Cogiton 10

Leaflet accompanying the packaging: patient information

COGITON 5

5 mg, film-coated tablets

COGITON 10

10 mg, film-coated tablets

Donepezil hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cogiton and what is it used for
• 2. Important information before taking Cogiton
• 3. How to take Cogiton
• 4. Possible side effects
• 5. How to store Cogiton
• 6. Contents of the pack and other information

1. What is Cogiton and what is it used for

Cogiton contains the active substance donepezil hydrochloride, which belongs to a group of medicines called acetylcholinesterase inhibitors.

Indications:

Symptomatic treatment of mild to moderate Alzheimer's disease. The symptoms of the disease are: memory loss, disorientation, and changes in behavior. As a result, people with Alzheimer's disease have increasing difficulty performing normal daily activities. Donepezil therapy leads to improved cognitive function, overall intellectual ability, and social function.

2. Important information before taking Cogiton

When not to take Cogiton

• if the patient is allergic to donepezil hydrochloride, other piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6),
• in women during pregnancy.

Warnings and precautions

Before starting treatment with Cogiton, the patient should discuss the following with their doctor:

• if the patient has or has had heart problems (such as irregular or very slow heartbeat, heart failure, myocardial infarction), sick sinus syndrome, sinoatrial block, atrioventricular block, as donepezil may slow down heart rate,
• if the patient has a heart condition called "prolonged QT interval" or has previously been diagnosed with certain heart rhythm disorders called torsades de pointes or has a history of "QT interval prolongation",
• if the patient has or has had low magnesium or potassium levels in the blood,
• if the patient frequently takes painkillers,
• if the patient has or has had stomach or duodenal ulcers,
• if the patient has difficulty urinating or mild kidney disease,
• if the patient has ever had a seizure, as donepezil may cause another seizure,
• if the patient has asthma or chronic obstructive pulmonary disease (such as COPD),
• if the patient has or has had liver disease.

The patient should consult a doctor, even if the above warnings refer to past situations. Donepezil treatment can only be started if the patient's medication can be continuously monitored.

Cogiton and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should inform their doctor about taking any of the following medicines:

• medicines used to treat heart rhythm disorders (such as amiodarone, sotalol),
• medicines used to treat depression (such as citalopram, escitalopram, amitriptyline, fluoxetine),
• antipsychotic medicines (such as pimozide, sertindole, ziprasidone),
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin),
• antifungal medicines (such as ketoconazole, itraconazole),
• medicines used to treat heart conditions (such as quinidine, beta-blockers, others),
• painkillers and anti-inflammatory medicines (such as acetylsalicylic acid, non-steroidal anti-inflammatory medicines, such as ibuprofen or diclofenac),
• medicines used to treat epilepsy (such as phenytoin, carbamazepine),
• muscle relaxants (such as diazepam, suxamethonium),
• other medicines used to treat Alzheimer's disease,
• medicines that affect the cholinergic system (used, among others, to relieve stomach cramps, Parkinson's disease, motion sickness, and other conditions).

In the event of a planned surgical procedure requiring general anesthesia, the patient should inform their doctor about taking donepezil, as this medicine may enhance the effects of anesthetics.

Cogiton with food, drink, and alcohol

Consuming food and drinks does not affect the absorption of Cogiton, so it can be taken with food and drink. However, the patient should not consume alcoholduring treatment with Cogiton, as alcohol may alter the effect of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Cogiton is contraindicated during pregnancy. Cogiton should not be taken during breastfeeding.

Driving and using machines

Cogiton has a minor or moderate effect on the ability to drive or operate machines. Alzheimer's disease may impair the ability to drive or operate machines. Additionally, Cogiton may cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment or after increasing the dose. The doctor will assess the patient's ability to continue driving or operating machines while taking Cogiton. Cogiton contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Cogiton

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

Adults/elderly patients: The initial dose is 5 mg once daily for at least one month. The 5 mg daily dose should be continued for at least one month to allow the doctor to assess the effectiveness of the treatment. If necessary, the doctor may increase the dose to the maximum recommended dose. The maximum recommended daily dose is 10 mg. If the patient feels that the effect of Cogiton is too strong or too weak, they should consult their doctor. Patients with liver disease: In patients with mild or moderate liver disease, the doctor will increase the dose according to the patient's individual tolerance. Patients with severe liver disease should not take this medicine due to the lack of data on its use in this group of patients. Patients with renal impairment: No dose adjustment is necessary in patients with renal impairment.

Use in children

Cogiton is not recommended for use in children.

Method of administration

Cogiton tablets should be taken orally, in the evening, immediately before bedtime. If the patient experiences unusual dreams, nightmares, or difficulty falling asleep (see section 4), the doctor may recommend taking Cogiton in the morning. The Cogiton 10 tablet can be divided into two equal doses.

Duration of treatment

The duration of treatment is determined by the doctor, who should periodically check the patient's condition and the severity of symptoms.

Taking a higher dose of Cogiton than recommended

The patient should not take a higher dose than recommended by their doctor. Overdose of Cogiton may lead to cholinergic crisis (excessive acetylcholine activity), which is characterized by severe nausea, vomiting, excessive salivation, sweating, slowed heart rate, decreased blood pressure, respiratory disorders, fainting, and seizures. It is also possible to experience progressive muscle weakness, which can lead to death if it affects the respiratory muscles. In case of overdose or accidental ingestion of Cogiton by another adult or child, the patient should immediately inform their doctor or go to the hospital. The patient should take the tablets and the carton with them to show the doctor.

Missing a dose of Cogiton

The patient should not take a double dose to make up for a missed dose. The treatment should be continued, following the established dosing schedule of Cogiton.

Stopping treatment with Cogiton

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist. After stopping Cogiton, the beneficial effects of the treatment gradually disappear. The patient should not stop taking Cogiton without consulting their doctor.

4. Possible side effects

Like all medicines, Cogiton can cause side effects, although not everybody gets them. The frequency of side effects is defined as follows:

• very common (may affect more than 1 in 10 people)
• common (may affect up to 1 in 10 people)
• uncommon (may affect up to 1 in 100 people)
• rare (may affect up to 1 in 1,000 people)
• frequency not known (cannot be estimated from the available data)

Severe side effects:

If the patient experiences any of the following severe side effects, they should immediately tell their doctor. It may be necessary to start treatment immediately.

• liver damage (such as hepatitis). Symptoms include: feeling unwell or nausea, loss of appetite, general weakness, fever, itching, yellowing of the skin and whites of the eyes, and dark urine (rare);
• stomach or duodenal ulcers. Symptoms include: stomach pain, discomfort (indigestion) in the area between the navel and the breastbone (uncommon);
• bleeding from the stomach or intestines. Black, tarry stools or bleeding from the anus may occur (uncommon);
• seizures (uncommon);
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called neuroleptic malignant syndrome),
• muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell, high fever, or dark urine. This may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis),

rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes.

• abnormal heart rhythm (such as sinoatrial block, atrioventricular block),

Other side effects observed during donepezil treatment:

Very common:

• diarrhea,
• nausea,
• headache.

Common:

• cold,
• loss of appetite,
• hallucinations (seeing or hearing things that do not exist), unusual dreams, including nightmares, agitation, aggressive behavior,
• fainting, dizziness, insomnia (difficulty falling asleep),
• vomiting, stomach upset,
• rash, itching,
• muscle cramps,
• urinary incontinence,
• fatigue, pain,
• increased susceptibility to accidents, including falls.

Uncommon:

• slow heart rate,
• mild increase in the activity of an enzyme called muscle creatine kinase in the blood.

Rare:

• muscle stiffness, tremors, involuntary movements, especially of the face and tongue, and hands and feet (extrapyramidal symptoms),

abnormal heart rhythm (such as sinoatrial block, atrioventricular block).

• changes in heart function visible on an ECG, known as "QT interval prolongation",
• increased libido, hypersexuality,
• a condition called "Pisa tower syndrome" (a disease characterized by involuntary muscle contraction with abnormal bending of the body and head to the side).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Cogiton

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cogiton contains

Cogiton 5

• The active substance is donepezil hydrochloride. One tablet contains 5 mg of donepezil hydrochloride, which corresponds to 4.56 mg of donepezil.
• The other ingredients are: tablet core:lactose monohydrate, pregelatinized starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate. tablet coating:hypromellose, macrogol 400, titanium dioxide (E 171).

Cogiton 10

• The active substance is donepezil hydrochloride. One tablet contains 10 mg of donepezil hydrochloride, which corresponds to 9.12 mg of donepezil.
• The other ingredients are: tablet core:lactose monohydrate, pregelatinized starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate. tablet coating:hypromellose, macrogol 400, titanium dioxide (E 171), yellow iron oxide (E 172).

What Cogiton looks like and contents of the pack

Cogiton 5
Round, biconvex, white film-coated tablets with a smooth surface, without spots or cracks.
Cogiton 10
Round, biconvex, light beige film-coated tablets with a score line on one side, with a smooth surface, without spots or cracks.
The tablets are packaged in PVC/Aluminum blisters, placed in a cardboard box.
Pack sizes:
Cogiton 5
28 or 56 film-coated tablets
Cogiton 10
14, 28, 56, or 84 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: biofarm@biofarm.pl

Date of last revision of the leaflet:

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