COGITON 5
COGITON 10
Donepezili hydrochloridum

5 mg or 10 mg, coated tablets

Active ingredients:

The active ingredient in the tablets is 5 mg of donepezil hydrochloride, which corresponds to 4.56 mg of donepezil, or 10 mg of donepezil hydrochloride, which corresponds to 9.12 mg of donepezil.

Auxiliary substances:
The tablet core contains:

lactose monohydrate, modified starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.

The tablet coating contains:

hypromelose, polyethylene glycol 400, titanium dioxide (E171).COGITON 10 contains additionally yellow iron oxide in tablet coating.

Available packaging:

cardboard boxes of 28 or 56 tablets in blister packs.

Name and address of the entity responsible:

Biofarm Sp. z o.o., 60-198 Poznań, ul. Wałbrzyska 13.

1. What is COGITON and when is it used?
2. Before using COGITON.
3. How should COGITON be used?
4. Possible side-effects.
5. Storage
6. Other information

1. What is COGITON and when is it used?

The active ingredient of COGITON is donepezil. The key effect of donepezil is specific and reversible inhibition of acetylcholinesterase, the main enzyme participating in acetylcholine breakdown in nerve endings in the central nervous system.
Donepezil treatment results in improvement of cognitive abilities, general intellectual abilities and functioning in the society.

COGITON is recommended in:

symptomatic treatment of mild and moderately severe forms of dementia in Alzheimer?s disease.

2. Before using COGITON

COGITON is contraindicated in patients with known hypersensitivity to donepezil hydrochloride, piperidine derivatives or any other ingredient of the medication. COGITON must not be given to children. COGITON is also contraindicated during pregnancy.

Precautions and special warnings

Donepezil treatment should only be started if constant monitoring of medication-taking by patient is possible.
Caution is advised and doctor must be informed in the following cases: scheduled surgeries under general anaesthesia, cardiac diseases, frequent use of analgesic medications, history of chronic peptic ulcer disease, history of bronchitic asthma, convulsive seizures and urination disorders.

Use of COGITON with food and beverages

Consumption of foods and beverages has no effect on the absorption of COGITON. Therefore it can be taken with food and beverages.

Use of COGITON in children

COGITON should not be used in children.

COGITON during pregnancy

Consult your doctor of pharmacist before taking any type of drug.

COGITON is contraindicated during pregnancy.

COGITON during lactation

COGITON should not be taken during lactation.

Driving and operation of machinery

Donepezil can cause a feeling of fatigue and dizziness. It can also bring about muscular contractions, particularly at the beginning of therapy and after a dosage increase.
The managing doctor should systematically assess the ability to drive motor vehicles and operate machinery in Alzheimer patients treated with donepezil.
It must be noted that physical and mental efficiency may be reduced as a result of Alzheimer?s disease.

Interactions with other drugs

Donepezil hydrochloride and its metabolites have no effect on the metabolism of warfarin, theophylline, cymetidine and digoxine in people.
Ketoconazole and quinidine (CYP3A4 and 2D6 inhibitors) inhibit donepezil metabolism. Other CYP3A4 inhibitors (e.g. itraconazole, erythromycin) and CYP2D8 (e.g. fluoxetine) can also inhibit donepezil metabolism. Ketoconazole may increase donepezil concentration by 30%.

Extreme caution is advised in the case of simultaneous administration of donepezil and rifampicin, fenytoine, carbamazepine and alcohol because of induction of microsomal enzymes of the liver and reduced donepezil concentration in the serum.
Donepezil shows interactions with cholinolytic drugs. If donepezil is taken in conjunction with succinylcholine, drugs inhibiting or stimulating cholinergic transmission or beta adrenolytic medications, synergism between drugs may occur.

Always inform your doctor of any medications taken recently, including non-prescription drugs.

3. How should COGITON be used?

The use of COGITON requires strict control. COGITON is to be taken orally, one tablet daily, in the evening. The medication is to be taken irrespective of meals.
The initial dose is 5 mg daily. The dosage must be maintained for at least one month, which enables a sufficient clinical evaluation of the efficacy of treatment. Following one month?s therapy, the dose may be increased to 10 mg daily.

The maximum recommended daily dose is 10 mg.

Patients with renal or hepatic failure do not require a change of dosage.
If the patient feels that COGITON?s action is too weak or too strong, consult your doctor.

Taking a higher COGITON dose than the recommended daily dose

The use of acetylcholinesterase inhibitors in excessive doses may result in cholinergic crisis manifesting itself in nausea, vomiting, excessive salivation, bradycardia, drop in blood pressure, dyspnoea (shortness of breath), collapse and convulsions.
Increasing muscular weakness may be life-threatening if respiratory muscles are affected.
In the case of overdosage, anticholinergic drugs must be administered (e.g. atropine) and resuscitation treatment must be given. Initial doses of atropine sulfate are from 1.0 to 2.0 mg intravenously. Subsequent atropine doses must be adjusted to the patient?s condition.

In the case of taking a dose that is higher than the recommended dose, consult your doctor or pharmacist immediately.

Missing a dose

Continue the treatment following the recommended dosage instructions.

Do not take a double dose to make up for a missed one.

4. Possible side-effects.

As with every type of drug, COGITON may produce undesirable side-effects.
The most common side-effects include digestive system disorders such as diarrhoea, nausea and vomiting. Muscular contractions, fatigue and insomnia were also observed. Other undesirable side-effects produced by donepezil include headaches, increased susceptibility to injuries, colds, gastrointestinal disorders, dizziness.

Other, though infrequent, side-effects include fainting, bradycardia, sinoatrial block, atrioventricular block, convulsions.
Cases of hepatitis were also recorded.
Very infrequent side-effects include mental disturbances, e.g. hallucinations, excitation, aggression.

Decrease in dosage or discontinuation of donepezil treatment resulted in total reduction of all symptoms. Sporadic symptoms include anorexia nervosa, chronic peptic and duodenal ulcer disease, bleeding in the digestive tract, extrapyramidal symptoms.
Increased muscle creatine kinase activity in the serum was also reported.

5. Storage

The drug should be stored in a place that is inaccessible and invisible to children.
The drug should be stored in a dry place at room temperature, i.e. 15oC ? 25oC.
Do not take the drug past the expiry date.

6. Other information

In order to obtain additional information about the drug, please contact a representative of the entity responsible.

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
POLAND
Telephone no.: 061 66 51 500