Signopam (Tablets) Instructions for Use

Marketing Authorization Holder

Tarchomin Pharmaceutical Works Polfa, S.A. (Poland)

ATC Code

N05CD07 (Temazepam)

Active Substance

Temazepam (Rec.INN registered by WHO)

Dosage Form

Signopam

Tablets 10 mg: 20 pcs.

Dosage Form, Packaging, and Composition

20 pcs. – blister packs (1) – cardboard packs

Clinical-Pharmacological Group

Hypnotic drug

Pharmacotherapeutic Group

Anxiolytic agent (tranquilizer)

Pharmacological Action

Anxiolytic agent (tranquilizer) from the group of benzodiazepine derivatives. It relieves states of tension, fear, anxiety, increased excitability, and irritability.

Pharmacokinetics

Temazepam is rapidly and almost completely absorbed from the gastrointestinal tract. C_max is achieved in 1-2 hours and is 669-982 ng/ml. Plasma protein binding is 96%. It penetrates the blood-brain barrier, placental barrier, and into breast milk. Steady-state concentration (C_ss) is noted after 1-3 days of treatment.

It is metabolized in the liver by direct conjugation with glucuronic acid to form inactive metabolites. Elimination occurs in 2 phases: T_1/2 in the first phase is 0.4-0.6 hours, in the second phase – 3.5-18.4 hours.80-90% is excreted by the kidneys, the remainder is excreted in feces. Accumulation upon repeated administration is minimal (belongs to benzodiazepines with short and medium T_1/2).

Indications

Neuroses and psychopathies accompanied by anxiety, fear, emotional tension, depressive and hypochondriacal syndrome, neurasthenia, involutional depression.

ICD codes

Dosage Regimen

Administer orally with water.

Initiate treatment at 10 mg three times daily.

For insufficient therapeutic response, increase the dose to a maximum of 20 mg three times daily.

Use the lowest effective dose for the shortest duration necessary to control symptoms.

Adjust dosage individually based on severity of symptoms and patient response.

Monitor patients for signs of tolerance or dependence, especially during long-term therapy.

In elderly or debilitated patients, initiate at a reduced dose to minimize risk of oversedation and ataxia.

Avoid abrupt discontinuation. Taper dose gradually to prevent withdrawal syndrome.

Total daily dosage typically should not exceed 60 mg.

Do not crush or chew tablets.

Adverse Reactions

From the central and peripheral nervous system: at the beginning of treatment (especially in elderly patients) – drowsiness, dizziness, increased fatigue, impaired concentration, ataxia, disorientation, unsteady gait and poor coordination of movements, lethargy, blunted emotions, slowed mental and motor reactions; rarely – headache, euphoria, depression, tremor, depressed mood, numbness, memory impairment (including anterograde amnesia), confusion, dystonic extrapyramidal reactions (uncontrolled body movements, including eyes), weakness, muscle weakness during the day, dysarthria, slurred speech; extremely rarely – paradoxical reactions (aggressive outbursts, psychomotor agitation, fear, suicidal tendency, muscle spasm, confusion, hallucinations, acute agitation, irritability, anxiety, insomnia).

From the cardiovascular system: decreased blood pressure; rarely – tachycardia.

From the hematopoietic system: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia.

From the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, anorexia, constipation, diarrhea, impaired liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice.

From the urinary system: urinary incontinence, urinary retention, impaired renal function.

From the reproductive system: increased or decreased libido, dysmenorrhea.

Allergic reactions: skin rash, itching.

Other: habituation, drug dependence; rarely – respiratory center depression, visual impairment (diplopia), bulimia, weight loss.

With a sharp dose reduction or discontinuation of use: withdrawal syndrome (irritability, headache, anxiety, agitation, excitement, feeling of fear, nervousness, sleep disturbance, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, including hyperacusis, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely – acute psychosis).

Contraindications

Coma, shock, acute alcohol intoxication with weakening of vital functions, acute intoxication with drugs that have a depressant effect on the central nervous system (narcotic, hypnotic and psychotropic drugs), myasthenia gravis, closed-angle glaucoma (acute attack or predisposition), severe COPD (progression of the degree of respiratory failure), acute respiratory failure, severe depression (suicidal tendencies may be noted), pregnancy, lactation (breastfeeding), children and adolescents under 18 years of age (safety and efficacy have not been established), hypersensitivity to temazepam.

Use in Pregnancy and Lactation

Temazepam is contraindicated for use during pregnancy and during lactation (breastfeeding).

Effect on the fetus: teratogenicity (especially in the first trimester), central nervous system depression, respiratory impairment and suppression of the sucking reflex in newborns whose mothers used Temazepam.

Use in Hepatic Impairment

Should be used with caution in patients with hepatic insufficiency.

Use in Renal Impairment

Should be used with caution in patients with renal insufficiency.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age (safety and efficacy have not been established).

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Should be used with caution in patients with hepatic and/or renal insufficiency, cerebral and spinal ataxias, hyperkinesis, history of drug dependence, tendency to abuse psychotropic drugs, organic brain diseases, psychosis (paradoxical reactions are possible), hypoproteinemia, sleep apnea (established or suspected), and in elderly patients.

Alcohol should not be consumed during treatment with the drug.

Effect on the ability to drive vehicles and operate machinery

Patients taking Temazepam should refrain from engaging in potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Drug Interactions

With simultaneous use of drugs that have a depressant effect on the central nervous system, an enhancement of the depressant effect on the central nervous system is possible.

With simultaneous use of oral contraceptives, the effectiveness of temazepam decreases.

A case of toxic effects of temazepam (drowsiness, confusion) has been described with simultaneous use with disulfiram.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.