Instruction for use: Exelon

Active substance: Rivastigmin

ATX Code

N06DA03 Rivastigmin

Pharmacological group

Cholinesterase inhibitor [m-, n-cholinomimetics, incl. Anticholinesterase drugs]

Nosological classification (ICD-10)

F00 Dementia in Alzheimer's Disease (G30 +)

Alzheimer's dementia, Dementia in Alzheimer's disease

Composition and form of release

Transdermal therapeutic system (TTS)

active substance:

Rivastigmine 9 mg/ 18 mg/ 27 mg

(The content of rivastigmine in the TTS is 4.6 mg / day, the area is 5 cm2, 9.5 mg / day, the area is 10 cm2, 13.3 mg / day, the area is 15 cm2, respectively)

Auxiliary substances: D, L-α-tocopherol - 0,03 / 0,06 / 0,09 mg; Methyl methacrylate and butyl methacrylate copolymer - 6/12/18 mg; Acrylic acid copolymer - 14.97 / 29.94 / 44.91 mg

Adhesive layer: silicone copolymer - 14.84 / 29.67 / 44.505 mg; Dimethicone (silicone oil 12.5 cSt) - 0.15 / 0.3 / 0.45 mg; D, L-α-tocopherol-0.015 / 0.03 / 0.045 mg

Polymer films: PET substrate, 23 μm - 5/10/15 cm2; Protective fluoropolymer PET film, 75 μm - 10.13 / 20.25 / 29.16 cm2

pharmachologic effect

Pharmacological action - anticholinesterase.

Dosing and Administration

Transdermally.

The drug should be treated only under the supervision of a doctor who has experience in treating patients with dementia and under the supervision of caregivers. Patients and caregivers should be instructed by the competent medical personnel about the particulars of the drug.

Weak or moderately severe dementia of the Alzheimer's type

The initial dose and the selection of the recommended effective dose. Treatment with the drug should begin with the use of TTS ExelonŽ 4.6 mg / day 1 time per day.

After 4 weeks of treatment, a minimum, with good tolerability, the dose of the drug should be increased to the recommended effective dose by applying TTS ExelonŽ 9.5 mg / day, which can be used as long as the therapeutic effect remains.

Dose build-up. For prolonged treatment in the presence of therapeutic efficacy, the use of TTS ExcelonŽ 9.5 mg / day is recommended in the patient. If the drug is well tolerated and at least after 6 months of treatment with Excelone 9.5 mg / day, the attending physician may increase the dose to 13.3 mg / day if necessary to achieve an additional therapeutic effect in patients who, despite the use of the TTS ExcelonŽ 9.5 mg / day, there is a significant impairment of cognitive functions (for example, worsening of results on a short scale of assessment of mental status) and / or impairment of functional status (based on a subjective assessment of the doctor).

Severe dementia of the Alzheimer's type

The initial dose and the selection of the recommended effective dose. Treatment with the drug should begin with the use of TTS ExelonŽ 4.6 mg / day 1 time per day. The dose of the drug should be consistently increased first to 9.5 mg / day, and then to the effective dose of 13.3 mg / day. Each increase in the dose is possible only after 4 weeks of treatment minimum and with good tolerability of the previous dose. A dose above 13.3 mg / day does not give a significant advantage, but increases the incidence of side effects.

Interruption of treatment

It should be regularly evaluated the clinical effect of therapy with the drug ExselonŽ TTC. In the absence of a clinical effect of therapy with the use of optimal doses of TTS Excelon, it is necessary to stop therapy with the drug.

It is necessary to temporarily stop therapy with the drug in case of adverse events (AE) from the digestive system and / or worsen existing extrapyramidal symptoms (including tremor) before their resolution. If the break in the use of the drug was no more than 3 days, you can resume taking the drug at the same dose. In the case of a longer period of cancellation, treatment should be resumed from the initial dose (ExcelonŽ TTS 4.6 mg / day).

Patients treated with rivastigmine in the form of capsules or oral solutions may switch to treatment with the TTS ExcelonŽ as follows:

- In patients who received oral rivastigmine at a dose of ≤6 mg / day, treatment should begin with the use of TTS ExcelonŽ 4.6 mg / day;

- in patients who received oral therapy rivastigmine in a stable and well-tolerated dose of 9 mg / day, treatment can be started immediately with the use of TTS ExelonŽ 9.5 mg / day. But if oral therapy was not stable and well tolerated, the transition to a transdermal form is recommended starting at a dose of 4.6 mg / day;

- in patients receiving oral therapy rivastigmine at a dose of 12 mg / day, treatment can begin immediately with the use of TTS ExelonŽ 9.5 mg / day.

After 4 weeks of treatment, at a minimum, with good tolerability, the dose of TTS ExcelonŽ 4.6 mg / day should be increased to the recommended effective dose by applying TTS ExelonŽ 9.5 mg / day.

Treatment of TTS ExcelonŽ is recommended starting the day after the last oral dose of rivastigmine.

Special patient groups

Patients weighing less than 50 kg. In patients with a body weight of less than 50 kg, there was a more frequent development of AEs and withdrawal of therapy, therefore, with increasing doses in this group of patients, special care should be taken, the dose should be carefully titrated and observed for development of AEs (eg, excessive nausea or vomiting) The possibility of reducing the dose of the drug by applying TTS ExcelonŽ 4.6 mg / day in the case of the development of such AEs. Particular care should be taken when titrating the dose above the recommended effective dose of TTS ExcelonŽ 9.5 mg / day.

Violation of the function of the liver. Correction of the dosing regimen of TTS ExcelonŽ is not required. However, due to the increased exposure of rivastigmine observed with rivastigmine intake in patients with mild to moderate hepatic impairment, it is recommended that the dose of rivastigmine be carefully titrated in accordance with individual tolerability in patients in this category.

The study of the use of TTS ExcelonŽ in patients with severe impairment of liver function was not performed. Special care should be taken when titrating the dose in patients in this category.

Patients with clinically significant impairment of liver function may experience a more frequent development of dose-related adverse events, which is why patients in this category should consider the possibility of using ExcelonŽ TTS 4.6 mg / day as the initial and maximum dose.

Impaired renal function. Correction of the dosing regimen of TTS ExcelonŽ is not required. However, due to the increased exposure of rivastigmine observed with rivastigmine inwards in patients with impaired renal function of mild to moderate severity, it is recommended that the dose of rivastigmine be carefully titrated in accordance with individual tolerability in patients in this category. Patients with clinically manifested renal dysfunction may experience a more frequent development of dose-related adverse events, which is why patients of this category should consider the possibility of using ExcelonŽ TTS 4.6 mg / day as the initial and maximum dose.

Children. The use of rivastigmine in children has not been studied, therefore it is not recommended to prescribe the drug to children.

Instructions for use

Attention! Only one TTS ExcelonŽ can be used at a time. Each subsequent TTS ExcelonŽ should be glued only after the removal of the previous one. TTS ExelonŽ can not be cut or divided into parts, or damaged in any way. It should be pressed tightly with the palm of the TTS ExcelonŽ at the attachment point for at least 30 seconds.

Place of attachment of TTS ExelonŽ:

- TTS ExelonŽ is glued on a clean, dry, undamaged skin with a minimal hairline;

- Do not use creams, lotions, oils, powder and other skin care products in the area of attachment to avoid peeling;

- TTS ExelonŽ can not be applied to reddened, rashy, irritated or damaged skin;

- Only one TTS ExelonŽ per day should be glued on one of the body parts: the left or right shoulder, the upper part of the chest on the left or the right (do not stick on the breast area), the upper back from the left or the right, the lower back on the left Or right.

Every 24 hours, you must remove the previous ExcelŽ TTS before you paste one new ExcellŽ TTC.

To avoid skin irritation, every subsequent TTS ExcelonŽ should be glued to another area of the skin (within the same anatomical area). For example, if the TTS ExcelonŽ was attached to the waist area on the right, then the next time you need to place the system on the left.

To minimize the risk of skin irritation, the TTS can be glued to the same skin area only at intervals of 2 weeks.

How to attach TTS ExelonŽ:

- carefully remove the previous TTS ExelonŽ;

- remove the preparation from the sealed packet immediately before use, cutting or tearing the package along the line or groove marked with a dashed line;

- Carefully remove the protective film protecting the adhesive side of the TTS ExcelonŽ without touching the surface;

- Immediately after removal of the protective film, apply TTS ExcelonŽ to the skin of the upper or lower half of the back, shoulder or chest;

- after attaching the TTS to the skin, it is necessary to remove the upper protective layer from the other side of the TTS;

- should be pressed firmly with the palm of the TTS ExelonŽ at the attachment point for a minimum of 30 s. It must be ensured that the system fits snugly against the skin, especially around the edges;

- if necessary, after gluing it is recommended to write on the TTS with a thin ballpoint pen the date of attachment (for example the day of the week).

TTS ExelonŽ should be worn constantly and replaced with a new one after 24 hours.

TTS ExelonŽ is a thin, opaque, plastic patch for gluing to the skin.

Do not remove the ExcelonŽ TTS from the sealed bag and remove the previous ExcelŽ TTS if you do not plan to glue the new one.

The drug should be used immediately afterwards.

How to recycle used TTS ExelonŽ:

- bend the used TTS in half and join the adhesive parts together;

- place the used TTS ExelonŽ in the package. The package with the used TTS should be thrown out of reach of children. After disposal, wash your hands with soap and water.

Conditions for wearing TTS ExelonŽ (water procedures, long stay near heat sources):

- TTS ExelonŽ does not come off during water procedures (shower, bath, pool). During water procedures it is necessary to make sure that the system is snug against the skin, especially along the edges;

- patients using TTS ExelonŽ should not stay in the vicinity of any external heat sources (excessive sun radiation, saunas, solariums) for a long time.

What to do if the TTS ExelonŽ is unfastened: if the TTS ExelonŽ has become unstuck, it must be replaced with a new TTS before the end of the day. The next day, as usual, the new TTS ExcelonŽ should be attached.

If more than one ExcelonŽ TTS is used at the same time: immediately remove all TTS from the skin and inform the attending physician about what happened. The patient may need medical attention. In some cases, an overdose of nausea, vomiting, diarrhea, increased blood pressure, hallucinations. Also, bradycardia and / or fainting may occur. If the patient forgot to paste the next TTS at the usual time, stick it immediately. The application of the next TTS is possible the next day at the usual time. Do not paste two TTS to compensate for the missed dose.

Form of issue

The transdermal therapeutic system, 4.6 mg / day or 9.5 mg / day. In the package of multilayer laminate (paper covered with a film of PET, aluminum foil and polyacrylonitrile copolymer), 1 pc. 3, 7, 30 pack. In a cardboard box.

The transdermal therapeutic system, 13.3 mg / day. In a package of laminated laminate (paper covered with a PET film, aluminum foil and polyacrylnitrate copolymer), 1 pc. 7, 30 pack. In a cardboard box.

Terms of leave from pharmacies

On prescription.

storage Conditions

In a dry place, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.