Revoxin Film Tablet

Revoxin is included in the group of drugs called selective serotonin reuptake inhibitors (SSRI).

Revoxin increase the effect of serotonin, a substance called serotonin, whose deficiency causes disorders such as depression and obsessive-compulsive disorder (OCD) (excessive rigor, desire for control, and often meaningless and repetitive behaviors to expel these thoughts from the mind). Revoxin contains a substance called fluvoksamine. It’s an antidepressant. It is used to treat depression (major depressive disorder – a state of grief that impairs social abilities). Revoxin is also used in the treatment of OCD.

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Description

Revoxin 100 mg film tablet 

It is applied through the oral tract.

  • Active item: Each film tablet contains 100 mg of fluvoxamine maleate.
  • Auxiliary substances: Mannitol, corn starch, prejelatinized starch, sodium stearil fumarate, colloidal silicon dioxide, methyl hydroxyropyl cellulose, polyethylene glycol 6000, talc, titanium dioxide.
ATC Public No. Equivalent Code Type Unit Quantity Packing Production Location License Tar. License No.
N06AB08 A10950 E429A Twenty Years 100 MG 30 manufactured 2009-02-13 218/27
World Health Organization (WHO)
Essential Medicine Children’s Basic Medicine Neonatal Essential Medicine
Not on the List Not on the List Not on the List

Revoxin 100 mg Tablets To consider before using

Situations that should not be used

  • If you are allergic to fluvoksamine or any other component of the drug (if you have hypersensitivity).
  • If you are taking or taking drugs called monoamine oxidase inhibitors (MAOI), a group of drugs used to treat depression and anxiety (internal distress), or if you have taken these drugs in the last two weeks. When you stop taking MAOI, your doctor will tell you how and when to start Revoxin.
  • If you’re breastfeeding.
  • If you are taking treizanidine, a drug usually used as a muscle relaxant.

 

If any of the above applies to you, do not use Revoxin and consult your doctor.

Situations that need to be used with caution

“The use of antidepressant drugs in children and young people up to the age of 24 is likely to increase suicidal thoughts or behaviors. Therefore, especially in the beginning and first months of treatment, it is necessary to closely monitor the patient’s family and therapeutics for reasons such as restlessness, excessive mobility or the possibility of suicide during the periods of increase/decrease or discontima of the drug dose.”

If any of the following applies to you, consult your doctor or pharmacist before using the drug.

  • If you’ve had a heart attack recently
  • If you’re pregnant or there’s a chance you’re pregnant
  • If you have epilepsy
  • If you have experienced bleeding problems in the past or regularly use medications (e.g. painkillers) that increase the risk of bleeding
  • If you have diabetes
  • If you are being treated with electroconvulsive therapy
  • If you have a mania story defined as excessive enthusiasm or a feeling of excitement
  • If you have liver or kidney problems
  • If you have high eye pressure (glaucoma)
  • if you are under 18 years of age (see also section 3)

 

If any of the above applies to you, your doctor will tell you if it is safe to start using Revoxin .

In the first weeks of treatment with Revoxin , until antidepressant action is seen, sometimes a feeling of restlessness (atatimate), such as not being able to sit or stand, may occur or increase. When such symptoms appear, consult your doctor immediately. In this case, it may be useful to make a dose adjustment.®

Suicidal thoughts and worsening of depression or anxiety disorder

You can tell a relative or close friend that you are depressed or have anxiety disorders and you can ask them to read this instruction to use it. When they think your depression or anxiety disorder is worsening or they’re worried about changes in your behavior, you can ask them to tell you.

If you are depressed and/or have anxiety disorder, sometimes thoughts of self-harm or suicide may occur. This condition can increase when antidepressant drugs are first used, since the duration of action of these drugs is usually two weeks and sometimes longer.

You are more likely to experience the idea of suicide or self-harm in the following cases:

  • If you have had suicidal or self-harm thoughts in the past
  • Information from clinical trials shows a higher risk of suicide-related behavior in adults under the age of 25 who are treated with antidepressants and have psychiatric problems.

 

If at any time the thought of self-harm or suicide occurs, consult your doctor immediately or go to the nearest hospital.

If you experience distressing thoughts or feelings, consult your doctor immediately.

Use in children and adolescents under the age of 18:

Revoxin should not be used in the treatment of adolescents and children under the age of 18, except for obsessive-compulsive disorder. Because REVOXIN is not used to treat depression in people under the age of 18. When under-18s take this type of drug, they are at increased risk of side effects such as suicide attempts and thoughts, aggression, anger, conflict.®®

In addition, it is not known whether using Revoxin under the age of 18 affects growth, maturation or development of intelligence or behavior in the long term.

If these warnings apply to you, even in any past period, please consult your doctor.

Vehicle and machine use

You can use a tool or machine when using Revoxin unless you feel sleepy.

Important information about some of the auxiliary substances contained in Revoxin

  • This product contains less than 1 mmol (23 mg) of sodium per dose. No adverse effects due to sodium are expected.

Use in combination with other drugs

  • Do not start a herbal drug called St. John’s Wort (yellow cantaron) when using Revoxin , as there may be an increase in undesirable effects. If you started Revoxin while buying St. John’s Wort, stop taking St. John’s Wort and tell your doctor the next time you check in.®®
  • If you have used medication to treat depression or anxiety in the last two weeks or have schizophrenia, consult your doctor or pharmacist

 

Selective Serotonin Reuptaxer (SSRI), Selective Serotonin /Norepinephrine Reuptaxer (SNRI) group drugs may cause serotonergic syndrome (excessive serotonin efficacy) in those with migraine headaches, 5-Hydroxydrotamine receptor agonistitis (a drug used for migraine).

Your doctor or pharmacist will check if you are taking other medications for the treatment of depression or related conditions, these drugs are:

  • Benzodiazepines
  • Tricyclic antidepressants
  • Neuroleptics or anti-psychotics
  • Lithium
  • Tryptophan
  • Monoamine oxidase inhibitors such as moclobemide (used to treat depression)
  • Selective serotonin reuptake inhibitors such as Sitalopram (SSRI) (used to treat disorders such as depression, OCD and panic attacks)

 

Your doctor will tell you if it is safe for you to start Revoxin treatment.®

Also, if you are taking any of the following medications, tell your doctor or pharmacist that your dose may need to be changed or you may need to be given a different medication:

  • Aspirin (acetylsalicylic acid) or aspirin-like drugs used to treat pain and arthritis (arthritis)
  • Cyclosporin, a drug that reduces the activity of the immune system
  • Methadone used to treat pain and signs of amputation
  • Memseletin used to treat abnormal heart rhythm
  • Phenytoin or carbamazepine used to treat epilepsy
  • Propranolol used to treat high blood pressure and heart disease
  • Ropinirol used to treat Parkinson’s disease
  • Group of ‘triptan’ drugs used to treat migraines, e.g. sumatriptan
  • Terfenadine used to treat allergies
  • Theophyll used to treat asthma and bronchitis
  • Tramadol, a painkiller
  • Warfarin, nicoomalon or any other drug used to prevent blood clotting

If you are currently using any prescription or over-the-counter medication or have used it recently, please inform your doctor or pharmacist about them.

Food and beverage interactions

(Open/Full/Alcohol use cases)

  • Do not drink alcohol while using Revoxin . Because alcohol increases the effect of the drug, making you feel sleepy and unstable.
  • Normally, if you consume too much soft drinks containing tea, coffee and caffeine, symptoms such as hand tremors, nausea, rapid heartbeat (palpitations), restlessness and difficulty sleeping can occur when you take Revoxin . These symptoms may disappear when you reduce caffeine intake.

How to Use Revoxin 100 mg Tablet?

Tablets should be taken with a sufficient amount of water, without chewing.

Always use Revoxin as your doctor tells you to do. If you are not sure how to use it, consult your doctor or pharmacist.

Normal starting dose for adults (18 years and older):

In the treatment of depression:

  • Initially, 50 mg or 100 mg of REVOXIN per day is taken in the evening.

 

In the treatment of obsessive-compulsive disorder:

  • Initially, 50 mg of REVOXIN per day is preferably taken in the evening.

 

If you do not start to feel good after using the drug for several weeks, consult your doctor. Your doctor may decide to gradually increase your dose.

The recommended maximum daily dose is 300 mg.

If your doctor tells you to take more than 150 mg per day, do not take the entire dose at once; ask your doctor how to get it.

Revoxin may take some time to take effect. In some patients, this period may be 2 or 3 weeks.

Do not stop taking the drug until your doctor tells you. Even if you start to feel better, your doctor may ask you to continue with the drug for a long time; you may need to continue treatment for at least 6 months to ensure that the drug is fully effective.

 

Use in Children and Infants

Normal dose in the treatment of obsessive-compulsive disorder (OCD) for children and adolescents aged 8 years and older:

It starts with 25 mg per day. Until the effective dose is reached, your doctor can increase your dose in increases of 25 mg every 4-7 days to the extent that it is tolerated. The highest daily dose is 200 mg.

If your doctor tells you to take more than 50 mg of doses per day, do not take the entire dose at once; ask your doctor how to get it. If the dose is not evenly divided, take the larger one before bedtime.

Adolescents and children under the age of 18 should not use this drug for the treatment of depression. This drug should only be given to children or adolescents for the treatment of obsessive-compulsive disorder (OCD).

Use in The Elderly

The data obtained in the elderly do not indicate significant clinical differences in normal daily doses compared to young patients. Nevertheless, the transition to high doses in the elderly should be slower, and dosing should always be done carefully.

Exceptions

Liver and kidney failure

If you have liver or kidney failure, please inform your doctor. Your doctor will adjust the dose of your treatment.

Infrequently, during Revoxin treatment, liver enzyme levels may increase, often accompanied by some complaints. In such cases, your doctor may decide to discontent treatment.

Overdose and Treatment

If you have used more than you should use revoxin, talk to a doctor or pharmacist.

If you or someone else takes too much Revoxin (overdose), contact your doctor immediately or the nearest hospital with the drug.

Symptoms of overdose include, but are not limited to, nausea, vomiting, diarrhoea and feeling sleepy or dizziness. Heart-related symptoms (slow or rapid heart rate, low blood pressure), liver problems, remit (seizures) and coma were also reported.

If You Forget to Use:

If you forget to take the tablet, wait for the next dose time.

Do not take double doses to balance forgotten doses.

Effects that may occur when treatment with Revoxin is terminated®

Do not abruptly discontize treatment. The following symptoms of interruption may appear:

  • Restlessness and anxiety (internal distress)
  • Confusion
  • Diarrhea
  • Difficulty sleeping
  • Dizziness
  • Emotional imbalance
  • Ligament pain
  • Irritability
  • Nausea and/or vomiting
  • Palpitations (increase in heart rate)
  • Sensory impairment (electric shock sensation or visual impairments)
  • Perspiration
  • Dithering

 

When you quit Revoxin , your doctor will tell you to gradually reduce your dose within a few weeks or months to reduce the likelihood of cutting effects. In most patients, the symptoms seen with the release of Revoxin are mild and disappear spontaneously within two weeks. In some patients, these symptoms may be more severe or may last longer.®®

If you see signs of discontivation when discontine treatment, your doctor may tell you to stop the drug more slowly. If you see signs of severe interruption when you quit Revoxin , consult your doctor. Your doctor may tell you to start the drug again and quit more slowly this time (see section 4).®

If any symptoms appear when you stop treatment, consult your doctor.

Follow these instructions unless your doctor makes a separate recommendation.

If you have an impression that the effect of Revoxin is too strong or too weak, talk to your doctor or pharmacist.®

If you have any further questions regarding the use of this drug, consult your doctor or pharmacist.

Pregnancy

Consult your doctor or pharmacist before using the drug.

Experience with revoxin’s use during pregnancy is limited. Do not use Revoxin during pregnancy unless absolutely necessary by your doctor. If you are already using Revoxin and plan to have children, consult your doctor to decide whether another treatment is necessary or appropriate.®®®

Studies on animals have shown that fluvoksaminin reduces sperm quality. Theoretically, this could affect fertility, but its effect on fertility in humans has not yet been observed.

Make sure your doctor knows you are taking Revoxin . In pregnancy, especially when taken in the last 3 months of pregnancy, drugs such as Revoxin can increase the risk of a serious condition called resistant lung hypertension in newborn babies, which causes faster breathing and bluish appearance on the skin. These symptoms usually begin to appear within the first 24 hours after the baby is born. If this type of condition occurs in your baby, consult your doctor immediately.

Do not abruptly discontize Revoxin treatment. If you are taking Revoxin in the last 3 months of pregnancy, when your baby is born, there may be difficulty breathing or bluish appearance on the skin, as well as other symptoms such as difficulty sleeping or feeding, body temperature being too high or too low, vomiting, constant crying, stiffness or slackness in the muscles, lethargy, sleepiness, tremors, irritability or seizures. If any of these symptoms occur when your baby is born, consult your doctor immediately.

If you find out that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding

Consult your doctor or pharmacist before using the drug.

Revoxin passes into breast milk. There is a risk of it affecting your baby. Therefore, you should talk to your doctor about the issue, and your doctor will decide whether to stop breastfeeding or your treatment with Revoxin .

Side Effects

Like all drugs, there may be side effects in people who are sensitive to the substances contained in Revoxin .

The frequency of observed side effects is defined as follows:

very common

occurs in more than 1 in 10 people

prevalent

occurs in 1-10 people in 100 people

unsym pervasive

occurs in 1-10 people per 1000 people

rare

occurs in 1-10 people per 10000 people

very rarely

less than 1 person per 10,000 people

unknown

The frequency of the available data cannot be estimated.

Side effects associated with this group of drugs

In the first weeks of treatment with Revoxin , sometimes thoughts of suicide or self-harm may occur or increase until antidepressant action is seen.

If you experience distressing thoughts or feelings, report them to your doctor immediately.

If you have many complaints at the same time, you may be experiencing one of the following rare conditions:

  • Serotonin syndrome (excessive serotonin efficacy): If you are sweating, if your muscles have hardening or contraction, if you feel imbalance, confusion, irritability or excessive restlessness.
  • Neuroleptic malignant syndrome (reaction to drugs affecting the nervous system): If you have hardening of your muscles, high fever, confusion and other related complaints.
  • SIADH (irregular release of the hormone that prevents urination in the body): If you feel fatigue, weakness or confusion, and your muscles have pain, stiffness or uncontrollability.

Stop using Revoxin and consult your doctor immediately.

If you experience unusual bruising or purple spots on your skin, vomit blood, or see blood in your feces, consult your doctor.

Cutting the use of Revoxin , especially abruptly, leads to signs of discontition in general (see section 3, ‘Effects that may occur when treatment with Revoxin is terminated’).

As Revoxin begins to take effect, sometimes patients feel a little nauseous. The feeling of nausea will soon go away if you continue to take your tablets as prescribed to you. It could take a few weeks to get through.®

Common side effects, especially those associated with Revoxin

  • Unrest
  • Anxiety (internal distress)
  • Constipation
  • Diarrhea
  • Difficulty sleeping
  • Dizziness
  • Dry mouth
  • Acceleration in heartbeat
  • Feeling sleepy
  • Feeling bad (discomfort)
  • Headache
  • Indigestion
  • Loss of appetite
  • Irritability
  • Stomachache
  • Perspiration
  • Dithering
  • Muscle weakness
  • Vomiting

 

Unsym pervasive side effects

  • Allergic skin reactions (swelling, rash, itching on the face, lips or tongue)
  • Confusion
  • Ejaculation delay (late ejaculation)
  • Dizziness felt when standing up too fast
  • Hallucination (imagination)
  • Lack of coordination
  • Muscle or joint pain

 

Sparse side effects:

  • Convulsion (involuntary contraction of muscles)
  • Liver complaints
  • Mania (feeling of extreme enthusiasm or excitement)
  • Sensitivity to sunlight
  • Unexpected milk coming from the chest

 

Other side effects reported:

  • Akatizi (inability to stand still)
  • Impairment in taste
  • Not being able to orgasm
  • Menstrual irregularity
  • Urination disorders (such as the need to urinate frequently during the day and/or at night, incontinence or inability to urinate)
  • Paresthesia (tingling or numbness)
  • Enlargement of the pupil
  • Increase in the hormone prolactin (a hormone that provides milk production in breastfeeding women)
  • Weight change

 

An increased risk of bone fractures was observed in patients using drugs in this group.

Side effects associated with and unpovoced in the treatment of OCD (obsessive-compulsive disorder) in children and adolescents:

  • Mania (feeling of extreme enthusiasm or excitement)
  • Unrest
  • Convulsion (involuntary contraction of muscles)
  • Difficulty sleeping
  • Lack of energy
  • Hyperactivity (motion increase)
  • Feeling sleepy
  • Indigestion

 

If any of the side effects become serious, inform your doctor or pharmacist.

If you experience any side effects not mentioned in this instructions for use, inform your doctor or pharmacist.

Store Conidtion

Store Revoxin in places and packaging that children cannot see or access.

Store at room temperature below 25°C and in its original packaging.

Use in accordance with the expiration date.

Revoxin after the expiration date on the packaging do not use .

Do not use Revoxin if you notice defects in the product and/or packaging.

Licensee

Recordati Pharmaceuticals Inc. and Tic. Inc.

Dogan Araslı Cad. No:219 34510 Esenyurt/Istanbul

Producer

Recordati Pharmaceuticals Inc. and Tic. Inc.

Dogan Araslı Cad. No:219 34510 Esenyurt/Istanbul

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Additional information

Dosage form

Pack size

Potency

100 Mg

Manufacturer

Origin

Generic Name (Ingredient)

Each Film Tablet; 100 Mg Fluvoxamine Maleate As Active Ingredient And Mannitol (E 421) As Adjuvant And Titanium Dioxide (E 171) As Dyestuff.

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The information on this page is not intended to be a substitute for professional medical advice, diagnosis, or treatment. always seek the advice for your physician or another qualified health provider with any questions you may have regarding a medical condition. Always remember to

  1. Ask your own doctor for medical advice.
  2. Names, brands, and dosage may differ between countries.
  3. When not feeling well, or experiencing side effects always contact your own doctor.

Cyberchondria

The truth is that when we’re sick, or worried about getting sick, the internet won’t help.

According to Wikipedia, cyberchondria is a mental disorder consisting in the desire to independently make a diagnosis based on the symptoms of diseases described on Internet sites.

Why you can't look for symptoms on the Internet

If diagnoses could be made simply from a textbook or an article on a website, we would all be doctors and treat ourselves. Nothing can replace the experience and knowledge of specially trained people. As in any field, in medicine there are unscrupulous specialists, differences of opinion, inaccurate diagnoses and incorrect test results.

UNDER NO CIRCUMSTANCES PLEASE DO NOT USE THE INTERNET TO DIAGNOSE ANY KIND OF HEALTH-RELATED PROBLEMS OR DISEASES!