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DAVEDAX 4MG TABLETS

Active substance(s): REBOXETINE METHANESULPHONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Edronax® 4mg Tablets / Davedax® 4mg Tablets
(reboxetine methanesulphonate)
This medicine is available in the above names but will be
referred to as Edronax throughout this 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.
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, 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.
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:
 Certain antifungals, e.g. ketoconazole
 Certain antibiotics, e.g. erythromycin, rifampicin
 Medicines called ergot derivatives used to treat migraine
or Parkinson’s disease
 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), e.g. thiazides
 Medicines used to treat epilepsy e.g. phenobarbital,
carbamazepine and phenytoin
 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.
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.
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.
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 via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.
5.

How to store Edronax





Do not store Edronax above 25°C.
Keep out of sight and reach of children.
Do not use Edronax after the expiry date which is stated on
the carton or the bottle. The expiry date refers to the last day
of that month.
 If your tablets become discoloured, or show any signs of
deterioration, talk to your pharmacist. If your doctor tells you
to stop taking this medicine, return it to your pharmacist for
safe disposal. Only keep this medicine if your doctor tells you
to.
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.

Further information

What Edronax contains:
Each tablet contains 4mg of the active ingredient reboxetine (as
reboxetine methanesulphonate. Each tablet also contains
microcrystalline cellulose, calcium hydrogen phosphate dihydrate,
crospovidone, colloidal hydrated silica and magnesium stearate.
What Edronax looks like and contents of the pack:
Edronax are round, white tablets marked ‘7671’ on one side and
on the reverse have a score line and ‘P’ marked on one side of
the line and ‘U’ marked on the other.
They are available in packs of 60 tablets.
This product is manufactured by:
Pfizer Italia S.r.I., Marino Del Tronto, Ascoli Piceno, Italy.
Procured from within the EU. Parallel Import Product Licence
Holder: G-Pharma Ltd. Salford M50 2PU
POM

PL 16369/1078
Edronax® 4mg Tablets/Davedax® 4mg Tablets
22nd July 2015
‘Edronax’ is a registered trademark of Pharmacia Italia SpA.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Edronax® 4mg Tablets / Davedax® 4mg Tablets
(reboxetine methanesulphonate)
This medicine is available in the above names but will be
referred to as Edronax throughout this 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.
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, 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.
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:
 Certain antifungals, e.g. ketoconazole
 Certain antibiotics, e.g. erythromycin, rifampicin
 Medicines called ergot derivatives used to treat migraine
or Parkinson’s disease
 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), e.g. thiazides
 Medicines used to treat epilepsy e.g. phenobarbital,
carbamazepine and phenytoin
 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.
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.
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.
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 via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.
5.

How to store Edronax





Do not store Edronax above 25°C.
Keep out of sight and reach of children.
Do not use Edronax after the expiry date which is stated on
the carton or the bottle. The expiry date refers to the last day
of that month.
 If your tablets become discoloured, or show any signs of
deterioration, talk to your pharmacist. If your doctor tells you
to stop taking this medicine, return it to your pharmacist for
safe disposal. Only keep this medicine if your doctor tells you
to.
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.

Further information

What Edronax contains:
Each tablet contains 4mg of the active ingredient reboxetine (as
reboxetine methanesulphonate. Each tablet also contains
microcrystalline cellulose, calcium hydrogen phosphate dihydrate,
crospovidone, colloidal hydrated silica and magnesium stearate.
What Edronax looks like and contents of the pack:
Edronax are round, white tablets marked ‘7671’ on one side and
on the reverse have a score line and ‘P’ marked on one side of
the line and ‘U’ marked on the other.
They are available in packs of 60 tablets.
This product is manufactured by:
Pfizer Italia S.r.I., Marino Del Tronto, Ascoli Piceno, Italy.
Procured from within the EU. Parallel Import Product Licence
Holder: G-Pharma Ltd. Salford M50 2PU
POM

PL 16369/1078
Edronax® 4mg Tablets/Davedax® 4mg Tablets
22nd July 2015
‘Edronax’ is a registered trademark of Pharmacia Italia SpA.

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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.

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