Medicinal Products

EFFEXOR LP 75 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
Active ingredients: Venlafaxine
laboratory: Pfizer Holding France

Sustained-Release Capsule
Box of 30
All forms

Indication

Treatment of major depressive episodes.

For the prevention of recurrence of major depressive episodes.

Treatment of generalized anxiety disorder.

Treatment of social anxiety disorder (social phobia).

Treatment of panic disorder, with or without agoraphobia.

Dosage EFFEXOR LP 75 mg Prolonged-release capsule Box of 30

Major depressive episodes

The recommended starting dose of venlafaxine extended-release is 75 mg once daily. Patients who do not respond to the initial dose of 75 mg / day may benefit from an increase in dosage up to a maximum dose of 375 mg / day. Dose increases can be done in increments of 2 weeks or more. If this is clinically justified because of the severity of the symptoms, the dosage may be increased at shorter time intervals, with a minimum of 4 days.

Due to the risk of dose-related adverse effects, the dose should be increased only after clinical evaluation (see section 4.4 ). The minimum effective dosage should be maintained.

Patients should be treated for a sufficient length of time, usually several months or more. Treatment should be reassessed regularly on a case-by-case basis. Longer-term treatment may also be warranted for the prevention of recurrence of major depressive episodes (MDEs). In most cases, the recommended dosage for preventing recurrence of MDEs is the same as that used during the current episode.

Antidepressant treatment should be continued for at least 6 months after remission

Generalized anxiety disorder

The recommended starting dose of venlafaxine extended-release is 75 mg once daily. Patients not responding to the initial dose of 75 mg / day may benefit from an increase in dosage up to a maximum dose of 225 mg / day. Dose increases can be done in increments of 2 weeks or more.

Due to the risk of dose-related adverse effects, the dose should be increased only after clinical evaluation (see section 4.4 ). The minimum effective dosage should be maintained.

Patients should be treated for a sufficient length of time, usually several months or more. Treatment should be reassessed regularly on a case-by-case basis.

Social Anxiety Disorder (Social Phobia)

The recommended dose of venlafaxine extended-release is 75 mg once daily. It has not been demonstrated that higher dosages provide additional benefit.

However, in some patients who do not respond to the initial dose of 75 mg / day, an increase in the dose may be considered up to a maximum dose of 225 mg / day. The dosage may be increased in increments of 2 weeks or more.

Due to the risk of dose-related adverse effects, the dose should be increased only after clinical evaluation (see section 4.4 ). The minimum effective dosage should be maintained.

Patients should be treated for a sufficient length of time, usually several months or more. Treatment should be reassessed regularly on a case-by-case basis.

Panic disorder

It is recommended to use a dosage of 37.5 mg / day of venlafaxine extended release for 7 days. The dosage should then be increased to 75 mg / day. Patients who do not respond to the 75 mg / day dose may benefit from an increase in dosage up to a maximum dose of 225 mg / day. Dose increases can be done in increments of 2 weeks or more.

Due to the risk of dose-related adverse effects, the dose should be increased only after clinical evaluation (see section 4.4 ). The minimum effective dosage should be maintained.

Patients should be treated for a sufficient length of time, usually several months or more. Treatment should be reassessed regularly on a case-by-case basis.

Use in elderly patients

No specific dose adjustment for venlafaxine is considered necessary based solely on the age of the patient. However, caution should be exercised when treating elderly patients (eg, because of the risk of renal failure, the possibility of age-related changes in sensitivity and affinity of neurotransmitters). The minimum effective dosage should always be used and patients should be carefully monitored during any dose increase.

Use in children and adolescents under 18 years

Venlafaxine is not recommended in children and adolescents.

Controlled clinical studies in children and adolescents with major depressive episodes have not demonstrated the efficacy of venlafaxine and do not support its use in these patients (see sections 4.4 and 4.4). Side effects ).

The efficacy and safety of venlafaxine in other indications in children and adolescents under 18 years of age have not been established.

Use in patients with hepatic impairment

In general, a dose reduction of 50% should be considered in patients with mild or moderate hepatic impairment. Because of the interindividual variability of clearance, an individual adaptation of the dosage seems nevertheless desirable.

Data for patients with severe hepatic impairment are limited. Caution is advised and a reduction of more than 50% in the dosage should be considered. The potential benefit should be weighed against the risk when treating patients with severe hepatic impairment.

Use in patients with renal insufficiency

Although no dose adjustment is necessary in patients with glomerular filtration rate (GRF) between 30 and 70 ml / minute, caution is advised. In hemodialysis patients and in patients with severe renal impairment (GFR <30 ml / min) the dosage should be reduced by 50%. Because of the interindividual variability of clearance in these patients, it is desirable to adjust the dosage on a case-by-case basis.

Withdrawal symptoms observed with discontinuation of venlafaxine

Abrupt cessation of treatment should be avoided. When discontinuing venlafaxine, the dose should be gradually reduced over a period of at least one to two weeks to reduce the risk of withdrawal reactions (see sections 4.4 and 4.4). use and side effects ).

In case of poorly tolerated symptoms after a dose reduction or when treatment is discontinued, the return to the previously prescribed dosage may be considered. Thereafter, the doctor may resume the decrease in dosage, but at a more gradual pace.

Oral way.

It is recommended to take venlafaxine extended-release capsules during one meal, if possible at a fixed time. The capsules should be swallowed with a little liquid, and should not be cut, crushed, crushed or dissolved.

Patients treated with immediate-release venlafaxine tablets may switch to venlafaxine extended-release capsules at the nearest equivalent daily dosage. For example, immediate-release tablets of venlafaxine 37.5 mg twice daily may be replaced by sustained-release 75 mg once-daily capsules of venlafaxine. Individual dosage adjustments may be necessary.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Combination with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome, manifesting as agitation, tremor, and hyperthermia. Venlafaxine should not be started within 14 days of stopping treatment with an irreversible MAOI.

Venlafaxine should be discontinued at least 7 days prior to initiation of irreversible MAOI (see sections 4.4 Special warnings and precautions for use and Interactions with other medicinal products and other forms of interaction ).

Adverse effects Effexor LP

In clinical studies, the most commonly reported adverse reactions (> 1/10) were nausea, dry mouth, headache and sweating (including night sweats).

Adverse reactions are listed below by anatomic-functional class and frequency.

Frequencies are defined as follows: very common (³ 1/10), common (³ 1/100, <1/10), uncommon (³ 1/1000, <1/100), rare (³ 1/10 000), <1/1000), not known (can not be estimated from the available data).

System Organ

Very common

Frequent

Rare

Rare

Not known frequency

Blood and lymphatic system disorders

Thrombocytopeni, blood disorders including agranulocytosis, aplastic anemia, neutropenia, pancytopenia.

Immune system disorders

Anaphylactic reaction.

Endocrine disorders

Syndrome of inappropriate secretion of antidiuretic hormone (SIADH).

Metabolism and nutrition disorders

Decreased appetite.

Hyponatremia.

Psychiatric disorders

Confusional state,

depersonalization,

anorgasmia,

decreased libido, nervousness,

insomnia, abnormal dreams.

Hallucination,

derealization,

agitation,

disorders of orgasm (in women),

apathy,

hypomania,

bruxism.

Mania.

Suicidal ideation and behavior *,

delirium,

aggressiveness**.

Nervous system disorders

Dizzying sensations,

headache ***.

Drowsiness,

tremors,

paresthesia

hypertension.

akathisia /
psychomotor agitation,

syncope,

myoclonus,

coordination disorder,

balance disorder,

dysgeusia.

Convulsion.

Neuroleptic malignant syndrome (NMS),

serotonin syndrome,

extrapyramidal disorder including dystonia and dyskinesia,

tardive dyskinesia.

Eye disorders

Decreased vision including blurred vision,

mydriasis, accommodation disorder.

Closed angle glaucoma.

Affections of the ear and labyrinth

Tinnitus.

Fear of heights.

Heart conditions

Palpitations.

Tachycardia.

Ventricular fibrillation,

ventricular tachycardia (including torsades de pointes).

Vascular disorders

Hypertension, vasodilation (mainly flushing).

Orthostatic hypotension.

Hypotension, bleeding (mucous bleeding).

Respiratory, thoracic and mediastinal disorders

Yawning.

Dyspnea.

Pulmonary eosinophilia.

Gastrointestinal disorders

nausea,

dry mouth.

vomiting,

diarrhea,

constipation.

Gastrointestinal haemorrhage.

Pancreatitis.

Hepatobiliary disorders

Hepatitis, liver test abnormalities.

Skin and subcutaneous tissue disorders

Hyperhidrosis

(including night sweats)

angioedema,

photosensitivity reaction,

bruising,

eruption,

alopecia.

Stevens-Johnson Syndrome,

erythema multiforme,

Lyell's syndrome,

pruritus, urticaria.

Musculoskeletal and systemic disorders

Rhabdomyolysis.

Renal and urinary disorders

Dysuria (mainly emotional delay), pollakiuria.

Urinary retention.

Urinary incontinence.

Disorders of reproductive organs and breast

Menstrual disorders with increased bleeding or irregular bleeding (eg, menorrhagia, metrorrhagia),

ejaculation disorder,

erectile dysfunction.

General disorders and administration site conditions

Asthenia,

tired,

chills.

investigations

Increased cholesterolemia.

Weight gain,

weightloss.

Extension of the QT interval to the electrocardiogram,

longer bleeding time,

increased prolactinemia.

* Cases of suicidal ideation and suicidal behavior have been reported during or shortly after venlafaxine treatment (see Warnings and Precautions section ).

** See section Warnings and precautions for use .

*** In cumulative analyzes of clinical studies, the incidence of headache was similar in the venlafaxine group and the placebo group.

Stopping venlafaxine (especially when it is brutal) usually leads to withdrawal symptoms. The most commonly observed reactions are: dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremors, dizziness, headache and flu syndrome .

Generally, these symptoms are mild to moderate and disappear spontaneously; however, in some patients they may be severe and / or prolonged. Therefore, when treatment with venlafaxine is no longer necessary, it is advisable to gradually reduce the dosage (see sections Posology and method of administration and Warnings and precautions for use ).

Pediatric patients

In general, the adverse event profile of venlafaxine (in placebo-controlled studies) in children and adolescents (aged 6 to 17 years) was similar to that seen in adults. As in adults, loss of appetite, weight loss, increased blood pressure, and increased cholesterol in the blood have been observed (see Warnings and Precautions for Use _Special_warnings "> Warnings and Precautions section). employment ).

Adverse reactions such as suicidal ideation have been observed in pediatric clinical studies. An increase in cases of hostility and, mainly in major depressive disorder, self-aggression, has also been reported.

In particular, the following side effects have been observed in pediatric patients: abdominal pain, agitation, dyspepsia, bruising, epistaxis and myalgia.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. www.ansm.sante.fr.

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