Skip to Content

EDRONAX 4MG TABLETS

Active substance(s): REBOXETINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

To help you remember to take Edronax, you may find it easier to take your tablets
at the same time every day.

reboxetine

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.

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.

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.

®

4 mg Tablets

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

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.

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. 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 (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.
4202097.17.2

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.

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
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
• Do not store Edronax above 25°C.
• Keep out of reach and sight 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.
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 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 halves.
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:
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 01/2015
Ref: ED 21_0

4202097.17.2

Expand view ⇕

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