NOREBOX 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Norebox 4 mg Tablets

reboxetine

Read all of 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Norebox and what is it used for
2. What you need to know before you take Norebox
3. How to take Norebox
4. Possible side effects
5. Storage of Norebox
6. Contents of the pack and further information

1. What is Norebox and what is it used for

The active substance of Norebox is reboxetine, which belongs to a group of medicines known as antidepressants. Norebox is used in the treatment of depressive disorders / major depression as well as in the maintenance of improvement of symptoms when you have initially responded to treatment with reboxetine.

2. What you need to know before you take Norebox

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 a history of seizures or epilepsy. Treatment with reboxetine should be discontinued if you suffer a seizure.
• you have any urinary problems, 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 a 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 disease that may 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 heartbeat, increased body temperature, rapid changes in blood pressure, sweating, hot flashes, tremors, hyperactive reflexes, nausea, vomiting, and diarrhea. Contact a doctor or go to the nearest emergency room immediately if you think you are experiencing serotonin syndrome.

Suicidal thoughts and worsening of depression:

If you are depressed, you may sometimes have thoughts of harming yourself or committing 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 to you:

• if you have previously had suicidal thoughts or self-harm.
• if you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 with psychiatric disorders who are being treated with antidepressants.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to the hospital immediately.

It may be helpful for you 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 normally be used in the treatment of children and adolescents under 18 years of age. However, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and anger) when taking this type of medicine. Nevertheless, your doctor may prescribe Norebox to patients under 18 years of age when they decide it is the most convenient for the patient. If your doctor has prescribed Norebox to a patient under 18 years of age and you want to discuss this decision, please go back to your doctor.

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

Additionally, the long-term effects on safety and 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 (fluid-eliminating medicine) that eliminates potassium, such as thiazides.
• Medicines used to treat epilepsy, such as phenobarbital, carbamazepine, and phenytoin.
• Herbal medicines containing St. John's Wort (Hypericum perforatum).
• Medicines that, when taken with Norebox, could 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 norepinephrine reuptake inhibitors (SNRIs), or lithium.
• Medicines known as triptans used to treat migraine.
• Other MAOIs such as linezolid (an antibiotic) or methylthioninium chloride (used to treat high levels of methemoglobin in the blood).
• Medicines containing opioids (such as buprenorphine) used to treat severe pain and/or opioid addiction.
• Medicines used to treat anxiety, such as buspirone.
• Products containing tryptophan (used to treat problems such as sleep or depression).

Your doctor will tell you if you can take Norebox with other medicines. Please tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, herbal medicines, 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There is not enough experience with 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 analysis of the risk/benefit. Inform your doctor immediately if you are pregnant or think you may be 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 treatment with Norebox.

Driving and using 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 (e.g., you feel dizzy) and you can perform these activities safely.

3. How to take Norebox

Follow exactly the administration instructions of this medicine 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 medicine, after 3 or 4 weeks, your doctor may increase your dose up 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 initial dose is 4 mg per day. This dose may be increased based on the individual response of each patient.

• Norebox is not recommended for use in elderly patients.

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

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

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

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

It is important 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 early, your symptoms may come back.

If you take more Norebox than you should

Never take more tablets than your doctor has recommended. If you have taken too many tablets, consult your doctor or go to the nearest hospital immediately. If you have taken more tablets than you should, you may experience symptoms of overdose, 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 medicine and the amount ingested.

If you forget to take Norebox

If you forget to take a dose of Norebox, take the next dose as usual when it is due. Do not take a double dose to make up for forgotten doses.

If you stop taking Norebox

Do not stop taking Norebox without consulting your doctor first, as your symptoms may come back.

Some cases of withdrawal symptoms have been reported, including headache, dizziness, nervousness, and nausea (vomiting), when patients stopped taking Norebox.

If you have any other questions 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 Norebox, most side effects are mild and usually disappear after the first few weeks of treatment.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell 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 up to 1 in 10 people)

• Headache.
• Lack or loss of appetite.
• Agitation, anxiety.
• Paresthesia (tingling), inability to sit or stand, altered taste.
• Blurred vision.
• Increased heart rate, palpitations (strong heartbeats).
• Increased diameter of blood vessels, low blood pressure when standing up, increased blood pressure.
• Vomiting.
• Rash.
• Feeling 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 up to 1 in 100 people)

• Dilated pupils.
• Feeling of spinning (vertigo).

Rare (may affect up to 1 in 1,000 people)

• Glaucoma (disease 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 behavior, hallucination.
• Suicidal ideation, suicidal behavior. There have been reports of suicidal ideation or suicidal behavior during treatment with reboxetine or shortly after stopping treatment (see section 2 "Warnings and precautions").
• Coldness in extremities, Raynaud's phenomenon (poor blood circulation to the extremities, normally 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 pressure in the eye.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Norebox

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

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

Do not store Norebox at a temperature above 25°C.

Bottle: Keep the container tightly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Norebox

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

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

Appearance of the product and contents of the pack

Norebox is presented in the form of white, round, convex tablets with a score line. It has a "P" engraved to the left of the score line and a "U" to the right of it. On the opposite face of the score line, the inscription "7671" is engraved. The tablet can be divided into two equal halves.

Norebox is available in packs of 20 or 60 tablets in blister packs or in a high-density polyethylene (HDPE) bottle with a cylinder containing silica gel desiccant, closed with a child-resistant polypropylene cap with a pressure and twist closure. Each bottle contains a silica gel desiccant that should be kept in the bottle to help protect your tablets. The silica gel desiccant is included in a separate cylinder and should not be swallowed.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pfizer, S.L.

Avenida de Europa 20 B

Parque Empresarial La Moraleja

1. Alcobendas (Madrid)

Spain

Manufacturer

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 the United Kingdom (Northern Ireland): Edronax
• Spain: Norebox

Date of the last revision of this leaflet: October 2023

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