Dumirox 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dumirox 100 mg film-coated tablets

fluvoxamine maleate

Read the entire leaflet carefully before you start taking this medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What Dumirox is and what it is used for

The active substance in Dumirox is fluvoxamine; it belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). It is an antidepressant and is used to treat depression (major depressive disorder).

Dumirox can also be used to treat people suffering from obsessive-compulsive disorder (OCD).

2. What you need to know before taking Dumirox

Do not take Dumirox:

• if you are allergic (hypersensitive) to fluvoxamine or to any of the other components of Dumirox (see section 6 “Further information”)
• if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs), sometimes prescribed for depression or anxiety, including linezolid (an antibiotic which is also an MAOI)

Treatment with fluvoxamine should begin at least 2 weeks after stopping an irreversible MAOI. However, treatment with fluvoxamine may be started the next day after discontinuing certain reversible MAOIs. In exceptional cases, linezolid (an antibiotic MAOI) may be used together with fluvoxamine if your doctor closely supervises you.

Your doctor will advise you on how to take Dumirox after stopping MAOIs.

• if you are taking tizanidine, a medicine frequently used as a muscle relaxant
• if you are breastfeeding
• if you are taking pimozide, a neuroleptic medicine 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

Talk to your doctor or pharmacist before taking this medicine:

• if you have recently had a heart attack
• if you are pregnant or think you might be pregnant
• if you have epilepsy
• if you have a history of bleeding problems or if you regularly take medicines that increase the risk of bleeding, such as painkillers, or if you are pregnant (see “Pregnancy” below)
• if you have diabetes
• if you are receiving combined electroconvulsive therapy (ECT)
• if you have a history of mania (feelings of euphoria or overexcitement)
• if you have hepatic or renal insufficiency
• if you have high eye pressure (glaucoma)
• if you are under 18 years of age (see also section 3 “How to take Dumirox”)
• if you are taking opioid-containing medicines such as buprenorphine or buprenorphine/naloxone, as these products taken in combination with Dumirox may cause serotonin syndrome, a potentially life-threatening condition (for symptoms, see section 4, “Possible side effects”) and “Other medicines and Dumirox”.

If any of the above circumstances apply to you, your doctor will determine whether it is safe for you. Consult your doctor if you are unsure whether you should start taking Dumirox.

Sometimes, restlessness or agitation may occur or worsen during the first weeks of treatment with Dumirox, until the antidepressant effect takes place. This may manifest as an inability to sit still (akathisia).

Inform your doctor immediately if you experience these symptoms. Dose adjustment may be helpful.

Severe skin reactions have been reported with the use of Dumirox. Stop taking Dumirox and contact your doctor immediately if you develop a rash or mucosal lesions. Serious rashes may include skin rash starting in the limbs, usually on both sides of the body, progressing to concentric rings resembling erythema (erythema multiforme), widespread blistering and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), or extensive skin peeling (more than 30% of body surface area – toxic epidermal necrolysis).

Medicines like Dumirox (so-called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes experience thoughts of self-harm or suicide. These may increase when starting antidepressant treatment for the first time, as these medicines take time to work—usually about two weeks, but sometimes longer.

You are more likely to have such thoughts if:

• you have previously had suicidal thoughts or self-harm.
• you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

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

It may be very helpful to tell a family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them for their opinion on whether your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Contact your doctor immediately if you have thoughts or experiences that distress you.

Use in children and adolescents under 18 years of age

Children and adolescents under 18 years of age should not take this medicine unless being treated for obsessive-compulsive disorder (OCD). This is because Dumirox is not used to treat depression in individuals under 18 years of age.

Patients under 18 years of age taking this type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility, including aggression, confrontational behaviour, and irritability.

If your doctor has prescribed Dumirox to a patient under 18 years of age for a condition other than obsessive-compulsive disorder and you wish to discuss this decision, please consult your doctor.

If a patient under 18 years of age is taking Dumirox, you should inform your doctor if any of the symptoms described above worsen or if complications arise.

There is no long-term safety data on the use of Dumirox in individuals under 18 years of age regarding growth, maturation, and intellectual and behavioural development.

Taking other medicines

• do not start taking the herbal remedy “St. John’s Wort” if you have been prescribed Dumirox, as it may increase 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 medicine for depression or anxiety within the last two weeks or if you have schizophrenia, consult your doctor or pharmacist.

Your doctor or pharmacist should know if you are taking other medicines for depression or related psychotic conditions containing the following:

• benzodiazepines
• tricyclic antidepressants
• neuroleptics or antipsychotics
• lithium
• tryptophan
• monoamine oxidase inhibitors (MAOIs) such as moclobemide
• pimozide
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram

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

Inform your doctor or pharmacist if you are taking any of the following medicines:

• aspirin (acetylsalicylic acid) or medicines similar to aspirin, used to treat pain and inflammation (arthritis)

• cyclosporine, used to reduce immune system activity

• 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

• ropinirole, 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 or buprenorphine/naloxone

• clopidogrel, warfarin, acenocoumarol, or any anticoagulant medicine

If you are taking or have recently taken any of the medicines listed above and have not informed your doctor, please see your doctor and ask what you should do. Your doctor may need to adjust your dose or prescribe a different medicine.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This also includes herbal remedies.

Taking Dumirox with food and drinks

• do not drink alcoholic beverages while taking this medicine. Alcohol may interact with Dumirox and may cause drowsiness and unsteadiness.
• if you usually drink large amounts of tea, coffee, or caffeinated soft drinks, you may experience symptoms such as trembling hands, discomfort, rapid heart rate (palpitations), restlessness, and difficulty sleeping (insomnia). If you reduce your caffeine intake, these symptoms may disappear.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

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

Animal studies have shown that fluvoxamine reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Ensure that your midwife and/or doctor know you are being treated with fluvoxamine. Medicines like fluvoxamine, if taken during pregnancy—particularly during the last 3 months—may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms generally begin within the first 24 hours after birth. If this occurs in your baby, you should inform your midwife and/or doctor immediately.

Do not stop fluvoxamine treatment suddenly. If you have taken fluvoxamine during the last 3 months of pregnancy, your baby may have additional symptoms at birth, besides breathing difficulties or bluish skin, such as inability to sleep or feed properly, being too hot or too cold, feeling unwell, excessive crying, stiff or floppy muscles, lethargy, drowsiness, tremors, nervousness, or seizures. If your baby has any of these symptoms at birth, consult your doctor immediately.

If you take Dumirox late in 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 be aware that you are taking Dumirox so they can advise you appropriately.

Breastfeeding

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

Driving and using machines

During treatment with Dumirox 100, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how Dumirox 100 affects you.

Dumirox contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Dumirox

How much Dumirox to take

Always take the amount of Dumirox your doctor has prescribed.

If you are unsure, consult your doctor or pharmacist.

Normal starting dose for adults (18 years and over):

Treatment of depression:

• Start with 50 or 100 mg once daily, taken at night.

Treatment of obsessive-compulsive disorder (OCD):

• Start with 50 mg once daily, 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 take the 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 over):

Start with 25 mg (half a tablet) once daily, preferably at bedtime. Your doctor may increase the dose every 4–7 days in increments of 25 mg, if tolerated, until the effective dose is reached.

The maximum daily dose is 200 mg.

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

Children and adolescents under 18 years should not take this medicine for the treatment of depression. This medicine should only be prescribed for children and adolescents in cases of obsessive-compulsive disorder (OCD).

How to take Dumirox

Swallow the tablets with water. Do not chew them.

You may split the tablets in half if your doctor advises you to do so.

When it takes effect

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

Continue taking the tablets until your doctor tells you to stop.

Even if you feel better, your doctor may advise you to continue taking the tablets for some time, at least six months, to ensure the medication has had its full effect.

Do not stop treatment with Dumirox abruptly.

You may experience withdrawal symptoms such as:

• agitation and anxiety
• confusion
• diarrhoea
• difficulty sleeping/intense dreams
• dizziness
• emotional instability
• headache
• irritability
• nausea and/or vomiting
• palpitations (faster heartbeat)
• sensory disturbances (such as electric shock sensations or visual disturbances)
• sweating
• tremors

To discontinue treatment with Dumirox, your doctor will instruct you to gradually reduce the dose over several weeks or months, which will help reduce the likelihood of withdrawal effects. Most people find that symptoms upon stopping Dumirox are mild and resolve within two weeks. For some individuals, these symptoms may be more severe or last longer.

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

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

If you take more Dumirox than you should

If you or someone else has taken more Dumirox than prescribed (an overdose), inform your doctor, go directly to hospital, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken. Take the medicine packaging with you.

Symptoms of overdose include, but are not limited to, nausea, vomiting, diarrhoea, and drowsiness or dizziness. Cardiac symptoms (slow or fast heart rate, low blood pressure), liver complications, seizures (fits), and coma have also been reported.

If you forget to take Dumirox

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

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

4. Possible adverse effects

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

Very common	affecting more than 1 in 10 patients
Common	affecting between 1 and 10 in 100 patients
Uncommon	affecting between 1 and 10 in 1,000 patients
Rare	affecting between 1 and 10 in 10,000 patients
Very rare	affecting less than 1 in 10,000 patients
Not known	cannot be estimated from the available data

Adverse reactions related to this type of medication

Occasionally, suicidal thoughts or self-harm ideation may occur or worsen during the first weeks of treatment with Dumirox, until the antidepressant effect takes place.

Contact your doctor immediately if you experience distressing thoughts or sensations.

If you have several symptoms at the same time, you may be experiencing one of the rare conditions described below:

• Serotonin syndrome: If you experience sweating, muscle rigidity or spasms, instability, confusion, irritability, or extreme agitation.
• Neuroleptic malignant syndrome: If you have muscle rigidity, 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 severe rashes or redness, including widespread rash starting in the limbs on both sides of the body and progressing to concentric rings resembling erythema (erythema multiforme), widespread blistering rash with skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of body surface area - toxic epidermal necrolysis). The frequency of these side effects is unknown (cannot be estimated from available data).

Stop taking Dumirox and consult your doctor immediately.

If you develop unusual bruising or purple spots on your skin, or if you vomit blood or have blood in your stools, contact your doctor.

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

Sometimes patients experience nausea when starting treatment with Dumirox and the medication begins to take effect. Although nausea is unpleasant, it should pass after a short time if you continue taking the tablets as prescribed. This may occur within the first few weeks.

Adverse reactions caused by Dumirox

Frequent adverse reactions:

• Agitation
• Anxiety
• Constipation
• Diarrhea
• Difficulty sleeping
• Dizziness
• Dry mouth
• Faster heartbeat
• Drowsiness (lethargy)
• Malaise
• Headache
• Indigestion
• Loss of appetite
• Nervousness
• Stomach pain
• Sweating
• Tremor
• Muscle weakness (asthenia)
• Vomiting

Uncommon adverse reactions:

• Allergic skin reactions (including facial, lip, or tongue swelling, rash, or itching)
• Confusion
• Delayed ejaculation
• Dizziness upon standing up too quickly
• Hallucinations
• Lack of coordination
• Muscle or joint pain
• Aggression

Rare adverse reactions:

• Seizures
• Liver disorders
• Mania (feeling of hyperexcitability)
• Photosensitivity
• Unexpected milk production (galactorrhea)

Very rare adverse reactions:

• Akathisia (restlessness)
• Abnormal taste
• Anorgasmia (inability to reach orgasm)
• In women: menstrual disorders (monthly bleeding)
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy” in section 2 for more information
• Urinary disturbances (such as frequent need to urinate during the day and/or night, sudden loss of urinary 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)

An increased risk of bone fractures has been observed in patients taking this type of medication.

Frequency not known

• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy” in section 2 for more information.

Adverse reactions related to OCD treatment in children and adolescents – frequencies not reported

• Hypomania (feeling of euphoria and overexcitement)
• Agitation
• Seizures
• Difficulty sleeping (insomnia)
• Lack of energy (asthenia)
• Hyperactivity (hyperkinesia)
• Drowsiness
• Indigestion

Reporting of adverse reactions:

If you experience any adverse reaction, talk to your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. Storage of Dumirox

Keep out of the reach and sight of children.

• Do not use the tablets after the expiry date stated on the carton after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.
• Do not store above 25 °C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Dumirox

The active substance is fluvoxamine maleate.

Each tablet contains 100 mg of fluvoxamine as maleate.

The other components are mannitol (E421), gluten-free maize starch, pregelatinized starch, sodium stearyl fumarate, colloidal anhydrous silica, hypromellose, macrogol 6000, talc, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Dumirox 100 mg is presented as film-coated tablets, white or almost white, oval-shaped, with the mark "313" on both sides separated by a central dividing line.

Dumirox 100 mg is available in packs of 15, 20, 30, 50, 60, 90, 100, 120, and 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Mylan Laboratories SAS
Route de Belleville, Lieu dit Maillard
01400 Châtillon-sur-Chalaronne
France

or

Meribel Pharma Parets, S.L.U.
C/ Ramón y Cajal, 2
08150 - Parets del Vallés (Barcelona)
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the EEA Member States under the following names:

Austria Floxyfral
Belgium Floxyfral
France Floxyfral
Germany Fevarin
Greece Dumyrox
Ireland Faverin
Italy Dumirox
Luxembourg Floxyfral
Norway Fevarin
Portugal Dumyrox
Spain Dumirox
Sweden Fevarin
Netherlands Fevarin
United Kingdom (NI) Faverin

Date of latest revision of this leaflet: April 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.es/