50 mg and 100 mg film-coated tablets 
fluvoxamine maleate

1. WHAT FEVARIN IS AND WHAT IT IS USED FOR

Fevarin belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). Fevarin contains a substance called fluvoxamine. Fluvoxamine is used to treat depression (periods of major depression).

Fevarin can also be used to treat patients with obsessive-compulsive disorder (OCD).

2. BEFORE YOU USE FEVARIN

Do not use Fevarin if any of the following apply to you:

  • if you are hypersensitive to fluvoxamine or any of the other ingredients of Fevarin (see section 6 “Other Information”).
  • if you are being treated at the same time with a so-called MAO inhibitor which is sometimes prescribed to treat depression or anxiety, including linezolid (an antibiotic that is also an MAO inhibitor ).

Treatment with fluvoxamine should be started at least 2 weeks after stopping treatment with an irreversible MAOI. However, treatment with fluvoxamine may be started the day after stopping treatment with certain reversible MAOIs. In exceptional cases, linezolid (an antibiotic that is also an MAOI ) can be used concomitantly with fluvoxamine provided your doctor closely monitors your treatment. Your doctor will instruct you on how to start taking Fevarin after stopping MAOIs.

  • if you are being treated with tizanidine, a muscle relaxant, at the same time.
  • if you are being treated with pimozide at the same time, a neuroleptic medicine used to treat schizophrenia and other psychiatric disorders.
  • if you are breast-feeding.

If any of the above applies to you, do not take Fevarin and talk to your doctor.

Take special care with Fevarin

Talk to your doctor or pharmacist before taking Fevarin if:

  • you recently had a heart attack
  • you are pregnant or may be pregnant
  • you have epilepsy
  • you have previously had problems with bleeding or if you regularly use medicines that may increase the risk of bleeding such as certain painkillers or if you are pregnant (see “Pregnancy”)
  • you have diabetes
  • you receive electrostimulation therapy (ECT)
  • you have or have had mania (a feeling of excessive optimism or excitement)
  • you have impaired kidney or liver function
  • you have increased pressure in the eyes ( glaucoma )
  • you are younger than 18 years (see section 3 “How to use Fevarin”).

If any of the above applies to you, your doctor will decide if it is appropriate for you to start using Fevarin.

Sometimes symptoms such as restlessness, difficulty sitting, or standing still ( akathisia ) occur or increase during the first weeks of treatment with Fevarin, until the antidepressant effect occurs. If you experience these symptoms, tell your doctor. A dose adjustment can help.

Serious skin reactions have been reported with the use of Fevarin. Stop takingFevarin and contact a doctor immediately if you develop a rash or ulcer on the mucous membrane. The severe rashes may include rashes, which start on the hands, feet, arms, or legs, usually on both sides of the body and develop into circles resembling a target (erythema multiforme), widespread rashes with blisters and flaky skin, mainly occurring around the mouth. , nose, eyes, and genitals ( Stevens-Johnson syndrome ), extensive flaky skin (more than 30% of body surface area – toxic epidermal necrolysis ).

Drugs such as Fevarin (so-called SSRIs ) can cause symptoms of sexual dysfunction(see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Suicidal ideation and worsening of your depression or anxiety disorder

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of drug to take effect, usually about two weeks, but sometimes longer.

You are more likely to get these symptoms:

  • if you have previously thought about harming yourself or committing suicide
  • if you are a younger adult. Results from studies show an increased risk of suicidal behavior in adults younger than 25 years with psychiatric illnesses treated with an antidepressant drug.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think your behavior is changing.

Tell your doctor immediately if you have any worrying thoughts or experiences.

Use in children and adolescents under 18 years of age:

Children and adolescents under 18 years of age should not take this medicine unless they are being treated for obsessive-compulsive disorder (OCD).

The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients younger than 18 years when they take drugs of this type.

Despite this, Fevarin can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are younger than 18 years and want to discuss why you received this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse.

The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents younger than 18 years.

Use of other medicines

  • You should not start treatment with St. John’s wort while you are being treated with Fevarin as it may increase the risk of side effects. If you are already taking St. John’s wort when you start treatment with Fevarin, stop taking St. John’s wort and tell your doctor at your next visit.
  • If you have been taking other medicines for depression or anxiety at any time during the last two weeks or if you have schizophrenia, you should talk to your doctor or pharmacist.

Your doctor or pharmacist will check if you are taking any other medicine for depression or other similar psychotic symptoms, such as:

  • Benzodiazepines
  • Tricyclic antidepressants (TCAs)
  • Neuroleptics or antipsychotic drugs
  • Lithium
  • Tryptophan
  • Monoamine oxidase inhibitors ( MAOIs ) such as moclobemide
  • Pimozide
  • Selective serotonin reuptake inhibitors ( SSRIs ) such as citalopram.

Your doctor will tell you if it is appropriate for you to start using Fevarin.

You should also tell your doctor or pharmacist if you have taken any medicine containing:

  • acetylsalicylic acid used to treat pain and inflammation ( arthritis )
  • ciclosporin, which is used to suppress the activity of the immune system
  • methadone, which is used in the treatment of pain or withdrawal symptoms
  • mexiletine, which is used to treat abnormal heart rhythms
  • phenytoin or carbamazepine used to treat epilepsy
  • propranolol, which is used to treat high blood pressure or heart disease
  • ropinirole, which is used to treat Parkinson’s disease
  • triptans (eg sumatriptan), used in migraine treatment
  • terfenadine, which is used to treat allergies. Fevarin should not be taken with terfenadine.
  • sildenafil, which is used to treat erectile dysfunction
  • theophylline, used in the treatment of asthma and bronchitis
  • tramadol, a painkiller
  • clopidogrel, warfarin, or other medicines used to prevent blood clots.

If you are taking or have recently taken any of the medicines mentioned above and have not already discussed this with your doctor, go back to your doctor to discuss what to do. Dose one may need to be changed or you may need to take another medicine instead.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This also applies to herbal medicines.

Use of Fevarin with food and drink

  • Do not drink alcohol if you are using Fevarin. Alcohol with Fevarin can make you sleepy and unsteady.
  • If you normally drink a lot of tea, coffee, or soft drinks containing caffeine, you may experience symptoms such as tremors, nausea, palpitations, restlessness, and difficulty sleeping. If you reduce your caffeine intake, these symptoms may go away.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Experience with use during pregnancy is limited. Do not take Fevarin if you are or are planning to become pregnant unless your doctor tells you it is necessary.

If you are currently taking fluvoxamine and are planning to become pregnant or are planning to have a baby (this also applies to men), you should consult your doctor to determine if another medicine is necessary or appropriate.

If you take fluvoxamine at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after giving birth, especially if you have had bleeding disorders in the past. Your doctor or midwife should be informed that you are taking fluvoxamine so that they can advise you on this.

Tell your midwife or doctor that you are using Fevarin. When drugs such as Fevarin are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and get bluish skin color. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

You should not stop treatment with Fevarin immediately. If you are taking Fevarin during the last three months of pregnancy, you should tell your doctor because your baby may have postpartum symptoms. These symptoms usually appear within 24 hours after delivery. Symptoms may include difficulty sleeping, difficulty eating, difficulty breathing, bluish skin color or too high or low body temperature, nausea, heavy crying, stiff or limp muscles, lethargy, drowsiness, tremors, anxiety, or seizures. Contact a doctor immediately if your baby has any of these symptoms after delivery.

Breast-feeding

Fluvoxamine passes into breast milk. There is a risk of affecting the child. Therefore, you should discuss with your doctor, and he/she will decide whether to stop breastfeeding or stop taking fluvoxamine

In animal studies, fluvoxamine has been shown to reduce sperm quality. In theory, this could affect fertility, but no such reducing effect of fluvoxamine on fertility has yet been demonstrated in humans.

Driving and using machines

Fevarin may cause drowsiness in some people. Caution should be exercised at times when sharpened attention is required, such as when driving and other precision work until you know how you react to the treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fevarin contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. HOW TO USE FEVARIN

How much Fevarin should you take?

Always follow your doctor’s prescription and the instructions on the pharmacy label. Ask your doctor or pharmacist if you are unsure.

The usual starting dose for adults (over 18 years):

When treating depression:

  • The usual starting dose is 50 mg or 100 mg daily until the evening.

In the treatment of the obsessive-compulsive disorder (OCD):

  • The usual starting dose is 50 mg daily, preferably in the evening.

Talk to your doctor if you do not start to feel better within a couple of weeks. He or she may advise you to increase the dose gradually.

The maximum recommended daily dose is 300 mg.

If your doctor prescribes a dose above 150 mg daily, do not take the full dose at one time. Ask your doctor how to take it.

The usual dose for children and adolescents (over 8 years) with obsessive-compulsive disorder (OCD):

  • Start with 25 mg (half a tablet) daily, preferably taken at bedtime. Your doctor may increase your dose every 4 to 7 days by 25 mg at a time until an effective dose is found.
  • The maximum recommended daily dose is 200 mg.

If your doctor prescribes a dose above 50 mg per day, do not take the full dose at one time. Ask your doctor how to take it. If the two doses are different sizes, the highest dose should be taken at bedtime.

Children and adolescents under 18 years of age should not use this medicine to treat depression. For children and adolescents, Fevarin should only be prescribed for obsessive-compulsive disorder (OCD).

How to use Fevarin

  • Swallow the tablets with water. Do not chew the tablets.

You can split the tablets if your doctor tells you to.

How long does it take before Fevarin works?

It may take some time before the effect of the treatment comes. Some patients do not feel any improvement until after 2-3 weeks.

Continue treatment until your doctor tells you to stop. Even if you feel better, your doctor may recommend that you continue to take Fevarin for a period of time, at least 6 months, to make sure that the treatment has worked completely.

Do not stop treatment abruptly as you may experience withdrawal symptoms such as:

  • anxiety and worry
  • confusion
  • diarrhea
  • difficulty sleeping / intense dreams
  • dizziness
  • emotional instability
  • headache
  • irritability
  • nausea and/or vomiting
  • palpitation
  • sensory and visual disturbances
  • sweating
  • shaking.

When you stop taking Fevarin, your doctor will help you reduce the dose gradually over a few weeks or months, this reduces the risk of withdrawal symptoms. Most people experience that the withdrawal symptoms are mild and disappear within two weeks. However, some people experience the symptoms as worse, and that they last for a longer period of time.

If you experience problems with withdrawal symptoms, your doctor may advise you to reduce the dose a little slower, which usually reduces the risk of withdrawal symptoms. Contact a doctor if you experience severe withdrawal symptoms after stopping treatment. Your doctor may ask you to start taking the tablets again and then reduce the dose slowly (see section 4 “Possible side effects”).

If you get any symptoms when you stop your treatment, contact your doctor.

If you use more Fevarin than you should

If you or anyone else has ingested too much (an overdose) of Fevarin, contact your doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the medicine pack to the hospital.

Symptoms of overdose include nausea, vomiting, diarrhea, drowsiness, dizziness. Impact on the heart (slow or fast heartbeat, low blood pressure ), liver problems, seizures, and coma have also been reported.

If you forget to use Fevarin

If you forget a tablet, wait until the next dose. Do not try to compensate for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fevarin can cause side effects, although not everybody gets them.

The frequencies of the observed side effects are defined as follows:

Very common Occurs in more than 1 in 10 users
Common Occurs in 1 to 10 out of 100 users
Less common Occurs in 1 to 10 out of 1000 users
Rare Occurs in 1 to 10 out of 10,000 users
Very rare Occurs in less than 1 in 10,000 users
No known frequency The frequency cannot be calculated from the available data

Side effects are related to the drug group

Sometimes thoughts of suicide or self-harm occur during the first weeks of treatment with Fevarin until the antidepressant effect comes.

Tell your doctor immediately if you have any worrying thoughts or experiences.

If you experience several symptoms/side effects at the same time, you may have had one of the following rare conditions:

  • Serotonergic syndrome: If you have sweating, muscle stiffness or muscle cramps, impaired coordination, confusion, irritability, or excessive anxiety
  • Malignant neuroleptic syndrome: if you have muscle stiffness, high fever, confusion, and other related symptoms
  • SIADH: If you feel tired, weak, or confused and have aching, stiff, or uncontrollable muscles.
  • Severe skin reactions such as severe skin rash or redness, including rashes, which start on the hands, feet, arms, or legs, usually on both sides of the body and develop into circles resembling a target (erythema multiforme), widespread rashes with blisters and flaky skin, mainly occurring around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), extensive flaky skin (more than 30% of body surface area – toxic epidermal necrolysis ). The frequency of these side effects is unknown (cannot be calculated from the available data).

Stop taking Fevarin and contact your doctor immediately.

If you get an unusual amount of bruising on your body or if you vomit blood or have blood in your stool, contact your doctor for advice.

Discontinuation of treatment with Fevarin (especially if it occurs rapidly) usually leads to withdrawal symptoms (see section 3 “How to use Fevarin”).

Sometimes patients experience nausea at the beginning of treatment with Fevarin. Although this is uncomfortable, it should pass if you continue to take your tablets as recommended by your doctor. It may take a few weeks.

Side effects are related to Fevarin

Common side effects:

  • concern
  • anxiety
  • constipation
  • diarrhea
  • difficulty sleeping
  • dizziness
  • dry mouth
  • palpitation
  • somnolence
  • feeling sick
  • headache
  • indigestion
  • loss of appetite
  • nervousness
  • abdominal pain
  • sweating
  • shaking
  • muscle weakness
  • vomiting.

Uncommon side effects:

  • hypersensitivity reaction in the skin (eg swelling of the face, lips or tongue, rash or itching )
  • confusion
  • delayed ejaculation
  • drop in blood pressure when standing
  • hallucinations
  • difficulty controlling muscle movements
  • joint or muscle pain aggression.

Rare side effects:

  • cramps
  • liver effects
  • mania (a feeling of excessive optimism or excitement)
  • sensitivity to sunlight
  • milk flow from the breast.

Has been reported (occurs in an unknown number of users) :

  • restlessness
  • taste changes
  • inability to reach orgasm
  • for female patients: menstrual disorders
  • severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy” in section 2 for more information
  • urinary incontinence (eg a need to urinate frequently during the day and/or night. Urination that is sudden and uncontrollable during the day and/or night or an inability to urinate)
  • tingling or numbness
  • glaucoma (increased pressure in the eye)
  • dilated pupil is
  • increase in the hormone et prolactin (a hormone that supports milk production in the breastfeeding woman)
  • weight changes.

An increased risk of bone fractures has been seen in patients taking this type of drug.

Side effects are related to the treatment of obsessive-compulsive disorder in children and adolescents (no known frequency):

  • hypomania (a feeling of excessive optimism or excitement)
  • concern
  • cramps
  • difficulty sleeping
  • impotence
  • hyperactivity
  • somnolence
  • indigestion.

5. HOW TO STORE FEVARIN

  • Keep out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
  • Do not store above 25 ° C.

If your doctor stops treatment, return all unused tablets to the pharmacy.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Content declaration

The active substance is fluvoxamine maleate. Each tablet contains 50 and 100 mg of fluvoxamine maleate, respectively.

The other ingredients are mannitol (E421), corn starch, pregelatinized starch, sodium stearyl fumarate, anhydrous colloidal silica, hypromellose, macrogol 6000, talc, and titanium dioxide (dye E171).

What the medicine looks like and the contents of the pack

Fevarin 50 mg: Round, biconvex, scored, white to off-white film-coated tablet debossed with ‘291’ on both sides of the score.

Fevarin 100 mg: Oval, biconvex, scored, white to off-white film-coated tablet debossed with ‘313’ on both sides of the score.

Fevarin is available in the following pack sizes:

50 mg film-coated tablets: 5, 10, 20, 30, 50, 60, 90, 100 and 250 tablets

100 mg film-coated tablets: 15, 20, 30, 50, 60, 90, 100, 120 and 250 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

BGP Products AB

Box 23033

104 35 Stockholm

Manufacturer:

Mylan Laboratories SAS

Belleville Route

Lieu dit Maillard

01400 Châtillon-sur-Chalaronne

France

This medicinal product is authorized under the European Economic Area under the names:
Austria Floxyfral
Belgium Floxyfral
France Floxyfral
Germany Fevarin
Greece Dumyrox
Ireland Faverin
Italy Dumirox
Luxembourg Floxyfral
Norway Fevarin
Portugal Dumyrox
Spain Dumirox
Netherlands Fevarin
UK Faverin

Muhammad Nadeem

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