Prospect: Information for the User

Norebox 4 mg Tablets

reboxetina

Read this 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 Irenor is reboxetine, which belongs to a group of medications known as antidepressants. Irenor is used inthe treatment of depressive disorders/depressive disorder as well as in the maintenance of improvement of its symptoms when you have initially responded to treatment with reboxetine.

Do not take Irenor:

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

Warnings and precautions

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

• you have seizures or epilepsy. Treatment with reboxetina should be interrupted if you experience a crisis.
• you have any urinary problems, an enlarged prostate, or a history of heart problems.
• you are being treated with medications to lower blood pressure.
• you have liver or kidney problems. Your doctor may need to adjust your dose.
• you are taking a medication called "monoamine oxidase inhibitor" (MAO) used for depression or if you have taken an MAO inhibitor in the last two weeks. Your doctor may need to interrupt the MAO inhibitor at least 2 weeks before starting treatment with Irenor.
• you have ever had episodes of mania (hyperactive behavior or accelerated thinking).
• you have any eye disorder, such as certain types of glaucoma (increased eye pressure).

Serotonin syndrome:

Serotonin syndrome is a potentially life-threatening condition that can occur when taking Irenor alone or in combination with other medications (see section 2 "Taking Irenor with other medications"). 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 flashes, tremors, hyperactive reflexes, nausea, vomiting, and diarrhea.Seek medical attention or go to the nearest emergency service 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 medications take time to work, usually one or two weeks or sometimes longer.

It is more likely to happen:

-if you have previously had thoughts of suicide 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 years old with psychiatric disorders, who are 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 the 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

Irenor 4 mg tablets should not be used normally in the treatment of children and adolescents under 18 years old. However, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as attempts at suicide, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritable reactions) when taking this type of medication. Despite this, the doctor who prescribes Irenor 4 mg tablets may prescribe it to patients under 18 years old when they decide what is best for the patient. If the doctor who prescribes Irenor 4 mg tablets to a patient under 18 years old 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 old are taking Irenor 4 mg tablets.

Additionally, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Irenor 4 mg tablets in this age group have not yet been demonstrated.

Taking Irenor with other medications

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

Irenor may affect or be affected by other medications. This includes:

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

• Certain antidepressants known as MAO inhibitors, tricyclic antidepressants, tetracyclic antidepressants, nefazodone, SSRIs (such as fluvoxamine), other serotonin and norepinephrine reuptake inhibitors (SNRIs), or lithium.
• Medications known as triptans used to treat migraines.
• Other MAO inhibitors such as linezolid (an antibiotic) or methylene blue (used to treat high levels of methemoglobin in the blood).
• Medications that contain opioids (such as buprenorphine) used to treat intense pain and/or opioid addiction.
• Medications 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 Irenor with other medications. Please inform your doctor or pharmacist if you are using or have used recently other medications, including those purchased without a prescription, herbal medications, as well as vitamins and minerals.

Taking Irenor with food and drinks

Irenor 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 medication.

Pregnancy

There is not enough experience with the use of Irenor in pregnant women. Do not take Irenor 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 planning to become pregnant.

Breastfeeding

Irenor is present 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 Irenor.

Driving and operating machinery

Caution is recommended when driving or operating machinery.

Do not drive or operate hazardous tools or machinery until you know that Irenor 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 Irenor is not recommended in elderly patients.

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

Irenor tablets should be taken twice a day, one dose in the morning and one at night. Irenor 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 Irenor. To make it easier, take the medication at the same time every day.

Like other medications, Irenor 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 Irenor 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 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Irenor

If you forget to take a dose of Irenor, 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 Irenor

You should not interrupt treatment with Irenor 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 Irenor.

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

Like all medications,this medicationcan cause side effects, although not everyone will experience them. With Irenor, most side effects that occur 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.

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

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

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

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

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

• Serotonin syndrome (see section 2 “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).
• Coldness in extremities, Raynaud's phenomenon (poor circulation of blood to the extremities, usually the fingers and toes, but also 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 through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: 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 storeIrenor at a temperature above25ºC.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Irenor

The active principle is reboxetina. Each tablet contains 4 mg of reboxetina.

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

Appearance of the product and content of the container

Irenor 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 equal doses.

Irenor is available in containers of 20 or 60 tablets in blister packaging. Not all container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa 20-B,

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Pfizer Italia S.r.l.

63100 Localita Marino del Tronto

Ascoli Piceno

Italy

Last review date of this prospectus: October 2023

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