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EDRONAX 4 MG TABLETS

Active substance(s): REBOXETINE / REBOXETINE METHANESULPHONATE

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Package Leaflet: Information for the user

Edronax® 4 mg Tablets / Reboxetine 4 mg Tablets
(reboxetine)
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 available using either of the above names but will be
referred to as Edronax throughout the remainder of this leaflet.

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.

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

Furthermore, if any of the symptoms listed above appear or worsen when
a patient under 18 is taking Edronax, you should inform your doctor.

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.

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 breastfeeding 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

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
• 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) FURTHER INFORMATION
What Edronax contains
The active ingredient is reboxetine. Each tablet contains 4mg reboxetine.

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.

The other ingredients are:
Microcrystalline cellulose, calcium hydrogen phosphate dihydrate,
crospovidone, hydrated colloidal silica, and magnesium stearate.

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.

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
marked “7671”.

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

Edronax is available in packs of 60 tablets.
Manufacturer
Pfizer Italia S.r.l.
63100 Localita Marino del Tronto
Ascoli Piceno
Italy
They are 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
PL 33532/0463
Leaflet dated 7th May 2015
Leaflet coded XXXXXXXXXX
Edronax® is a registered trademark of Pfizer Italia S.r.l., Italy.

POM

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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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