FEVARIN. 50 mg. 30 tablets
FEVARIN. 50 mg. 30 tablets
WHAT FEVARIN 50 mg / FEVARIN 100 MG AND WHAT IT IS USED
Pharmacotherapeutic group: antidepressants, selective inhibitor of serotonin reuptake . Fevarin is a medicine for treatment periods of depression and obsessive -compulsive disorders.
How does fevarin 50 mg / 100 mg Fevarin ?
Fevarin acts selectively on serotonin - a chemical in the brain that regulates mood and activity . It belongs to the group of so-called SSRI ( SSRI ) drugs that selectively retain the reuptake of serotonin in brain neurons . With increased concentration of serotonin , symptoms of depression and obsessive compulsive disorder subside .
The product can be taken with food.
Fevarin pharmacokinetics are similar in healthy adults , the elderly and patients with renal insufficiency. Fevarin metabolism is impaired in patients with liver disease.
Steady state plasma concentrations of fevarin are two times higher in children ( 6-11 years of age) compared to adolescents ( 12-17 years) . Plasma concentrations in adolescents are similar to those in adults .
2 . BEFORE YOU TAKE FEVARIN 50 MG / 100 MG FEVARIN
Do not take Fevarin 50 mg / 100 mg Fevarin if:
• you are allergic (hypersensitive) to fluvoxamine maleate or any of the ingredients of Fevarin !
• take fevarin tablets in combination with tizanidine and monoamine oxidase inhibitors ( MAOIs)
Fevarin treatment can be initiated :
two weeks after discontinuation of an irreversible MAOI or the day after discontinuation of a reversible MAOI ( eg moclobemide).
We need to go at least one week between discontinuation of Fevarin and initiation of therapy with an MAOI .
Special precautions for use of Fevarin 50 mg / 100 mg fevarin
Depression is associated with an increased risk of suicidal thoughts , suicide attempts and suicide. The risk exists to achieve significant remission. Clinical experience has shown that the risk of suicidal behavior is highest early in the disease and may increase again in the early stages of recovery. Therefore patients should be monitored closely , especially at the beginning of antidepressant treatment or at any time during dose adjustments to the establishment of improvement.
Obsessive - compulsive disorder ( OCD ) may also be associated with an increased risk of suicide . Therefore, these patients should follow the same precautions.
Patients with a history of suicide-related events and those exhibiting a significant degree of suicidal ideation prior to commencement of treatment , may be at higher risk of suicidal thoughts or suicide attempts . Patients (and caregivers ) should be informed about the need to monitor in order to establish the occurrence of suicidal behavior, and immediately seek medical advice in case of such symptoms.
Fevarin should not be used to treat children and adolescents under the age of 18 years except for patients with obsessive- compulsive disorder ( OCD ) . Suicide-related behaviors ( suicide attempt and suicidal thoughts ), and hostility (predominantly aggression, resistance and anger) were more frequently observed in clinical trials with children and adolescents treated with antidepressants compared to those treated with placebo. When deciding on treatment based on clinical need , the patient should be carefully monitored for the appearance of suicidal symptoms .
In addition , there are no long-term safety data in children and adolescents concerning growth, maturation and development of cognitive behavior.
Have liver or kidney failure patients should commence treatment with a low dose and be carefully monitored .
Treatment with fevarin rarely been associated with an increase in liver enzymes, normally accompanied by clinical symptoms . Treatment in such cases should be discontinued . Glycemic control may be impaired , especially in the early phases of treatment. You may need a dose adjustment of antidiabetic drugs.
Although Fevarin not demonstrated proconvulsant properties in animal studies , it is recommended that the drug be used with caution in patients with a history of convulsive disorders.
Fevarin should be avoided in patients with unstable epilepsy and those with controlled epilepsy should be carefully monitored . Fevarin treatment should be discontinued at the onset or increased frequency of seizures .
Rare cases of development of serotonin or events , such neuroleptic malignant syndrome , in conjunction with treatment with Fevarin , especially when administered in combination with other serotonergic and / or neuroleptic drugs. As these syndromes may result in potentially life-threatening conditions , treatment with fevarin should be discontinued if such events ( characterized by clusters of symptoms such as hyperthermia, rigidity, myoclonus , autonomic instability and possible rapid fluctuations of vital signs , mental status changes including confusion , irritability, extreme agitation progressing to delirium and coma) in which to be supportive symptomatic treatment . As with other selective inhibitors of serotonin reuptake ( SIOZS ) upon discontinuation of treatment with Fevarin rarely been observed hyponatraemia. Some cases were possibly due to the syndrome of inappropriate secretion of antidiuretic hormone. Most reports were associated with older patients.
There are literature data for abnormalities such as ecchymoses skin bleeding and redness due to capillary bleeding in the skin and internal gastrointestinal bleeding with SIOZS . It is recommended that patients receiving SIOZS be monitored closely , especially the elderly, and patients who concurrently used drugs known to affect platelet function [ as atypical antipsychotics and phenothiazines, most tricyclic antidepressants (TA ) , aspirin , non-steroidal inflammatory drugs (NSAIDs )] or medications that increase the risk of bleeding , and patients with a history of bleeding and those with predisposing conditions (eg thrombocytopenia) .
In combination with Fevarin plasma concentrations of terfenadine, astemizole , or cisapride may increase , leading to an increased risk of prolonged QT interval Torsade de Pointes.
Therefore Fevarin should not be co-administered with these drugs.
Data in elderly patients showed no clinically relevant differences in normal daily doses , compared with younger individuals. However, the adjustment of dose escalation in the elderly must be done slowly and the dosage should always be carried out with caution, can cause fevarin negligible delay pulse ( 2-6 bpm ) .
Due to lack of clinical experience , the use of Fevarin for the treatment of depression in children can not be recommended .
Taking other medicines
Fevarin should not be used in combination with an MAOI (see section 2).
Reported increase in previously stable plasma levels of those tricyclic antidepressants (eg clomipramine, imipramine, amitriptyline) and neuroleptics (eg, clozapine, olanzapine), which are metabolized primarily by the cytochrome P450 1A2 by coadministration with Fevarin . At the start of treatment with Fevarin should consider reducing the dose of these products.
Patients receiving both drugs as Fevarin and tacrine, theophylline, methadone, mexiletine, should be carefully monitored and , if necessary, dose adjustment of these drugs.
When used with Fevarin , warfarin plasma concentrations increased significantly and prothrombin time is prolonged.
Isolated cases of cardiac toxicity when combining fevarin with thioridazine.
As plasma concentrations of propranolol was increased in combination with Fevarin , it may be necessary to reduce the dose of propranolol.
Likely caffeine plasma levels may be increased when coadministered fevarin . Therefore, patients who consume large amounts of caffeine-containing beverages should limit their intake with concomitant fevarin because adverse reactions of caffeine (such as tremor , palpitations, nausea , anxiety, insomnia).
Since plasma concentrations of ropinirol can be enhanced in combination with Fevarin , increasing thus the risk of overdose may need monitoring and dose reduction ropinirol during treatment with Fevarin after termination of treatment.
Patients receiving concomitant fevarin and phenytoin should be carefully monitored and , if necessary, dose adjustment of these drugs.
Terfenadine, astemizole, cisapride: see also Special precautions for use .
Patients receiving concomitant fevarin and carbamazepine, ciclosporin, should be carefully monitored and , if necessary, dose adjustment of these
Probably the plasma levels of oxidatively metabolised benzodiazepines (eg, triazolam, midazolam, alprazolam, and diazepam) may be increased when coadministered Fevarin .
Dose of these benzodiazepines should be reduced by concomitant administration of Fevarin .
Fevarin did not affect plasma concentrations of digoxin.
Fevarin did not affect plasma concentrations of atenolol.
Fevarin serotonergic effects may be enhanced when used in combination with other serotonergic agents ( including triptans , (tramadol, SIOZS and preparations of St. John's Wort (see Special precautions for use).
Fevarin was used in combination with lithium for the treatment of severely ill and drug-resistant patients. However, lithium (and possibly tryptophan ) enhances the serotonergic effect of Fevarin . The combination should be used with caution in patients with severe and resistant depression medication . When receiving oral anticoagulants and Fevarin patients , the risk of bleeding may be increased and therefore these patients should be monitored carefully.
• As with other psychotropic medications , patients should be advised to avoid alcohol while taking Fevarin .
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Adoption of fevarin 50 mg / 100 mg Fevarin with food and drink :
As with other psychotropic medications , patients should be advised to avoid alcohol while taking Fevarin .
Data from a limited number of exposed pregnancies indicate no drug side effects of Fevarin on pregnancy . There are currently no other drug-related epidemiological data .
Reproductive studies in animals at high doses revealed no evidence of impaired fertility , fertility or teratogenic effects in the offspring . At doses of fluvoxamine, which significantly (about 4 times) exceed the maximum recommended human dose , they found impaired fertility , increased incidence of embryo- fetal death , decreased fetal weight and increased incidences of fetal eye anomalies ( the folded retina ) . The potential risk for humans is unknown. Care must be taken when prescribing to pregnant women.
Isolated cases of symptoms of dependence in the newborn have been described after using Fevarin late in pregnancy . Some newborns are experiencing difficulties in feeding and / or breathing difficulties , seizures , unstable temperature , hypoglycemia, tremor, abnormal muscle tone , tremors and constant crying after exposure SIOZS during the third trimester of pregnancy , so you may need prolonged hospitalization .
Fevarin is excreted in small amounts in breast milk . Therefore , the drug should not be used by women who are breastfeeding .
Driving and using machines
Fevarin to 150 mg has no or negligible influence on the ability to drive and use machines. The drug showed no effect on psychomotor skills related to driving and operating machinery in healthy volunteers. But was reported drowsiness during treatment with fevarin . Therefore , caution is advised in the establishment of individual response to the drug.
Important information about some of the ingredients fevarin 50 mg / 100 mg Fevarin
Mannitol (E421) can have a mild laxative effect.
3 . HOW TO TAKE FEVARIN 50 MG / 100 MG FEVARIN
The recommended starting dose is 50 or 100 mg, once in the evening. Gradual increase in the dose until an effective dose . The usual effective dose is 100 mg per day, and it must be adjusted according to the individual response of the patient. Doses up to 300 mg daily. Dosages above 150 mg daily should be administered in divided doses.
In accordance with the unanimous request of the SZO antidepressants should be taken for at least 6 months after recovery from a depressive episode.
Fevarin in a fixed dose of 100 mg is the recommended dose for the prevention of new depressive episode .
Obsessive Compulsive Disorder ( OCD )
The recommended starting dose is 50 mg daily for 3-4 days. The effective dose generally ranges between 100 mg and 300 mg per day . The dose should be increased gradually until an effective dose , the maximum dose is 300 mg per day for adults and 200 mg a day for children aged 8 years / adolescents .
Doses up to 150 mg may be administered as a single dose , and preferably in the evening . It is recommended that a total daily dose greater than 150 mg be administered in 2 or 3 divided doses. If achieved good therapeutic response , treatment can be continued at a dose adjusted according to individual response . If no improvement is seen within 10 weeks , treatment with Fevarin should be reviewed . While there are no systematic studies that answer the question of how long to continue treatment fevarin , OCD is a chronic condition and it is reasonable to consider continuation of treatment and after 10 weeks in responding patients . Dose adjustments should be made carefully according to individual response of the patient to place maintenance therapy with the lowest effective dose.
The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioral psychotherapy for patients who have responded well to drug therapy.
Treatment of severe liver or renal failure patients should start with a low dose and patients need to be carefully monitored.
Fevarin tablets should be swallowed with water without chewing .
If you take more than the required dose fevarin 50 mg / Fevarin 100 mg) :
Symptoms include gastrointestinal complaints ( nausea , vomiting and diarrhea) , drowsiness and dizziness. Have also been reported cardiac events (tachycardia , bradycardia, hypotension) , liver function abnormalities , convulsions and coma. Fevarin has a wide margin of safety in overdose . Since its introduction on the market , reports of deaths attributed to overdose with fevarin were extremely rare. The highest documented dose Fevarin absorbed by the patient , is 12 grams. This patient recovered completely.
Were sometimes observed serious complications in cases of intentional overdose fevarin in combination with other medicines.
There is no specific antidote for fevarin . In case of overdose, gastric lavage as soon as possible after ingestion of the tablets and provide symptomatic treatment . It is also recommended reusable medical charcoal , if necessary, by an osmotic laxative.
Forced diuresis or dialysis is unlikely to be helpful.
If you forget to take fevarin 50 mg / 100 mg fevarin
Do not take a double dose to make up for the missed tablet and continue with the next prescribed dose.
If you have stopped taking Fevarin 50 mg / 100 mg fevarin
Reactions are possible depending upon discontinuation of therapy Fevarin , although the available preclinical and clinical data do not suggest that this treatment causes addiction. The following symptoms have been reported in connection with the discontinuation of the product: dizziness , paresthesia , headache, nausea and anxiety. Most of the reactions were mild dependency and self-limiting . Discontinuation of treatment may be considered a gradual reduction in dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS TO FEVARIN 50 MG / 100 MG FEVARIN
Like all medicines, Fevarin may cause side effects , although not all of them receive.
Nausea, sometimes accompanied by vomiting, is the most commonly observed symptom associated with treatment Fevarin . This effect is usually attenuates within the first two weeks of treatment . Other adverse reactions observed in clinical trials with the following frequencies , often associated with the disease itself , and not necessarily with the treatment.
Common ( 1-10% frequency ):
Metabolism and nutrition disorders: anorexia
Nervous system: agitation, anxiety , dizziness , headache, insomnia , nervousness, somnolence, tremor
Cardiac disorders: palpitations (tachycardia)
Gastrointestinal disorders : abdominal pain, constipation, diarrhea , dry mouth , dyspepsia
Disorders of the skin and subcutaneous tissue disorders: sweating
General disorders and site conditions : asthenia , malaise
Uncommon (incidence < 1%):
Psychiatric disorders : confusion , hallucinations
Nervous system disorders : ataxia, extrapyramidal symptoms
Vascular disorders ( postural ) hypotension
Disorders of the skin and subcutaneous tissue disorders: allergic skin reactions ( including rash , pruritus, angioedema)
Musculoskeletal disorders and connective tissue disorders : arthralgia, myalgia
Disorders of the reproductive system and breast disorders: abnormal (delayed ) ejaculation
Rare (incidence <0.1 %):
Psychiatric disorders : obsession
Nervous system: seizures
Hepatobiliary disorders : abnormal liver function
Disorders of the skin and subcutaneous tissue sensitivity to light
Disorders of the reproductive system and breast disorders: galactorrhea
Other side effects reported during the marketing of the product
Been reported gain or weight loss.
Have been reported rarely serotonin syndrome resembling the neuroleptic malignant syndrome events , hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) ( see also Special precautions for use).
Please see Section 3 for potential adverse effects upon discontinuation of therapy.
Been reported as exhibiting signs of bleeding such as ecchymoses, capillary bleeding , gastrointestinal bleeding ( see also special care ) .
Very rarely been reported paraesthesia, anorgasmia and dysgeusia .
Within each frequency grouping , adverse reactions are listed by decreasing severity.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . STORAGE FEVARIN 50 MG / 100 MG FEVARIN
Shelf life 3 years guarantee from the company on the condition that The product is stored in the original , undamaged packaging at temperatures below 25 ° C.
Fevarin tablets should be kept dry and protected from direct sunlight.
Keep this medicine out of the reach and sight of children.
Fevarin not use after the expiry date stated on the packaging after EXP .
6 . ADDITIONAL INFORMATION
What does fevarin 50 mg / 100 mg Fevarin
• The active substance is fluvoxamine maleate
• The other ingredients ( excipients ) are mannitol ( E421 ) , corn starch , pregelatinized starch , sodium stearyl fumarate, colloidal anhydrous silica , hypromellose , polyethylene glycol 6000, talc , titanium dioxide ( E171 ) .
Looks like Fevarin 50 mg / 100 mg Fevarin and contents of the pack
Fevarin is round , biconvex , split , covered with a white film coated tablet for oral administration.
A standard label of the tablet 291 (twice) on one side and S from the other side.
The tablet can be divided equal halves.
Tablets Fevarin ( shuohagshpe ta1eate ) are supplied in packs containing 60 tablets (50 mg) or 30 tablets ( 100 mg) packed in PVC / RVDS - aluminum blister strip of tablets that are released by pressure, in 20 of 15 tablets in the band .
Not all pack sizes may be marketed .
Marketing Authorisation Holder: Netherlands
Manufacturers: Netherlands, France