ZOLPIGEN Film-coated tablet

Country: Saudi Arabia

Language: English

Source: SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

Active ingredient:

ZOLPIDEM

Available from:

RIYADH PHARMA, Saudi Arabia

ATC code:

N05CF02

INN (International Name):

ZOLPIDEM

Dosage:

10 mg

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

20 Blister

Class:

Generic

Prescription type:

Prescription

Manufactured by:

RIYADH PHARMA, Saudi Arabia; RIYADH PHARMA(Saudi Arabia)

Product summary:

Agent: RIYADH PHARMA; Price: 27.7; Storage conditions: store below 30°c

Authorization status:

Marketed; Valid

Authorization date:

2005-01-01

Patient Information leaflet

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