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 Use in children and adolescents:
medicine. Edronax should not usually be used in children and adolescents less
• Keep this leaflet. You may need to read it again. than 18 years old. Patients under 18 have an increased risk of
• If you have any further questions, ask your doctor or pharmacist. undesirable effects, such as suicide attempt, suicidal thoughts and
• This medicine has been prescribed for you. Do not pass it on to others. hostility (mainly aggressiveness, oppositional behaviour and anger) when
It may harm them, even if their symptoms are the same as yours. they are treated with this class of medicines. Nevertheless, it is possible
• If any of the side effects gets serious, or if you notice any side effects that your doctor decides to prescribe Edronax to a patient under 18 if it is
not listed in this leaflet, please tell your doctor or pharmacist. in the patient's interest. If your doctor has prescribed Edronax to a patient
• Your medicine is available using either of the above names but will be less than 18 years old and you want to discuss this, please contact
referred to as Edronax throughout the remainder of this leaflet. him/her.
In this leaflet: Furthermore, if any of the symptoms listed above appear or worsen when
1) What Edronax is and what it is used for a patient under 18 is taking Edronax, you should inform your doctor.
2) Before you take Edronax
3) How to take Edronax Also, the long-term safety of Edronax in regard to growth, maturation and
4) Possible side effects cognitive and behavioural development in this age group has not yet
5) How to store Edronax been demonstrated.
6) Further information
Taking other medicines
Given that Edronax may interact with other medicines, tell your doctor if
1) WHAT EDRONAX IS AND WHAT IT IS USED FOR you are taking the following medicines:
The active substance in Edronax is reboxetine which is part of a group of • Certain antifungals, e.g. ketoconazole
medicines called antidepressants. Edronax is used in acute treatment of • Certain antibiotics, e.g. erythromycin, rifampicin.
depressive illness / major depression as well as for maintaining the • Medicines called ergot derivatives used to treat migraine or
improvement of your symptoms when you have initially responded to Parkinson’s disease
treatment with reboxetine. • Certain antidepressants called MAO inhibitors, tricyclics, nefazodone,
SSRIs (such as fluvoxamine) or lithium
2) BEFORE YOU TAKE EDRONAX • 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),
Do not take Edronax e.g thiazides
• if you are allergic (hypersensitive) to reboxetine or any of the other • Medicines used to treat epilepsy e.g. phenobarbital, carbamazepine
ingredients of Edronax. For a full list of excipients, see section 6. and phenytoin
• Herbal medicines containing St. John’s Wort (Hypericum perforatum)
Take special care with Edronax
Your doctor will tell you whether you can take Edronax with other
Tell your doctor if you: medicines. Please tell your doctor or pharmacist if you are taking or have
• suffer from convulsions or epilepsy. Treatment with reboxetine should recently taken any other medicines, including medicines obtained without
be stopped if seizures occur. a prescription, herbal medicines, as well as vitamins and minerals.
• have any signs of urinary problems, enlarged prostate or a history of
heart problems. Taking Edronax with food and drink
• are taking medicines to lower your blood pressure. Edronax can be taken with or without food.
• have liver or kidney problems. Your doctor may need to adjust your
dosage. Pregnancy and Breast-feeding
• are taking any other medicine for depression such as MAO inhibitors, Ask your doctor or pharmacist for advice before taking any medicine.
tricyclics, nefazodone, SSRIs (such as fluvoxamine) or lithium.
• are taking other MAO inhibitors such as linezolid (an antibiotic) or Pregnancy
methylene blue (see section “Taking other medicines”). There are no adequate experiences from the use of Edronax in pregnant
• ever had episodes of mania (overactive behaviour or thoughts). women. Do not take Edronax if you are pregnant, unless your doctor
• have eye problems, such as certain kinds of glaucoma (increased considers it absolutely necessary, following a careful clinical risk/benefit
pressure in the eye). consideration. Tell your doctor immediately if you are pregnant or are
planning to become pregnant.
Thoughts of suicide and worsening of your depression:
If you are depressed you can sometimes have thoughts of harming Breast-feeding
or killing yourself. These may be increased when first starting Edronax passes into the breast milk in small amounts. There is a risk of a
antidepressants, since these medicines all take time to work, usually potential effect on the baby. Therefore, you should discuss the matter
about two weeks but sometimes longer. with your doctor and he/she will decide whether you should stop breast-
feeding or stop the therapy with Edronax.
You may be more likely to think like this:
- If you have previously had thoughts about killing or harming yourself. Driving and using machines
- If you are a young adult. Information from clinical trials has shown an Caution is recommended when driving or using machines.
increased risk of suicidal behaviour in adults aged less than 25 years You should not drive or operate machinery until you know you are not
with psychiatric conditions who were treated with an antidepressant. affected (i.e. feel drowsy) by Edronax, and that it is safe to do so.
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.
3) HOW TO TAKE EDRONAX Uncommon side effects (between 1 and 10 out of 1000 patients)
• Dilated pupils
• Spinning sensation
• 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 Rare side effects (between 1 and 10 out of 10000 patients)
doctor may tell you to take up to 10 mg per day if necessary. The • Glaucoma (a condition resulting in increased pressure in the eye)
maximum daily dose should not exceed 12 mg.
• In patients with poor kidney or liver function, the starting dose is 4 mg After marketing reboxetine, the following side effects have been
per day. This may be increased depending on the individual response. reported:
• The use of Edronax 4 mg tablets cannot be recommended for elderly • Hyponatremia (very low levels of sodium in the blood)
patients. • Aggressive behaviour, hallucination
• Edronax should not be used in children and adolescents under • Suicidal ideation, suicidal behaviour
18 years. Cases of suicidal ideation and suicidal behaviours have been reported
during reboxetine therapy or early after treatment discontinuation (see
The tablets should be taken in two divided doses, one dose in the section 2 “Take special care with Edronax”)
morning and one in the evening. You should swallow your tablet whole • Cold extremities, Raynaud’s phenomenon (poor blood circulation to
with a glass of water. Do not chew the tablet. the extremities usually in the toes and fingers but could also affect
nose and ears, the skin turns pale and becomes cold and numb)
To help you remember to take Edronax, you may find it easier to take • Allergic skin inflammation
your tablets at the same time every day.
• Testicular pain
• Irritability
Always take Edronax exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. • Increased pressure in the eye
Like other drugs Edronax will not relieve your symptoms immediately.
Reporting of side effects
You should start to feel better within a few weeks.
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
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 report side effects directly (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
taking your tablets too early, your symptoms might come back.
If you take more Edronax than you should United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard
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 5) HOW TO STORE EDRONAX
symptoms of overdose including low blood pressure, anxiety and
hypertension.
• Keep out of the sight and reach of children.
• Do not store above 25oC.
If you forget to take Edronax
If you forget to take Edronax, take your next dose at the normal time. Do • Do not use Edronax after the expiry date which is stated on the carton
not take a double dose to make up for a forgotten tablet. 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
If you intend to stop Edronax return them to your pharmacist.
You should not stop your medicine without talking to your doctor, as your • Medicines should not be disposed of via wastewater or household
symptoms may come back. waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
There have been a few reports of withdrawal symptoms including
headache, dizziness, nervousness and nausea, (feeling sick), when 6) FURTHER INFORMATION
patients stopped treatment with Edronax.
What Edronax contains
4) POSSIBLE SIDE EFFECTS The active ingredient is reboxetine. Each tablet contains 4mg reboxetine.
Like all medicines, Edronax can cause side effects, although not The other ingredients are:
everybody gets them. With Edronax most side effects are mild and Microcrystalline cellulose, calcium hydrogen phosphate dihydrate,
usually go away after the first few weeks of treatment. crospovidone, hydrated colloidal silica, and magnesium stearate.
If any of the side effects below gets serious, or if you notice any side What Edronax looks like and contents of the pack
effects not listed in this leaflet, please tell your doctor or pharmacist. 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
Very common side effects (more than one in 10 patients) marked on the right side of the breakline. The reverse side of the tablet is
• Difficulties to sleep (insomnia) marked “7671”.
• Dizziness
Edronax is available in packs of 60 tablets.
• Dry mouth
• Constipation
Manufacturer
• Nausea (feeling sick) Pfizer Italia S.r.l.
• Sweating 63100 Localita Marino del Tronto
Ascoli Piceno
Common side effects (less than one in 10 patients) Italy
• Headache
• Lack or loss of appetite They are procured from within the EU by Product Licence holder:
• Agitation, anxiety MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
• Paraesthesia (pins and needles), inability to sit or stand still, altered Aldridge, Walsall WS9 8ER.
taste sensation
• Lack of visual focus Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
• Increased heart rate, palpitation (heart pounding)
• Widened blood vessels, fall in blood pressure when standing up, PL 33532/0463 POM
increased blood pressure
• Vomiting Leaflet dated 7th May 2015
• Rash Leaflet coded XXXXXXXXXX
• Sensation of incomplete emptying or slowed emptying of the bladder,
urinary infection, painful urination, inability to completely empty the Edronax® is a registered trademark of Pfizer Italia S.r.l., Italy.
bladder
• Erectile dysfunction (impotence), ejaculatory pain, or ejaculatory delay
• Chills
