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Instructions

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Instruction for use: Alcenorm

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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

F02.3 Dementia in Parkinson's Disease (G20 +)

Composition and form of release

Capsules 1 caps.

active substance:

Rivastigmine hydrotartrate 2.4 mg/ 4.8 mg/7.2 mg/ 9.6 mg

(Equivalent to 1.5, 3, 4.5 and 6 mg of rivastigmine, respectively)

Auxiliary substances: MCC - 57.18 / 114.36 / 171.54 / 228.72 mg; Silicon dioxide colloidal - 0.12 / 0.24 / 0.36 / 0.48 mg; Magnesium stearate - 0.3 / 0.6 / 0.9 / 1.2 mg

Hard gelatin capsule (cap): gelatin - 14,857 / 18,689 / 30,056 / 37,965 mg; Titanium dioxide (E171) - 0.203 / 0.384 / 0.243 / 0.307 mg; The dye "Sunset Sun" yellow - 0.001 / 0.127 / 0.055 / 0.07 mg; Dye quinoline yellow - 0.14 (- / - / - mg; Dye azorubin - - (-) 0.046 / 0.058 mg

Hard gelatin capsule (body): gelatin - 22,285 / 28,034 / 45,084 / 56,068 mg; Titanium dioxide (E171) 0.304 / 0.576 / 0.365 / 1.152 mg; The dye "Sunset Sun" yellow - 0.001 / 0.19 / 0.083 / 0.38 mg; Dye quinoline yellow - 0.21 (- / - / - mg; Dye azorubin - - / - (0.068) - mg

Red ink (for capsules 1,5, 3 and 6 mg): shellac; Propylene glycol; Concentrated ammonia solution; Red iron oxide dye (E172); Potassium hydroxide; Ethanol; Isopropanol; Butanol; water

White ink (for capsules 4,5 mg): shellac; Propylene glycol; Titanium dioxide (E171); Sodium hydroxide; Ethanol; Isopropanol; Butanol; Povidone

Solution for oral administration 1 ml

active substance:

Rivastigmine hydrotartrate 3.2 mg

(Equivalent to 2 mg of rivastigmine)

Auxiliary substances: sodium benzoate - 1 mg; Sodium citrate - 7.1 mg; Citric acid - 6.9 mg; Dye yellow 06 098 (quinoline yellow (E104) - 28%, dextrose - 60%, sodium sulfate - 11.7%, silicon dioxide - 0.3%) - 0.02 mg; Water - up to 1 ml

pharmachologic effect

Pharmacological action - anticholinesterase.

Dosing and Administration

Capsules

Inside, with food, 2 times a day. Capsule must be swallowed completely, without violating its integrity.

The initial dose for adults is 1.5 mg per reception. With good tolerability (no earlier than 2 weeks), the dose can be increased to 3 mg and then to 4.5-6 mg twice a day.

The maintenance dose is 3-6 mg twice a day.

The maximum daily dose is 12 mg.

If the drug was interrupted for several days, the treatment should be resumed from the initial dose of 1.5 mg 2 times a day, gradually increasing the dose.

In patients with impaired renal and hepatic function, dose adjustment is not required.

Solution for oral administration

Inside, with meals, 2 times a day during breakfast and dinner.

Selection of a dose. The initial dose is 1.5 mg (0.75 ml solution) 2 times a day. When using Alcenorm in patients especially sensitive to cholinergic drugs, treatment should be started with a dose of 1 mg (0.5 ml solution) 2 times a day.

With good tolerability (no earlier than 2 weeks), the dose can be increased to 3 mg (1.5 ml solution). In case of good tolerance, a further dose increase up to 4.5 mg (2.25 ml solution) 2 times a day and further up to 6 mg (3 ml solution) 2 times a day with a time interval of not less than 2 weeks after each Increase in dose.

Undesirable effects, namely nausea, vomiting, abdominal pain, decreased appetite or weight loss observed during treatment, may decrease after skipping one or more doses. If undesirable effects persist, the daily dose of the Alcenorm should be reduced to a dose that the patient tolerated well.

The maintenance dose is from 1.5 mg (0.75 ml solution) to 6 mg (3 ml solution) 2 times a day. In order to achieve a good clinical effect, the dose should be kept at the maximum tolerable level.

The maximum daily dose is 12 mg (6 mg twice a day).

If the Alcenorm has been interrupted for several days to reduce the risk of developing adverse events, treatment should be resumed from the initial dose of 1.5 mg (0.75 ml solution) 2 times a day, gradually increasing the dose.

In patients with impaired renal and / or liver function, dose adjustment is not required.

Method of dosing solution for oral administration. The required amount of solution should be removed from the vial using the dispenser attached to it. The solution can be taken directly from the dispenser.

Form of issue

Capsules, 1.5 mg, 3 mg, 4.5 mg, 6 mg. For 14 caps. In a blister of PVC / aluminum foil. For 2, 4 or 8 blisters in a cardboard box.

Solution for oral administration, 2 mg / ml. For 120 ml of solution in a vial of dark glass, closed with a polypropylene lid with a control of the first opening and a system against opening the children. On 1 . Together with a syringe for dosing and a stopper for selection in a cardboard bundle.

Terms of leave from pharmacies

On prescription.

storage Conditions

At a temperature not exceeding 25 C.

Keep out of the reach of children.

Shelf life

Solution for oral administration of 2 mg / ml - 3 years. After opening the bottle - 1 month.

Capsules 1.5 mg - 3 years.

Capsules 3 mg - 3 years.

Capsules 4.5 mg - 3 years.

Capsules 6 mg - 3 years.

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

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