EDRONAX 4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. EDRONAX, 4 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Edronax and what is it used for
4. Important information before taking Edronax
   1. When not to take Edronax
   2. Warnings and precautions
   3. You should contact your doctor or go to the emergency department of the nearest hospital immediately if you observe symptoms of serotonin syndrome.
   4. Suicidal thoughts and worsening of depression or anxiety disorders
   5. Edronax and other medicines
   6. Taking Edronax with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
5. How to take Edronax
   1. Use in children and adolescents
   2. Overdose of Edronax
   3. Missed dose of Edronax
   4. Stopping Edronax treatment
6. Possible side effects
   1. Reporting side effects
7. How to store Edronax
8. Contents of the pack and other information
   1. What Edronax contains
   2. What Edronax looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: 04/2025
   6. What is depression?

Package Leaflet: Information for the User

EDRONAX, 4 mg, tablets

Reboxetine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Edronax and what is it used for
• 2. Important information before taking 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

Edronax is indicated for the intensive treatment of depression (including its severe form) and for maintenance treatment in patients who have responded well to initial treatment.
Many chemical compounds present in the brain affect mood. Noradrenaline is one of these compounds. The concentration of noradrenaline in people with depression is low. Edronax contains reboxetine, which belongs to a group of medicines called selective noradrenaline reuptake inhibitors. Edronax enhances the action of noradrenaline in the central nervous system, thereby reducing the symptoms of its deficiency. It alleviates the symptoms of depression and improves mood, and reduces fatigue and anxiety.
Despite improvement, which usually occurs after a few weeks, do not stop taking Edronax without consulting your doctor. This will reduce the risk of recurrence of disease symptoms.

2. Important information before taking Edronax

When not to take Edronax

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor if you have any of the following conditions, as a dose change or selection of another medicine may be necessary:

• kidney or liver disease;
• seizures (epilepsy);
• glaucoma or increased eye pressure;
• urination difficulties, with or without prostate enlargement;
• low blood pressure;
• cardiovascular disease, such as hypertension, previous myocardial infarction;
• taking antidepressant medicines called "monoamine oxidase inhibitors" (MAOIs) or taking MAOIs in the last 2 weeks. Your doctor may advise you to stop taking MAOIs for at least 2 weeks before starting Edronax.

Serotonin syndrome:
Serotonin syndrome is a potentially life-threatening condition that may occur when taking Edronax alone or in combination with other medicines (see section 2 "Edronax and other medicines"). Symptoms of serotonin syndrome may include: confusion, restlessness, hallucinations, coma, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, sweating, hot flashes, tremors, overreactivity, nausea, vomiting, and diarrhea.

You should contact your doctor or go to the emergency department of the nearest hospital immediately if you observe symptoms of serotonin syndrome.

Suicidal thoughts and worsening of depression or anxiety disorders

People suffering from depression and/or anxiety disorders may sometimes feel like hurting themselves or committing suicide. This may worsen after starting to take antidepressant medicines, as their effect develops over a period of time, usually appearing only after about two weeks of treatment, and sometimes later.
Such thoughts occur more frequently:

• in people who have already felt like hurting themselves or committing suicide in the past;
• in young people. Clinical trials have shown that the risk of suicidal behavior is higher in people under 25 years of age with mental disorders who have taken antidepressant medicines. If you feel like hurting yourself or committing suicide, you should immediately contact your doctor or go to the hospital. It's worth talking to your loved ones about depression or anxiety and asking them to read this leaflet. You can also ask them to pay attention to whether the symptoms of depression or anxiety are worsening and to assess whether changes in behavior are disturbing.

Edronax and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Edronax may interact with medicines such as:

• blood pressure lowering medicines;
• medicines that, when taken with Edronax, may increase the risk of developing serotonin syndrome (see section 2 "Warnings and precautions"): o antidepressant medicines called MAO inhibitors, tricyclic antidepressants, tetracyclic antidepressants, nefazodone, selective serotonin reuptake inhibitors (SSRIs) (e.g. fluvoxamine), other serotonin and noradrenaline reuptake inhibitors (SNRIs) or lithium compounds; o triptans used to treat migraines; o other MAO inhibitors such as linezolid (an antibiotic) and methylene blue (used to treat high methemoglobin levels in the blood); o opioid-containing medicines (such as buprenorphine) used to treat severe pain and/or opioid dependence; o anxiolytic medicines, such as buspirone; o products containing tryptophan (used for sleep problems or depression);
• certain antibiotics (e.g. erythromycin, rifampicin);
• azole antifungal agents (e.g. fluconazole, ketoconazole);
• medicines containing ergotamine derivatives (which may be a component of migraine or Parkinson's disease medicines, or medicines used to prevent and treat bleeding after abortion or childbirth);
• diuretics that cause potassium loss;
• medicines used to treat epilepsy and other conditions (e.g. phenytoin, carbamazepine, phenobarbital);
• medicines used to treat depression and anxiety disorders - products containing St. John's wort ( Hypericum perforatum).

Taking Edronax with food, drink, and alcohol

Edronax does not increase the effect of alcohol on cognitive abilities, however, you should not drink alcohol while taking Edronax.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
There are no clinical data on the use of Edronax in pregnant women. Limited data obtained after the medicine was placed on the market do not indicate that the medicine has a harmful effect on the course of pregnancy or the health of the fetus and/or newborn.
Edronax can be used in pregnancy only if the expected benefits of treatment for the mother outweigh the risk to the developing fetus. Before taking the medicine, consult your doctor.
Edronax passes into breast milk. The expected concentration of the active substance in breast milk is very low; however, available information is not sufficient to rule out the risk to the breastfed child. The use of Edronax during breastfeeding can be considered if the potential benefits outweigh the risk to the child.
There are no clinical data on the effect of Edronax on fertility. However, animal studies have not shown any effect on fertility parameters.

Driving and using machines

Do not drive or operate hazardous machines until you are sure that the medicine does not affect your ability.

3. How to take Edronax

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended therapeutic dose for the treatment of depression in adults is usually 4 mg taken orally twice a day, which gives a total daily dose of 8 mg. If there is an incomplete clinical response after 3-4 weeks, the dose may be increased to 10 mg per day. The maximum daily dose should not exceed 12 mg.
Edronax should not be used in the elderly (over 65 years of age).
The initial dose in patients with renal or hepatic impairment should be 2 mg twice a day. This dose can then be increased depending on the patient's response to the medicine.
As with other medicines, the effect of Edronax will not be immediate. Improvement may occur only after several weeks of therapy.
If you feel that the effect of Edronax is too strong or too weak, consult your doctor.

Use in children and adolescents

Edronax should not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age taking medicines from this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they consider it beneficial. If such a patient has any doubts, they should discuss it with their doctor again.
Tell your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Edronax. It has also not been shown that long-term safety regarding the effect on growth, maturation, and development of cognitive and behavioral functions in this age group.

Overdose of Edronax

If you have taken more Edronax than recommended, contact your doctor.
Depending on the symptoms, your doctor will provide appropriate treatment.

Missed dose of Edronax

Do not take a double dose to make up for a missed dose.

Stopping Edronax treatment

Continue taking the medicine, despite subjective improvement, for the period prescribed by your doctor. The treatment period may be several months. Stopping the medicine too early may cause a relapse of disease symptoms.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Edronax can cause side effects, although not everybody gets them.
With Edronax, side effects are usually mild and disappear after a few weeks of treatment.
If any of the following side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Very common(may affect more than 1 in 10 people)

• insomnia
• dizziness
• dry mouth
• constipation
• excessive sweating

Common(may affect up to 1 in 10 people)

• akathisia (inability to stay still)
• taste disorders
• accommodation disorders
• rapid heartbeat
• palpitations
• vasodilation
• orthostatic hypotension
• hypotension
• loss of appetite
• urination disorders
• feeling of incomplete bladder emptying
• urinary tract infections
• painful urination
• urinary retention
• chills
• ejaculation and erection disorders, pain during ejaculation, delayed ejaculation, testicular disorders - mainly testicular pain

Uncommon(may affect up to 1 in 100 people)

• vertigo of labyrinthine origin

Additionally, in spontaneous reports, the following side effects have been reported:
Very common(may affect more than 1 in 10 people)

• nausea

Common(may affect up to 1 in 10 people)

• agitation
• anxiety
• paresthesia (sensory disturbances in the form of tingling and numbness, which can occur all over the body)
• hypertension
• vomiting

Uncommon(may affect up to 1 in 100 people)

• pupil dilation

Frequency not known(cannot be estimated from the available data)

• serotonin syndrome (see section 2 "Warnings and precautions")
• hyponatremia
• hallucinations
• aggressive behavior
• peripheral coldness
• Raynaud's syndrome (poor blood circulation in the limbs, usually in the fingers and toes, although it can also affect the nose and ears; the skin turns pale, becomes cold and numb)
• testicular pain
• allergic skin inflammation
• rash
• irritability

During treatment with Edronax or shortly after stopping treatment, cases of suicidal thoughts and behaviors have been observed (see section: Warnings and precautions).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Edronax

Store in a temperature below 25°C.
Bottle: Store the container tightly closed to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Edronax contains

• The active substance of Edronax is reboxetine. One tablet contains 4 mg of reboxetine (as reboxetine methanosulfonate).
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, crospovidone, colloidal silica, magnesium stearate.

What Edronax looks like and contents of the pack

White, round, convex tablets with a diameter of 8 mm, with a dividing line on one side. On the left side of the dividing line is the letter "P", on the right side is the letter "U". On the back of the tablet is the number "7671".
The packaging of Edronax contains 20 or 60 tablets in blisters or in a high-density polyethylene (HDPE) bottle with a cylinder containing a desiccant in the form of silica gel, closed with a child-resistant polypropylene cap, which is closed by pressing and twisting. Each bottle contains a desiccant in the form of silica gel, which should be kept in the bottle to protect the tablets. The desiccant is in a separate cylinder and should not be swallowed.
Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Italia S.r.l
63100 Localita Marino del Tronto
Ascoli Piceno
Italy
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet: 04/2025

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://www.pfizer.pl/ulotka-edronax and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl .

What is depression?

Patients with depression have a low mood and reduced energy. Depression is a common disease and affects people of all ages. There is no obvious cause of depression, it can be caused by a physical illness, loss of a loved one, stress, overwork, relationship problems, financial problems, or even the birth of a child.