
on one side. A ‘P’ is marked on the left side of the breakline and a ‘U’ is
marked on the right side of the breakline. The reverse side of the tablet is
Edronax is available in packs of 60 tablets.
Pfizer Italia S.r.l.
63100 Localita Marino del Tronto
Procured from within the EU by Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Leaflet dated 5th October 2017
Leaflet coded XXXXXXXXXX
Edronax® is a registered trademark of Pfizer Italia S.r.l., Italy.
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