TORPEZIL TABLETS 10MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

DONEPEZIL HCL

Available from:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (International Name):

DONEPEZIL HCL

Units in package:

10tablet Tablets; 30tablet Tablets; 100tablet Tablets

Manufactured by:

TORRENT PHARMACEUTICALS LTD.

Summary of Product characteristics

GASTROINTESTINAL CONDITIONS
Patients at increased risk for developing ulcers, e.g., those with a
history of
ulcer disease or those receiving concurrent nonsteroidal
anti-inflammatory
drugs (NSAIDs), should be monitored for symptoms.
GENITOURINARY
Cholinomimetics may cause bladder outflow obstruction.
NEUROLOGICAL CONDITIONS
Seizures: Cholinomimetics are believed to have some potential to cause
generalised
convulsions.
However,
seizure
activity
may
also
be
a
manifestation of Alzheimer's disease. Cholinomimetics may have the
potential to exacerbate or induce extrapyramidal symptoms.
PULMONARY CONDITIONS
Because of their cholinomimetic actions, cholinesterase inhibitors
should
be prescribed with care to patients with a history of asthma or
obstructive
pulmonary disease.
The administration of Donepezil hydrochloride tablets concomitantly
with
other inhibitors of acetyl cholinesterase, agonists or antagonists of
the
cholinergic system should be avoided.
SEVERE HEPATIC IMPAIRMENT
There are no data for patients with severe hepatic impairment.
INTERACTIONS WITH OTHER MEDICAMENTS
Donepezil hydrochloride and/or any of its metabolites do not inhibit
the
metabolism of theophylline, warfarin, cimetidine or digoxin in humans.
The
metabolism of donepezil hydrochloride is not affected by concurrent
administration of digoxin or cimetidine. The cytochrome P450
isoenzymes
3A4 and to a minor extent 2D6 are involved in the metabolism of
donepezil.
Ketoconazole and quinidine, inhibitors of CYP3A4 and 2D6 respectively,
inhibit
donepezil
metabolism.
Therefore
these
and
other
CYP3A4
inhibitors, such as Itraconazole and erythromycin, and CYP2D6
inhibitors,
such as fluoxetine could inhibit the metabolism of donepezil.
Ketoconazole
reportedly increased mean donepezil concentrations by about 30% in
healthy
volunteers.
Enzyme
inducers,
such
as
rifampicin,
phenytoin,
carbamazepine and alcohol may reduce the levels of donepezil. Since
the
magnitude of an inhibiting or inducing effect is unknown, such drug
combinations should be used with care.