Fevarin

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Fevarin (Dumyrox)
50 mg, film-coated tablets
Fluvoxamine maleate
Fevarin and Dumyrox are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Fevarin is and what it is used for

What Fevarin is
Fevarin belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Fevarin contains the active substance fluvoxamine. It is an antidepressant medicine used in the treatment of depression (major depressive episodes).
Fevarin may also be used in the treatment of patients with obsessive-compulsive disorder, characterized by symptoms such as recurrent intrusive thoughts, images, or compulsive behaviors (rituals).

2. Important information before taking Fevarin

When not to take Fevarin

• if the patient is allergic to fluvoxamine or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking medicines containing tizanidine
• if the patient is taking or has taken within the last two weeks medicines called monoamine oxidase inhibitors (MAOIs). The doctor will advise when to start taking Fevarin after stopping MAOI treatment
• if the patient is taking pimozide (a neuroleptic medicine used to treat schizophrenia and other psychiatric disorders)
• if the patient is taking medicines containing ramelteon.

If any of the above conditions apply to the patient, Fevarin should not be taken,
but the patient should contact their doctor.
Warnings and precautions
Before starting to take Fevarin, consult a doctor or pharmacist if:

• the patient has heart disease (e.g. history of heart attack, heart rhythm disorders)
• the patient is pregnant or may be pregnant
• the patient has epilepsy or has had seizures in the past
• the patient has had bleeding in the past or is regularly taking medicines that increase the risk of bleeding, such as commonly available painkillers, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility")
• the patient has diabetes
• the patient has glaucoma
• the patient is undergoing electroconvulsive therapy (ECT)
• the patient has ever experienced mania (feelings of euphoria or excessive excitement)
• the patient has kidney or liver problems
• the patient is under 18 years of age (see also section 3 "How to take Fevarin")
• the patient is taking medicines containing buprenorphine or buprenorphine with naloxone, as taking these medicines together with Fevarin may lead to serotonin syndrome – a potentially life-threatening condition (symptoms are listed in section 4. "Possible side effects"), see also "Fevarin with other medicines".

If any of the above statements apply to the patient, the doctor will advise whether it is safe
to start taking Fevarin.
Severe adverse reactions have been reported during treatment with Fevarin. If a rash or mucosal lesions occur, stop taking Fevarin and contact a doctor immediately. These severe reactions may include: a rash starting on the limbs, usually on both sides of the body, developing into concentric rings resembling target lesions (erythema multiforme); extensive rash with blisters and skin peeling, particularly affecting the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome); widespread skin peeling (more than 30% of body surface – toxic epidermal necrolysis).
Medicines such as Fevarin (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about two weeks or longer to start working.
The risk of suicidal thoughts or thoughts of self-harm is higher if:

• the patient has previously experienced suicidal thoughts or self-harm
• the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact a doctor immediately or go to hospital.
Informing family members or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask family or friends for help and ask them to inform the patient if they notice worsening of depression or anxiety or concerning changes in behaviour.
Contact a doctor immediately if any disturbing thoughts or experiences occur.
Use of Fevarin in children and adolescents under 18 years of age
Fevarin should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD).
Fevarin is not indicated for the treatment of depression in patients under 18 years of age.
In patients under 18 years of age taking this type of medicine, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts and hostility (aggression, defiant behaviour and anger).
In addition, there is a lack of long-term safety data on the use of the medicine in children and adolescents regarding growth, puberty, and cognitive and behavioural development.
If a doctor has prescribed Fevarin to a patient under 18 years of age and you have any doubts, please consult the doctor. Inform the doctor if any of the above-mentioned symptoms occur or worsen in a person under 18 years of age taking Fevarin.
During the first few weeks of treatment with Fevarin, restlessness may occasionally occur or worsen until the antidepressant effect is achieved, e.g. the patient cannot sit or stand still (akathisia). If such symptoms occur, contact a doctor immediately.
After stopping treatment with Fevarin, withdrawal symptoms may occur, such as dizziness, sensory disturbances, visual disturbances, electric shock sensations, sleep disturbances, agitation, irritability, emotional instability, headache, nausea, vomiting, diarrhoea, excessive sweating, palpitations, tremor, anxiety and others. If such symptoms occur, contact a doctor immediately.
Alcohol should be avoided while taking Fevarin.
Fevarin with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• warfarin, nicoumalone, clopidogrel or any other medicine used to prevent blood clots
• acetylsalicylic acid or similar medicines used to treat pain and inflammation (non-steroidal anti-inflammatory drugs)
• medicines used to treat allergies (terfenadine, astemizole, cisapride)
• tacrine used to treat Alzheimer's disease
• theophylline, used to treat asthma and bronchitis
• methadone, used to treat pain and withdrawal symptoms
• mexiletine, a medicine used to treat heart rhythm disorders
• phenytoin or carbamazepine, used to treat epilepsy
• cyclosporine, used to suppress the immune system
• ropinirole, used in Parkinson's disease
• propranolol, used to treat high blood pressure and heart conditions
• sildenafil, used to treat erectile dysfunction
• tramadol, a painkiller
• buprenorphine or buprenorphine with naloxone
• triptans, used to treat migraine
• pimozide.

If the patient is taking or has recently taken any of the above medicines and has not informed the doctor, contact them and ask how to proceed.
A dose adjustment or change of medicine may be necessary.
If the patient has taken antidepressants or anti-anxiety medicines within the last two weeks, or suffers from schizophrenia, contact the doctor or pharmacist.
The doctor or pharmacist will check whether the patient is taking other antidepressants or medicines for conditions related to depression, such as:

• benzodiazepines
• tricyclic antidepressants
• neuroleptics or antipsychotics
• lithium
• tryptophan
• monoamine oxidase inhibitors (MAO inhibitors), such as moklobemide
• selective serotonin reuptake inhibitors (SSRIs), such as citalopram.

The doctor will advise whether it is safe for the patient to start taking Fevarin.
Do not start taking herbal remedies containing St. John's wort extract while taking Fevarin, as this may worsen adverse reactions. If the patient is currently taking St. John's wort at the start of Fevarin treatment, stop taking St. John's wort and inform the doctor at the next visit.
Fevarin with food, drink and alcohol

• Do not consume alcohol while taking Fevarin.
• Patients who usually consume large amounts of tea, coffee and caffeine-containing drinks may experience symptoms such as hand tremor, nausea, palpitations, restlessness and insomnia. These symptoms may resolve if the patient reduces their caffeine intake.

Pregnancy, breastfeeding and fertility
Consult a doctor or pharmacist before taking any medicine.
Pregnancy
Do not take fluvoxamine during pregnancy unless the doctor decides it is absolutely necessary. If the patient is currently taking fluvoxamine and plans pregnancy, or if the patient plans to become a father, consult the doctor, who will decide whether a change of medicine is necessary.
Taking Fevarin late in pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Fevarin, they should inform the doctor or midwife so appropriate advice can be given.
Inform the doctor and/or midwife about taking Fevarin. Taking medicines such as Fevarin during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension in the newborn (PPHN). This condition is characterised by rapid breathing and cyanosis, and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
If the patient took fluvoxamine during the last three months of pregnancy, the newborn may experience other symptoms in addition to rapid breathing and cyanosis, such as feeding and/or breathing difficulties, seizures, temperature instability, low blood sugar, tremor, convulsions, abnormal muscle tone, cyanosis, irritability, lethargy, drowsiness, vomiting, sleep problems and constant crying. If any of these symptoms occur in the newborn, contact a doctor immediately.
Breastfeeding
Fluvoxamine is excreted in small amounts in breast milk, therefore the medicine should not be used in breastfeeding women. Consult a doctor, who will decide whether to discontinue breastfeeding or stop taking fluvoxamine.
Fertility
Animal studies have shown that fluvoxamine reduces semen quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans to date.
Driving and operating machinery
In studies in healthy volunteers, the medicine did not show a significant effect on psychomotor performance related to driving and operating machinery. However, as excessive drowsiness may occur during treatment with fluvoxamine, caution should be exercised until the individual response to the medicine is known.
Fevarin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to take Fevarin

Fevarin should always be taken exactly as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist.
Fevarin is available in the following strengths: 50 mg, 100 mg.
Recommended dose
Adults (18 years and older)

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

If there is no improvement after several weeks, consult your doctor.
Your doctor may decide to gradually increase the dose.
The maximum recommended daily dose is 300 mg.
If your doctor prescribes more than 150 mg per day, do not take it as a single dose.
Ask your doctor when to take the medication.
Children and adolescents (8 years and older)

• For treatment of obsessive-compulsive disorder (OCD):
  • Start with 25 mg (half a tablet of Fevarin 50 mg) once daily, preferably taken before bedtime. Your doctor may increase the dose by 25 mg every 4–7 days, depending on tolerance, until an effective dose is reached. The maximum daily dose is 200 mg.

If your doctor prescribes more than 50 mg per day, the medication should be taken in two
divided doses. Ask your doctor when to take the medication. If the dose is not divided equally,
the larger part of the dose should be taken in the evening.
Do not use this medication for the treatment of depression in children and adolescents under 18 years of age.
This medication may be used in children and adolescents under 18 years of age only for the treatment of
obsessive-compulsive disorder.
How to take Fevarin
Swallow Fevarin tablets whole with water, without chewing.
Tablets may be divided in half if instructed by your doctor.
How quickly does Fevarin start working?
Fevarin may take some time to start working. Some patients may notice improvement
after several weeks of treatment.
Continue taking the medication until your doctor decides to stop treatment. Even if symptoms improve,
your doctor may recommend continuing treatment for a certain period, at least
6 months after symptoms have resolved.
Taking more Fevarin than recommended
If more than the recommended dose has been taken (overdose) by the patient or another person,
seek immediate medical advice from a doctor or go to the nearest hospital. Take the
medication packaging with you.
Overdose of Fevarin may cause gastrointestinal symptoms (nausea,
vomiting, and diarrhoea), drowsiness, and dizziness. Cardiac events have also been reported
(increased or decreased heart rate, low blood pressure), liver function abnormalities, seizures, and coma.
Missing a dose of Fevarin
If a dose is missed, wait until the next scheduled dose. Do not
take a double dose to make up for a missed dose.
Stopping Fevarin
Do not stop taking Fevarin too quickly. Withdrawal symptoms may occur, such as:

• psychomotor agitation and restlessness
• confusion
• diarrhoea
• sleep disturbances
• dizziness
• emotional instability
• headache
• nausea or vomiting
• palpitations (rapid heartbeat)
• sensory disturbances (such as electric shock sensations or visual disturbances)
• sweating
• tremor.

When discontinuing Fevarin, your doctor will advise how to gradually reduce the dose, which should
help minimize the risk of withdrawal symptoms. In most people, symptoms after stopping Fevarin
are mild and resolve spontaneously. However, in some individuals, these symptoms may
be more severe or prolonged.
If any symptoms occur after stopping the medication, contact your doctor.
If withdrawal symptoms occur after stopping the tablets, your doctor may
decide to taper the medication more slowly. If severe withdrawal symptoms occur, contact your doctor.
Your doctor may recommend resuming the tablets and tapering them more gradually.
If you have any further questions about the use of this medication, contact your
doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of observed adverse reactions has been defined as follows:

Common adverse reactions

• Psychological anorexia (anorexia)
• Psychomotor agitation, nervousness, anxiety
• Insomnia
• Drowsiness
• Tremor
• Headache
• Dizziness
• Palpitations, increased heart rate
• Abdominal pain
• Constipation
• Diarrhea
• Dry mouth
• Indigestion
• Nausea
• Vomiting
• Excessive sweating
• Malaise, fatigue.

Uncommon adverse reactions

• Hallucinations, disorientation
• Aggression
• Movement disorders, coordination disturbances
• Orthostatic hypotension (drop in blood pressure upon assuming upright position)
• Skin hypersensitivity reactions (including angioedema, rash or itching)
• Joint or muscle pain
• Delayed or impaired ejaculation.

Rare adverse reactions

• Mania (feeling of euphoria or excessive excitement)
• Seizures
• Liver function disorders
• Light sensitivity
• Unexpected milk leakage from breasts (galactorrhea).

Adverse reactions of unknown frequency

• Gastrointestinal bleeding, gynecological bleeding, petechiae, purpura
• Increased concentration of prolactin hormone (hormone responsible for milk production in breastfeeding women)
• Inappropriate secretion of antidiuretic hormone responsible for water reabsorption in the kidneys and regulation of urine volume
• Decreased sodium concentration in serum (hyponatremia)
• Increase or decrease in body weight
• Suicidal thoughts
• Suicidal behavior
• Serotonin syndrome
• Symptoms resembling neuroleptic malignant syndrome
• Motor restlessness (akathisia)
• Sensory disturbances
• Taste disturbances
• Glaucoma (increased intraocular pressure)
• Pupil dilation
• Inability to achieve orgasm (anorgasmia)
• In women: menstrual disorders
• Severe vaginal bleeding occurring shortly after childbirth (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effect on fertility" in section 2.
• Urinary disorders (such as need for frequent urination during the day and/or night, daytime and/or nighttime urinary incontinence, and inability to urinate)
• Severe skin reactions, such as severe rashes or redness, including rash starting on the skin of limbs, usually on both sides of the body, developing into concentric rings resembling target lesions (erythema multiforme), generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genital organs (Stevens-Johnson syndrome), extensive skin peeling (affecting more than 30% of body surface area – toxic epidermal necrolysis).

In patients taking medicines such as Fevarin, there is an increased risk of bone fractures.
Discontinuation of fluvoxamine (especially abrupt discontinuation) often leads to withdrawal symptoms (see also section 3 – "How to take Fevarin").
Suicidal thoughts or self-harming thoughts may occasionally occur or worsen during the first few weeks of treatment with Fevarin, until the antidepressant effect begins.
You should immediately inform your doctor if any such thoughts occur.
If several symptoms occur simultaneously, it may indicate one of the following rare conditions:

• Serotonin syndrome: if sweating, muscle stiffness or spasms, imbalance, confusion, irritability, or extreme agitation occur
• Neuroleptic malignant syndrome: if muscle stiffness, high fever, confusion, or other similar symptoms occur
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH): if fatigue, weakness, confusion, and muscle pain, stiffness, or loss of muscle control occur, stop taking Fevarin and contact your doctor immediately.

If unusual bruising, petechiae on the skin, vomiting blood, or blood in stool occur, contact your doctor immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fevarin

• Keep out of the sight and reach of children.
• Do not use Fevarin after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Do not store above 25°C.

If your doctor decides to discontinue treatment, any unused tablets should be returned
to a pharmacy.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the pack and other information

What Fevarin contains

• The active substance in Fevarin is fluvoxamine maleate. Each film-coated tablet contains 50 mg of fluvoxamine maleate.
• Other ingredients are: mannitol, maize starch, pregelatinized starch, sodium stearyl fumarate, colloidal anhydrous silica; coating: hypromellose, macrogol 6000, talc, titanium dioxide (E 171).

What Fevarin looks like and contents of the pack
Fevarin 50 mg is a white or almost white, round, biconvex film-coated tablet that can be divided into two equal parts.
The pack contains 20 or 60 film-coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Portugal, country of export:
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, No 44C – 7.3 and 7.4
1990-095 Lisbon, Portugal
Manufacturer:
Mylan Laboratories SAS
Route de Belleville
Lieu-dit "Maillard"
01400 Châtillon sur Chalaronne
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorization number in Portugal, country of export: 5897681
Parallel import authorization number: 51/23