EDRONAX 4 mg Tabletka

Treść ulotki

1. EDRONAX 4 mg tablets
   1. What is Edronax and what is it 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

EDRONAX 4 mg tablets

reboxetine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

1. What is Edronax and what is it used for

The active ingredient of Edronax is reboxetine, which belongs to the group of medicines called
antidepressants. Edronax is used in the acute treatment of depressive illness/major depression and to maintain the improvement of its symptoms once it
has initially responded to treatment with reboxetine.

2. What you need to know before you take Edronax

Do not take Edronax
If you are allergic to reboxetine or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Edronax if:

• you suffer from convulsions or epilepsy. Treatment with reboxetine should be stopped if epileptic seizures occur.
• you have any symptom of urinary problems, enlarged prostate or if you have had

previous heart problems.

• you are taking medicines to reduce blood pressure.
• you have problems with the liver or kidneys. Your doctor may need to adjust the dose.
• you are taking a medicine called “monoamine oxidase inhibitor” (MAOI) used for depression or have taken an MAOI in the last 2 weeks. Your doctor may need to stop the MAOI at least 2 weeks before starting therapy with Edronax.
• you have experienced episodes of mania (hyperactive behaviour or thoughts).
• you have problems with your eyes, such as certain types of glaucoma (increased pressure in the eye).

Serotonin syndrome:
Serotonin syndrome is a potentially life-threatening condition that can
occur when you take Edronax, alone or in combination with other medicines (see
section 2 “Other medicines and Edronax”). Signs and symptoms of serotonin syndrome may
include a combination of the following effects: confusion, restlessness, hallucinations, coma,
rapid heartbeat, increased body temperature, rapid changes in blood
pressure, sweating, flushing, tremor, overactive reflexes, nausea, vomiting and diarrhoea.

Contact a doctor or go immediately to the nearest emergency room if you think you have
serotonin syndrome.
Suicidal thoughts and worsening of depression:

If you are depressed you may sometimes think about harming yourself or committing suicide. This may occur
more frequently at the beginning of therapy with antidepressants, as all these medicines
take time to exert their effects, usually about two weeks but sometimes also
longer.
You may be more likely to have these thoughts if:

• You have already had previous thoughts of killing yourself or harming yourself.
• You are young. Information from clinical studies has shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric illnesses and being treated with an antidepressant. If at any time you think about harming yourself or committing suicide, contactyour doctor immediately or go to hospital.

It may help to confide in a relative or friend that you are depressed, and ask them
if they notice that you are getting worse or if they are worried about changes in your behaviour.

Children and adolescents
Normally Edronax should not be used in children and adolescents under the age of 18
years. If this class of medicines is taken, patients under 18 years of age
have an increased risk of undesirable effects such as suicide attempt, suicidal ideation
and hostility (essentially aggression, oppositional behaviour and anger). However, it
is possible that in the patient’s interest the doctor may decide to prescribe Edronax to patients under 18 years of age if he/she considers it strictly necessary. If your doctor has prescribed Edronax
to a patient under 18 years of age and you wish to have more information, contact
your doctor.
Also, if any of the symptoms listed above occur or worsen during
treatment with Edronax in a patient under 18 years of age, you should inform the doctor.
The effects on long-term safety of Edronax relating to growth, maturation and
cognitive and behavioural development have not yet been demonstrated in this group of
patients.

Other medicines and Edronax
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Edronax can influence or be influenced by other medicines. These include:

• Some antifungal medicines, e.g. ketoconazole.
• Some antibiotics, e.g. erythromycin, rifampicin.
• Medicines called ergotamine derivatives used for the treatment of migraine or Parkinson’s disease.
• Any diuretic that causes potassium loss (medicines for eliminating fluids), e.g. thiazides.
• Medicines used for the treatment of epilepsy, e.g. phenobarbital, carbamazepine and phenytoin
• Herbal medicines containing St John’s Wort ( Hypericum perforatum)
• Medicines that, when taken together with Edronax, can increase the risk of developing serotonin syndrome (see section 2 “Warnings and precautions”): o Some antidepressants called monoamine oxidase inhibitors (MAOIs), tricyclic and tetracyclic antidepressants, nefazodone, SSRIs (such as fluvoxamine), other serotonin and noradrenaline reuptake inhibitors (SNRIs) o lithium o Medicines called triptans used for the treatment of migraine o Other MAO inhibitors such as linezolid (an antibiotic) and methylene blue (used for the treatment of high levels of methaemoglobin in the blood) o Medicines containing opioids (such as buprenorphine) used for the treatment of severe pain and/or opioid dependence o Medicines used for the treatment of anxiety such as buspirone o Products containing tryptophan (used for problems such as sleep or depression)

The doctor will tell you if you can take Edronax with other medicines. Tell your doctor or pharmacist if
you are taking or have recently taken any other medicines, even those without
prescription, herbal medicines as well as vitamins and minerals.

Edronax with food and drink
Edronax can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
There is not enough information available on the use of Edronax during pregnancy. Do not take
Edronax if you are pregnant, unless your doctor, after carefully considering the
clinical risk/benefit, considers it strictly necessary. Tell your doctor immediately if you are pregnant or if you are planning a pregnancy.

Breastfeeding
Edronax passes into breast milk in small amounts. There is a risk of a potential effect on
the baby. Therefore, you should discuss this with your doctor who will decide whether to stop
breastfeeding or the therapy with Edronax.

Driving and using machines
Caution is recommended when driving or operating machinery.
You should not drive vehicles or operate machinery until you have ascertained whether this
medicine alters your ability to perform these activities (e.g. you feel sleepy) and until
you can perform these activities safely.

3. How to take Edronax

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose in adults is 8 mg per day (one 4 mg tablet twice a day). Depending on your response to the medicine, if necessary after 3-4 weeks, your doctor
may prescribe up to 10 mg per day. The maximum daily dose should not exceed 12 mg.

• The initial dose in patients with reduced renal or hepatic function is 4 mg per day. This may be increased depending on individual response.
• The use of Edronax 4 mg is not recommended in elderly patients.
• Edronax should not be used in children and adolescents under 18 years of age.

The tablets should be taken in two separate doses, one dose in the morning and one in the evening.
You should swallow the tablet with a glass of water. The tablets can be divided into
equal doses. Do not chew the tablet.
To remember to take Edronax, you may find it easier to take the tablets every day at the
same time.
Like other medicines, Edronax will not immediately relieve your symptoms. You should start to
feel better within a few weeks.
It is important to continue taking the tablets, even when you feel better, until your
doctor advises you to stop treatment. You must be patient because if
you stop treatment too soon, the symptoms may return.

If you take more Edronax than you should
You should never take more tablets than prescribed by your doctor. If you take too many
tablets, contact your doctor or the nearest hospital immediately. If you take a number of
Edronax tablets higher than those prescribed, symptoms of overdose may occur,
including reduced blood pressure, anxiety and hypertension.

If you forget to take Edronax
If you forget to take Edronax, take the next dose at the scheduled time. Do not take a
double dose to compensate for the missed dose.

If you stop taking Edronax
You should not stop taking the medicine without informing your doctor, as the symptoms
may return.
There have been some cases of withdrawal symptoms including headache, dizziness, nervousness and nausea,
in patients who have stopped treatment with Edronax.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. With Edronax many of the side effects lessen or disappear after the first few weeks of treatment.
If any of the side effects gets worse, or if you notice any side effect

Very common:may affect more than 1 in 10 people

• Difficulty sleeping (insomnia)
• Dizziness
• Dry mouth
• Constipation
• Nausea (feeling sick)
• Sweating

Common:may affect up to 1 in 10 people

• Headache
• Loss or decrease of appetite
• Agitation, anxiety
• Paresthesia (pins and needles), inability to sit or stand still, altered sense of taste
• Difficulty focusing vision
• Increased heart rate, palpitations (heart racing)
• Enlargement of veins, sudden drop in blood pressure when standing up, increased blood pressure
• Vomiting
• Rash
• Sensation of incomplete bladder emptying or slow bladder emptying, urinary infections, painful urination, inability to completely empty the bladder.
• Erectile dysfunction (impotence), ejaculatory pain or delayed ejaculation
• Shivers

Uncommon:may affect up to 1 in 100 people

• Dilated pupils
• Confusional state

Rare:may affect up to 1 in 1,000 people

• Glaucoma (a condition that causes increased pressure in the eye)

Not known:(frequency cannot be estimated from the available data):

• Serotonin syndrome (see section 2 “Warnings and precautions”)
• Hyponatremia (very low levels of sodium in the blood)
• Aggressive behaviour, hallucinations
• Suicidal ideation, suicidal behaviour
• Cases of suicidal ideation and suicidal behaviour have occurred during treatment with reboxetine or immediately after discontinuation of treatment (see section 2 “Warnings and precautions”)
• Feeling of coldness in the extremities, Raynaud’s phenomenon (poor circulation, usually in the toes and fingers, but also in the nose and ears, the skin becomes white, cold and numb)
• Allergic skin inflammation
• Testicular pain
• Irritability
• Increased eye pressure

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 through
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Edronax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store Edronax at a temperature above 25°C
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Edronax contains
The active ingredient is reboxetine.

• Each tablet contains 4 mg of reboxetine. The excipients are:
• microcrystalline cellulose, dibasic calcium phosphate dihydrate, crospovidone, hydrated colloidal silica and magnesium stearate.

Description of the appearance of Edronaxand contents of the pack:
Edronax tablets are white, round, convex, with a fracture line.
A P is printed to the left of the fracture line and a U to the right. The opposite side of the tablet
is marked 7671. The tablets can be divided into two equal doses.
Edronax is available in packs of 10, 20, 50, 60, 100, 120 and 180 tablets in blisters and in
multipacks with blisters containing 180 (3x60), 300 (5x60) and 600 (10x60) tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
PFIZER ITALIA S.r.l – Via Isonzo, 71 – 04100 Latina
Manufacturer:
Pfizer Italia S.r.l, Località Marino del Tronto - 63100 Ascoli Piceno
This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, Portugal, Sweden and United Kingdom (Northern
Ireland): Edronax
Spain: Norebox

This leaflet was last updated on