Oropram 20 mg. 30 tablets

COMPOSITION
Drug in one tablet: Citalopram hydrobromide, eq. Citalopram 20 mg of
Other ingredients: microcrystalline cellulose, mannitol, magnesium stearate, colloidal anhydrous silica, hiproleloza, macrogol, pigment - titanium dioxide (E171)
 
 
PHARMACEUTICAL FORM AND CONTENTS
Oropram  20 mg in a 10-tablet blister, 3 blisters in a box
 
 
ACTION
Oropram is effective against depression and anxiety. Its effect is due to specific inhibition of the reuptake of serotonin (a substance that mediates the transmission of the pulses) in the brain. The drug did not affect the conduction system of the heart, blood pressure and increases the effects of alcohol. There is a mild sedative.
 
 
INDICATIONS
• Depression;
• Panic disorder with or without fear of open spaces (agoraphobia).
 
 
NECESSARY INFORMATION BEFORE USE
 
CONTRAINDICATIONS
• Hypersensitivity to the product or any of the excipients;
• Concomitant treatment with MAO inhibitors.
 
 
SPECIAL PRECAUTIONS FOR USE
The product is used with caution in patients with impaired hepatic or renal function.
Depression is accompanied by suicidal risk and early treatment this risk can be increased.
In some patients with panic disorder at the beginning of treatment may be enhanced anxiety - a paradoxical reaction, which subsides in about two weeks. In elderly patients may decline the level of sodium in the blood, probably due to altered secretion of antidiuretic hormone. In abrupt withdrawal of treatment can be observed withdrawal symptoms and therefore it should be done gradually over 2 weeks. In some cases, in patients with bipolar disorder may provoke manic phase, which requires discontinuation of treatment. In some cases can develop t. Pomegranate. Serotonin syndrome - anxiety, tremors, confusion, muscle cramps and fever.
 
 
 
DRUG INTERACTIONS AND OTHER
Oropram and MAO inhibitors should not be taken simultaneously. When required between the adoption of these products must have at least 14 days interval.Pri combined ingestion of lithium can not exclude interaction, which requires caution.
In patients on insulin therapy and glucose may be a change in response to insulin, which may require dose adjustment of antidiabetic medications.
 
 
SPECIAL WARNINGS FOR USE IN SPECIFIC GROUPS OF PATIENTS
 
The product is used with caution in patients with impaired hepatic or renal function.
 
Pregnancy and lactation
Experience with Oropram in pregnant women is limited, and therefore the application must be done only after careful benefit / risk.Ne known whether the product passes into breast milk, but in laboratory animal studies small amounts are found in milk.
 
 
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Patients taking Oropram can expect impaired attention and concentration ability. They can be caused by disease, treatment, or both. Such patients should be warned that their ability to drive or operate machinery may be impaired.
 
 
 
INFORMATION FOR PROPER USE DOSAGE
adults
The product was applied once daily, the dose may vary.
• Depression - initial dose of 20 mg daily, can be increased to 40 mg daily if necessary. Doses higher than 60 mg daily are not recommended. For patients over 65 years of age, the recommended dose is half of that - 10-30 mg daily and the maximum dose is 40 mg daily.
The product should be taken at least 2-3 weeks before the last nego.Prodalzhitelnostta effect of treatment is 4-6 months depending on the patient's response.
 
• Panic disorders - in order to avoid exacerbation of the condition are recommended lower doses. The recommended starting dose is 10 mg daily. After one week of treatment the dosage is increased up to 20 mg daily. The usual maintenance dose is 20-30 mg daily. If the patient's response is not satisfactory, the dose can be increased, but the maximum dose should not exceed 60 mg. In the treatment of panic disorder maximum effect is achieved after three months and continued with continuous treatment.
Discontinuation of treatment should be gradual.
In patients with impaired hepatic function the maximum daily dose should not exceed 30 mg.
 
 
children
The product is not recommended for children.
 
 
 
ACTION OVERDOSE
In case of overdose with the product, adverse reactions may be intensified. Can be observed confusion, sweating, nausea, vomiting, tremor, drowsiness, rapid heartbeat.
 
treatment
Adequate access of air. Can be applied emptying of the stomach or gastric lavage and activated charcoal. There are cardiac and vital signs by symptomatic and supportive treatment.
Not suitable Forced diuresis, dialysis, hemoperfusion. There is no specific antidote.
 
 
SIDE EFFECTS
Side effects of the product were mild and resolved rapidly even during prolonged treatment.
Common (> 1%):
System - headache, sweating, fatigue, headache, tremor, weight changes, dizziness, abnormal ejaculation, menstrual disorders; Cardiovascular system - feeling fast heartbeat, drop in blood pressure on standing up, fast heartbeat;
CNS - sleep disturbances and perception, prickling, extrapyramidal disorders;
Gastrointestinal - nausea, constipation, diarrhea, dry mouth; Genitourinary system - difficulty in urination, abnormal ejaculation, menstrual disorders;
Eye analyzer - accommodation disorders.
 
Rare (0.1-1%):
System - malaise, yawning;
CNS - hyperexcitability, confusion, concentration difficulties, reduced libido, and interrupted ejaculation;
Gastrointestinal tract - increased salivation;
Skin - rashes;
Respiratory system - nasal congestion;
Analizator- eye dilated pupils.
 
 
Very rare (<0.1%):
CNS - mania.
 
 
STORAGE
At temperatures below 25 c.
 
 
SHELF LIFE
4 (four) years from date of manufacture.