Dumirox

DUMIROX
50 mg and 100 mg film-coated tablets
Fluvoxamine maleate

READ THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms
are the same as yours, as it could be harmful.
If you experience any adverse effects, including those not listed in this leaflet, contact your
doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What DUMIROX is and what it is used for
2. Before you take DUMIROX
3. How to take DUMIROX
4. Possible side effects
5. How to store DUMIROX
6. Further information

1. WHAT DUMIROX IS AND WHAT IT IS USED FOR

DUMIROX belongs to a class of medicines called selective serotonin reuptake inhibitors (SSRIs). Dumirox contains a substance called fluvoxamine. This is an antidepressant and is used to treat depression (major depressive episode).
DUMIROX may also be used to treat people with obsessive-compulsive disorder (OCD).

2. BEFORE TAKING DUMIROX

Do not use Dumirox if any of the conditions listed below apply to you:

• if you are allergic (hypersensitive) to fluvoxamine or to any of the other excipients in the tablet (see section 6 “Further information”)
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs), sometimes prescribed to treat depression or anxiety, including linezolid (an antibiotic which is also an MAOI). Treatment with fluvoxamine must begin at least 2 weeks after stopping an irreversible MAOI. However, treatment with fluvoxamine may be started the next day after stopping certain reversible MAOIs. In exceptional cases, linezolid (an antibiotic which is also an MAOI) may be used concomitantly with fluvoxamine provided that your doctor can monitor you closely.

Your doctor will advise you on how to start using Dumirox after stopping treatment with an MAOI.

• if you are taking tizanidine, a medicine often used as a muscle relaxant
• if you are taking pimozide, a neuroleptic drug used to treat schizophrenia and other psychiatric disorders
• if you are breastfeeding

If any of the above conditions apply to you, do not take Dumirox and speak with your doctor.

Take particular care:

Before taking this medicine, talk to your doctor or pharmacist if:

• you have recently had a heart attack
• you are pregnant or may be pregnant
• you have epilepsy
• you have previously had bleeding problems, or if you regularly take medicines that increase the risk of bleeding, such as common painkillers
• you have diabetes
• you are undergoing electroconvulsive therapy (ECT)
• you have ever had mania (feelings of euphoria or overexcitement)
• you have liver or kidney problems
• you have high eye pressure (glaucoma)
• you are under 18 years of age (see also section 3 “How to take Dumirox”)

If any of the above conditions apply to you, your doctor will determine whether it is safe for you to start taking Dumirox.

Occasionally, feelings of restlessness, for example an inability to sit still or stand still (akathisia), may appear or worsen during the first few weeks of treatment with Dumirox, until the antidepressant effect begins. Inform your doctor immediately if these symptoms occur. A dosage adjustment may then be helpful.

Serious skin reactions have been reported during the use of Dumirox. Stop taking Dumirox and contact a doctor immediately if you develop skin rashes or mucosal lesions. Severe skin rashes may include rash starting on the extremities, usually on both sides of the body, progressing into concentric circles resembling a target (erythema multiforme), widespread rash with blisters and skin peeling, 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 such as Dumirox (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Suicidal thoughts and worsening of your depression or anxiety disorders

If you are depressed and/or suffer from anxiety disorders, you may sometimes have self-harming or suicidal thoughts. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines take time to work—usually two weeks, but sometimes longer.

You are more likely to have these thoughts:

• if you have previously had self-harming or suicidal thoughts
• if you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders being treated with an antidepressant.

If you develop self-harming or suicidal thoughts at any time, contact your doctor immediately or go to hospital.

It may be helpful to tell a relative or close friend that you are depressed or suffer from an anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Inform your doctor immediately if you have any distressing thoughts or experiences.

Use in children and adolescents under 18 years of age

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

Individuals under 18 years of age who take this type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility including aggression, oppositional behaviour, and anger.

If your doctor has prescribed Dumirox for a patient under 18 years of age and you wish to discuss this, please contact your doctor again. You must inform the doctor if any of the symptoms described above appear or worsen during treatment with Dumirox in a patient under 18 years of age.

Furthermore, it is not known whether taking Dumirox under the age of 18 may have long-term effects on growth, maturation, or intellectual and behavioural development.

Are you taking other medicines?

• During treatment with Dumirox, do not start taking the herbal remedy St. John’s wort, as it may increase side effects. If you are already taking St. John’s wort at the start of treatment with Dumirox, stop taking it and inform your doctor at your next visit.
• If you are currently taking or have taken within the last two weeks a medicine to treat depression or anxiety, or if you suffer from schizophrenia, check with your doctor or pharmacist.

Your doctor or pharmacist will check whether you are taking other medicines to treat your depression or other related psychiatric conditions; these may include:

• 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 determine whether it is safe for you to start taking Dumirox.

You must also inform your doctor or pharmacist if you are taking any of the following medicines:

• aspirin (acetylsalicylic acid) or aspirin-like medicines, used to treat pain and inflammation (arthritis)
• cyclosporine, used to reduce the activity of the immune system
• methadone, used to treat pain and withdrawal symptoms
• mexiletine, used to treat irregular heart rhythm
• phenytoin or carbamazepine, used to treat epilepsy
• propranolol, used to treat high blood pressure and heart conditions
• ropinirole, for Parkinson’s disease
• a “triptan”, used to treat migraine, such as sumatriptan
• terfenadine, used to treat allergies. Dumirox must not be used together with terfenadine
• sildenafil, used to treat erectile dysfunction
• theophylline, used to treat asthma and bronchitis
• tramadol, a painkiller
• clopidogrel, warfarin, nicoumalone, or any other medicine used to prevent blood clots

If you are taking or have recently taken any of the medicines listed above and have not yet discussed this with your doctor, return to them and ask what you should do. Your dose may need to be changed, or you may need a different medicine.

Inform your doctor or pharmacist if you are taking or have taken any other medicines—including those not requiring a prescription. This also includes herbal medicines.

Taking Dumirox with food and drinks

• Do not drink alcohol while taking this medicine, as alcohol acts together with Dumirox to make you drowsy and less alert.
• If you normally drink large amounts of tea, coffee, or other caffeine-containing drinks, you may experience symptoms such as hand tremors, discomfort, rapid heartbeat (palpitations), restlessness, and difficulty falling asleep (insomnia). Reducing your caffeine intake may help these symptoms disappear.

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Experience with the use of fluvoxamine during pregnancy is limited. Do not take fluvoxamine if you are pregnant, unless your doctor considers it absolutely necessary.

If you are already taking fluvoxamine and planning a pregnancy, or, as a father, planning to conceive, consult your doctor to decide whether alternative treatment is necessary or appropriate.

In animal studies, fluvoxamine has been shown to reduce sperm quality. In theory, this could affect fertility, but so far no impact on fertility has been observed.

Ensure that your midwife and/or doctor know that you are being treated with fluvoxamine. Medicines such as fluvoxamine, when 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 rapidly and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this occurs in your baby, inform your midwife or doctor immediately.

Do not stop treatment with fluvoxamine abruptly. If you are taking fluvoxamine during the last 3 months of pregnancy, your baby may experience additional symptoms at birth, including breathing difficulties or bluish skin, as well as inability to sleep or feed properly, being too hot or too cold, discomfort, prolonged crying, stiff or floppy muscles, lethargy, tremors, agitation, or seizures. If your baby has any of these symptoms after birth, inform your doctor immediately.

Breastfeeding

Fluvoxamine passes into breast milk. There is a risk of effects on the infant; therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or stop treatment with fluvoxamine.

Driving and using machines

You may drive and operate machinery while on treatment, provided this medicine does not make you drowsy.

Dumirox contains sodium

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

3. HOW TO TAKE DUMIROX

How much Dumirox to take
Always take Dumirox exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Usual starting dose for adults (18 years and older):
For the treatment of depression:

• Start with 50 or 100 mg daily, taken in the evening
  For the treatment of obsessive-compulsive disorder (OCD):
• Start with 50 mg daily, preferably in the evening

If you do not start to feel better after a couple of weeks, discuss this with your doctor, who will
advise you. Your doctor may decide to gradually increase your dose.
The maximum recommended daily dose is 300 mg.
If your doctor advises you to take more than 150 mg daily, do not take it all at once; instead,
ask your doctor when to take it.
Usual dose for children and adolescents with obsessive-compulsive disorder (OCD) (8 years and
older):
Start with 25 mg (half a tablet) daily, preferably before going to bed. Your doctor may increase
the dose by 25 mg at a time every 4–7 days, depending on tolerability, until an effective dose is
reached.
The maximum daily dose is 200 mg.
If your doctor advises you to take more than 50 mg daily, do not take it all at once; instead,
consult your doctor about when to take it. If the dose is not divided into equal parts, the higher
dose should be taken at bedtime.
Children and adolescents under 18 years of age must not take this medicine for the treatment of
depression. This medicine should be prescribed for children and adolescents only for 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 has instructed you to do so.
How long does it take to work?
Dumirox may take some time to start working. Some patients may not notice improvements in
the first 2 or 3 weeks of treatment.
Continue taking your tablets until your doctor tells you to stop. Even when you start to feel
better, your doctor may want you to continue taking the tablets for some time—at least six
months—to ensure the treatment has been fully effective.
Do not stop taking Dumirox too quickly.
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 (rapid heartbeat)
• sensory disturbances (such as electric shock-like sensations or visual disturbances)
• sweating
• tremors

When stopping treatment with DUMIROX, your doctor will help you gradually reduce the dose
over several weeks or months, which should help reduce the occurrence of withdrawal
symptoms. For most people, withdrawal symptoms after stopping Dumirox are mild and resolve
on their own within 2 weeks. For some individuals, these symptoms may be more severe or last
longer.
If you experience withdrawal symptoms while stopping the tablets, your doctor may decide that
you need to stop more slowly. If you experience severe withdrawal symptoms after stopping
Dumirox, see your doctor. They may ask you to restart taking the tablets and then stop more
slowly (see also section 4 “Possible side effects”).
If you have any symptoms when stopping treatment, contact your doctor.
If you take more Dumirox than you should
If you or someone else has taken too much DUMIROX (overdose), contact a doctor or go to a
hospital as soon as possible. Take the medicine packaging with you.
Symptoms of overdose include, but are not limited to, nausea, vomiting, diarrhoea, drowsiness, or
dizziness.
Cardiac events (slow or rapid heartbeat, low blood pressure), liver problems, seizures, and coma
have also been reported.
If you forget to take Dumirox
If you forget to take a tablet, wait until it is time for your next dose. Do not take a double dose to
make up for the missed dose.
If you have any further questions about using this product, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicinal products, DUMIROX may cause adverse reactions (unwanted effects or reactions), although not everyone experiences them.
The observed frequencies of adverse reactions are defined as follows:

Undesirable effects associated with this type of medicine
Occasionally, suicidal or self-harming thoughts may occur or worsen during the first weeks of treatment with Dumirox, until the antidepressant effect begins.
Contact your doctor immediately if you experience any distressing thoughts or events.
If you have several symptoms at the same time, you may be experiencing one of the rare conditions listed below:

• Serotonin syndrome: if you experience sweating, muscle stiffness or spasms, unsteadiness, confusion, irritability, or severe agitation
• Neuroleptic Malignant Syndrome: if you have muscle rigidity, high fever, confusion, and other associated symptoms
• SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion): if you feel tired, weak, or confused and have painful, stiff, or uncontrollable muscles
• Severe skin reactions such as rashes or redness, including a rash starting on the extremities, usually on both sides of the body, progressing into concentric rings resembling a target (erythema multiforme), widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin shedding (affecting more than 30% of body surface area – toxic epidermal necrolysis). The frequency of these adverse effects is unknown (frequency cannot be estimated from available data).

Stop taking Dumirox and contact your doctor immediately.
If you notice unusual bruising or red spots on your skin, or if you vomit blood or find blood in your stools, contact your doctor for advice.
Stopping fluvoxamine (especially abruptly) commonly leads to withdrawal symptoms (see section 3 Withdrawal symptoms).
Sometimes patients experience mild nausea when Dumirox starts to take effect. Although nausea is unpleasant, it should resolve quickly if you continue taking your tablets as prescribed. This may take a few weeks.

Undesirable effects specifically associated with Dumirox

Common undesirable effects:

• agitation
• anxiety
• constipation
• diarrhoea
• difficulty sleeping
• dizziness
• dry mouth
• increased heart rate
• drowsiness (lethargy)
• malaise
• headache
• indigestion
• loss of appetite
• nervousness
• stomach pain
• sweating
• tremor
• muscle weakness (asthenia)
• vomiting

Uncommon undesirable effects:

• allergic skin reactions (including swelling of the face, lips, or tongue, rash, or itching)
• confusion
• delayed ejaculation
• dizziness when standing up too quickly
• hallucinations
• lack of coordination
• muscle or joint pain
• aggression

Rare undesirable effects:

• seizures
• liver problems
• mania (feelings of euphoria or overexcitement)
• increased sensitivity to sunlight
• unexpected milk discharge from the nipple

Other reported undesirable effects:

• akathisia (inability to remain still)
• altered taste
• anorgasmia (failure to achieve orgasm)
• in female patients: menstrual disorders (bleeding related to menstruation)
• urinary disorders (such as frequent need to urinate 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)
• glaucoma (high eye pressure)
• dilated pupils
• increased prolactin hormone levels (a hormone that stimulates milk production in breastfeeding women)
• weight fluctuations

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

Undesirable effects during OCD treatment in children and adolescents with unspecified frequencies:

• hypomania (feelings of euphoria or overexcitement)
• agitation
• seizures
• difficulty sleeping (insomnia)
• lack of strength (asthenia)
• hyperactivity (hyperkinesis)
• feeling drowsy (somnolence)
• indigestion

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DUMIROX

Keep Dumirox out of the reach and sight of children.

• Do not use the tablets after the expiry date (EXP) stated on the carton and blister pack.
• Do not store above 25°C.

If your doctor stops your treatment, return any unused tablets to a
pharmacist.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Dumirox 50 mg and Dumirox 100 mg contain
The active substance is fluvoxamine maleate.
Each 50 mg tablet contains 50 mg of fluvoxamine maleate. Each 100 mg tablet contains 100 mg of fluvoxamine maleate.
The excipients are: mannitol (E421), maize starch, pregelatinized starch, sodium stearil fumarate, anhydrous colloidal silica, hypromellose, macrogol 6000, talc and titanium dioxide (E171).

Description of the appearance of Dumirox and contents of the pack
The Dumirox 50 mg tablet is film-coated, white to off-white, round, with '291' imprinted on both sides of the breakline.
The Dumirox 100 mg tablet is film-coated, white to off-white, oval, with '313' imprinted on both sides of the breakline.
Dumirox 50 mg is available in packs containing 5, 10, 20, 30, 50, 60, 90, 100 and 250 tablets.
Dumirox 100 mg is available in packs containing 15, 20, 30, 50, 60, 90, 100, 120 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Mylan Italia S.r.l.
Via Vittor Pisani 20
20124 Milano, Italy

Dumirox is manufactured by:
Mylan Laboratories SAS, Route de Belleville, Lieu dit Maillard, 01400 Châtillon sur Chalaronne, France

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Belgium, France, Luxembourg: Floxyfral
Denmark, Finland, Germany, Italy, Norway, Netherlands, Sweden: Fevarin
Ireland, United Kingdom: Faverin
Greece, Portugal: Dumyrox
Italy, Spain: Dumirox
Italy: Maveral