Alzamed
(Donepezil)




COMPOSITION

A film-coated tablet contains: Active ingredients: Donepezil hydrochloride 5 mg or 10 mg. Excipients: Lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, hydroxypropyl cellulose Film coating composition: Opadry yellow 02F22025 (hypromellose, titanium dioxide, macrogol 6000, yellow iron oxide, talc).

THERAPEUTIC INDICATIONS

Alzamed tablets are indicated for the treatment of mild to moderately severe Alzheimer's dementia.

CONTRAINDICATIONS

- Alzamed is contraindicated in patients with a known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.

- pregnancy and lactation;

- age under 18.

ADVERSE EFFECTS

Cerebrovascular adverse reactions: uncommon - brachycardia; rarely - sinoatrial block, atrio-ventricular block.

CNS and peripheral nervous system adverse reactions: common - Syncope, increased fatigability, dizziness, headache, muscular cramps, insomnia, hallucinations, anxiety, aggressive behavior; uncommon - convulsive attacks, rarely - extrapyramidal symptoms.

GIT adverse reactions: very common - diarrhea, nausea; common - vomiting, dyspepsia, anorexia, gastrointestinal disorders; uncommon - gastrointestinal hemorrhage, peptic and duodenal ulcers.

Renal, urinary and hepatic adverse reactions: common - urorrhea; uncommon - compromised hepatic function, including hepatitis.

Skin and subcutaneous tissue adverse reactions: common - rash, itching.

Laboratory studies: uncommon - elevated serum creatine phosphokinase levels.

Other: pain of various location, 'cold'.

There have been reports of syncope and seizures. In investigating such patients the possibility of heart block or long sinusal pauses should be considered.

DOSAGE AND ADMINISTRATION

Alzamed should be taken orally, in the evening, just prior to retiring before or after the meals. Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one-month clinical assessment of treatment at 5 mg/day, the dose of Alzamed can be increased to 10 mg/day (once-a-day dosing).

In case of impaired renal and hepatic functions dose adjustments are not required.

DRUG INTERACTIONS

Due to limited clinical data on Alzmed therapy experience, the risk of currently unknown drug interactions should be considered.

Donepezil hydrochloride and/or any of its metabolites donot 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. In vitro studies have shown that the cytochrome P450 isoenzymes 3A4 and to a minor extent 2D6 are involved in the metabolism of donepezil. Drug interaction studies performed in vitro show that 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. In a study in healthy volunteers, ketoconazole increased mean donepezil concentrations by about 30%. 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. Donepezil hydrochloride has the potential to interfere with medications having anticholinergic activity. There is also the potential for synergistic activity with concomitant treatment involving medications such as succinylcholine, other neuro-muscular blocking agents or cholinergic agonists or beta blocking agents which have effects on cardiac conduction. However in an in vitro study, donepezil hydrochloride had minimal effects on hydrolysis of succinylcholine. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate.

PREGNANCY AND LACTATION

There are no adequate data from the use of donepezil in pregnant women so Alzamed should not be used during pregnancy.

Film-coated tablets. 14 tablets in a blister. 1 or 2 blisters with a leaflet in a carton box.

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