Expiration date: 10/2025

Structure and Composition: 

Film-coated tablets. 1 tablet contains paroxetine hydrochloride 0.0228 g

Excipients: dibasic calcium phosphate, corn starch, sodium carboxymethyl starch magnesium stearate, hydroxypropyl methylcellulose PVP titanium dioxide (povidone), talc Tween 80 (polysorbate)

in blisters of 10 pieces. in a stack of cardboard 3 packaging.

Description pharmaceutical form:

Tablets, film-coated, white or almost white, round, biconvex shape. The cross section shows one or two layers. The inner layer is a white or nearly white.

Pharmacokinetics:

When administered orally at a dose of 30 mg / day, the time to reach equilibrium plasma concentration (Css) is 7-14 days. Cmax plasma levels of 61.7 ng / ml, the time to achieve -. 5.2 hours, absorption is high. Protein binding - 95%. It is metabolized in the liver to inactive metabolites (an inhibitor of CYP2D6 enzyme system). Excreted by the kidneys - 64% (unchanged - 2%) and through the gastrointestinal tract - 36% (unchanged - 1%). T1 / 2 - 21 hours.

With increasing doses and / or duration of treatment there is a nonlinear dependence on the dose pharmacokinetic parameters.

Description of the pharmacological actions:

Selectively inhibits the reuptake of serotonin (5-HT) in the central nervous system, enhances serotonergic transmission in the CNS. The action is shown in 7-14 days. It reduces anxiety, depression.

Testimony:

• Depression of various etiologies (including alarming, reactive, recurrent, atypical and postpsihoticheskih, depressive episodes of bipolar disorder, dysthymia, depression on the background of schizophrenia, organic CNS diseases and alcoholism)
  
• obsessive-compulsive (OCD)
  
• panic disorder (including with agoraphobia)
  
• Social Anxiety Disorder / Social Phobia
  
• generalized anxiety disorder
  
• Post Traumatic Stress Disorder.
  

Contraindications:

• hypersensitivity
  
• MAO inhibitors and the period within 2 weeks after their withdrawal
  
• pregnancy
  
• lactation.
  

Application of pregnancy and breastfeeding:

Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.

Side effect:

From the nervous system: insomnia, somnolence, dizziness, paraesthesia, tremor, nervousness, amnesia, agitation, fatigue, poor concentration, anxiety.

From the musculoskeletal system: myalgia, muscle weakness, myoclonus, myopathic syndrome.

From the senses: taste change, impaired vision.

With the genitourinary system: urinary retention, frequent urination, sexual dysfunction (including reduction of potency, abnormal ejaculation), decreased libido.

From the digestive system: change in appetite (increase or decrease), nausea, dry mouth, and constipation or diarrhea.

Other: rhinitis, sweating, skin rash.

Drug Interactions:

Incompatible with MAO inhibitors (interval between administration - 14 days).

When concomitant administration with tryptophan can cause "serotonin syndrome": agitation, anxiety, diarrhea.

Increases concentration protsiklidina.

In patients receiving anticoagulants increases the bleeding time at an unchanged PT.

Inductors microsomal oxidation in the liver (phenobarbital, phenytoin) reduce the concentration and effectiveness of inhibitors of microsomal oxidation - increase.

Antidepressants (nortriptyline, amitriptyline, imipramine, desipramine and fluoxetine), phenothiazines (thioridazine), antiarrhythmic drugs class IC (including propafenone) increase the risk of side effects.

Dosage and administration:

Inside, once in the morning, the tablet is swallowed whole with water.

When depression: 20 mg / day, if necessary, gradually increase the dose to 10 mg / day, with an interval of at least 1 week, the maximum daily dose - 50 mg / day. The course of treatment lasting. Efficacy was assessed after 6-8 weeks.

In renal and / or hepatic insufficiency, elderly and debilitated patients: The initial daily dose - 10 mg, the maximum daily dose - 40 mg.

Obsessive-compulsive disorder: the average therapeutic dose - 40 mg / day, if necessary - 60 mg / day.

When panic disorder: an initial dose - 10 mg / day (for possible risk reduction of acute panic symptoms), followed by weekly increases of 10 mg average therapeutic dose - 40 mg / day, the maximum dose - 60 mg / day.

Overdose:

Symptoms include nausea, vomiting, tremor, mydriasis, dry mouth, irritability.

Treatment: gastric lavage, the appointment of activated carbon. If necessary - symptomatic therapy.

Precautionary measures:

Joint reception with preparations containing lithium, carried out under the control of the concentration of lithium ions in the blood.

During the period of treatment should refrain from the use of ethanol and from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.

Caution should be exercised when administering the drug to patients with hepatic insufficiency, chronic renal insufficiency, narrow-angle glaucoma, prostatic hyperplasia, the elderly.