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EDRONAX 4MG TABLETS

Active substance(s): REBOXETINE / REBOXETINE / REBOXETINE

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evening. You should swallow your tablet with a glass of water. The tablet can be divided
into equal doses. 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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

tablets

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.

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

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 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.

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.

4. Possible side effects

2. What you need to know before you take Edronax

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.

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
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 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.
Other medicines and Edronax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

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.

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 “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
• 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
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353
1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
5. How to store Edronax

Edronax may affect or be affected by other medicines. These include:
Keep this medicine out of the sight and reach of children.





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.
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.
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
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 patients.
• Edronax should not be used in children and adolescents under 18 years.

Do not use this medicine after the expiry date which is stated on the carton or the bottle.
The expiry date refers to the last day of that month.
Do not store Edronax above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.
6. Contents of the pack and other information
What Edronax contains:
The active substance is reboxetine.
• Each tablet contains 4 mg of reboxetine
The other ingredients are:
• Cellulose microcrystalline, calcium hydrogen phosphate dihydrate, crospovidone, silica
colloidal hydrated and magnesium stearate.
What Edronax looks like and contents of the pack:
Edronax are white, round, convex tablets with a breakline. A ‘P’ is marked on the left side
of the breakline and a ‘U’ is marked on the right side. The side opposite the breakline is
marked “7671”. The tablet can be divided into equal doses.
Edronax is available in 10, 20, 50, 60, 100, 120, and 180 tablets in blisters packs, 60 tablets
in glass bottles, multipacks of 3x60, 5x60 and 10x60 tablets in blisters; and 3x60, 5x60 and
10x60 tablets in glass bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.
Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business
Campus, Dublin 24.
Manufacturer:
Pfizer Italia S.r.l. – 63100 Localita Marino Del Tronto - Ascoli Piceno, Italy
This medicinal product is authorised under the name Edronax in Austria, Belgium, Denmark,
Finland, Germany, Ireland, Italy, Luxembourg, Portugal, Sweden and United Kingdom. It is
also authorised in Spain under the name Norebox.
This leaflet was last revised in:
UK: 06/2017
IE: MM/YYYY
Ref: ED 22_1

The tablets should be taken in two divided doses, one dose in the morning and one in the
4202097.18.9

4202097.18.9

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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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