Paroxetine 20 mg. 30 tablets

SANDOZ
Paroxetine 20 mg. 30 tablets
€ 17.00
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Qualitative and quantitative composition:
Paroxetine Sandoz 20 mg film-coated tablets contain 20 ml paroxetine / paroksetinov as hydrochloride, anhydrous 22.2 mg /

Therapeutic indications:
Treatment of:
- Major depressive episode
- OCD
- Panic disorder and agoraphobia or without
- Social Anxiety Disorder / Social Phobia
- Generalized anxiety
- PTSD

Dosage and administration:
It is recommended that paroxetine be used as a single daily dose in the morning with food. The tablets should be swallowed whole and not chewed.

Major depressive episode:
The recommended starting dose is 20 mg daily. The improvement started after one week, but manifests itself after the second week of therapy. As with all antidepressants, if necessary, the dose should be reviewed and adjusted between 3-4ta week after initiation of therapy and then, if necessary, according to clinical judgment. In some patients with insufficient response at 20 mg, the dose may be increased gradually to a maximum of 10 mg to 50 mg per day, depending on individual patient tolerance.
Patients with depression should be treated long enough for at least six months to complete resolution of symptoms.

Obsessive-compulsive disorder:
The recommended dose is 40 mg daily. The starting dose is 20 mg daily and may be increased gradually to 10 mg recommended dose. If after several weeks of treatment with the recommended dose insufficient response is seen in some patients the dose may be increased gradually to a maximum of 60 mg per day. Patients with OCD should be treated for a sufficient period until the symptomatology disappeared. This period may be several months or longer time.

Panic disorder:
The recommended dose is 40 mg daily. The initial dose is 10 mg daily and may be increased gradually to 10 mg, depending on individual patient tolerance. It is recommended that a lower dose in order to minimize the potential deterioration of the symptoms, which usually occurs early in the course of treatment. If after a few weeks with the recommended dose insufficient response is seen in some patients the dose may be increased gradually to a maximum of 60 mg per day.
Patients with panic disorder should be treated for a sufficient period until symptoms disappear. This period may be several months or longer time.

Social Anxiety Disorder / Social Phobia:
The recommended dose is 20 mg daily. If, after a couple of weeks, there was no satisfactory response, in some patients the dose may be increased gradually to a maximum of 10 mg to 50 mg daily. Prolonged use should be regularly evaluated.

Generalized anxiety:
The recommended dose is 20 mg daily. If, after a couple of weeks, there was no satisfactory response, the dose may be increased gradually to a maximum of 10 mg to 50 mg daily. Prolonged use should be regularly evaluated.

PTSD:
The recommended dose is 20 mg daily. If, after a couple of weeks, there was no satisfactory response, the dose may be increased gradually to a maximum of 10 mg to 50 mg daily. Prolonged use should be regularly evaluated.

Contraindications:
- Hypersensitivity to paroxetine or to any of the excipients.
Paroxetine is contraindicated in combination with monoamine oxidase inhibitors. Treatment with paroxetine can be initiated:
- Two weeks after discontinuation of irreversible MAOI or
- At least 24 hours after stopping the reversible MAOI.
It is necessary for at least one week between stopping paroxetine and initiation of therapy with MAOI.
Paroxetine should not be used in combination with thioridazine, and other drugs which inhibit the liver enzyme CYP450 2D6, since paroxetine may increase the plasma levels of thioridazine. Thioridazine alone can lead to an extension of QT- interval with severe ventricular arythmias as torsades de pointes, and sudden death.

Paroxetine should not be used in combination with pimozide.
Paroxetine should not be used in the treatment of children and adolescents under 18 years. In clinical studies in children and adolescents are more often sablyudavani hostility and suicidal behavior in patients treated with paroxetine compared with placebo.

Pregnancy and lactation
Some epidemiological studies presented slightly increased risk of cardiovascular malformations associated with the use of paroxetine during the first trimester. The mechanism is unknown. The data show that the risk to the infant when exposed to paroxetine pregnancy is less than 2/100, compared with the expected frequency of 1/100 these defects in the general population. The available data do not show an increase in the incidence of congenital defects in general.

Paroxetine should not be used during pregnancy only under strict indications. Women who plan to become pregnant and that pregnancy is detected during perapiya must consult with the prescriber. Abrupt discontinuation during pregnancy should be avoided.

Neonates should be observed if maternal use of paroxetine continues into the later stages of pregnancy, particularly the third trimester. In these cases can be observed following symptoms: respiratory distress, cyanosis, apnea, seizures, temperature fluctuations, poor feeding, vomiting, constant crying, somnolence, sleep disorders, nervousness. These symptoms may be due to serotonergic effects or withdrawal symptoms. In most cases, complications are started immediately or soon after birth.

Breastfeeding
Small amounts of paroxetine pass into breast milk. Nevertheless, paroxetine should not be used during lactation unless the benefit outweighs the potential risk to the child.


Undesirable effects:
Blood and lymphatic system:
Uncommon - bleeding, mainly skin and mucous membranes
Very rare - thrombocytopenia

Immune system disorders:
Very rare - allergic reactions

Endocrine disorders:
Very rare - syndrome of inappropriate antidiuretic hormone

Metabolism and nutrition disorders:
Common - decreased appetite
Rare - hyponatraemia
Hyponatremia has been reported predominantly in elderly patients and in some cases due to the syndrome of inappropriate antidiuretic hormone.

Psychiatric disorders:
Common: somnolence, insomnia, agitation
Uncommon - confusion, hallucinations
Rare - manic reactions, anxiety, panic attacks
With some frequency - there are reported cases of suicidal ideation and suicidal behavior during treatment with paroxetine or soon after stopping treatment.

Nervous system disorders:
Common - dizziness, tremor
Uncommon - extrapyramidal disorder
Rare - psychomotor restlessness, seizures
Very rare - serotonin syndrome, confusion, hallucinations, myoclonus, tremor, tachycardia and tremor

Eye disorders:
Common - blurred vision
Very rare - acute glaucoma

Cardiac disorders:
Uncommon - sinus tachycardia
Rare - bradycardia

Vascular disorders:
Uncommon - transient increase or decrease in blood pressure
Changes in blood pressure were observed following treatment with paroxetine in patients with pre-existing hypertension or fear.

Respiratory, thoracic and mediastinal disorders:
Common - yawning

Gastrointestinal disorders:
Very common - nausea
Uncommon - constipation, diarrhea, dry mouth
Very rare - gastrointestinal bleeding

Hepatobiliary disorders:
Rare - elevation of liver enzymes
Very rare - liver disorders

Skin and subcutaneous tissue disorders:
Common - increased sweating
Uncommon - rash, itching
Very rare - photosensitivity reactions

Renal and urinary:
Uncommon - urinary retention

Reproductive system and breast disorders:
Very common - sexual dysfunction
Rare - hyperprolactinaemia / galactorrhoea
Very rare - priapism

Disorders of the musculoskeletal system:
Rare - arthralgia, myalgia
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