Fevarin

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Fevarin(Dumyrox)

50 mg, coated tablets

Fluvoxamine maleate
Fevarin and Dumyrox 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 you by a doctor. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 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 with 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 decide 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); a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis).
Medicines like Fevarin (SSRIs) may cause 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 antidepressants, as these medicines usually start to work 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 antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should immediately
contact their doctor or go to the hospital.
It may be helpful to inform relatives or friendsabout depression or anxiety disorders 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 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 disorder (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 data on the safety of using 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 patient should contact their doctor 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, and anxiety. If such symptoms occur, the patient should contact their doctor immediately.
While taking 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 patient should inform their doctor or pharmacist if they are 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, cyzapride)
• 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
• cyclosporin 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 what to do.
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 has 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
• neuroleptics or antipsychotic medicines
• lithium
• tryptophan
• monoamine oxidase inhibitors (MAOIs), such as moklobemide
• selective serotonin reuptake inhibitors, such as citalopram.

The doctor will decide whether the patient can safely start taking Fevarin.
While taking 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 drinks, 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 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 medicines like Fevarin during pregnancy, especially in the last three months, may increase the risk of severe 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 3 months of pregnancy, the baby may experience symptoms such as difficulty feeding and/or breathing, seizures, temperature instability, low blood sugar, tremors, convulsions, abnormal muscle tone, cyanosis, irritability, 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 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 reduce 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, the patient should be cautious until they know how they react to the medicine.

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

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 disorder:
• 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 disorder - 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.
The patient should 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 disorder.

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 long does it take for Fevarin to 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 the treatment. Even if the patient feels better, the doctor may recommend continuing the treatment for some time, at least 6 months from the time the symptoms disappear.

Taking a higher dose of Fevarin than recommended

In case of an overdose (taking more than the recommended dose), the patient or someone else should immediately consult 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 heart problems (rapid or slow heart rate, low blood pressure), liver problems, 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 Fevarin treatment

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 Fevarin, the doctor will recommend how to gradually reduce the dose, which should minimize the risk of withdrawal symptoms. In most people, the symptoms after stopping Fevarin are mild and disappear on their own. However, in some people, these symptoms may be more severe or last longer.
If the patient experiences any symptoms after stopping the medicine, they should contacttheir doctor.
If withdrawal symptoms occur after stopping the tablets, the doctor may decide to reduce the dose more slowly. If severe withdrawal symptoms occur, the patient should contact their doctor. The doctor may recommend taking the tablets again and reducing the dose 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 is 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 (low 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 (a feeling of euphoria or excessive excitement)
• seizures
• liver problems

• 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
• low sodium levels in the blood (hyponatremia)
• weight gain or loss
• suicidal thoughts
• suicidal behavior
• serotonin syndrome
• symptoms similar to neuroleptic malignant syndrome
• restlessness (akathisia)
• sensory disturbances
• taste disturbances
• glaucoma (increased pressure in the eye)
• pupil dilation
• inability to achieve orgasm (anorgasmia)
• in women: menstrual disorders
• severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2
• 2.
• urinary disorders (such as frequent urination during the day and/or night, urinary 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 peeling of the skin (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").
Occasionally, 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 at the same time, 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
• syndrome of inappropriate antidiuretic hormone secretion (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 on the skin, 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 tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, 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 side effects can help gather more information on the safety of the medicine.

5. How to store Fevarin

• The medicine should be stored out of sight and reach of children.
• Fevarin should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• The medicine should not be stored at temperatures above 25°C.

If the doctor decides to stop the 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. Contents of the packaging and other information

What Fevarin contains

• The active substance of Fevarin is fluvoxamine maleate. Each coated tablet contains 50 mg of fluvoxamine maleate.
• The 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, coated tablet that can be divided into two halves.
The packaging of the medicine contains 20 or 60 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, N.º 44C – 7.3 e 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number:5897681
8610949

Parallel import authorization number: 51/23 Date of leaflet approval: 20.03.2023

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