Fevarin

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Fevarin (Fluvoxamine maleate Mylan)

100 mg, coated tablets
Fluvoxamine maleate
Fevarin and Fluvoxamine maleate Mylan are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Fevarin and what is it used for
• 2. Important information before taking Fevarin
• 3. How to take Fevarin
• 4. Possible side effects
• 5. How to store Fevarin
• 6. Package contents and other information

1. What is Fevarin and what is it used for

What is Fevarin

Fevarin belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Fevarin contains a substance called fluvoxamine. It is an antidepressant. It is used to treat depression (severe depressive episodes).
Fevarin may also be used to treat people with obsessive-compulsive disorders, which are characterized by symptoms such as recurring intrusive thoughts, images, or compulsive behaviors (rituals).

2. Important information before taking Fevarin

When not to take Fevarin

If any of the above conditions apply to the patient, they should not take Fevarin, but should consult a doctor.

Warnings and precautions

Before starting to take Fevarin, the patient should consult a doctor or pharmacist if:

• the patient has heart disease (e.g., post-myocardial infarction, arrhythmias)
• the patient is pregnant or may be pregnant
• the patient has epilepsy or has had seizures in the past
• the patient has had bleeding or is taking medications that increase the risk of bleeding, such as common 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 had mania (a feeling of euphoria or excessive excitement)
• the patient has kidney or liver disease
• the patient is under 18 years old (see also section 3 "How to take Fevarin")
• the patient is taking medicines containing buprenorphine or buprenorphine with naloxone, as taking these medicines at the same time as Fevarin may lead to serotonin syndrome - a potentially life-threatening condition (symptoms see section 4 "Possible side effects"), see also "Fevarin and other medicines".

If the patient has any of the above, the doctor will inform whether it is safe to start taking Fevarin.
Severe side effects have been reported during treatment with Fevarin. If a rash or mucosal lesions occur, the patient should stop taking Fevarin and contact their doctor immediately.
These severe reactions may include: a rash starting on the skin of the limbs, usually on both sides of the body, developing into concentric rings resembling target marks (erythema multiforme); widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of the body surface - toxic epidermal necrolysis).
Medicines like Fevarin (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Suicidal thoughts, worsening depression, or anxiety disorders

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after 2 weeks, and sometimes later.
Suicidal thoughts or self-harm are more likely to occur if:

• the patient has had suicidal thoughts or self-harm in the past
• the patient is a young adult. Data from clinical trials indicate an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressant medicines.

If the patient experiences suicidal thoughts or self-harm, they should immediatelycontact their doctor or go to the hospital.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are worrying changes in behavior.
The patient should contact their doctor immediatelyif they experience any worrying thoughts or experiences.

Using 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 disorders (OCD). Fevarin is not indicated for the treatment of depression in people under 18 years of age.
In patients under 18 years of age taking this type of medicine, there is an increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (aggression, rebellious behavior, and manifestations of anger).
Additionally, there is a lack of long-term safety data on the use of the medicine in children and adolescents, regarding growth, maturation, and cognitive and behavioral development.
If the doctor has prescribed Fevarin to a patient under 18 years of age, and there are any doubts, please consult the doctor. The doctor should be informed if any of the above 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, such as the patient being unable to sit or stand still (akathisia). If such symptoms occur, the doctor should be contacted immediately.
After stopping treatment with Fevarin, withdrawal symptoms may occur, such as dizziness, sensory disturbances, visual disturbances, electric shock sensation, sleep disturbances, agitation, irritability, emotional instability, headaches, nausea, vomiting, diarrhea, excessive sweating, palpitations, tremors, anxiety, and other symptoms. If such symptoms occur, the doctor should be contacted immediately.
During treatment with Fevarin, the patient should avoid consuming alcohol.

Fevarin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor or pharmacist should be informed if the patient is taking any of the following medicines:

• warfarin, nicoumalone, clopidogrel, or any other medicine used to prevent blood clots
• aspirin 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 arrhythmias
• phenytoin or carbamazepine used to treat epilepsy
• cyclosporine used to weaken the immune system
• ropinirole used to treat Parkinson's disease
• propranolol used to treat high blood pressure and heart disease
• sildenafil used to treat erectile dysfunction
• tramadol, a painkiller
• buprenorphine or buprenorphine with naloxone
• triptans used to treat migraines
• pimozide.

If the patient is taking or has recently taken any of the above medicines and has not informed their doctor, they should contact their doctor and ask how to proceed.
A dose change or a change in the medicine itself may be necessary.
If the patient has taken medicines for depression or anxiety in the last two weeks, or is suffering from schizophrenia, they should contact their doctor or pharmacist.
The doctor or pharmacist will check if the patient is not taking other medicines for depression or related conditions, such as:

• benzodiazepines
• tricyclic antidepressants
• antipsychotics or antipsychotic medicines
• lithium
• tryptophan
• monoamine oxidase inhibitors (MAOIs), such as moclobemide
• selective serotonin reuptake inhibitors, such as citalopram.

The doctor will inform whether the patient can safely start taking Fevarin.
During treatment with Fevarin, the patient should not start taking herbal medicines containing St. John's Wort, as this may increase the risk of side effects. If the patient is taking St. John's Wort when starting treatment with Fevarin, they should stop taking St. John's Wort and inform their doctor at the next visit.

Fevarin with food, drink, and alcohol

• The patient should not consume alcohol while taking Fevarin.
• In patients who usually consume large amounts of tea, coffee, and caffeine-containing beverages, symptoms such as hand tremors, nausea, palpitations, anxiety, and insomnia may occur. These symptoms may disappear if the patient reduces their caffeine intake.

Pregnancy, breastfeeding, and fertility

Before taking any medicine, the patient should consult their doctor or pharmacist.
Pregnancy
Fluvoxamine should not be used during pregnancy, unless the doctor decides that it is absolutely necessary. If the patient is currently taking fluvoxamine and plans to become pregnant or the patient plans to become a father, they should consult their doctor, who will decide whether a change in the medicine is necessary.
Taking Fevarin at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Fevarin, they should inform their doctor or midwife so that they can provide appropriate advice.
The patient should inform their doctor and/or midwife about taking Fevarin. Taking medicines like Fevarin during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs in the first day after birth. If such symptoms occur in the newborn, the patient should contact their doctor and/or midwife immediately.
If the patient took fluvoxamine in the last three months of pregnancy, the newborn may experience symptoms such as difficulty feeding and/or breathing, seizures, instability of body temperature, low blood sugar, tremors, convulsions, abnormal muscle tone, cyanosis, agitation, lethargy, drowsiness, vomiting, sleep problems, and constant crying. If the newborn experiences any of these symptoms, the patient should contact their doctor immediately.
Breastfeeding
Fluvoxamine is excreted in small amounts into breast milk, so the medicine should not be used in breastfeeding women. The patient should consult their doctor, who will decide whether to stop breastfeeding or stop taking fluvoxamine.
Fertility
In animal studies, fluvoxamine has been shown to decrease sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

In studies on healthy volunteers, the medicine did not show a significant effect on psychomotor performance related to driving and operating machinery. However, since excessive drowsiness may occur during fluvoxamine treatment, caution should be exercised until the individual reaction to the medicine is established.

Fevarin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Fevarin

Fevarin should alwaysbe taken as directed by the doctor.
Fevarin is available in the following doses: 50 mg, 100 mg.
In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Adults (18 years and older)

• For depression: The patient should start with 50 or 100 mg per day, taken in the evening.
• For obsessive-compulsive disorders: The patient should start with 50 mg per day, taken preferably in the evening.

If there is no improvement after a few weeks, the patient should consult their doctor.
The doctor may decide to gradually increase the dose.
The maximum recommended daily dose is 300 mg.
If the doctor recommends taking more than 150 mg per day, the patient should nottake them all at once.
The patient should ask their doctor when to take the medicine.

Children and adolescents (8 years and older)

• For obsessive-compulsive disorders (OCD): The patient should start with 25 mg (half a 50 mg Fevarin tablet) per day, taken preferably before bedtime. The doctor may increase the dose by 25 mg every 4-7 days, depending on tolerance, to achieve an effective dose. The maximum daily dose is 200 mg. If the doctor recommends taking more than 50 mg per day, the medicine should be taken in two doses. The patient should ask their doctor when to take the medicine. If the dose is not divided evenly, the larger part of the dose should be taken in the evening.

Do notuse this medicine to treat depression in children and adolescents under 18 years of age.
This medicine may be used in children and adolescents under 18 years of age onlyfor obsessive-compulsive disorders.

How to take Fevarin

Fevarin tablets should be swallowed whole without chewing, with a glass of water.
The tablets can be divided into halves if the doctor recommends it.

How quickly does Fevarin start working

Fevarin may start working only after some time. Some patients may feel improvement after a few weeks of treatment.
The medicine should be taken until the doctor decides to stop treatment. Even if improvement is achieved, the doctor may recommend continuing treatment for some time, at least 6 months from the time symptoms disappear.

Taking a higher dose of Fevarin than recommended

In case of taking a higher dose of the medicine than recommended (overdose) by the patient or another person, they should immediatelyconsult a doctor or go to the nearest hospital. The patient should take the packaging of the medicine with them.
Overdose of Fevarin may cause gastrointestinal disorders (nausea, vomiting, and diarrhea), drowsiness, and dizziness. There have also been reports of cardiac events (accelerated or slowed heart rate, decreased blood pressure), liver dysfunction, seizures, and coma.

Missing a dose of Fevarin

In case of missing a dose, the patient should wait until the next scheduled dose. The patient should nottake a double dose to make up for the missed dose.

Stopping treatment with Fevarin

The patient should notstop taking Fevarin too quickly. Withdrawal symptoms may occur, such as:

• restlessness and anxiety
• confusion
• diarrhea
• sleep disturbances
• dizziness
• emotional instability
• headaches
• nausea or vomiting
• palpitations (rapid heart rate)
• sensory disturbances (such as electric shock sensation or visual disturbances)
• sweating
• tremors.

When stopping treatment with Fevarin, the doctor will recommend how to gradually reduce the dose, which should limit the possibility of withdrawal symptoms. In most people, withdrawal symptoms after stopping Fevarin are mild and resolve on their own. However, in some people, these symptoms may be more severe or longer-lasting.
If any symptoms occur after stopping the medicine, the patient should contacttheir doctor.
If withdrawal symptoms occur after stopping the tablets, the doctor may decide to taper off the medicine more slowly. If severe withdrawal symptoms occur, the patient should contact their doctor. The doctor may recommend taking the tablets again and tapering them off more slowly.
If the patient has any further questions about taking this medicine, they should contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fevarin can cause side effects, although not everybody gets them.
The frequency of observed side effects has been determined as follows:

Common side effects

• loss of appetite (anorexia)
• psychomotor agitation, nervousness, anxiety
• insomnia
• drowsiness
• tremors
• headache
• dizziness
• palpitations, rapid heart rate
• abdominal pain
• constipation
• diarrhea
• dry mouth
• indigestion
• nausea
• vomiting
• excessive sweating
• malaise, fatigue

Uncommon side effects

• hallucinations, disorientation
• aggression
• movement disorders, coordination disorders
• orthostatic hypotension (decreased blood pressure when standing up)
• skin hypersensitivity reactions (including angioedema, rash, or itching)
• joint or muscle pain
• abnormal ejaculation (delayed ejaculation)

Rare side effects

• mania (feeling of euphoria or excessive excitement)
• seizures
• liver dysfunction
• photosensitivity
• unintended milk secretion (galactorrhea)

Side effects with unknown frequency

• gastrointestinal bleeding, gynecological bleeding, bruising, petechiae
• increased prolactin levels (hormone responsible for milk production in breastfeeding women)
• abnormal secretion of antidiuretic hormone responsible for water reabsorption in the kidneys and regulation of urine volume
• decreased sodium levels in the blood (hyponatremia)
• weight gain or loss
• suicidal thoughts
• suicidal behavior
• serotonin syndrome
• symptoms similar to malignant neuroleptic syndrome

• akathisia (restlessness)
• sensory disturbances
• taste disturbances
• glaucoma (increased pressure in the eye)
• pupil dilation
• anorgasmia (inability to achieve orgasm)
• in women: menstrual disorders
• severe postpartum hemorrhage (see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2)
• urinary disorders (such as frequent urination during the day and/or night, incontinence during the day and/or night, and inability to urinate)
• severe skin reactions, such as severe skin rashes or redness, including a rash starting on the skin of the limbs, usually on both sides of the body, developing into concentric rings resembling target marks (erythema multiforme), generalized rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of the body surface - toxic epidermal necrolysis).

Patients taking medicines like Fevarin have an increased risk of fractures.
Stopping fluvoxamine treatment (especially sudden cessation) often leads to withdrawal symptoms (see also section 3 "How to take Fevarin").
Suicidal thoughts or self-harm may occur or worsen during the first few weeks of treatment with Fevarin, until the antidepressant starts working.
The patient should immediately inform their doctorif they experience any such thoughts.
If several symptoms occur at the same time, it may indicate one of the following rare conditions:

• serotonin syndrome: if sweating, stiffness, or muscle spasms, balance disorders, confusion, irritability, or extreme agitation occur
• malignant neuroleptic syndrome: if muscle stiffness, high fever, confusion, or other similar symptoms occur
• inappropriate antidiuretic hormone secretion syndrome (SIADH) if fatigue, weakness, or confusion and pain, stiffness, or lack of muscle control occur.

The patient should stoptaking Fevarin and immediately contact their doctor.
In case of unusual bruising, bleeding, or blood in the stool, the patient should immediately contact their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Fevarin

Store in a place out of sight and reach of children.
Do not use Fevarin after the expiry date stated on the packaging.
Store at a temperature below 25°C. Store in the original packaging.
If the doctor decides to stop treatment, any unused tablets should be returned to the pharmacy.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fevarin contains

• The active substance of Fevarin is fluvoxamine maleate. Each coated tablet contains 100 mg of fluvoxamine maleate.
• Other ingredients are: mannitol, cornstarch, pregelatinized starch, sodium stearyl fumarate, colloidal anhydrous silica; coating: hypromellose, macrogol 6000, talc, titanium dioxide.

What Fevarin looks like and what the package contains

Fevarin, 100 mg, is a white or almost white, oval, biconvex, coated tablet that can be divided into halves. The packaging of the medicine contains 30 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
Netherlands

Manufacturer:

Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
Netherlands
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 29190

Netherlands parallel import license number: 143/20 Date of leaflet approval: 19.12.2022

[Information about the trademark]