Medicinal Products

PAROXETINE EVOLUGEN 20 mg

Deroxat Generic Drug
Therapeutic Class: Neurology-Psychiatry
active ingredients: Paroxetine
laboratory: Evolupharm

Divisible coated tablet
Box of 14
All forms

Indication

Treatment of :

· Major depressive episode,

· Obsessive Compulsive Disorders,

· Panic disorder with or without agoraphobia,

· Social Anxiety Disorder / Social Phobia,

· Generalized anxiety disorder,

· State of post-traumatic stress.

Dosage PAROXETINE EVOLUGEN 20 mg Film-coated tablet scored box of 14

It is recommended to take paroxetine once daily in the morning during breakfast.

The tablets should be swallowed rather than chewed.

MAJOR DEPRESSIVE EPISODE

The recommended dosage is 20 mg daily.

In general, improvement of the patient begins after one week of treatment but may not become apparent until the second week.

As with all antidepressant medications, the dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of starting treatment and thereafter if clinically justified.

In some patients with insufficient response at 20 mg, the dosage can be increased gradually in 10 mg increments depending on the therapeutic response, up to a maximum of 50 mg daily

Patients with depression should be treated for a sufficient period of at least 6 months to ensure the disappearance of symptoms.

COMPULSIVE OBSESSIVE DISORDERS

The recommended dosage is 40 mg daily. Treatment will be started at a dose of 20 mg per day, which may be increased gradually in 10 mg increments to the recommended dose.

In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose, up to a maximum of 60 mg per day.

Patients with obsessive-compulsive disorder should be treated for a sufficient period of time to ensure the disappearance of symptoms. This period may last several months or even longer (see section Pharmacodynamic properties ).

PANIC DISORDER

The recommended dosage is 40 mg daily. The treatment will be started at the dose of 10 mg per day, which may be increased gradually in 10 mg increments depending on the therapeutic response up to the recommended dose.

A low initial dose is recommended to minimize potential worsening of panic disorder symptoms that may occur at the beginning of treatment. In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose, up to a maximum of 60 mg per day.

Patients with panic disorder should be treated for a sufficient period of time to ensure the disappearance of symptoms. This period may last several months or even longer (see section Pharmacodynamic properties ).

SOCIAL ANXIETY DISORDER / SOCIAL PHOBIA

The recommended dosage is 20 mg daily. In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose in 10 mg increments up to a maximum of 50 mg per day.

Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties ).

GENERALIZED ANXIETY DISORDER

The recommended dosage is 20 mg daily. In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose in 10 mg increments up to a maximum of 50 mg per day.

Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties ).

STATE OF POST-TRAUMATIC STRESS

The recommended dosage is 20 mg daily. In the event of an inadequate response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual dose increase in 10 mg increments per week, up to a maximum of 50 mg per day. Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties ).

GENERAL INFORMATIONS

WEATHER SYMPTOMS OBSERVED DURING PAROXETINE ARREST

Abrupt discontinuation of treatment should be avoided (see Warnings and Precautions and Adverse Reactions sections).

The pattern used in the clinical trials included a gradual discontinuation of treatment with a decrease in the daily dose of 10 mg per week.

The occurrence of uncomfortable symptoms during the dose reduction or at the end of treatment may necessitate the resumption of the previously prescribed dose. The doctor can then continue to decrease the dose at a more gradual rate.

Special populations

Elderly

An increase in plasma concentrations is observed in the elderly, but they remain within the limits of those observed in younger patients. The initial dosage is the same as in adults. A dose increase may be useful in some patients, but the maximum dose should not exceed 40 mg per day.

Children and adolescents (7-17 years old):

Paroxetine is not recommended in children and adolescents, as controlled clinical studies have shown that paroxetine is associated with an increased risk of suicidal behavior and hostility. In addition, the efficacy of paroxetine has not been sufficiently demonstrated in these trials (see sections Warnings and precautions for use and undesirable effects ).

Children under 7 years old:

The use of paroxetine has not been studied in children under 7 years of age. Paroxetine is not recommended until its effectiveness and safety of use has been demonstrated in this age group.

Hepatic or renal insufficiency:

An increase in paroxetine plasma concentrations is observed in patients with severe renal impairment (creatinine clearance <30 ml / min) and in patients with hepatic impairment. The lowest recommended dosage should not be exceeded in these patients.

Against indications

Known hypersensitivity to paroxetine or any of the excipients.

Paroxetine is contraindicated in combination with Monoamine Oxidase Inhibitors (MAOIs). In exceptional circumstances, linezolid (a reversible non-selective MAOI antibiotic) may be used in combination with paroxetine provided that it is able to provide close monitoring to detect symptoms suggestive of serotonin syndrome and follow-up. blood pressure (see section Interactions with other medicinal products and other forms of interaction ).

Treatment with paroxetine may be initiated:

· 2 weeks after stopping treatment with an irreversible MAOI, or

· At least 24 hours after stopping a reversible MAOI (eg moclobemide, linezolid, methylthioninium chloride (methylene blue, preoperative marking agent that is a reversible non-selective MAOI).

Observe a delay of at least one week between stopping paroxetine and the start of treatment with an MAOI.

Paroxetine should not be used in combination with thioridazine. Like other CYP450 2D6 inhibitors, it is likely to increase the plasma concentrations of thioridazine (see section 4.5 ). Administration of thioridazine alone may lead to prolongation of the QTc interval associated with severe ventricular arrhythmias such as torsades de pointes, and sudden death.

Paroxetine should not be used in combination with pimozide (see section 4.5, Interactions with other medicinal products and other forms of interaction ).

Due to the presence of soy lecithin, this medicine is contraindicated in cases of peanut or soy allergy.

Side effects Paroxetine Evolugen

Some of the side effects listed below may decrease in intensity and frequency with continued treatment and usually do not require treatment discontinuation.

The undesirable effects are listed below by organ system and frequency.

Frequencies are defined as follows: very common (≥ 1/10), frequent (≥ 1/100, <1/10), infrequent (≥ 1/1000, <1/100), rare (≥ 1/10) 000, <1/1000) and very rare (<1 / 10, 000), including isolated observations.

Hematologic and lymphatic system disorders

Uncommon: abnormal bleeding, mainly mucocutaneous (especially bruising).

Very rare: thrombocytopenia.

Immune system disorders

Very rare: allergic reactions (including urticaria and angioedema).

Endocrine disorders

Very rare: syndrome of inappropriate secretion of antidiuretic hormone (SIADH).

Metabolism and nutrition disorders

Frequent: increased cholesterolemia, decreased appetite.

Rare: hyponatremia. Most cases have been described in elderly patients and are sometimes due to an inappropriate syndrome of secretion of antidiuretic hormone (SIADH).

Psychiatric disorders

Frequent: drowsiness, insomnia, agitation, abnormal dreams (including nightmares).

Uncommon: confusion, hallucinations.

Rare: manic reactions, anxiety, depersonalization, panic attacks, akathisia (see Warnings and Precautions ).

Frequency not known: suicidal thoughts and behaviors

Cases of suicidal ideation and behavior have been reported during or shortly after discontinuation of paroxetine (see Warnings and Precautions ).

These symptoms may also be due to the underlying pathology.

Nervous system disorders

Frequent: dizziness, trembling, headache, difficulty concentrating.

Uncommon: extrapyramidal syndromes.

Rare: convulsions, restless legs syndrome.

Very rare: serotonin syndrome (symptoms may include agitation, confusion, hypersudation, hallucinations, hyperreflexia, myoclonus, chills, tachycardia and tremors).

Extra-pyramidal syndromes including oral-facial dyskinesias have been reported in patients with sometimes underlying abnormal movements or in patients treated with neuroleptics.

Eye disorders

Common: blurred vision

Uncommon: mydriasis (see Warnings and Precautions section ).

Very rare: acute glaucoma.

Ear and labyrinth disorders

Not known: Tinnitus

Cardiac disorders

Uncommon: sinus tachycardia.

Rare: bradycardia.

Vascular disorders

Uncommon: transient elevations or decreases in blood pressure, orthostatic hypotension.

Cases of transient elevations or decreases in blood pressure have been reported following paroxetine treatment, usually in patients with pre-existing hypertension or anxiety.

Respiratory, thoracic and mediastinal disorders

Frequent: yawning

Gastrointestinal disorders

Very common: nausea.

Frequent: constipation, diarrhea, vomiting, dry mouth.

Very rare: gastrointestinal bleeding.

Hepatobiliary disorders

Rare: elevation of liver enzymes.

Very rare: liver problems (such as hepatitis, sometimes associated with jaundice and / or hepatocellular insufficiency).

Cases of hepatic enzyme elevation have been reported. Very rarely, cases of hepatitis, sometimes associated with jaundice and / or hepatocellular insufficiency, have been reported after the marketing of paroxetine. In case of prolonged elevation of liver function tests, discontinuation of treatment should be considered.

Skin and subcutaneous tissue disorders

Frequent: sweating.

Uncommon: rash, pruritus.

Very rare: serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis or Lyell syndrome), photosensitization reactions.

Renal and urinary disorders

Uncommon: urinary retention, urinary incontinence.

Disorders of the reproductive organs and breast

Very common: sexual dysfunction.

Rare: hyperprolactinemia / galactorrhea.

Very rare: priapism.

Musculoskeletal and systemic disorders

Rare: arthralgia, myalgia.

Epidemiological studies, conducted primarily in patients 50 years of age and older, indicate an increased risk of fractures in patients taking SSRIs and tricyclic antidepressants. The mechanism leading to this risk is not known.

General disorders and administration site conditions

Frequent: asthenia, weight gain.

Very rare: peripheral edema.

Withdrawal symptoms upon discontinuation of treatment

Frequent: dizziness, sensory disturbances, sleep disorders, anxiety, headache.

Uncommon: agitation, nausea, tremors, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhea, irritability.

Stopping treatment with paroxetine, especially when it is brutal, frequently leads to withdrawal symptoms.

Dizziness, sensory disturbances (including paresthesia and sensations like electric shocks and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremors, confusion, sweating, headache, diarrhea, palpitations, have been observed. emotional instability, irritability and visual disturbances.

Generally these effects are of mild to moderate intensity and spontaneously resolving; however, in some patients they may be severe and / or prolonged.

It is therefore recommended to gradually reduce the doses of paroxetine when the treatment is no longer necessary (see sections Posology and method of administration and Warnings and precautions for use ).

ADVERSE EFFECTS DURING PEDIATRIC CLINICAL TRIALS

The following adverse events have been observed:

Increased suicidal behavior (including suicidal attempts and suicidal thoughts), self-aggressive behavior, and increased hostility. Suicidal thoughts and suicide attempts have mainly been observed in clinical studies of adolescents with major depressive disorder. Increased hostility occurred particularly in children with obsessive-compulsive disorder and mainly in children under 12 years of age.

Other events observed: decreased appetite, tremor, excessive sweating, hyperkinesia, agitation, emotional lability (including crying and fluctuating mood), adverse events related to bleeding, mainly in the skin and mucous membranes.

The events observed after stopping / decreasing paroxetine are: emotional lability (including crying, mood changes, self-aggression, suicidal thoughts and suicide attempts), nervousness, dizziness, nausea, and pain abdominal (see Warnings and Precautions for Use : Special Warnings and Precautions).

See Pharmacodynamic Properties for further information on pediatric clinical studies.

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