Instructions for use Fevarin film-coated tablets 100 mg blister No. 15
Composition
active ingredient: fluvoxamine;
1 tablet contains fluvoxamine maleate 50 mg or 100 mg;
excipients: mannitol (E 421), corn starch, pregelatinized starch, sodium stearyl fumarate, colloidal anhydrous silica, hypromellose, macrogol 6000, talc, titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties:
Film-coated tablets, 50 mg: round, biconvex, white or almost white, film-coated, with a score on one side and marking “291” on both sides; diameter – approximately 9 mm; the tablet can be divided into two equal parts.
Film-coated tablets, 100 mg: oval, biconvex, white or almost white, film-coated, with a score on one side and marking “313” on both sides; length – approximately 15 mm, width – approximately 8 mm; the tablet can be divided into two equal parts.
Pharmacotherapeutic group
Antidepressants. Selective serotonin reuptake inhibitors. ATC code N06A B08.
Pharmacological properties
Pharmacodynamics.
Receptor binding studies have shown that fluvoxamine is a potent serotonin reuptake inhibitor both in vitro and in vivo and has minimal affinity for serotonin receptor subtypes. The drug has negligible binding to α-adrenergic, β-adrenergic, histaminergic, muscarinic, cholinergic or dopaminergic receptors.
Fluvoxamine has a high affinity for sigma-1 receptors, for which it acts as an agonist at therapeutic doses.
Pharmacokinetics.
Absorption.
Fluvoxamine is completely absorbed after oral administration. Peak plasma concentrations are reached 3-8 hours after administration. Due to the first-pass mechanism, the mean absolute bioavailability is 53%.
The pharmacokinetics of Fevarin® are not affected by simultaneous food intake.
Distribution.
In vitro, fluvoxamine is 80% bound to plasma proteins. The volume of distribution in humans is 25 l/kg.
Metabolism.
Fluvoxamine is extensively metabolized in the liver. Although in vitro the major isoenzyme involved in fluvoxamine metabolism is CYP2D6, plasma concentrations in individuals with reduced CYP2D6 activity are not significantly higher than in extensive metabolizers.
The mean plasma elimination half-life is approximately 13-15 hours after a single dose and is slightly prolonged (17-22 hours) after multiple doses. Steady-state plasma concentrations are usually reached within 10-14 days.
Fluvoxamine is extensively metabolized in the liver, mainly by oxidative dimethylation, resulting in the formation of at least nine metabolites that are excreted by the kidneys. The two main metabolites show little pharmacological activity. The other metabolites are pharmacologically inactive. Fluvoxamine is a potent inhibitor of CYP1A2 and CYP2C19, and moderately inhibits CYP2C9, CYP2D6 and CYP3A4.
Fluvoxamine exhibits linear pharmacokinetics following single-dose administration. Steady-state plasma concentrations are higher than those predicted from single-dose data, and this disproportionate increase is most pronounced at higher daily doses.
Special patient groups.
The pharmacokinetics of fluvoxamine are similar in healthy adults, the elderly and patients with renal insufficiency. The metabolism of fluvoxamine is impaired in patients with liver disease.
Steady-state plasma concentrations of fluvoxamine are twice as high in children aged 6 to 11 years compared to those aged 12 to 17 years. Plasma concentrations in children aged 12 to 17 years are similar to those in adults.
Indication
Depression
Obsessive-compulsive disorder (OCD).
Contraindication
The drug is contraindicated in patients with hypersensitivity to fluvoxamine maleate or to any of the other components of the drug.
It should not be administered simultaneously with tizanidine, monoamine oxidase inhibitors (MAOIs) (see sections "Interaction with other medicinal products and other types of interactions" and "Special instructions for use"). Treatment with Fevarin® can be started no earlier than two weeks after stopping irreversible MAOIs or the next day after stopping reversible MAOIs (e.g. moclobemide, linezolid).
Treatment with any of the MAOI drugs can be started no earlier than one week after stopping Fevarin®.
Fevarin® should not be administered concomitantly with pimozide and ramelteon (see sections “Interaction with other medicinal products and other types of interactions”).
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors.
The drug should not be prescribed in combination with monoamine oxidase inhibitors, including linezolid, due to the risk of serotonin syndrome (see section "Contraindications").
Fluvoxamine may inhibit the metabolism of drugs metabolized by certain cytochrome P450 (CYP) isoenzymes. In vitro and in vivo studies have shown that fluvoxamine has a potent inhibitory effect on CYP1A2 and CYP2C19, but CYP2C9, CYP2D6 and CYP3A4 are inhibited to a lesser extent. Drugs metabolized primarily by these isoenzymes may have higher, and in some cases lower (e.g. clopidogrel, which is a prodrug) plasma concentrations of the active substance/metabolites when co-administered with fluvoxamine. Fluvoxamine treatment with such drugs should be initiated or adjusted at the lowest dose of their therapeutic range, rather than the highest. Plasma concentrations, efficacy or adverse effects of concomitant medications should be closely monitored and the dose reduced or increased as necessary. This is especially important to consider when using drugs with a narrow therapeutic index.
Ramelteon.
When fluvoxamine maleate immediate-release tablets were administered at a dose of 100 mg twice daily for 3 days, followed by a single dose of 16 mg ramelteon concomitantly with fluvoxamine maleate immediate-release tablets, the AUC of ramelteon increased approximately 190-fold and the Cmax increased approximately 70-fold compared to when ramelteon was administered as monotherapy.
Compounds with a narrow therapeutic index.
Patients taking fluvoxamine concomitantly with drugs with a narrow therapeutic index (such as tacrine, theophylline, methadone, mexiletine, phenytoin, carbamazepine and cyclosporine) that are metabolised exclusively by CYP or by CYPs that are inhibited by fluvoxamine should be closely monitored and the doses of these drugs adjusted if necessary.
Due to the narrow therapeutic range of pimozide and its known ability to prolong the QT interval, the concomitant use of pimozide and fluvoxamine is contraindicated (see section "Contraindications").
Tricyclic antidepressants and neuroleptics.
Increased plasma concentrations of tricyclic antidepressants (e.g. clomipramine, imipramine, amitriptyline) and neuroleptics (e.g. clozapine, olanzapine, quetiapine), which are primarily metabolised by cytochrome P450 1A2, have been reported when co-administered with fluvoxamine. A dose reduction of these drugs should be considered when added to fluvoxamine treatment.
Benzodiazepines.
Plasma concentrations of benzodiazepines that are metabolized by oxidation (such as triazolam, midazolam, alprazolam and diazepam) may increase when co-administered with fluvoxamine. The dose of these benzodiazepines should be reduced when co-administered with fluvoxamine.
Increased plasma concentration.
When ropinirole is taken in combination with fluvoxamine, its plasma concentration may increase, which increases the risk of overdose. In this regard, patients should be monitored and, if necessary, the dose of ropinirole should be reduced (both during treatment with fluvoxamine and after its withdrawal).
Since the plasma concentration of propranolol increases when taken simultaneously with fluvoxamine, it may be necessary to reduce its dose.
When used together with fluvoxamine, the plasma concentration of warfarin increases significantly and the prothrombin time is prolonged.
Increased likelihood of adverse reactions.
Isolated cases of cardiac disorders (cardiotoxic effect) have been reported with the simultaneous use of fluvoxamine with thioridazine.
Plasma caffeine levels may increase when co-administered with fluvoxamine. Side effects of caffeine (tremor, palpitations, nausea, restlessness, insomnia) may occur. Therefore, patients who consume significant amounts of caffeinated beverages should reduce their intake if they are prescribed fluvoxamine.
For terfenadine, astemizole, cisapride, sildenafil, see the section "Special warnings and precautions for use".
Glucuronidation.
The drug does not affect the plasma concentration of digoxin.
Renal excretion.
The drug does not affect the plasma concentration of atenolol.
Pharmacodynamic interaction.
Serotonergic effects may be enhanced when fluvoxamine is administered concomitantly with other serotonergic drugs (including triptans, tramadol, buprenorphine, buprenorphine/naloxone, selective serotonin reuptake inhibitors and St. John's wort) and may lead to potentially life-threatening conditions (see also section "Special warnings and precautions for use").
Fluvoxamine has been used in combination with lithium in the treatment of severe, treatment-resistant patients. However, lithium (and possibly also tryptophan) potentiates the serotonergic effects of fluvoxamine. This combination should be used with caution in patients with severe, treatment-resistant depression. Patients receiving oral anticoagulants and fluvoxamine should be carefully monitored because they may be at increased risk of bleeding.
As with other psychotropic drugs, patients should refrain from drinking alcohol while taking fluvoxamine.
Application features
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until remission is achieved. As improvement may not occur within the first few weeks of treatment or even for a longer period, patients should be closely monitored by their doctor until improvement is noted. General clinical experience suggests that the risk of suicide may be increased in the early stages of recovery.
Other psychiatric conditions for which fluvoxamine is used may also be associated with an increased risk of suicide-related events. In addition, such conditions may be comorbid with major depressive disorder. Therefore, patients with other psychiatric disorders should be closely monitored when treated with fluvoxamine.
Patients with a history of suicide-related events and patients who demonstrate a high level of suicidal ideation prior to initiation of therapy are known to be at greater risk of suicidal thoughts or suicide attempts and therefore require close monitoring during treatment.
Close monitoring of patients, particularly those at high risk, is necessary during drug therapy, especially at the beginning of treatment and after changes in dosage.
Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts, and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Akathisia/psychomotor agitation
Fluvoxamine may be associated with the development of akathisia, which is characterized by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still. The onset of such phenomena is most likely during the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be harmful.
Liver and kidney dysfunction
In patients with hepatic or renal insufficiency, treatment should be started with low doses under close medical supervision.
Rarely, treatment with fluvoxamine has been associated with increases in liver enzymes, usually accompanied by relevant clinical symptoms. In such cases, treatment with the drug should be discontinued.
Nervous system disorders
Although fluvoxamine has not been shown to have convulsant properties in animal studies, caution should be exercised when prescribing fluvoxamine to patients with a history of seizure disorders. The drug should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be closely monitored. If a patient develops seizures or their frequency increases, treatment with the drug should be discontinued.
Isolated cases of serotonin syndrome or neuroleptic malignant syndrome-like events have been reported in association with fluvoxamine treatment, particularly when used concomitantly with other serotonergic and/or neuroleptic agents or in combination with buprenorphine or buprenorphine/naloxone. As these syndromes can lead to potentially life-threatening conditions, fluvoxamine treatment should be discontinued if such events (characterized by a cluster of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid changes in vital signs, changes in mental status including confusion, irritability, excessive agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated.
Metabolism and eating disorders
As with other selective serotonin reuptake inhibitors, hyponatremia has been reported rarely with fluvoxamine, resolving after discontinuation of the drug. Some cases may have been associated with the syndrome of inappropriate antidiuretic hormone secretion. Most reports have been in the elderly.
Glycemic control may be impaired (including hyperglycemia, hypoglycemia, decreased glucose tolerance), especially in the early stages of treatment. Patients with a history of diabetes mellitus may require adjustment of the dosage of antidiabetic drugs while taking fluvoxamine.
Nausea, sometimes accompanied by vomiting, is the most common side effect seen with fluvoxamine treatment. This side effect usually decreases within the first two weeks of treatment.
Vision disorders
Mydriasis has been reported with selective serotonin reuptake inhibitors (such as fluvoxamine). Therefore, it is recommended that fluvoxamine be used with caution in patients with increased intraocular pressure or at increased risk of acute angle-closure glaucoma.
Cases of cutaneous bleeding, such as ecchymoses and purpura, and other haemorrhagic manifestations, such as gastrointestinal bleeding or gynaecological/postpartum haemorrhage, have been reported with SSRIs. Special caution is advised when prescribing SSRIs to patients taking SSRIs, particularly in the elderly and in patients receiving concomitant medicinal products that affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs) or medicinal products that increase the risk of bleeding, and in patients with a history of haemorrhagic conditions and in patients with conditions predisposing to bleeding (e.g. thrombocytopenia or coagulation disorders).
Selective serotonin reuptake inhibitors (SSRIs) may increase the risk of postpartum haemorrhage (see sections “Use during pregnancy or lactation” and “Adverse reactions”).
Heart disorders
When used concomitantly with fluvoxamine, plasma concentrations of terfenadine, astemizole or cisapride may increase, leading to an increased risk of QT prolongation/torsade de pointes. Therefore, the drug should not be administered with these drugs. Fluvoxamine may cause a slight decrease in heart rate (by 2-6 beats per minute).
Electroconvulsive therapy (ECT)
It is recommended to prescribe fluvoxamine with extreme caution in combination with ECT due to the lack of clinical trial data.
Drug withdrawal reactions
Withdrawal symptoms may occur when fluvoxamine is discontinued, but available preclinical and clinical data do not suggest that this drug is addictive. The most common symptoms reported in connection with the withdrawal of fluvoxamine are: dizziness, sensory disturbances (including paraesthesia, visual disturbances and electric shock sensations), sleep disturbances (including insomnia and vivid dreams), agitation, irritability, confusion, emotional lability, headache, nausea and/or vomiting, diarrhoea, sweating, palpitations, tremor and anxiety (see section 4.8). These effects are usually mild to moderate and self-limiting, but in some patients they may be severe and/or persistent. They usually occur within the first few days after discontinuation of treatment. It is therefore recommended to gradually reduce the dose of fluvoxamine to discontinue treatment according to the patient's needs (see section "Method of administration and dosage").
Mania/hypomania
It is recommended that fluvoxamine be used with extreme caution in patients with a history of mania/hypomania. Fluvoxamine should be discontinued in any patient who develops a manic phase.
Sexual dysfunction
Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section 4.8). Long-term sexual dysfunction, symptoms of which persist after discontinuation of SSRIs, has been reported.
Elderly people
Data in the elderly do not indicate clinically significant differences in normal daily doses compared to those in younger patients. However, in elderly patients, dose titration should be slower and always done with caution.
Young adults (18 to 24 years old)
A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients under 25 years of age with psychiatric disorders showed an increased risk of suicidal behavior when treated with antidepressants (compared to placebo).
Use during pregnancy or breastfeeding
Epidemiological evidence suggests that use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension of the newborn (PPHN). The risk has been estimated to be approximately 5 cases per 1000 pregnancies. In the general population, there are 1-2 cases of PPHN per 1000 pregnancies.
Fluvoxamine should not be used during pregnancy unless the clinical condition of the woman requires treatment with fluvoxamine.
Isolated cases of withdrawal symptoms in the newborn have been described after use of fluvoxamine in late pregnancy. Following use of selective serotonin reuptake inhibitors during the third trimester of pregnancy, some newborns have experienced feeding and/or breathing difficulties, convulsions, temperature instability, hypoglycaemia, tremor, muscle tone disorders, nervousness, cyanosis, irritability, lethargy, drowsiness, vomiting, sleep disturbances and constant crying, which may require prolonged hospitalization.
Observational data indicate an increased risk (less than 2-fold) of postpartum hemorrhage after use of SSRIs during the month before delivery (see sections “Special warnings and precautions for use” and “Adverse reactions”).
Fluvoxamine is excreted in small amounts in breast milk, so it should not be prescribed to women who are breastfeeding.
Fertility
Reproductive toxicity studies in animals have shown that fluvoxamine reduces reproductive function in male and female animals. The relevance of these findings to humans is unknown. Fluvoxamine should not be used in patients attempting to conceive unless the clinical condition of the patient requires treatment with fluvoxamine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Fevarin® in a daily dose of 150 mg has no or little effect on the ability to drive vehicles and operate machinery. In healthy volunteers, no effect on psychomotor reactions associated with driving a car and operating mechanical devices was detected. However, cases of drowsiness have been reported during treatment with fluvoxamine, so it should be used with caution until the individual response to the drug is established.
Method of administration and doses
Fevarin® tablets should be swallowed without chewing and washed down with sufficient water.
Depression (adults).
The recommended initial dose is 50 or 100 mg once in the evening. It is recommended to increase the dose gradually until an effective dose is reached. The effective dose is usually 100 mg per day. It should be selected individually, according to the patient's response to treatment. The daily dose should not exceed 300 mg. If doses exceeding 150 mg are prescribed, they should be administered in several doses. According to the guidelines of the World Health Organization, after the patient recovers from depression, treatment should be continued for at least 6 months. The recommended dose for preventing relapse of depression is 100 mg of fluvoxamine once a day.
Obsessive-compulsive disorders.
Adults.
The recommended initial dose is 50 mg per day for the first 3-4 days of treatment. The effective dose is usually 100-300 mg per day. The dose should be gradually increased until an effective dose is reached. The maximum daily dose of Fevarin® for adults is 300 mg.
Doses up to 150 mg can be taken once a day, preferably in the evening. In the case of doses above 150 mg, they should be divided into 2-3 doses during the day. If a therapeutic effect has been achieved, treatment can be continued at a dose selected according to the clinical effect. If no improvement occurs within ten weeks of treatment, the appropriateness of further administration of Fevarin® should be reviewed. Although systematic studies of how long fluvoxamine treatment can last have not been conducted, taking into account the chronic nature of obsessive-compulsive disorders, it is advisable to continue treatment for patients in whom a clinical effect has been achieved for more than 10 weeks. The dose should be selected very carefully and individually so that the patient receives maintenance therapy with the drug at the minimum effective dose. The appropriateness of continued treatment should be reviewed periodically. For patients who have a positive effect from pharmacotherapy, some clinicians recommend concomitant behavioral psychotherapy.
Children aged 8 and over.
The initial dose for children over 8 years of age is 25 mg per day, preferably at bedtime. The dose may be increased by 25 mg every 4-7 days until an effective dose is reached. The effective daily dose is usually 50-200 mg. The maximum daily dose for children should not exceed 200 mg. If the total daily dose exceeds 50 mg, it should be divided into 2 doses. If, when dividing the dose into two parts, one of the parts turns out to be larger, this larger part should be taken at bedtime.
Abrupt discontinuation of fluvoxamine treatment should be avoided. When discontinuing fluvoxamine treatment, the dose should be gradually reduced over 1 to 2 weeks to reduce the risk of withdrawal symptoms (see sections 4.8 and 4.4). If intolerable symptoms develop after dose reduction or discontinuation, the previous dose should be resumed. The doctor may then continue to reduce the dose, but more gradually.
Treatment of patients with hepatic or renal insufficiency should be initiated at a low dose under close medical supervision of the patient's health status.
Children.
Fevarin® should not be used to treat children and adolescents (under 18 years of age), except in patients with obsessive-compulsive disorder (OCD). Fluvoxamine cannot be recommended for the treatment of depression in children due to lack of clinical experience. Suicidal behavior (suicidal attempts and suicidal thoughts) and hostility (mainly aggression, oppositional behavior and anger) were more frequently observed in children and adolescents treated with antidepressants in clinical trials compared to the placebo group. If a decision to treat is made based on clinical need, the patient should be carefully monitored for the emergence of suicidal symptoms.
In addition, long-term safety data on the use of the drug in children and adolescents with regard to physical, sexual, cognitive and behavioral development are insufficient.
Overdose
Symptoms: Symptoms include gastrointestinal complaints (nausea, vomiting, diarrhea), drowsiness, and dizziness. Cardiovascular disorders (tachycardia, bradycardia, hypotension), liver dysfunction, convulsions, and coma have also been reported.
Fluvoxamine has a wide safety margin for overdose. Since its introduction into the market, reports of fatal cases of overdose with fluvoxamine have been extremely rare. The highest documented dose of fluvoxamine taken by a patient is 12 g. The patient recovered completely. More serious complications have sometimes been observed in cases of intentional overdose of the drug in combination with other drugs.
Treatment. There is no specific antidote for fluvoxamine. In case of overdose, gastric lavage should be performed as soon as possible and symptomatic treatment should be initiated. Repeated administration of activated charcoal and, if necessary, an osmotic laxative is also recommended. Forced diuresis or hemodialysis are ineffective.
Side effects
Adverse events observed in clinical trials with the frequencies listed below were often disease-related and not necessarily treatment-related.
Side effects are classified by frequency as follows:
Very common: ≥ 1/10.
Common: ≥1/100 to <1/10.
Uncommon: ≥1/1000 to <1/100.
Rare: ≥1/10,000 to <1/1,000.
Very rare: < 1/10,000.
Frequency not known: cannot be estimated from the available data.
Endocrine disorders
Frequency unknown: hyperprolactinemia, inappropriate secretion of antidiuretic hormone.
Metabolic and nutritional disorders
Common: anorexia (loss of appetite).
Frequency unknown: hyponatremia, weight gain or loss.
Mental disorders
Uncommon: hallucinations, confusion, aggression.
Rare: mania.
Frequency unknown: suicidal ideation, suicidal behavior.
Nervous system disorders
Common: agitation, nervousness, anxiety, insomnia, drowsiness, tremor, headache, dizziness.
Uncommon: extrapyramidal disorders, ataxia.
Rare: convulsions.
Frequency unknown: serotonin syndrome; neuroleptic malignant syndrome-like phenomena; akathisia/psychomotor agitation; paraesthesia; dysgeusia.
Vision disorders
Frequency unknown: glaucoma, mydriasis.
Heart disorders
Common: palpitations/tachycardia.
Vascular disorders
Uncommon: hypotension (orthostatic).
Frequency unknown: bleeding (including gastrointestinal bleeding, gynaecological bleeding, ecchymosis, purpura).
Gastrointestinal disorders
Common: abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, nausea, vomiting.
Hepatobiliary disorders
Rare: liver dysfunction.
Skin and subcutaneous tissue disorders
Common: hyperhidrosis.
Uncommon: cutaneous hypersensitivity reactions (including rash, pruritus, angioedema).
Rare: photosensitivity reaction.
Musculoskeletal, connective tissue and bone disorders
Uncommon: arthralgia, myalgia.
Frequency unknown: bone fractures*.
*Epidemiological studies, mainly conducted in patients aged 50 years and older, have shown an increased risk of bone fractures in patients receiving SSRIs (selective serotonin reuptake inhibitors) and TCAs (tricyclic antidepressants). The mechanism leading to this risk is unknown.
Kidney and urinary system disorders
Frequency unknown: urinary disorders (including urinary retention, urinary incontinence, pollakiuria, nocturia and enuresis).
Reproductive system and mammary gland disorders
Uncommon: impaired (delayed) ejaculation.
Rare: galactorrhea.
Frequency unknown: anorgasmia, menstrual disorders (such as amenorrhea, hypomenorrhea, metrorrhagia and menorrhagia), postpartum hemorrhage**.
**This event was reported in association with the SSRI pharmacotherapeutic group (see sections “Special warnings and precautions for use” and “Use during pregnancy or lactation”).
General disorders
Common: asthenia, malaise.
Frequency unknown: drug withdrawal syndrome, including in infants.
Withdrawal symptoms observed when stopping fluvoxamine
Discontinuation of fluvoxamine treatment (especially abrupt) usually leads to withdrawal symptoms. In order to avoid withdrawal symptoms, it is recommended to discontinue fluvoxamine gradually by gradually reducing the dose (see sections "Method of administration and dosage" and "Special warnings and precautions for use").
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children!
Packaging
The tablets are packaged in PVC/PVDC-aluminum blisters of 15 tablets per blister, 1 or 2 blisters per carton; or 20 tablets per blister, 3 blisters per carton.
Vacation category
According to the recipe.
Producer
Mylan Laboratories SAS, France.
Location of the manufacturer and address of its place of business. Route de Belleville, Lieu dit Maillard, 01400, Chatillon-sur-Chalaronne, France.
