Active substanceRivastigmineRivastigmine Similar drugsTo uncover Alzenorm solution inwards Teva Pharmaceutical Enterprises Co., Ltd. Israel Alzenorm capsules inwards Teva Pharmaceutical Enterprises Co., Ltd. Israel Excelon® solution inwards Novartis Pharma AG Switzerland Excelon® patch through. Novartis Pharma AG Switzerland Excelon® capsules inwards Novartis Pharma AG Switzerland Dosage form: & nbspcapsules Composition:1 capsule contains: active substance: rivastigmine hydrotartrate 2.4 mg, 4.8 mg, 7.2 mg or 9.6 mg (equivalent to rivastigmine 1.5 mg, 3 mg, 4.5 mg or 6 mg); Excipients: silicon dioxide colloidal - 0.8 mg, 0.8 mg, 0.8 mg, 0.8 mg; hypromellose 1.0 mg, 2.0 mg, 2.0 mg, 2.0 mg; magnesium stearate - 1.5 mg, 1.5 mg, 1.5 mg, 1.5 mg; cellulose microcrystalline, powdered powder - 46.6 mg, 93.2 mg, 90.8 mg, 88.4 mg; cellulose microcrystalline, granular powder - 107.7 mg, 57.7 mg, 57.7 mg, 57.7 mg; shell capsules: ferric oxide, yellow oxide (E 172) 0.1116 mg, 0.403 mg, 0.279 mg, 0.353 mg; titanium dioxide (E 171) - 0.62 mg, 0.826 mg, 0.62 mg, 0.744 mg; gelatin - 61.268 mg, 60.733 mg, 60.81 mg, 60.76 mg. The capsule shell 3 mg, 4.5 mg, 6 mg contains the iron dye red oxide (E 172) - 0.037 mg, 0.291 mg, 0.139 mg, respectively. Description:Capsule 1.5 mg: opaque capsule №2 yellow color with radial marking with red ink "EXELON 1,5 mg" on the capsule body.Capsule 3 mg: opaque capsule №2 of orange color with radial marking with red ink "EXELON 3 mg" on the capsule body.Capsule 4.5 mg: opaque capsule №2 of red color, with radial marking with white ink "EXELON 4,5 mg" on the capsule body.Capsules 6 mg: opaque capsule No. 2 with a red lid and an orange-colored body, radially marked with red ink "EXELON 6 mg" on the capsule body.Contents of capsules: powder from almost white to light yellow color. Pharmacotherapeutic group:cholinesterase inhibitor ATX: & nbspN.06.D.A Cholinesterase inhibitorsN.06.D.A.03 Rivastigmine Pharmacodynamics:Rivastigmine - selective inhibitor of acetyl- and butyrylcholinesterase of the brain, used to treat Alzheimer's disease and dementia in Parkinson's disease. Rivastigmine slows the destruction of the mediator acetylcholine produced by functionally preserved neurons, and improves synaptic transmission. Wherein rivastigmine selectively increases the content of acetylcholine in the cerebral cortex and hippocampus and thus contributes to the improvement of the cholinergic neural transmission. Exelon® may have a beneficial effect in reducing the cognitive function associated with acetylcholine deficiency, particularly in dementia associated with Alzheimer's disease and Parkinson's disease.In addition, there is evidence that inhibition of cholinesterases can slow the formation of protein amyloid precursor beta fragments participating in amyloidogenesis, and thus slow the formation of amyloid plaques, which are one of the main pathological signs of Alzheimer's disease. Rivastigmine interacts with the target enzyme to form a covalent bond, which leads to a temporary inactivation of the enzyme. It was shown that in young healthy men, after taking the drug at a dose of 3 mg, the activity of acetylcholinesterase in cerebrospinal fluid (CSF) decreases by approximately 40% during the first 1.5 hours. After reaching the maximum inhibitory effect, the enzyme activity returns to its original after about 9 hours. It was shown that the activity of butyrylcholinesterase in CSF in young healthy volunteers is inhibited reversibly and restored to the original one after 3.6 hours. In patients with Alzheimer's disease inhibition of rivastigmine activity of acetylcholinesterase in CSF has a dose-dependent character in the studied dose range (up to the highest dose of 6 mg twice a day).Inhibition of butyrylcholinesterase activity is also dose-dependent; a dose of 6 mg twice a day causes a decrease in enzyme activity by more than 60% compared to the initial one. This effect of the drug Exselon® persisted for 12 months of therapy (the maximum period studied). A statistically significant correlation was found between the degree of inhibition of both CSF enzymes in rivastigmine and changes in cognitive function in patients with Alzheimer's disease; In this case, inhibition of butyrylcholinesterase in CSF is significantly and stably correlated with improved memory test results, attention and reaction speed. Pharmacokinetics:SuctionRivastigmine is rapidly and completely absorbed. The maximum concentration in the blood plasma (Cmax) is reached after about 1 hour. Due to the interaction of rivastigmine with the target enzyme, increasing the dose of the drug increases its bioavailability by 1.5 times that expected (for a given dose increase). After taking a 3 mg dose, the absolute bioavailability is about 36 ± 13%. When taking rivastigmine along with food, the absorption of rivastigmine slows down (the time of reaching Tmax is increased by 90 minutes); the value of Cmax decreases,while the area under the concentration-time curve (AUC) increases by approximately 30%.DistributionRivastigmine binds to blood plasma proteins to a low degree (approximately 40%). Rivastigmine is distributed between blood and plasma (blood / plasma ratio 0.9) in concentrations from 1 to 400 ng / ml. Easily penetrates the blood-brain barrier, reaching a maximum concentration in the blood plasma after 1-4 hours, AUC of cerebrospinal fluid and plasma is 40%. The apparent volume of distribution after intravenous administration is 1.8-2.7 l / kg.MetabolismRivastigmine is rapidly metabolized (plasma half-life (T1 / 2) is about 1 hour), mainly by hydrolysis with cholinesterase to form a decarbamylated metabolite (NAP226-90). In vitro this metabolite shows a minimal ability to inhibit acetylcholinesterase (<10%). Based on the data obtained in in vitro studies, no interaction with drugs metabolized by the following isoenzymes of the cytochrome system is expected: CYP1A2, CYP2D6, CYP3A4 / 5, CYP2E1, CYP2C9, CYP2C8, CYP2C19 or CYP2B6. According to the data obtained in the experimental studies, the main isoenzymes of cytochrome P450 are involved in the metabolism of rivastigmine to a minimal extent.These data also correspond to observations indicating the absence of human interactions of rivastigmine with drugs metabolized with the participation of cytochrome P450. The total clearance of rivastigmine after intravenous administration is approximately 130 l / h at a dose of 0.2 mg, and decreases to 70 l / h at 2.7 mg.ExcretionRivastigmine is excreted mainly by the kidneys in the form of metabolites; in the unchanged form in urine is not found out. After 24 hours after taking more than 90% of the dose is withdrawn. Less than 1% of the dose is excreted through the intestine. In patients with Alzheimer's disease, no cumulation of rivastigmine or its decarbamated metabolite is noted.Pharmacokinetics in elderly patientsIn a study of the effect of age on the pharmacokinetics of rivastigmine after oral administration at a dose of 1.0 mg, it was shown that blood plasma rivastigmine concentration is higher in older healthy volunteers (61-71 years) than in young (19-40 years). This difference increased with an increase in the dose of rivastigmine (2.5 mg): in elderly healthy volunteers, the concentration of rivastigmine plasma was 30% higher than in young ones.Age did not affect the concentration of decarbamylated phenolic metabolites. In patients with Alzheimer's disease at the age of 50 to 92 years old, clinical trials have not revealed changes in bioavailability associated with age.Impaired renal functionIt was shown that with a single oral dose of 3 mg, the concentration of rivastigmine in plasma does not differ in healthy patients and in patients with impaired renal function of severe degree (GFR <10 ml / min). Rivastigmine clearance was 4.8 l / min and 6.9 l / min in patients and in healthy volunteers, respectively. However, in patients with impaired renal function of moderate severity (GFR 10-50 ml / min), the maximum concentration of rivastigmine in blood plasma was increased by almost 2.5 times and the AUC of decarbamylated phenolic metabolites was increased by approximately 50%. The clearance of rivastigmine was 1.7 l / min. The reason for the discrepancy between the severity of renal dysfunction and the clearance of rivastigmine is not clear.Impaired liver functionAfter oral administration, the maximum concentration of rivastigmine was approximately 60% higher and the AUC was more than 2 times greater in patients with impaired liver function of mild to moderate severity compared with healthy volunteers.When 3 mg of rivastigmine was taken once or twice after taking the drug 6 mg twice daily, rivastigmine clearance was approximately 60-65% less in patients with impaired liver function of mild and moderate severity compared with healthy patients. These pharmacokinetic features do not affect the incidence and severity of adverse events. Indications:- Weak or moderately expressed dementia of the Alzheimer's type (probable Alzheimer's disease, Alzheimer's disease).- Weak or mild dementia in Parkinson's disease. Contraindications:- Hypersensitivity to rivastigmine, other carbamate derivatives or other substances that make up the drug.- Age to 18 years.- Contact allergic dermatitis in history, which arose on the background of the use of the drug Exselon® TTC. Carefully:Exelon ®, like other cholinomimetic drugs, should be used with caution in patients with sinus node weakness syndrome or conduction disorders (sinoatrial block, atrioventricular block).Cholinergic stimulation can increase the secretion of hydrochloric acid in the stomach, lead to increased obstruction of the urinary tract and exacerbation of the convulsive syndrome, so caution should be exercised when using Excelon® in patients who are predisposed to these conditions.Exelon ®, as well as other cholinomimetics, should be used with caution in patients with bronchial asthma or obstructive airways disease in the anamnesis.The use of rivastigmine in patients with severe liver dysfunction is possible under the close supervision of medical personnel; studies in this category of patients were not conducted.Taking into account the pharmacodynamic properties of rivastigmine, it should not be used concurrently with other cholinomimetic drugs. Pregnancy and lactation:PregnancyIn studies in animals rivastigmine penetrated through the placenta. There is no data on the ability of rivastigmine to penetrate the human hematoplacental barrier. Experimental data showed that rivastigmine does not have teratogenic properties.In studies in animals, there was an increase in the duration of the gestational period. The safety of the use of the drug Excelon® in pregnancy in humans has not been established so far, so the drug can be used in pregnancy only in those cases when the expected benefit of treatment exceeds the potential risk for the fetus.Breast-feedingIn studies rivastigmine and its metabolites were excreted with the milk of lactating animals. It is not known whether rivastigmine in breast milk, so during the use of the drug should abandon breast-feeding.FertilityThere is no evidence of the effect of rivastigmine on women of reproductive age.There is no evidence of the effect of rivastigmine on fertility in humans. In studies in animals, there was no negative effect on the fertility of males and females, both parents and offspring. Dosing and Administration:The drug Exelon® should be taken orally 2 times a day, during breakfast and dinner.Initial dose is 1.5 mg twice a day. When using the drug in patients, especially sensitive to the effects of cholinergic drugs, treatment should be started at a dose of 1 mg 2 times a day.Selection of a dose. The initial recommended dose is 1.5 mg 2 times a day.If after a minimum of two weeks of treatment a good tolerability is noted, the dose may be increased to 3.0 mg twice a day. In case of good tolerability, further increase to 4.5 mg 2 times a day and further up to 6 mg 2 times a day with an interval of at least 2 weeks after each dose increase is possible.Undesirable effects, namely, nausea, vomiting, abdominal pain, decreased appetite or weight loss observed during treatment, may decrease after skipping one or more doses of the drug. If undesirable effects persist, the daily dose of the drug should be reduced to the previous well-tolerated or stop taking the drug.Maintenance dose is from 3 mg to 6.0 mg twice a day. In order to achieve the best therapeutic effect, the dose of the drug should be kept at the maximum tolerable level. The effectiveness of the drug with a duration of application of more than 6 months is not established.The maximum daily dose: 6.0 mg twice a day.Supportive treatment can be continued as long as the therapeutic effect remains. Therefore, the therapeutic effect should be evaluated regularly, especially in patients receiving doses less than 3 mg twice a day.If, after 3 months of therapy with the drug in the maintenance dose, the patient does not have a positive dynamics of reducing the symptoms of dementia, treatment should be discontinued. Consideration should also be given to discontinuing therapy with the drug if the previously noted therapeutic effect is no longer observed.Renewal of the drug after a breakThe incidence and severity of AEs tend to increase with increasing doses. If the interruption in taking the drug is more than three days, resumption of treatment should be from the initial dose in order to reduce the risk of recurrence of adverse reactions (eg, severe vomiting). Gradual increase in dose is carried out stepwise, as described above.In patients with impaired renal or hepatic function, correction of the dosage regimen is not required. However, due to an increase in the exposure of the drug in patients with impaired renal function of moderate severity and poor liver function of mild and moderate severity, it is recommended that the dose of rivastigmine be carefully selected in this category of patients, due to the increased risk of developing dose-dependent adverse events.The use of rivastigmine in patients with severe liver dysfunction is possible under the close supervision of medical personnel, studies in this category of patients have not been conducted. Side effects:The most frequently reported adverse events (AEs) from the digestive system: nausea (38%), vomiting (23%), mainly during the period of increasing the dose. According to clinical studies, adverse reactions from the digestive system and weight loss were more common in women.The incidence of adverse reactions was estimated as follows: "very often" arising ≥10%, "often" - ≥1% - <10%, "infrequently" - ≥0.1% - <1%, "rarely" - ≥0 , 01% - <0.1%, "very rarely" - <0.01%, including individual spontaneous reports of AEs.In patients with Alzheimer's dementia who received Exelon® therapy, the following AEs were observed:Infectious and parasitic diseases: very rarely - urinary tract infections.Disorders of the psyche: often agitation, anxiety, confusion; infrequently-insomnia, depression; very rarely - hallucinations.Impaired nervous system: very often - dizziness; often - headache, drowsiness, tremor; rarely - a syncope; rarely convulsive seizures; very rarely - extrapyramidal symptoms (including worsening of the course of concomitant Parkinson's disease).Heart Disease: rarely - angina pectoris, myocardial infarction; very rarely - arrhythmia (bradycardia, atrioventricular block, atrial fibrillation, tachycardia).Vascular disorders: very rarely - increased blood pressure (BP).Disorders from the digestive system: very often - nausea, vomiting, diarrhea, decreased appetite; often - abdominal pain and indigestion; rarely - stomach ulcers and duodenal ulcers; very rarely - bleeding of the gastrointestinal tract (GIT), pancreatitis, severe vomiting, leading to rupture of the esophagus.Disorders from the liver and bile ducts: infrequently - violations of laboratory indicators of liver function.Disturbances from the skin and subcutaneous tissues: often hyperhidrosis; rarely - a rash, itching.Disorders from the metabolism and nutrition: often - weight loss.General disorders and disorders at the site of administration: often - increased fatigue and asthenia, general malaise; infrequently - falling.Below are the AEs that develop in patients with dementia in Parkinson's disease who received Exelon® therapy. The incidence of adverse reactions was estimated as follows: "very often" arising ≥10%, "often" - ≥1% - <10%, "infrequently" - ≥0.1% - <1%, "rarely" - ≥0 , 01% - <0.1%, "very rarely" - <0.01%, including individual reports of AEs.Disorders of the psyche: often - insomnia, anxiety, anxiety.Impaired nervous system: very often - a tremor; often - dizziness, drowsiness, headache, worsening of Parkinson's disease, bradykinesia, dyskinesia, hypokinesia, rigidity as a "cogwheel"; infrequently - dystonia.Heart Disease: often bradycardia; infrequently - atrial fibrillation, atrioventricular block.Disorders from the digestive system: very often - nausea, vomiting; often diarrhea, abdominal pain and indigestion, increased salivation, decreased appetite.Disturbances from the skin and subcutaneous tissues: often - increased sweating.General disorders and disorders at the site of administration: very often - falls; often-dehydration, increased fatigue and asthenia, gait disturbance.In addition to the above AEs with the use of the Excellon® capsule form in patients with dementia in Parkinson's disease, the following AEs were observed during a 76-week clinical trial: often, an increase in blood pressure, a decrease in blood pressure.When using the drug Exselon ® TTS in patients with dementia in Parkinson's disease during the clinical study, the following AEs were observed: frequent -diagnosis, depression.Separate reports of the following AEs were received in the form of capsules and solution in the postmarketing period (since messages are received voluntarily from a population of undetermined size, it is not possible to establish the frequency of these reactions): dehydration, aggression, anxiety, extrapyramidal disorders in patients with Alzheimer's dementia, sinus node weakness syndrome, hepatitis, common allergic dermatitis.When using the drug Excelon® TTC, the following AEs are reported: often - urinary incontinence; infrequently - impaired cerebral circulation, delirium, psychomotor agitation; rarely - erythema, urticaria, blistering, allergic dermatitis.When using Exelon® in a clinical trial in patients with dementia in Parkinson's disease, the following undesirable effects were observed, possibly indicating a worsening of the course of Parkinson's disease (compared to placebo): a tremor of 10.2% (3.9% in the placebo group) dropping 5.8% (6.1% in the placebo group), worsening of Parkinson's disease - 3.3% (1.1% in the placebo group), increased salivation - 1.4% (not detected in the placebo group), dyskinesia - 1.4% (0.6% in the placebo group), parkinsonism - 2.2% (0.6% in the placebo group), hypokinesia -0.3% (not detected in groups placebo), motor disorders - 0.3% (not detected in the placebo group), bradykinesia 2.5% (1.7% in the placebo group), dystonia 0.8% (0.6% in the placebo group), gait disorder - 1.4% (not detected in the placebo group), muscle rigidity 0.3% (not detected in the placebo group), imbalance 0.8% (1.1% in the placebo group), musculoskeletal stiffness - 0.8% (not detected in the placebo group), tremor - 0.3% (not detected in the placebo group), motor dysfunction 0.3% (not detected in the placebo group). Overdose:Symptoms. Accidental overdose of the drug in most cases was not accompanied by any clinical manifestations; almost all patients continued treatment with the drug.Overdose: nausea, vomiting, diarrhea, abdominal pain, dizziness, tremor, headache, drowsiness, bradycardia, confusion, increased sweating, increased blood pressure, hallucinations and general malaise. An overdose of cholinesterase inhibitors can lead to a cholinergic crisis with the development of symptoms such as severe nausea, vomiting, excessive salivation, increased sweating, bradycardia, lowering blood pressure, respiratory depression and seizures. Perhaps the development of muscle weakness, which can lead to a lethal outcome with the involvement of respiratory muscles. Given the vagotonic effect of cholinesterase inhibitors on the heart rate (heart rate), bradycardia and / or syncope can not be ruled out. When an overdose of the drug, there were rare cases of deaths, but the association with the use of the drug remains unclear. Symptoms and outcome varied in different patients. There was no clear connection between the dose taken and the severity of the outcome.Treatment. Since the half-life of rivastigmine from blood plasma is about 1 hour, and the duration of inhibition of acetylcholinesterase is about 9 hours, in cases of asymptomatic overdose it is recommended not to use Exelon® for the next 24 hours. If an overdose is accompanied by severe nausea and vomiting, consider the use of anti-emetics. If other undesirable phenomena occur, if necessary, appropriate symptomatic treatment is performed.If a significant overdose can be applied atropine, the initial dose of which is 0.03 mg / kg intravenously; the subsequent dosing depends on the clinical effect. The use of scopolamine as an antidote is not recommended. Interaction:Rivastigmine is metabolized predominantly by hydrolysis with the participation of esterases. The metabolism of rivastigmine with the participation of the main isoenzymes of cytochrome P450 occurs to a minimal extent. Thus, the pharmacokinetic interactions of rivastigmine with other drugs metabolized with the participation of these enzymes are unlikely.Unsupported interactionMetoclopramideGiven the possibility of the emergence of the combined effect of drugs on the extrapyramidal system, simultaneous use of metoclopramide and rivastigmine is not recommended.Drugs affecting the cholinergic system.Given the pharmacodynamic characteristics of rivastigmine, simultaneous use of it with other cholinomimetics should be avoided in connection with the possibility of developing their combined effect. Rivastigmine can affect the effect of cholinergic blockers (eg, oxybutynin, tolterodine).Salts of suxamethoniumWhen conducting anesthesia rivastigmine, being an inhibitor of cholinesterase, can enhance the effects of depolarizing muscle relaxants (eg suxamethonium salts). It is recommended to be careful when choosing anesthetics. If necessary, before the anesthesia may reduce the dose of rivastigmine or temporary stop therapy.Interactions that should be taken into accountBeta-blockersWith the simultaneous use of rivastigmiva with various beta-blockers (including atenolol), a synergistic interaction was noted that led to the development of a bradycardia, which, in turn, can cause syncopal conditions. Despite the fact that simultaneous use with cardioselective beta-blockers is associated with the greatest risk of development of such effects, AE data were also observed in patients receiving other drugs of this group. Interaction with nicotineIncreased absorption of rivastigmine by 23% when administered orally (in the form of capsules in a dose of up to 12 mg / day) in patients taking nicotine.Interaction with the most commonly used drugsIn healthy volunteers, there was no pharmacokinetic interaction between rivastigmine and digoxin, warfarin, diazepam, or fluoxetine. The increase in prothrombin time caused by warfarin with rivastigmine did not change. The simultaneous use of rivastigmine and digoxin had no adverse effect on intracardiac conductivity. The simultaneous use of rivastigmine with such commonly used drugs as antacids, antiemetics, hypoglycemic agents,anti-hypertensive agents of central action, blockers of "slow" calcium channels, drugs that have a positive inotropic effect, antianginal agents, estrogens, analgesics, including nonsteroidal anti-inflammatory drugs, benzodiazepines and antihistamines, were not accompanied by any changes in the kinetics of rivastigmine or an increased risk of clinically significant undesirable phenomena. Special instructions:Treatment should always begin with a dose of 1.5 mg 2 times a day, which is gradually increased to a maintenance dose. If the treatment is interrupted for more than three days, it is necessary to resume therapy with a minimum daily dose to reduce the likelihood of developing unwanted events.Digestive system disorders such as nausea, vomiting and diarrhea may occur at the beginning of treatment or with an increase in the dose of the drug, and may stop with a reduced dose. Otherwise, treatment with Excelon® should be discontinued. Patients who developed signs of dehydration, due to prolonged diarrhea or vomiting, are recommended intravenous fluids and a reduced dose or withdrawal of rivastigmine therapy. Dehydration can have serious consequences.It is necessary to control body weight in patients with Alzheimer's disease, since this group of patients may reduce body weight when taking cholinesterase inhibitors, including rivastigmine.Patients weighing less than 50 kg, tolerate rivastigmine better and are more likely to discontinue treatment due to AEs.As with the use of other cholinomimetics, with the use of rivastigmine, the development of urinary tract obstruction is possible, as well as the appearance or increase in the severity of extrapyramidal disorders. With the use of rivastigmine in patients with dementia in Parkinson's disease, there was an increase in the severity of motor disorders (especially tremor).After an increase in the dose of Excelon®, a short-term increase in blood pressure and hallucinations in patients with Alzheimer's dementia may occur, as well as exacerbation of extrapyramidal disorders (especially tremor) in patients with dementia in Parkinson's disease. These symptoms may disappear when the dose is reduced, otherwise the drug should be discontinued.It is necessary to regularly assess the condition of patients to identify these adverse events.Skin ReactionsSkin reactions that occur with the use of the drug Exselon® TTS, as a rule, were of mild or moderate severity. These reactions are not indicative of a patient's sensitization to rivastigmine. Nevertheless, against the background of the use of the drug Exselon ® TTS, allergic contact dermatitis may occur. With the development of contact allergic dermatitis in patients with Exelon® TTC, if there is a need to continue therapy with rivastigmine, the patient under the supervision of medical personnel and after receiving a negative result of allergological testing is recommended to be transferred to rivastigmine dosage forms for oral administration. In some patients with sensitization to rivastigmine after application of the drug Exselon® TTC, the use of rivastigmine in other dosage forms may not be possible. Allergic contact dermatitis should be suspected if a skin reaction has occurred at the site of attachment of the TTS, extending beyond the size of the TTS,or skin reactions at the attachment site have reached a marked intensity (eg, increased erythema, edema, papules, vesicles), and if the severity of skin reactions does not decrease significantly within 48 hours after removal of the TTS. In these cases, treatment with the drug should be discontinued (see section Contraindications).In the postmarketing period, data were obtained on the development of common allergic dermatitis in some patients with rivastigmine, regardless of the route of administration (either inward or transdermally). In these cases, the drug should be completely discontinued (see Contraindications section). Patients and caregivers should be informed of the possibility of developing appropriate skin reactions while using rivastigmine. Effect on the ability to drive transp. cf. and fur:Parkinson's disease and Alzheimer's disease by themselves can reduce the ability to drive vehicles and mechanisms. In patients receiving rivastigmine therapy, dizziness and drowsiness may develop, especially at the beginning of treatment or when the dose of the drug is changed.The ability of a patient with dementia treated with Excelon® to control the vehicle and / or mechanisms should be evaluated regularly by the attending physician. Form release / dosage:Capsules 1.5 mg, 3 mg, 4.5 mg, 6 mg. Packaging:14 capsules in blisters. For 1, 2, 4 or 8 blisters together with the instructions for use are placed in a cardboard box. Storage conditions:At a temperature of no higher than 30 ° C.The drug should be stored out of the reach of children.List B. Shelf life:5 years.The drug should not be used after the expiration date. Terms of leave from pharmacies:On prescription Registration number:П N014495 / 01 Date of registration:25.11.2009 The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland Manufacturer: & nbspNOVARTIS FARMACEUTICA, S.A. Spain Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC Information update date: & nbsp0910.2015 Illustrated instructions × Illustrated instructions Instructions