Package Insert: Information for the User

Dumirox 50 mg Film-Coated Tablets

fluvoxamine maleate

Read the entire package insert carefully before starting to take the medication

− Keep this package insert, as you may need to refer to it again.

− If you have any questions, consult your doctor or pharmacist.

− This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

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

1. What Dumirox is and for what it is used

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

3. How to take Dumirox

4. Possible adverse effects

5. Storage of Dumirox

6. Contents of the package and additional information

The active ingredient of Dumirox is fluvoxamine; it belongs to the group of medications known as selective serotonin reuptake inhibitors (SSRIs). It is an antidepressant and is used to treat depression (major depressive disorder).

Dumirox may also be used to treat individuals who suffer from obsessive-compulsive disorder (OCD)

Do not take Dumirox:

- if you are allergic (hypersensitive) to fluvoxamine or any of the other components of Dumirox (see section 6 “Additional information”)

- if you are being treated with medications called monoamine oxidase inhibitors (MAOIs) sometimes prescribed to treat depression or anxiety, including linezolid (an antibiotic that is also an MAOI).

The treatment with fluvoxamine should start at least 2 weeks after stopping an irreversible MAOI. However, treatment with fluvoxamine after stopping certain reversible MAOIs can be initiated the next day. In exceptional cases, linezolid (an antibiotic MAOI) can be used with fluvoxamine if your doctor closely monitors you.

Your doctor will advise you how to take Dumirox once you have stopped taking MAOIs

- if you are taking tizanidine, a medication used frequently as a muscle relaxant

- if you are breastfeeding

- if you are taking pimozide, a neuroleptic medication used in the treatment of schizophrenia and other psychiatric disorders

If any of the above circumstances apply to you, do not take Dumirox and consult your doctor

Warnings and precautions

Consult your doctor or pharmacist before taking the medication:

- if you have had a recent heart attack

- if you are pregnant, or think you may be pregnant

- if you have epilepsy

- if you have a history of bleeding problems or if you regularly take medications that increase the risk of bleeding, such as analgesics, or if you are pregnant (see “Pregnancy” 2)

- if you have diabetes

- if you are undergoing electroconvulsive therapy (ECT)

- if you have a history of having had mania (feeling of euphoria or overexcitement)

- if you have liver or kidney insufficiency

- if you have high eye pressure (glaucoma)

- if you are under 18 years old (see also section 3 “How to take Dumirox”)

- if you are taking medications that contain opioids such as buprenorphine or buprenorphine/naloxone, as these products taken in combination with Dumirox may cause serotonin syndrome, a potentially fatal condition (for symptoms, see section 4, “Possible side effects” and “Other medications and Dumirox”).

If any of the above circumstances apply to you, your doctor will advise you whether it is safe for you to consult your doctor if they recommend starting Dumirox treatment.

In some cases, agitation ideas, cannot sit or stay still (akathisia) may occur in the first weeks of treatment with Dumirox, until the antidepressant effect is produced.

Inform your doctor immediately if you have these symptoms. Adjusting the dose may be helpful.

Severe skin reactions have been reported when using Dumirox.Stop takingDumirox and contact your doctor immediately if you develop a rash or lesions on the mucous membranes. Severe rashes may include skin rash, which begins on the extremities, usually on both sides of the body and evolving into concentric circles that resemble erythema (erythema multiforme), generalized rash with blisters and skin peeling, which occurs particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of the body surface - toxic epidermal necrolysis).

Medications like Dumirox (called ISRS) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms have continued after stopping treatment.

Ideas of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may have ideas of self-harm or suicide. This may increase when starting antidepressant treatment for the first time, as these medications take time to take effect, usually two weeks, but sometimes longer.

You are likely to think this way if:

- you have previously had ideas of self-harm or suicide.

- you are a young adult. Information from clinical trials has shown an increase in the risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

If you have ideas of self-harm or suicide,inform your doctor immediately or go directly to a hospital.

It may be very helpful to tell a family member or friendthat you are depressed or have an anxiety disorder, and ask them to read the leaflet. You can ask them for their opinion on whether your depression or anxiety is getting worse, or if they are concerned about the changes in your behavior.

Inform your doctor immediatelyif you have ideas or experiences that cause you distress.

Use in children and adolescents under 18 years old

Children and adolescents under 18 years old should not take this medication, unless they are being treated for obsessive-compulsive disorder (OCD). This is because Dumirox is not used to treat depression in people under 18 years old.

When taking this type of medication, patients under 18 years old have a higher risk of adverse effects such as suicidal attempts, ideas of suicide, and hostility, such as aggression, confrontational behavior, and irritability.

If your doctor has prescribed Dumirox to a patient under 18 years old to treat another condition other than OCD and wants to discuss this decision, return to your doctor.

If a patient under 18 years old is taking Dumirox, inform your doctor if any of the symptoms mentioned above progress or if you have complications.

There is no information on the long-term safety of Dumirox in children under 18 years old regarding growth, maturation, and intellectual and behavioral development.

Other medications and Dumirox

-do not start taking the medicinal herb “St. John's Wort” if you have been prescribed Dumirox, as it may increase the adverse effects. If you are already taking St. John's Wort when starting Dumirox treatment, stop taking St. John's Wort and consult your doctor at your next visit.

- if you have been taking a medication to treat depression or anxiety in the last two weeks or have schizophrenia, consult your doctor or pharmacist.

Your doctor or pharmacist should know if you are taking other medications to treat depression or related conditions that contain the following:

- benzodiazepines

- tricyclic antidepressants

- neuroleptics or antipsychotics

- lithium

- tryptophan

- monoamine oxidase inhibitors (MAOIs) such as moclobemide

- selective serotonin reuptake inhibitors (SSRIs) such as citalopram

Your doctor will tell you if it is safe for you to start treatment with Dumirox.

Inform your doctor or pharmacist if you are takingany of the medications listedbelow:

- aspirin (acetylsalicylic acid) or similar medications used to treat pain and inflammation (arthritis)

- ciclosporin, used to reduce the activity of the immune system

- methadone, used to treat pain and withdrawal syndrome

- mexiletine, used to treat heart rhythm disorders

- phenytoin or carbamazepine, used to treat epilepsy

- propranolol, used to treat high blood pressure and heart disorders

- ropinirol, for Parkinson's disease

- a “triptan”, used to treat migraines, such as sumatriptan

- terfenadine, used to treat allergies. Dumirox should not be used together with terfenadine

- sildenafil, used in the treatment of erectile dysfunction

- theophylline, used to treat asthma and bronchitis

- tramadol (analgesics)

- buprenorphine/naloxone

- clopidogrel, warfarin, acenocoumarol, or any anticoagulant medication

If you are taking or have taken any of the medications listed above and have not informed your doctor, return to your doctor and ask what you should do. You may need to change your dose or take a different medication.

Inform your doctor or pharmacist if you are taking or have taken recently othermedications, including those obtained without a prescription. This also includes medicinal herbs.

Taking Dumirox with food and drinks

- do not take alcoholic beverages while taking this medication. Alcohol may interact with Dumirox and cause drowsiness and instability.

- if you normally drink a lot of tea, coffee, or soft drinks with caffeine, you may experience symptoms such as shaky hands, discomfort, rapid heartbeat (palpitations), restlessness, and difficulty sleeping (insomnia). If you reduce the amount of caffeine you drink, these symptoms may disappear.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

There is limited experience regarding the use of fluvoxamine during pregnancy. Do not take Dumirox if you are pregnant unless your doctor considers it absolutely necessary. If you are currently taking fluvoxamine and are planning to become pregnant, please consult your doctor to decide whether it is necessary or appropriate to change your medication.

Studies in animals have shown that fluvoxamine reduces the quality of sperm. Theoretically, this could affect fertility, but so far, there has been no observed impact on human fertility.

Make sure your midwife and/or doctor know that you are taking fluvoxamine. If you take it during pregnancy, especially in the last three months of pregnancy, medications like fluvoxamine may increase the risk of a severe condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should inform your midwife and/or doctor immediately.

Do not stop treatment with fluvoxamine suddenly. If you have been taking fluvoxamine for the last three months of pregnancy, your baby may have other symptoms at birth in addition to difficulty breathing or blue skin, such as being unable to sleep or feed properly, being very hot or cold, feeling unwell, crying a lot, stiff or hypotonic muscles, lethargy, drowsiness, tremors, becoming nervous or having seizures. If your baby has any of these symptoms at birth, consult your doctor immediately.

If you take Dumirox in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Dumirox to be able to advise you.

Breastfeeding

Fluvoxamine passes into breast milk. There is a risk that it may affect the newborn. Therefore, discuss with your doctor whether you should stop breastfeeding or stop treatment with fluvoxamine.

Driving and operating machinery

During treatment with Dumirox 50, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Dumirox 50 affects you.

Dumirox contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

How much Dumirox to take

Takethe amount of Dumirox that your doctor has prescribed.

If you are unsure, consult your doctor or pharmacist..

Normal initial dose for adults (18 years and older):

Depression treatment:

•Start with 50 or 100 mg per day, taken at night.

Obsessive-compulsive disorder treatment:

• Start with 50 mg per day, preferably at night.

If you do not start to feel better after a couple of weeks, inform your doctor, who will advise you. Your doctor will tell you how to gradually increase the dose.

The maximum recommended daily dose is 300 mg.

If your doctor advises you to take more than 150 mg per day,do not takethe entire dose at once; ask your doctor when to take each dose.

Normal dose for children and adolescents with obsessive-compulsive disorder (OCD) (8 years and older):

Start with 25 mg (half a tablet) per day, preferably at bedtime. Your doctor may increase the dose every 4-7 days by 25 mg if tolerated to reach the effective dose.

The maximum daily dose is 200 mg.

If your doctor advises you to take more than 50 mg per day,do not takethe entire dose at once; ask your doctor when to take each dose. If the dose cannot be divided into equal parts, the highest dose should be taken at night.

Children and adolescents under 18 yearsshould not takethis medication for depression. This medicationshould onlybe prescribed for children and adolescents in the case of obsessive-compulsive disorder (OCD).

How to take Dumirox

Swallow the tablets with water.Do notchew them.

You can break the tablets in half if your doctor advises you to.

When it takes effect

Dumirox takes some time to take effect. Some patients do not feel better during the first 2 or 3 weeks of treatment.

Take thetablets until your doctor tells you to stop.

Although you feel better, your doctor may advise you to continue taking the tablets for some time, at least six months, to ensure that the medication has taken full effect.

Do not interruptthe treatment with Dumirox abruptly.

You may experiencewithdrawal symptomssuch as:

- agitation and anxiety

- confusion

- diarrhea

- difficulty sleeping/intense dreams

- dizziness

- emotional instability

- headache

- irritability

- nausea and/or vomiting

- palpitations (faster heart rate)

- sensory disturbances (such as electric shock sensation or visual disturbances)

- sweating

- tremors

To withdraw from Dumirox treatment, your doctor will advise you to gradually reduce the dose over a number of weeks or months, which will help reduce the incidence of withdrawal symptoms. Most people find that withdrawal symptoms from Dumirox are mild and resolve within two weeks. For some people, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms when stopping treatment, your doctor may advise you to stop treatment more slowly. If you experience more severe withdrawal symptoms when stopping Dumirox, please consult your doctor. Your doctor may advise you to take the tablets again and taper off more slowly (see section 4 “Possible side effects”).

If any of these symptoms occur when withdrawing from treatment,consult your doctor.

If you take too much Dumirox

If you or someone has taken more Dumirox than they should (an overdose), inform your doctor, go directly to the hospital, or call the Toxicology Information Service, phone 91 562 04 20,indicating the medication and the amount taken. Bring the medication packaging with you.

The symptoms of an overdose include, but are not limited to, nausea, vomiting, diarrhea, and a feeling of drowsiness or dizziness. Cardiac symptoms (slow or fast heart rate, low blood pressure) have been reported, as well as liver complications, seizures (attacks), and coma.

If you forget to take Dumirox

If you forget to take a tablet, wait until the next dose. Do not take a double dose to make up for the missed dose.

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

Like all medicines, Dumirox may cause side effects, although not everyone experiences them.The frequencies of side effects observed are defined as described below:

Side effects related to this type of medication

In some cases, suicidal thoughts or self-harm may occur or increase during the first weeks of treatment with Dumirox, until the antidepressant effect occurs.

Inform your doctor immediatelyif you have anxious thoughts or experiences.

Ifyou have several symptoms at the same timeyou may have one of the rare conditions described below:

• Serotonin syndrome: If you have sweating, muscle stiffness or spasms, instability, confusion, irritability, or extreme agitation.

• Neuroleptic malignant syndrome: If you have muscle stiffness, fever, confusion, and other related symptoms.

• SIADH: If you feel tired, weak, or confused and have painful, numb, or uncontrolled muscles.

• Severe skin reactions, such as skin eruptions or severe redness, including generalized rash, which starts on the extremities on both sides of the body and evolves into concentric circles resembling erythema (erythema multiforme), generalized skin rash with blisters and skin peeling, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of the body surface - toxic epidermal necrolysis). The frequency of these side effects is unknown (cannot be estimated from available data).

Stop taking Dumiroxand consult your doctor immediately.

If unusual bruises or purple rashes appear on your skin or if you vomit blood or have blood in your stool, contact your doctor.

Stopping fluvoxamine (especially when done abruptly) often leads to withdrawal symptoms (see section 3 withdrawal symptoms).

Sometimes patientshave nauseawhen starting treatment with Dumirox and it begins to take effect. Although nausea is unpleasant, it should pass over time if you continue taking the tablets as prescribed. This may occur a few weeks after starting treatment.

Side effects caused by Dumirox

Common side effects:

- agitation

- anxiety

- constipation

- diarrhea

- difficulty sleeping

- dizziness

- dry mouth

- faster heart rate

- drowsiness (somnolence)

- discomfort

- headache

- indigestion

- loss of appetite

- nervousness

- stomach pain

- sweating

- tremor

- muscle weakness (asthenia)

- vomiting

Uncommon side effects:

- allergic skin reactions (including facial sweating, lip or tongue swelling, rash, or itching)

- confusion

- delayed ejaculation

- dizziness when standing up too quickly

- hallucinations

- lack of coordination

- muscle or joint pain

- aggression

Rare side effects:

- convulsions

- liver disorders

- mania (feeling of hyperexcitement)

- photosensitivity

- unexpected milk flow

Very rare side effects:

- akathisia (agitation)

- abnormal taste

- anorgasmia (inability to achieve orgasm)

- in women: menstrual irregularities (monthly bleeding)

- excessive vaginal bleeding after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information

- urinary disorders (such as frequent urination during the day and/or night, sudden loss of bladder control during the day and/or night, or inability to urinate)

- paresthesia (tingling or numbness)

- increased prolactin (a hormone that stimulates milk production in breastfeeding mothers)

- dilated pupils

- changes in body weight

- glaucoma (increased eye pressure).

A higher risk of bone fractures has been observed in patients taking this type of medication.

Unknown frequency

- excessive vaginal bleeding after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Side effects related to OCD treatment in children and adolescents, frequencies are not provided

- hypomania (feeling of euphoria and overexcitement)

- agitation

- convulsions

- difficulty sleeping (insomnia)

- fatigue (asthenia)

- hyperactivity (hyperkinesia)

- feeling of drowsiness

- indigestion

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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance 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 out of reach and sight of children.

- Do not use the tablets after the expiration date that appears on the box after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This way, you will help protect the environment.

Composition of Dumirox

The active ingredient is fluvoxamine maleate.

Each tablet contains 50 mg of fluvoxamine as maleate.

The other components are mannitol (E421), cornstarch without gluten, pregelatinized starch, sodium stearoylfumarate, anhydrous colloidal silica, hypromellose, macrogol 6000, talc, and titanium dioxide (E171).

Appearance of the product and contents of the package

Dumirox is presented in the form of coated tablets, white or almost white, round, and with a mark “291” on the two sides separated by the dividing line.

Dumirox 50 mg is available in packages of 5, 10, 20, 30, 50, 60, 90, 100, 120, and 250 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate, Dublin 13

Ireland

Responsible manufacturer

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

01400 Châtillon-sur-Chalaronne

France

or

Recipharm Parets, S.L.U.

C/ Ramón y Cajal 2

08150 Parets del Vallés (Barcelona)

Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

This pharmaceutical product is authorized in the member states of the EEA under the following names:

Austria Floxyfral

Belgium Floxyfral

Denmark Fevarin

Finland Fevarin

France Floxyfral

Germany Fevarin

Greece Dumyrox

Ireland Faverin

Italy Dumirox

Luxembourg Floxyfral

Norway Fevarin

Portugal Dumyrox

Spain Dumirox

Sweden Fevarin

Netherlands Fevarin

United Kingdom Faverin

Last revision date of this leaflet: April 2025

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/