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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.

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.

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 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

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)

•    Dry mouth

•    Constipation

•    Nausea (feeling sick)

•    Sweating

Common side effects (less than one in 10 patients)

•    Headache

•    Lack or loss of appetite

•    Agitation, anxiety

•    Dizziness, 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 Edronax, 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, pharmacist or nurse. 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

•    Keep out of the sight and reach of children.

•    Do not store above 25C.

•    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. The other ingredients are:

Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, crospovidone, hydrated colloidal silica, and magnesium stearate.

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”.

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 date: 23^rd December 2013 Leaflet code: XXXXXXXXXX

Edronax® is a registered trademark of Pfizer Italia S.r.l., Italy.