Lafaxine XR is indicated for the following indications:
Active substance: venlafaxine hydrochloride;
1 tablet contains venlafaxine hydrochloride 84.85 mg 169, 70 mg, which is equivalent to venlafaxine based on 75 mg or 150 mg;
Excipients: microcrystalline cellulose, hypromellose 2208, ethyl cellulose, magnesium stearate, colloidal silicon dioxide, shell (ethyl cellulose aqueous dispersion, dibutyl sebacate, hypromellose, macrogol 400, carnauba wax (only for dosing 150 mg).
Hypersensitivity to venlafaxine or to any of the excipients of the preparation.
Concomitant treatment with irreversible MAO inhibitors (MAO inhibitors) is contraindicated due to the risk of developing serotonin syndrome with symptoms such as agitation, tremors, and hyperthermia. Venlafaxine should not be started for at least 14 days after stopping treatment with irreversible MAO inhibitors.
Treatment with venlafaxine should be discontinued at least 7 days before starting therapy with irreversible MAO inhibitors.
For oral administration.
It is recommended to take venlafaxine extended-release with food at about the same time every day. Swallow the tablets whole with liquid. They cannot be divided, crushed, chewed or dissolved.
Pregnant
There are no relevant data on the use of venlafaxine in pregnant women.
Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Venlafaxine should be given to pregnant women only if the expected benefit outweighs the potential risk.
Children
Lafaxin® XR should not be used to treat children and adolescents under the age of 18.
Drivers
Any psychoactive preparation can impair judgment, thinking, and motor skills. Thus, patients receiving venlafaxine should be warned about the effect of the preparation on driving and operating mechanisms.
It is recommended to carry out general supportive and symptomatic measures; heart rate and vital signs must be monitored. Vomiting is not recommended if there is a risk of aspiration. Gastric lavage may be prescribed immediately after taking the preparation or in patients with symptoms. The intake of activated carbon can also limit the absorption of the active substance. It is unlikely that forced diuresis, dialysis, hemoperfusion, and exchange transfusion will benefit the patient. No specific antidotes for venlafaxine are known.
The most common (> 1/10) adverse reactions reported were nausea, dry mouth, headache, and intense sweating (including night sweats).
Venlafaxine should not be used in combination with irreversible non-selective MAO inhibitors. Venlafaxine should not be started for at least 14 days after stopping treatment with irreversible non-selective MAO inhibitors. Treatment with venlafaxine should be discontinued at least 7 days before starting therapy with irreversible nonselective MAO inhibitors (see Sections "Contraindications" and "Peculiarities of use").
Keep out of the reach of children at a temperature not exceeding 25 ° C.
Shelf life is 3 years.
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