Fevarin

Leaflet accompanying the packaging: patient information

Fevarin

50 mg, coated tablets

100 mg, coated tablets

Fluvoxamine maleate

It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. 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. Contents of the packaging and other information

1. What is Fevarin and what is it used for

What is Fevarin

Fevarin belongs to a group of medications called selective serotonin reuptake inhibitors (SSRIs). Fevarin contains the active substance fluvoxamine. It is an antidepressant. It is used to treat depression (severe depressive episodes).
Fevarin may also be used to treat patients with obsessive-compulsive disorders, which are characterized by recurring, 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 medication (listed in section 6)
• if the patient is taking medications containing thiazide
• if the patient is taking monoamine oxidase inhibitors (MAOIs) or has taken them in the last two weeks. The doctor will inform how to start taking Fevarin after stopping MAOI treatment
• if the patient is taking pimozide (an antipsychotic medication used to treat schizophrenia and other psychiatric disorders)
• if the patient is taking medications containing ramelteon

If any of the above conditions apply to the patient, they should not take Fevarin, but 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 (feelings 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 medications containing buprenorphine or buprenorphine with naloxone, as taking these medications with Fevarin may lead to serotonin syndrome - a potentially life-threatening condition (symptoms see section 4 "Possible side effects"), see also "Fevarin and other medications".

If the patient is affected by any of the above statements, the doctor will inform 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, 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 lesions (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).
Medications like Fevarin (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

Suicidal thoughts, worsening depression, or anxiety disorders

Patients 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 antidepressants, as these medications usually start to work after 2 weeks, and sometimes later.
The occurrence of suicidal thoughts or self-harm is more likely 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 old with mental disorders treated with antidepressants.

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 friendsabout 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 the doctor if they notice that the depression or anxiety has worsened or if there are any 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 old

Fevarin should not be used in children and adolescents under 18 years old, except for patients with obsessive-compulsive disorders (OCD). Fevarin is not indicated for the treatment of depression in patients under 18 years old.
In patients under 18 years old taking this type of medication, there is an increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (aggression, rebellious behavior, and manifestations of anger).
Additionally, there is a lack of long-term data on the safety of using Fevarin in children and adolescents, regarding growth, maturation, and cognitive and behavioral development.
If the doctor has prescribed Fevarin to a patient under 18 years old, 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 patient under 18 years old taking Fevarin.
During the first few weeks of treatment with Fevarin, the patient may occasionally experience or worsen restlessness, such as being unable to sit or stand still (akathisia). If such symptoms occur, the patient should contact their doctor immediately.
After stopping treatment with Fevarin, the patient may experience withdrawal symptoms, 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 patient should contact their doctor immediately.
During treatment with Fevarin, the patient should avoid consuming alcohol.

Fevarin and other medications

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

• warfarin, nicoumalone, clopidogrel, or any other medication used to prevent blood clots
• aspirin or similar medications used to treat pain and inflammation (non-steroidal anti-inflammatory drugs)
• medications 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 medication 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 medications and has not informed their doctor, they should contact their doctor and ask how to proceed.
A dose change or medication change may be necessary.
If the patient has taken medications 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 medications for depression or related conditions, such as:

• benzodiazepines
• tricyclic antidepressants
• antipsychotics or antipsychotic medications
• 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 medications containing St. John's Wort, as this may increase the risk of adverse reactions. 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 resolve if the patient reduces their caffeine intake.

Pregnancy, breastfeeding, and fertility

Before taking any medication, the patient should consult their doctor or pharmacist.
Pregnancy
Fluvoxamine should not be used during pregnancy unless the doctor decides 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 medication change is necessary.
Taking Fevarin at the end of pregnancy may increase the risk of severe postpartum hemorrhage, 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 medications like Fevarin during pregnancy, especially in the last three months, may increase the risk of persistent pulmonary hypertension in 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, in addition to rapid breathing and cyanosis, other symptoms such as feeding or breathing difficulties, seizures, temperature instability, low blood sugar, tremors, seizures, abnormal muscle tone, cyanosis, agitation, lethargy, 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 medication should not be used in breastfeeding women. The patient should consult their doctor, who will decide whether to stop breastfeeding or discontinue 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 medication did not show a significant effect on psychomotor performance related to driving and operating machinery. However, since excessive sleepiness may occur during fluvoxamine treatment, the patient should exercise caution until they establish their individual reaction to the medication.

Fevarin contains sodium

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

3. How to take Fevarin

Fevarin should alwaysbe taken as directed by the doctor.
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 medication.

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 medication should be taken in two doses. The patient should ask their doctor when to take the medication. If the dose is not divided evenly, the larger portion of the dose should be taken in the evening.

Do notuse this medication to treat depression in children and adolescents under 18 years old.
This medication may be used in children and adolescents under 18 years old 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 in half if the doctor recommends it.

How long does it take for Fevarin to start working

Fevarin may take some time to start working. Some patients may feel improvement after a few weeks of treatment.
The medication should be taken until the doctor decides to stop treatment. Even if the patient feels better, the doctor may recommend continuing treatment for some time, at least 6 months after the symptoms have resolved.

Taking a higher dose of Fevarin than recommended

In case of an overdose (taking more than the recommended dose), the patient should immediately contact their doctor or go to the nearest hospital. The patient should take the medication packaging with them.
Overdose of Fevarin may cause gastrointestinal symptoms (nausea, vomiting, and diarrhea), sleepiness, and dizziness. There have also been reports of cardiac events (rapid or slow heart rate, low blood pressure), liver dysfunction, seizures, and coma.

Missing a dose of Fevarin

If the patient misses a dose, they should wait until the next scheduled dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Fevarin

Do 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 Fevarin, the doctor will recommend how to gradually reduce the dose to minimize the risk of withdrawal symptoms. In most cases, the symptoms after stopping Fevarin are mild and resolve on their own. However, in some cases, the symptoms may be more severe or prolonged.
If the patient experiences any symptoms after stopping the medication, they should contacttheir doctor.
If withdrawal symptoms occur after stopping the tablets, the doctor may decide to taper off the medication more slowly. If severe withdrawal symptoms occur, the patient should contact their doctor. The doctor may recommend restarting the tablets and tapering them off more slowly.
If the patient has any further questions about taking this medication, they should contact their doctor or pharmacist.

4. Possible side effects

Like all medications, Fevarin can cause side effects, although not everyone will experience them.
The frequency of observed side effects is as follows:

Common side effects

• loss of appetite
• psychomotor agitation, nervousness, anxiety
• insomnia
• sleepiness
• 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 (low blood pressure when standing up)
• skin hypersensitivity reactions (including angioedema, rash, or itching)
• joint or muscle pain
• abnormal ejaculation

Rare side effects

• mania (feelings of euphoria or excessive excitement)
• seizures
• liver dysfunction

• photosensitivity
• unintended milk secretion from the breast (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
• low sodium levels in the blood (hyponatremia)
• weight gain or loss
• suicidal thoughts
• suicidal behavior
• serotonin syndrome
• symptoms similar to neuroleptic malignant 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 lesions (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).

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

• serotonin syndrome: if sweating, muscle stiffness or spasms, balance disorders, confusion, irritability, or extreme agitation occur
• neuroleptic malignant 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.

If the patient experiences unusual bruising, petechiae, vomiting blood, or blood in the stool, they 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 inform their doctor or 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to store Fevarin

• Store in a place out of sight and reach of children.
• Do not use Fevarin after the expiration date stated on the packaging and blister.
• Store at a temperature not exceeding 25°C.

If the doctor decides to stop treatment, any remaining unused tablets should be returned to the pharmacy.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fevarin contains

• The active substance of Fevarin is fluvoxamine maleate
• each coated tablet contains 50 mg or 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 contents of the pack

Fevarin, 50 mg is a white or almost white, round, biconvex, coated tablet that can be divided into two halves. The packaging contains 30 or 60 coated tablets.
Fevarin, 100 mg is a white or almost white, oval, biconvex, coated tablet that can be divided into two halves. The packaging contains 15 or 30 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer

Mylan Laboratories SAS
Route de Belleville, Lieu-dit Maillard
01400 Châtillon sur Chalaronne, France
Recipharm Parets, S.L.U.
C/ Ramón y Cajal 2
08150 Parets del Vallés (Barcelona)
Spain
To obtain more detailed information, the patient should contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel. 22 546 64 00
Date of last revision of the leaflet:04/2025