Pajjiż: Għarabja Sawdita
Lingwa: Ingliż
Sors: SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء
ZOLPIDEM
RIYADH PHARMA, Saudi Arabia
N05CF02
ZOLPIDEM
10 mg
Film-coated tablet
Oral use
20 Blister
Generic
Prescription
RIYADH PHARMA, Saudi Arabia; RIYADH PHARMA(Saudi Arabia)
Agent: RIYADH PHARMA; Price: 27.7; Storage conditions: store below 30°c
Marketed; Valid
2005-01-01
ZOLPIGEN ® 10 MG FILM COATED TABLETS COMPOSITION: TABLETS: Each film coated tablet contains Zolpidem Tartrate (BP) 10 mg. CLINICAL PHARMACOLOGY: Zolpidem Tartrate is an imidazopyridine which is reported to have similar sedative properties to the benzodiazepines, but minimal anxiolytic, muscle relaxant and anticonvulsant properties. It has a rapid onset and short duration of action. INDICATIONS: ZOLPIGEN is indicated for the short-term treatment of insomnia in situations where the insomnia is debilitating or is causing severe distress for the patient. CONTRAINDICATIONS: n Hypersensitivity to zolpidem or any component of the formulation. n Obstructive sleep apnoea, myasthenia gravis, severe hepatic insufficiency, acute pulmonary insufficiency or respiratory depression. n Zolpidem should not be prescribed for children under the age of 18 years. PRECAUTIONS: n As with other hypnotic drugs, zolpidem should be used with caution in patients exhibiting symptoms of depression. n Zolpidem should not be prescribed for patients with psychotic illness. n Caution should be exercised when prescribing for patients with a history of drug or alcohol abuse. n Caution should be used in patients with hepatic impairment and avoided if severe. n Caution should be used in patients with renal impairment and elderly. n As with all hypnotics, avoid prolonged use of zolpidem. EFFECT ON ABILITY TO DRIVE AND USE MACHINES: Vehicle drivers and machines operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness the morning after therapy. ADVERSE REACTIONS: Diarrhoea, nausea, vomiting, vertigo, dizziness, headache, drowsiness, asthenia, amnesia, dependence, memory disturbances, nightmares, nocturnal restlessness, depression, confusion, diplopia, tremor, ataxia, falls, skin reactions, changes in libido and paradoxical effect. DRUG INTERACTIONS: n Concomitant administration of zolpidem with alcohol may enhance the sedative effect. This affects the ability to drive or use machines. n Concomitant use of zolp Aqra d-dokument sħiħ