IRENOR 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is Irenor and what is it used for

The active substance of Irenor is reboxetine, which belongs to a group of medicines known as antidepressants. Irenor 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 Irenor

Do not take Irenor:

• 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 Irenor if:

• you have seizures or epilepsy. Treatment with reboxetine should be discontinued if you suffer a seizure.
• you have any urinary problems, enlarged prostate or 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 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 pressure in the eye).

Serotonin syndrome:

Serotonin syndrome is a potentially life-threatening disease that can occur when taking Irenor alone or in combination with other medicines (see section 2 "Taking Irenor with other medicines"). The signs and symptoms of serotonin syndrome may include a combination of the following: confusion, agitation, hallucinations, coma, rapid heartbeat, increased body temperature, rapid changes in blood pressure, sweating, flushing, 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 or killing yourself. These thoughts can 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 were being treated with antidepressants.

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

It may be helpful for you to explain to a family member or close 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

Irenor 4 mg tablets 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 class of medicines. Nevertheless, your doctor may prescribe Irenor 4 mg tablets to patients under 18 years of age when they decide what is best for the patient. If your doctor has prescribed Irenor 4 mg tablets 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 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 medicines

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

Irenor 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 potassium-eliminating diuretic (fluid-eliminating medicine), 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 Irenor 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 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 for 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 Irenor 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 Irenor with food and drinks

Irenor 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 Irenor in pregnant women. Do not take Irenor 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 planning to become pregnant.

Breastfeeding

Irenor 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 Irenor.

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 Irenor does not affect your ability (e.g., you feel dizzy) and you can perform these activities safely.

3. How to take Irenor

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 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.

• Irenor is not recommended for use in elderly patients.

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

Irenor tablets should be taken twice a day, one dose in the morning and one in the evening. 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 medicine at the same time every day.

Like other medicines, Irenor 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 stop treatment too soon, your symptoms may come back.

If you take more Irenor than 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Irenor

If you forget to take a dose of Irenor, 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 Irenor

Do not stop taking Irenor 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 (feeling sick), when patients stopped taking Irenor.

If you have any further questions on 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 Irenor, most side effects that occur are mild and usually disappear after the first few weeks of treatment.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

• Difficulty sleeping (insomnia).
• Dry mouth.
• Dizziness.
• Constipation.
• Feeling sick (nausea).
• 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 (a 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. Cases of suicidal ideation or suicidal behavior have been reported during treatment with reboxetine or shortly after stopping treatment (see section 2).
• Cold hands and feet, Raynaud's phenomenon (poor blood circulation to the hands and feet, 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, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Irenor

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 carton after EXP. The expiry date refers to the last day of the month shown.

Do not store Irenor 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. Return any unused medicine to your pharmacist. 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

Composition of Irenor

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

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

Appearance of the product and pack contents

Irenor 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 equal doses.

Irenor 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.

Avda. de Europa 20-B,

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Pfizer Italia S.r.l.

63100 Localita Marino del Tronto

Ascoli Piceno

Italy

Date of 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”