Fevarin

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Fevarin (Fluvoxamine maleate Mylan)
100 mg, film-coated tablets
Fluvoxamini maleas
Fevarin and Fluvoxamine maleate Mylan are different trade names for the same medicine.
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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 called selective serotonin reuptake inhibitors (SSRIs). Fevarin contains the active substance fluvoxamine. It is an antidepressant medicine used to treat depression (major depressive episodes).
Fevarin may also be used to treat patients with obsessive-compulsive disorder, characterised by symptoms such as recurrent intrusive thoughts, images, or compulsive behaviours (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). Your doctor will advise when it is safe 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, do not take Fevarin,
but contact your doctor.
Warnings and precautions
Before starting to take Fevarin, consult your 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 over-the-counter 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 together with Fevarin may lead to serotonin syndrome—a potentially life-threatening condition (symptoms are described in section 4 "Possible side effects"), see also "Fevarin with other medicines".

If any of the above apply, your 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 your doctor immediately. These serious 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); widespread blistering rash with skin peeling, particularly affecting areas around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome); extensive skin peeling (affecting more than 30% of body surface area— 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 stopping treatment.
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts about self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to start working.
The risk of suicidal thoughts or self-harm is higher if:

• the patient has previously had suicidal thoughts or self-harm tendencies
• 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 antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, seek medical help 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 support and ask them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behaviour.
Contact your doctor immediately if any troubling 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 in 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 Fevarin in children and adolescents regarding growth, puberty, and cognitive and behavioural development.
If your doctor has prescribed Fevarin for a patient under 18 years of age and you have any concerns, please consult your doctor. Inform your doctor 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 or worsen before the antidepressant effect develops, e.g. the patient is unable to sit or stand still (akathisia). If such symptoms occur, contact your 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 your doctor immediately.
Alcohol should be avoided while taking Fevarin.
Fevarin with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take.
Inform your doctor or pharmacist if you are 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 to treat 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 you are currently taking or have recently taken any of the above medicines and have not informed your doctor, contact them to find out what to do.
Your dose or the medicine itself may need to be adjusted.
If you have taken antidepressants or medicines for anxiety or schizophrenia within the last two weeks, contact your doctor or pharmacist.
Your doctor or pharmacist will check whether you are taking other medicines for depression or related conditions, such as:

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

Your doctor will advise whether it is safe to start taking Fevarin.
Do not start taking herbal remedies containing St. John's wort extract while taking Fevarin, as this may worsen side effects. If you are currently taking St. John's wort when starting treatment with Fevarin, stop taking St. John's wort and inform your doctor at your next visit.
Fevarin with food, drink and alcohol

• Do not consume alcohol while taking Fevarin.
• Patients who usually consume large amounts of tea, coffee or other 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 your doctor or pharmacist before taking any medicine.
Pregnancy
Do not take fluvoxamine during pregnancy unless your doctor decides it is absolutely necessary. If you are currently taking fluvoxamine and planning a pregnancy, or if you are planning to become a father, consult your doctor to determine whether a change of treatment is needed.
Taking Fevarin in late pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If you are taking Fevarin, inform your doctor or midwife so they can provide appropriate advice.
Inform your 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 of the newborn (PPHN). This condition is characterised by rapid breathing and cyanosis (bluish skin), and usually occurs within the first day after birth. If these symptoms occur in the newborn, contact your doctor and/or midwife immediately.
If you have taken fluvoxamine during the last three months of pregnancy, the newborn may experience additional symptoms after birth, including rapid breathing and cyanosis, as well 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 your doctor immediately.
Breastfeeding
Fluvoxamine is excreted in small amounts in breast milk; therefore, the medicine should not be used in breastfeeding women. Consult your doctor, who will decide whether to discontinue breastfeeding or stop taking fluvoxamine.
Fertility
Animal studies have shown that fluvoxamine reduces sperm quality. This could theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and using machines
In studies in 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 treatment with fluvoxamine, exercise caution until your individual response to the medicine is known.
Fevarin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to use Fevarin

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

• For the treatment of depression: Start with 50 or 100 mg once daily, taken in the evening.
• For the 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 the treatment of obsessive-compulsive disorder (OCD): Start with 25 mg (half of a 50 mg Fevarin tablet) 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 doses are not equal, the larger part should be taken in the evening.

Fevarin should not be used 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
Fevarin tablets should be swallowed whole with water, without chewing.
Tablets may be divided in half if so directed 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.
The medication should be taken for as long as your doctor recommends. Even if symptoms improve, your doctor may advise continuing treatment for a certain period, at least 6 months after symptoms have resolved.
Taking more than the recommended dose of Fevarin
If a patient or another person takes more than the recommended dose (overdose), seek immediate medical advice or go to the nearest hospital. Bring the medication packaging with you.
Overdose of Fevarin may cause gastrointestinal symptoms (nausea, vomiting, diarrhoea), drowsiness, and dizziness. Cardiac events have also been reported (such as increased or decreased heart rate, low blood pressure), as well as liver function disturbances, seizures, and coma.
Missed dose of Fevarin
If a dose is missed, wait until the next scheduled dose. Do not take a double dose to make up for the 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 dose more slowly. If severe withdrawal symptoms occur, contact your doctor. Your doctor may recommend restarting 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 all medicines, 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
• Dyspepsia
• 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 (impaired) ejaculation

Rare adverse reactions

• Mania (feeling of euphoria or excessive excitement)
• Seizures
• Liver function abnormalities
• Photophobia (light sensitivity)
• Unexpected milk leakage from breasts (galactorrhea)

Adverse reactions with unknown frequency

• Gastrointestinal bleeding, gynecological bleeding, petechiae, purpura
• Increased prolactin hormone levels (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 plasma (hyponatremia)
• Increased or decreased 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 effects on fertility" in section 2
• Urinary disorders (such as frequent urination during day and/or night, daytime and/or nighttime urinary incontinence, and inability to urinate)
• Severe skin reactions, such as severe skin 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, especially 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-harm ideation may occasionally occur or worsen during the first few weeks of treatment with Fevarin, until the antidepressant effect begins.
You should contact your doctor immediately if any such thoughts occur.
If several symptoms occur together, this may indicate one of the following rare conditions:

• Serotonin syndrome: if sweating, muscle rigidity or spasms, loss of coordination, confusion, irritability or extreme agitation occur
• Neuroleptic malignant syndrome: if muscle rigidity, high fever, confusion or other similar symptoms occur
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH): if fatigue, weakness or confusion occur, along with pain, stiffness or loss of muscle control.

You should 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 not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 181 C, 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 gather more information on the safety of the medicine.

5. How to store the medicine Fevarin

Keep the medicine out of sight and reach of children.
Do not use Fevarin after the expiry date stated on the packaging.
Store below 25°C. Keep in the original packaging.
If your doctor decides to discontinue treatment, any unused tablets should be returned to the
pharmacy.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Fevarin contains

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

What Fevarin looks like and contents of the pack
Fevarin 100 mg is a white or almost white, oval, biconvex coated tablet that can be divided into two equal parts. The pack contains 30 coated tablets.

For further information, contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
The Netherlands

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

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

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

Netherlands marketing authorisation number, country of export: RVG 29190
Parallel import authorisation number: 143/20