Prospecto: Information for the User

Norebox 4 mg Tablets

reboxetina

Read this entire prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Norebox and for what it is used

2.What you need to know before starting to take Norebox

3.How to take Norebox

4.Possible adverse effects

5.Storage of Norebox

6.Contents of the package and additional information

The active ingredient of Norebox is reboxetine, which belongs to a group of medications known as antidepressants. Norebox is used inthe treatment of depressive disorders/depression and in the maintenance of improvement of its symptoms when you have initially responded to treatment with reboxetine.

Do not take Norebox:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Norebox if:

• you have seizures or epilepsy. Treatment with reboxetine should be discontinued if you have a seizure.
• you have any urinary problems, an enlarged prostate or a history of heart problems.
• you are being treated with medicines to lower blood pressure.
• you have liver or kidney problems. Your doctor may need to adjust your dose.
• you are taking a medicine called "monoamine oxidase inhibitor" (MAOI) used for depression or if you have taken an MAOI in the last two weeks. Your doctor may need to stop the MAOI at least 2 weeks before starting treatment with Norebox.
• you have ever had episodes of mania (hyperactive behavior or accelerated thinking).
• if you have any eye disorder, 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 taking Norebox alone or in combination with other medicines (see section 2 "Taking Norebox with other medicines"). The signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, hallucinations, coma, rapid heart rate, increased body temperature, rapid changes in blood pressure, sweating, hot flushes, tremors, hyperactive reflexes, nausea, vomiting, and diarrhea.Seek medical attention or contact your doctor immediately if you think you are experiencing serotonin syndrome.

Thoughts of suicide and worsening of depression:

If you are depressed, you may sometimes have thoughts of harming yourself or suicide.These thoughts may increase at the beginning of treatment with antidepressants, because all these medicines take time to work, usually one or two weeks or sometimes longer.

It is more likely to happen:

- if you have had thoughts of suicide or self-harm before.

- if you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders, who were being treated with antidepressants.

if you have thoughts of harming yourself or suicide at any time,contact your doctor or go to the hospital immediately.

It may be helpful to explain to a close family member or friendthat you are depressed and ask them to read this leaflet. You can also ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Children and adolescents

Norebox should not be used normally in the treatment of children and adolescents under 18 years. However, you should know that in patients under 18 years there is a higher risk of adverse effects such as attempts at suicide, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritable reaction) when taking this type of medicine. Despite this, the doctor who prescribes Norebox may prescribe it to patients under 18 years when they decide it is the best option for the patient. If the doctor who prescribes Norebox to a patient under 18 years wants to discuss this decision, please go back to your doctor.

You should inform your doctor if any of the symptoms listed above progress or if you experience complications when patients under 18 years are taking Norebox.

Additionally, the long-term safety effects and those related to growth, maturity, and cognitive and behavioral development of Norebox in this age group have not yet been demonstrated.

Taking Norebox with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Norebox may affect or be affected by other medicines. This includes:

• Certain antifungals, such as ketoconazole.
• Certain antibiotics, such as erythromycin, rifampicin.
• Medicines known as ergot derivatives used to treat migraine and Parkinson's disease.
• Any diuretic (medicine to eliminate liquids) potassium eliminator, such as thiazides.
• Medicines used to treat epilepsy, such as phenobarbital, carbamazepine, and phenytoin.
• Medicines based on plants that contain St. John's Wort (Hypericum perforatum).
• Medicines that taken with Norebox may increase the risk of developing serotonin syndrome (see section 2 "Warnings and precautions"):

• Certain antidepressants known as MAOIs, tricyclic antidepressants, tetracyclic antidepressants, nefazodone, SSRIs (such as fluvoxamine), other serotonin and noradrenaline reuptake inhibitors (SNRIs) or lithium.
• Medicines known as triptans used to treat migraine.
• Other MAOIs such as linezolid (an antibiotic) or methylene blue (used to treat high levels of methemoglobin in the blood).
• Medicines that contain opioids (such as buprenorphine) used to treat intense pain and/or opioid addiction.
• Medicines used to treat anxiety, such as buspirone.
• Products that contain tryptophan (used to treat problems such as sleep or depression).

Your doctor will tell you if you can take Norebox with other medicines. Please inform your doctor or pharmacist if you are using or have used recently other medicines, even those purchased without a prescription, medicines based on plants, as well as vitamins and minerals.

Taking Norebox with food and drinks

Norebox can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is not enough experience of the use of Norebox in pregnant women. Do not take Norebox if you are pregnant unless your doctor considers it absolutely necessary after conducting a thorough clinical risk-benefit analysis. Inform your doctor immediately if you are pregnant or if you are thinking of becoming pregnant.

Breastfeeding

Norebox is found in small amounts in breast milk. There is a risk of producing a possible effect on the baby. Therefore, you should discuss this with your doctor and they will decide whether you should stop breastfeeding or the treatment with Norebox.

Driving and operating machines

Caution is recommended when driving or operating machines.

Do not drive or operate hazardous tools or machines until you know that Norebox does not affect your ability (for example, you feel dizzy) and therefore, you can perform these activities safely.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose for adults is 8 mg per day (one 4 mg tablet, twice a day). Depending on how you respond to the medication, after 3 or 4 weeks, your doctor may increase your dose to 10 mg per day, if necessary. The maximum daily dose should not exceed 12 mg per day.

• In patients with reduced renal or hepatic function, the starting dose is 4 mg per day. This dose may be increased based on the individual response of each patient.

• The use of Norebox is not recommended in elderly patients.

• Norebox should not be used in children and adolescents under 18 years old.

Norebox tablets should be taken twice a day, one dose in the morning and one dose at night. Norebox tablets should be swallowed with a glass of water. The tablet can be divided into equal doses. Do not chew the tablet.

Remember to take Norebox. To make it easier, take the medication at the same time every day.

Like other medications, Norebox will not alleviate your symptoms immediately. You will start to feel better after a few weeks.

It is essential that you continue taking your tablets, even if you feel better, until your doctor tells you to stop treatment. Please be patient, if you interrupt treatment too soon, your symptoms may return.

If you take more Norebox than you should

You should never take more tablets than your doctor has recommended. If you have taken many tablets, consult your doctor or go to the nearest hospital immediately. If you have taken more tablets than you should, you may experience overdose symptoms including low blood pressure, anxiety, and hypertension.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Norebox

If you forget to take a dose of Norebox, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Norebox

You should not interrupt treatment with Norebox without consulting your doctor first, as your symptoms may return.

Some cases of withdrawal symptoms, including headache, dizziness, nervousness, and nausea (urge to vomit), have been reported when patients interrupted treatment with Norebox.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationmay cause side effects, although not everyone will experience them. With Norebox, most side effects are mild and usually disappear after the first few weeks of treatment.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Very common(may affect more than 1 in 10 people)

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

Common (may affect less than 1 in 10 people)

• Headache.
• Loss or decrease of appetite.
• Restlessness, anxiety.
• Paresthesia (tingling), inability to sit or stand, altered taste.
• Blurred vision.
• Increased heart rate, palpitations (strong heartbeats).
• Increased diameter of blood vessels, drop in blood pressure when standing, increased blood pressure.
• Vomiting.
• Skin rash.
• Sensation of incomplete or slow emptying of the bladder, urinary tract infection, painful urination, inability to empty the bladder completely.
• Erectile dysfunction (impotence), pain during ejaculation, or delayed ejaculation.
• Chills.

Uncommon (may affect between 1 and 10 in every 1,000 people)

• Dilated pupils.
• Sensation of spinning (dizziness).

Rare (may affect between 1 and 10 in every 10,000 people)

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

Unknown (the frequency cannot be estimated from the available data)

• Serotonin syndrome (see section2 “Warnings and precautions”).
• Hypontremia (very low sodium levels in the blood).
• Aggressive behavior, hallucination.
• Suicidal ideation, suicidal behavior. Cases of suicidal ideation or suicidal behavior have been reported during treatment with reboxetina or shortly after treatment was stopped (see section 2 “Warnings and precautions”).
• Cold extremities, Raynaud's phenomenon (poor blood circulation to the extremities, usually the fingers and toes, but can also affect the nose and ears, the skin becomes pale, cold, and numb).
• Allergic skin inflammation.
• Testicular pain.
• Irritability.
• Increased eye pressure.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not storeNorebox at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Norebox

The active ingredient is reboxetine. Each tablet contains 4 mg of reboxetine.

The other components are microcrystalline cellulose, dibasic calcium phosphate dihydrate, crospovidone, hydrated colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

Norebox is presented in the form of white, round, convex tablets with a groove. It has a "P" engraved to the left of the groove and a "U" to the right of the same. On the opposite side of the groove, the inscription "7671" is engraved. The tablet can be divided into half doses.

Norebox is available in packaging of 20 or 60 tablets in blister packs. Not all packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja

28108. Alcobendas (Madrid)

Spain

Responsible for manufacturing

Pfizer Italia S.r.l.

63100 Località Marino del Tronto

Ascoli, Piceno

Italy

This medicine is authorized in the member states of the European Economic Community and in the United Kingdom (Northern Ireland) under the following names:

• Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, Portugal, Sweden, and United Kingdom (Northern Ireland): Edronax
• Spain: Norebox

Last review date of this leaflet: October 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es