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4.2 Posology and application form
Posology / application frequency and duration:
Adults / seniors:
The treatment starts with a single dose of 5 mg per day. The earliest clinical responses to treatment
and for achieving steady-state concentrations of donepezil hydrochloride 5
Dosage of mg / day should be maintained for at least one month. Dosage of 5 mg daily for one month
assessed the clinical response provided by DOZYL, the dose of 10 mg per day
It can be upgraded. The highest recommended daily dose is 10 mg. Doses above 10 mg / day
have not been examined in clinical trials.
If treatment is interrupted, a beneficial decrease in the beneficial effects of DOZYL is observed.
After a sudden interruption of treatment, any "rebound" effect or withdrawal effect
It was encountered.
Method of Application:
DOZYL should be taken orally once a day and just before bedtime.
Additional information on special populations
Renal insufficiency: Since the clearance of donepezil hydrochloride is not affected by these conditions,
a dose program similar to patients with renal impairment may be administered.
2nd
Hepatic insufficiency: possible exposure to mild to moderate hepatic insufficiency
dose adjustments should be made according to individual tolerability. Stable alcoholic cigar
In a study involving 10 patients, the DOZYL clearance, age and gender
compared to 10 healthy individuals who were mated.
Pediatric population: Donepezil hydrochloride reveals efficacy and safety in children
it is not recommended to use it in children.
Geriatric population: Originally the association of the pharmacokinetics of DOZYL with age
No study has been done to investigate. However, Alzheimer's
the mean plasma concentrations followed in elderly patients are higher in young healthy volunteers
is comparable to what is seen.
4.3 Contraindications
DOZYL donepezil hydrochloride, piperidine derivatives or derivatives thereof
is contraindicated in patients known to be hypersensitive to any substance.
4.4 Special warnings and precautions for use
The treatment establishes a diagnosis of Alzheimer type dementia and is experienced in treating the disease
be initiated and guided by a physician. Diagnosis is based on accepted guidelines (eg,
DSM IV, ICD 10). Donepezil therapy is the only treatment
should be initiated when there is a responsible person (patient relatives, caregiver etc) who can check.
As long as the patient benefits from the medication, the treatment should continue. Therefore,
the clinical benefits of donepezil should be reassessed for a period of time. Therapeutic effect
when there is no evidence of its existence it should be decided to stop the medicine. the people
the response they will give to the donepezil is unpredictable.
Donepezil hydrochloride can be used for other dementia types and other memory disorders (eg Amnesty
Mild cognitive impairment).
Anesthesia: Donepezil hydrochloride, a cholinesterase inhibitor,
succinylcholine type may increase muscle relaxation.
Cardiovascular states: Cholinesterase inhibitors cause heart disease due to pharmacological effects
may cause vagotonic effects (such as bradycardia) on the pulse. Potential to see this effect
"sick sinus syndrome", other supraventricular disorders such as sinoatrial or atrioventricular block
may be particularly important for patients with impaired cardiac conduction.
Reports of syncope and convulsions are available. When these patients are examined, heart block or
should be considered on the long sinus pause.
Gastrointestinal conditions: Cholinomimetics can increase gastric acid production. Ulcer
story or non-steroidal anti-inflammatory drug (NSAID) sites such as ulcers
Patients with high developmental risk should be closely monitored in terms of the indication. With this
In clinical studies comparing donepezil hydrochloride with placebo, peptic ulcer
or no increase in the incidence of gastrointestinal bleeding.
Genitourinary system: Donepezil hydrochloride can not be observed in clinical trials
Together, cholinomimetics can lead to bladder outlet obstruction.

Central nervous system: Seizures: Cholinomimetics leading to generalized convulsions
are believed to be carrying potential. However, seizures are also indicative of Alzheimer's disease
can. Cholinomimetics have the potential to induce or enhance extrapyramidal indications
has.
Pulmonary system: Depending on the cholinomimetic effects, cholinesterase inhibitors
should be used with caution in patients with a history of obstructive pulmonary disease.
Donepezil hydrochloride, with other acetylcholinesterase (AChE) inhibitors, cholinergic system
agonist or antagonist should be avoided.
Mortality in vascular dementia clinical trials: High-probability or possible vascular
6-month 3-month study of individuals who meet the NINDS-AIREN criteria for dementia (VaD)
clinical trial was conducted. NINDS-AIREN criteria, dementia completely vascular
to identify patients caused by causes and Alzheimer's disease patients
out of work.
When the mortality rates in these three VaD studies are combined, donepezil hydrochloride
mortality rate (1.7%) in the placebo group as numerical value
(1.1%) compared to the previous year. However, this result was not statistically significant.
Mortality in patients using donepezil hydrochloride or placebo may be due to various vascular
of the underlying vascular diseases, such as the elderly
is an expected result for the population.
Analysis of vascular events, both fatal and non-fatal, was performed in the donepezil hydrochloride group
compared with placebo.
When Alzheimer's disease trials were combined (n = 4146), these studies showed that vascular dementia
(n = 6888) were included in the placebo group
the mortality frequency in the donepezil hydrochloride group was calculated numerically
overshoot.
Neuroleptic malignant syndrome (NMS): NMS is a disease threatening life and hyperthermia, muscle
rigidity, autonomic instability, variable consciousness status, serum creatinine phosphokinase levels
characterized by ascension; in addition to myoglobinuria (rhabdomyolysis) and acute renal
failure may also be seen. NMS associated with donepezil use, particularly concurrent antipsychotic
reported in infrequent cases. If the patient points to the NMS
when symptoms are present or when there is no other clinical manifestation of NMS
If unexplained high fever occurs, donepezil treatment should be discontinued.
This drug contains lactose. Rare hereditary galactose intolerance, Lapp lactose insufficiency or
patients with glucose-galactose malabsorption problems should not use this drug.
4.5 Interactions with other medicinal products and other forms of interaction
Simultaneous use of donepezil hydrochloride and other cholinesterase inhibitors
It should be avoided.
Donepezil hydrochloride and / or any of its metabolites may be administered to humans in the presence of theophylline,
cimetidine, digoxin, thioridazine, risperidone and sertraline.
Donepezil hydrochloride metabolism, digoxin, cimetidine, thioridazine, risperidone, and
is not affected by simultaneous use with sertraline.
4
In a study of patients with Parkinson's disease who received optimal treatment with L-Dopa / carbidopa, 21
day of donepezil hydrochloride administration L-Dopa or carbidopa blood levels
it has no effect. No effect was seen on motor activity in this study. In vitro
Studies have shown that in donepezil metabolism, cytochrome P450 isoenzyme CYP3A4 and less
has also shown that isoenzyme CYP2D6 is involved. In vitro drug interaction studies,
Ketoconazole, a CYP3A4 inhibitor, and quinidine, a CYP2D6 inhibitor, donepezil
metabolism. For this reason, this and other CYP3A4 inhibitors
(such as itraconazole and erythromycin) and CYP2D6 inhibitors (such as fluoxetine)
metabolism. In a study of healthy volunteers, ketoconazole
the average donepezil concentrations increased by 30%. These increases,
than the increase in ketoconazole on other agents sharing the CYP-3A4 system
and it is unlikely that there will be clinical interest. Donepezil administration ketoconazole
has no effect on pharmacokinetics.
Enzyme inducers such as rifampicin, phenytoin, carbamazepine and alcohol, donepezil levels
It may decrease. Since the prophylactic effect of the inhibiting or inducing effect is unknown,
combinations should be used with caution. Donepezil hydrochloride anticholinergic activity
have the potential to interact with medicines they have. At the same time, succinylcholine, other
neuromuscular junction blocking agents or cholinergic agonists or cardiac delivery
synergistic activity with concurrent therapy with drugs such as beta-blocker agents
There is also potential.
4.6. Pregnancy and lactation
General advice:
Pregnancy Category: C
Woman with childbearing potential

it can cause fatigue, dizziness and muscle cramps during the increase. Therapeutic practitioner
physician, donepezil treatment patients with the ability to use a vehicle or a complex machine
regularly.
4.8 Undesirable effects
The most common undesirable effects are diarrhea, muscle cramps, fatigue, nausea, vomiting, and
Insomnia.
Alzheimer's patients in all stages using DOZYL below have undesirable effects
encounter frequency.
The incidents reported more than once are based on the frequency of incidence and system organ class
listed: [Very common (≥1 / 10); common (≥1 / 100, <1/10); uncommon (≥1 / 1,000,
<1/100), and rare (≥1 / 10,000, <1 / 1,000), very infrequent (<1/10000), unknown
can not be predicted by moving from the data)].
Infections and infestations:
Common: Colds
Metabolism and nutritional disorders:
Common: Anorexia
Psychiatric disorders:
Common: Halusation **, agitation **, aggressive behavior **, abnormal dreams
Nervous system disorders:
Common: Syncope *, dizziness, insomnia
Uncommon: Seizure *
Rare: Extrapyramidal symptoms
Very rare: Neuroleptic malignant syndrome
Cardiac disorders:
Uncommon: Bradycardia
Rare: Sinoatrial block, atrioventricular block
Gastrointestinal disorders:
Very common: diarrhea, nausea
Common: Vomiting, abdominal discomfort
Uncommon: gastrointestinal bleeding, gastric and duodenal ulcers
Hepato-bilious disorders:
Rare: liver dysfunction including hepatitis ***
Skin and subcutaneous tissue disorders:
Common: Rash, itching
Musculoskeletal, connective tissue and bone disorders:
Common: Muscle cramps
Kidney and urinary system disorders:
Common: Urinary incontinence
6
General and application zone disorders:
Very common: Headache
Common: Pain, exhaustion
Research:
Uncommon: slight increases in muscle protein kinase concentrations in serum
Injury and poisoning:
Common: Accident
Patients diagnosed with syncope or seizures have a long history of heart block or sinus rhythm
the possibility of a pause should be considered. (see Section 4.4)
** Declaration of hallucinations, agitation and aggressive behaviors may result in dose reduction or
treatment has been resolved.
*** Termination of DOZYL treatment in case of unexplained liver dysfunction
It should be considered.
4.9 Overdose and treatment
Animal study data
Donepezil hydrochloride, taken as a single oral dose in mice, rats and dogs,
mean lethal dose are 45, 32 and 15 mg / kg, respectively, which are the maximum recommended for human
dose is approximately 225, 160 and 75 times the value of 10 mg per day, respectively. cholinergic
The dose-related indications of the stimulation were observed in the animals,
decrease, prone lying position, walking sagging, tear secretion, clonic
convulsions, difficulty in breathing, saliva secretion, myosin, fasciculation and body surface
The temperature is also falling.
Symptoms of overdose / Cholinergic crisis
Overdosage with cholinesterase inhibitors, severe nausea, vomiting, salivation, sweating,
bradycardia, hypotension, respiratory distress, collapse and convulsions.
may result in a crisis. Increased muscle weakness is a possibility, including respiratory muscles
it can result in death.
Treatment
As with any overdose case, general support measures should be used. Donepezil
the dose of atorvastatin (1 to 2 mg intravenous infusion
dose may be followed by subsequent doses depending on the clinical response) such as tertiary (tertiary)
anticholinergics in the structure can be used. In quaternary (quaternary) structures such as glycopyrrolate
When taken with anticholinergics, other cholinomimetics may cause blood pressure and heart beat
atypical responses have been reported. Donepezil hydrochloride and / or its metabolites can be dialysed
(hemodialysis, peritoneal dialysis or hemofiltration) is not known.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cholinesterase inhibitors
ATC code: N06DA02
Acetylcholinesterase, the predominant cholinesterase in the donepezil hydrochloride brain,
is a reversible (reversible) inhibitor. Donepezil hydrochloride, mainly the central nerve

which is an enzyme outside of the system,
1000 times more potent inhibitor.
Clinical studies
Alzheimer's disease of mild to moderate severity
In clinical trials involving patients with Alzheimer type dementia, 5 mg or 10 mg
taking single dose of donepezil hydrochloride per day, measurements following desire
the activity of acetylcholinesterase (63.6% and 77.3%, respectively, on erythrocyte membranes
measured steady state inhibition. AChE in red blood cells
inhibiting by hydrochloride and examining selected properties of cognitive function
has been shown to be consistent with the changes in the ADAS-COG which is a sensitive scale. Donepezil
Hydrochloride has the potential to alter the course of the underlying neuropathology
not been studied. For this reason, donepezil hydrochloride has an effect on the progression of the disease
unthinkable.
The efficacy of Donepezil in the treatment of Alzheimer type dementia was studied in four placebo controlled studies
(2 studies for 6 months and 2 studies for 1 year).
In clinical trials, an analysis was performed as a result of 6 months of donepezil treatment. It
In the analysis, 3 efficacy criteria were used together. ADAS-cog, information from the patient
(CIBIC + - global functions of the clinician)
Measures), Daily Life Activities of Clinical Dementia Measurement Scale Subscale (CDR - Social
at home, at home and in personal care).
Patients who meet the features listed below are considered to have responded to treatment.
Answer = At ​​least 4 points improvement in ADAS-Cog
No deterioration in CIBIC +
The Daily Living Activities of the Clinical Dementia Measurement Scale
Donepezil, dozza dependence in the percentage of patients who were decided to respond to treatment
in terms of statistical significance.
8
5.2 Pharmacokinetic properties
1. Absorption: Maximum plasma levels are reached approximately 3 to 4 hours after oral intake.
Plasma concentrations and area under the curve (EAA) are increasing proportionally.
Since the half-life is about 70 hours, it is stable to take a single dose daily
resulting in a gradual approach to the situation. 2 - 3 weeks after treatment is started
the approximate steady state is reached. Once the steady state has been reached,
Concentrations of donepezil hydrochloride and its related pharmacodynamic activity were measured throughout the day
very little change.
The absorption of donepezil hydrochloride is not affected by food.
2. Distribution: Donepezil hydrochloride accounts for approximately 95% of plasma proteins
Connected. Attachment of the active metabolite 6-O-desmethyldonepeziline to plasma proteins
It is unknown. Donepezil hydrochloride is dispersed to various body tissues precisely
not been studied. However, a mass balance in healthy male volunteers
the dose of C14-labeled donepezil hydrochloride 5 mg was 240
After about 28% of the drug was not released. This may be achieved by using donepezil hydrochloride and / or
metabolites may last 10 days in the body for a long time.
3. Biotransformation: Donepezil hydrochloride cytochrome P450 system (especially CYP3A4 and
moreover, the CYP2D6 isoenzymes)
number of metabolites are translated. A single dose of 5 mg of 14 C-labeled donepezil hydrochloride
, the dose taken is expressed as a percentage of the plasma radioactivity
essentially, intact donepezil hydrochloride (30%), 6-O-desmethyl donepezil (11%
the only metabolite exhibiting activity similar to donepezil hydrochloride activity), donepezil-cis-Noxide
(9%), 5-O-desmethyl donepezil (7%), 5-O-desmethyl donepezil glucuronide conjugate (3%
It has been identified.
4. Elimination: Plasma half life is about 70 hours. Acid donepezil hydrochloride
Approximately 57% of the dose was excreted in urine (17% unconjugated), 14.5% stool
, indicating that biotransformation and excretion by urine are the main routes of excretion
shows. Any of the donepezil hydrochloride and / or its metabolites
there is no evidence of enterohepatic circulation.
Special groups:
Plasma concentrations of donepezil hydrochloride of sex, race and smoking habits
there is no clinical effect that can be considered significant. Donepeziline pharmacokinetics are healthy
in the elderly, Alzheimer's patients or vascular dementia patients
not been studied. However, the average plasma levels of the patients
close to the volunteers.
In patients with mild to moderate hepatic insufficiency, the steady state of donepezil
konsan

mutagenicity
Donepezil was not mutagenic in the analysis of bacterial and mammalian cell mutations.
Donepezil hydrochloride reverse bacterial mutation and in mouse lymphoma tests genotoxic
It is not. In chromosomal exchange tests, in vitro, the cells are over-toxic
3000 times more than plasma levels in steady-state and steady-state
some clastogenic effects have been observed in concentrations but in vivo mouse micronucleus
no clastogenic or other genotoxic effects have been observed in the model and in vivo / in
No DNA damage was observed in the UDS test in vitro.
carcinogenicity
Donepezil hydrochloride was administered in CD-1 mice and dosed at 180 mg / kg / day (mg / kg
Approximately 1100 times the highest recommended human dose or mg / m2 recommended
about 90 times the highest human dose) for a period of up to 88 weeks
carcinogenicity study, or Sprague-Dawley rats at 30 mg / kg / day (mg / kg
approximately 180 times the recommended highest human dose or mg / m2 recommended
about 30 times higher than the highest human dose)
evidence of carcinogenic potential in carcinogenicity studies
unsubstituted.
Fertility
Donepezil hydrochloride, 10 mg / kg / day (mg / m2 recommended highest human
dose about 8 times the dose) in the rats on fertility
the mating cycle did not have any effect except for a slight extension of the cycle. Donepezil
hydrochloride was not found to be teratogenic in rats or rabbits. 10 pregnant rats
At doses up to mg / kg / day, stillbirths and lightness on newborn survival
(see Section 4.6 - Pregnancy and lactation).
6. PHARMACEUTICAL PROPERTIES
6.1 List of auxiliary substances
Lactose Granule
Kollidon VA 64
Prejelatinized starch
Avicel PH 102
Magnesium Stearate
Film Coating Content:
Opadry II 85F32019 Yellow *
* Composition: Quinoline yellow lacquer, polyethylene glycol, talc, titanium dioxide E171,
polyvinyl alcohol, yellow iron oxide E172.
6.2 Incompatibilities
It is invalid.
6.3 Shelf life
36 months.
6.4 Special measures for storage
Store at room temperature below 25 ° C, protected from light and moisture.
10
6.5. The nature and content of the packaging
Each film-coated tablet contains 28 tablets of blister pack containing 10 mg of donepezil hydrochloride
It is presented.
6.6. Removal of remaining substances from medical medicinal products and other special measures
"Medical Waste Control Regulation" and "Packaging and Packaging Waste Control
Regulation ".

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