Maveral

MAVERAL
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, consult 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. WHAT MAVERAL IS AND WHAT IT IS USED FOR

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

2. BEFORE TAKING MAVERAL

Do not use Maveral if any of the following conditions apply to you:

• if you are allergic (hypersensitive) to fluvoxamine or to any of the other excipients in the tablet (see section 6 “Other 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 discontinuation of 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 Maveral 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 Maveral and speak with your doctor.
Exercise particular caution:
Before taking the medicine, talk to your doctor or pharmacist if:

• you have recently had a heart attack
• you are pregnant or might be pregnant
• you have epilepsy
• you have previously had bleeding problems or 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 experienced mania (feelings of euphoria or over-excitement)
• 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 Maveral”)

If any of the above conditions apply to you, your doctor will determine whether it is safe for you to start taking Maveral.
Occasionally, restlessness symptoms, such as inability to sit or stand still (akathisia), may appear or worsen during the first few weeks of treatment with Maveral, until the antidepressant effect begins.
Inform your doctor immediately if such symptoms occur. A dosage adjustment may be helpful.
Serious skin reactions have been reported during use of Maveral. Stop taking Maveral and contact a doctor immediately if you develop skin rashes or mucosal lesions. Severe skin reactions may include a rash starting from 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), or extensive skin shedding (more than 30% of body surface area – toxic epidermal necrolysis).
Medicines such as Maveral (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. Clinical study data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders 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 experience any distressing thoughts or events.
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 Maveral is not used to treat depression in patients under 18 years of age.
People 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 Maveral for a patient under 18 years of age and you wish to discuss this, contact your doctor again. You must inform the doctor if any of the symptoms described above appear or worsen during treatment with Maveral in a patient under 18 years of age.
Furthermore, it is not known whether taking Maveral 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 Maveral, 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 Maveral, 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 Maveral.
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. Maveral 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 your doctor and ask what to 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 without a prescription. This also includes herbal medicines.
Taking Maveral with food and drinks

• Do not drink alcohol while taking this medicine, as alcohol may interact with Maveral and make you drowsy and less alert.
• If you normally consume 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 caffeine intake may help these symptoms disappear.

Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before taking any medicine.
Pregnancy
There is only limited experience regarding the use of fluvoxamine during pregnancy. 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 if you (as a father) intend to
father a child, 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 no impact on fertility has been observed so far.
Ensure that your midwife and/or doctor are aware that you are being treated with fluvoxamine. Medicines such as fluvoxamine, when taken during pregnancy, particularly during the last three 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 three 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 shows 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, discuss this with your doctor, who will decide whether you should stop breastfeeding or discontinue fluvoxamine treatment.
Driving and using machines
You may drive and operate machinery during treatment, provided this medicine does not make you drowsy.
Maveral contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. HOW TO TAKE MAVERAL

How much Maveral to take
Always take Maveral exactly as directed 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 feeling better after a couple of weeks, discuss this with your doctor, who will advise you accordingly. 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 bedtime. 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, ask your doctor 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 Maveral
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?
Maveral may take some time to start working. Some patients do not notice improvement during 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 Maveral 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 MAVERAL, your doctor will help you gradually reduce the dose over several weeks or months, which should help minimize withdrawal symptoms. For most people, withdrawal symptoms from Maveral 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 discontinuing the tablets, your doctor may decide that you should taper off more slowly. If you experience severe withdrawal symptoms upon stopping Maveral, see your doctor. He or she may ask you to restart taking the tablets and then discontinue them more gradually (see also section 4, "Possible side effects").
If you experience any symptoms when stopping treatment, contact your doctor.

If you take more Maveral than you should
If you or someone else has taken too much MAVERAL (overdose), contact a doctor or go to a hospital immediately. Bring the medicine packaging with you.
Symptoms of overdose may include, but are not limited to, nausea, vomiting, diarrhoea, drowsiness, or dizziness.
Cardiac events (slow or fast heartbeat, low blood pressure), liver problems, seizures, and coma have also been reported.

If you forget to take Maveral
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 medicines, MAVERAL may cause adverse reactions (undesired effects or reactions),
although not everyone experiences them.
The frequencies of the observed adverse reactions are defined as follows:

Undesirable effects associated with this type of medicine
Occasionally, suicidal thoughts or self-harming behaviour may occur or worsen during the first
weeks of treatment with Maveral, until the antidepressant effect begins to take effect.
Inform your doctor immediately if you experience any distressing thoughts or feelings.
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 rigidity 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 from 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 (more than 30% of body surface area – toxic epidermal necrolysis). The frequency of these adverse effects is unknown (frequency cannot be estimated from the available data).

Stop taking Maveral and contact your doctor immediately.
If you develop unusual bruising or red spots on your skin, or if you vomit blood or notice blood in your
stool, contact your doctor for advice.
Discontinuation of fluvoxamine (especially abrupt discontinuation) commonly leads to withdrawal
symptoms (see section 3 Withdrawal symptoms).
Sometimes patients may experience mild nausea shortly after Maveral begins to work. Although
nausea may be unpleasant, it should resolve quickly if you continue taking your tablets as prescribed.
This may take a few weeks.

Undesirable effects specifically associated with Maveral

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)
• 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 between periods)
• urinary disorders (such as need to urinate frequently during the day and/or night, sudden loss of bladder control during the day and/or night, or inability to urinate)
• paraesthesia (tingling or numbness)
• glaucoma (increased 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 treatment for OCD in children and adolescents with unspecified frequencies:

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

Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report adverse effects directly via the national reporting system at
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 MAVERAL

Keep Maveral out of the reach and sight of children.

• Do not use the tablets after the expiry date (EXP) printed 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 Maveral 50 mg and Maveral 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 other ingredients are: mannitol (E421), maize starch, pregelatinized starch, sodium stearyl fumarate, anhydrous colloidal silica, hypromellose, macrogol 6000, talc and titanium dioxide (E171).

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

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

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

This medicinal product is authorised 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