Cogiton Odt

Leaflet attached to the packaging: patient information

Cogiton ODT

10 mg, orally disintegrating tablets

Donepezil hydrochloride

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

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

1. What is Cogiton ODT and what is it used for

Cogiton ODT contains the active substance donepezil hydrochloride, which belongs to a group of medicines called acetylcholinesterase inhibitors.
Cogiton ODT is used to treat the symptoms of dementia in people with mild or 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 find it increasingly difficult to cope with normal daily activities.
This medicine is intended for use only in adults.

2. Important information before taking Cogiton ODT

When not to take Cogiton ODT

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6),
• in children,
• in pregnant women,
• in breastfeeding women.

Warnings and precautions

Before starting treatment with Cogiton ODT, you should consult a doctor:

• if you have irregular or slow heartbeats (sick sinus syndrome, sinoatrial block, atrioventricular block), as donepezil may slow down the heart rate,
• if you often take painkillers,
• if you have ever had stomach or duodenal ulcers,
• if you have difficulty urinating or mild kidney disease,
• if you have ever had a seizure, as donepezil may cause another attack,
• if you have asthma or chronic lung disease (such as obstructive lung disease),
• if you have ever had liver disease.

Treatment with donepezil can only be started if it is possible to constantly monitor the patient's medication intake.

Other medicines and Cogiton ODT

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

• antifungal medicines (e.g., ketoconazole, itraconazole),
• medicines used to treat heart diseases (e.g., quinidine, beta-blockers, others),
• analgesic and anti-inflammatory medicines (e.g., acetylsalicylic acid, non-steroidal anti-inflammatory medicines such as ibuprofen or diclofenac),
• antibiotics (e.g., erythromycin, rifampicin),
• antidepressant medicines (e.g., fluoxetine),
• medicines used to treat epilepsy (e.g., phenytoin, carbamazepine),
• muscle relaxants (e.g., diazepam, succinylcholine),
• 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 diseases).

In the case of planned surgery requiring general anesthesia, the patient should inform the doctor about taking donepezil, as this medicine may enhance the effect of anesthetics.

Cogiton ODT with food, drinks, and alcohol

You should not consume alcoholduring treatment with Cogiton ODT. Alcohol may change the effect of the medicine.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, you should consult a doctor or pharmacist before taking this medicine.
Cogiton ODT is contraindicated during pregnancy.
Cogiton ODT should not be used during breastfeeding.

Driving and operating machinery

Alzheimer's disease may impair the ability to drive or operate machinery. These activities should not be performed unless the treating doctor considers it safe.
If you experience fatigue, dizziness, or muscle cramps, you should not drive or operate machinery.
Cogiton ODT contains lactose. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
Cogiton ODT contains aspartame (E951)- a source of phenylalanine. It may be harmful to patients with phenylketonuria.
Cogiton ODT contains maltodextrin (glucose). If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Cogiton ODT

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.

Dosage

The initial dose is 5 mg once a day for at least one month. If necessary, the doctor may increase it to the maximum recommended dose, which is 10 mg once a day.
NOTE:
Cogiton ODT, 10 mg, orally disintegrating tablets are not suitable for
starting treatment, as the tablets cannot be divided.
In order to start treatment, you should use otherorally disintegrating tablets
containing 5 mg of donepezil.
Patients with liver disease
The dose should be increased according to the individual patient's tolerance. Patients with severe liver disease should not take the medicine due to the lack of data on its use in this group of patients.

Method of administration

Cogiton ODT tablets should be taken orally, in the evening, immediately before bedtime.
The tablet should be placed on the tongue and left to dissolve, then swallowed. The tablet can be washed down with water.
The orally disintegrating tablet should not be divided.

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.

Use in children

Cogiton ODT should not be used in children.

Taking a higher dose of Cogiton ODT than recommended

You should not take a higher dose than recommended by your doctor.
Overdose of Cogiton ODT may lead to cholinergic crisis (too strong acetylcholine action), which is characterized by severe nausea, vomiting, excessive salivation, sweating, slow heart rate, low blood pressure, breathing disorders, fainting, and seizures. It is also possible to experience progressive muscle weakness, which can lead to death in the case of respiratory muscle involvement.
If you have taken an excessive dose of donepezil or if someone else has accidentally taken Cogiton ODT, you should immediately inform your doctor or go to the hospital. You should take the tablets and the carton with you to show them to the doctor.

Missing a dose of Cogiton ODT

You should not take a double dose to make up for a missed dose.
Treatment should be continued, following the established dosage regimen of Cogiton ODT.

Stopping treatment with Cogiton ODT

If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.
After stopping Cogiton ODT, the beneficial effects of treatment gradually disappear. You should not stop taking Cogiton ODT without consulting a doctor.

4. Possible side effects

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

• very common (more than 1 in 10 people),
• common (between 1 in 10 and 1 in 100 people),
• uncommon (between 1 in 100 and 1 in 1,000 people),
• rare (between 1 in 1,000 and 1 in 10,000 people),
• very rare (less than 1 in 10,000 people).

Severe side effects:

If you experience any of the following severe side effects, you should immediately tell your doctor. It may be necessary to start treatment immediately.

• liver damage (e.g., 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. There may be black, tarry stools or bleeding from the anus (uncommon);
• seizures (uncommon);
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called malignant neuroleptic syndrome), as immediate medical attention may be necessary;
• muscle weakness, tenderness, or pain, especially if they occur together with 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) (very rare).

Other side effects observed during treatment with donepezil:

Very common:

• diarrhea,
• nausea,
• headache.

Common:

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

Uncommon:

• slow heart rate,
• mild increase in the activity of the 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),
• heart rhythm disorders (sinoatrial block, atrioventricular block).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Cogiton ODT

Store in a place out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister pack and carton.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cogiton ODT contains

• The active substance of the medicine is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• Other ingredients are: lactose monohydrate, microcrystalline cellulose, crospovidone (type B), colloidal anhydrous silica, sodium croscarmellose, aspartame (E951), flavor [aromatic substances, maltodextrin (potato), vegetable oil (coconut-palm), modified starch E1450 (corn), triacetin E1518], sodium stearyl fumarate, yellow iron oxide (E172).

What Cogiton ODT looks like and what the packaging contains

The tablets are round (10.6 mm), flat on both sides, light beige in color, with a smooth surface, without spots or cracks.
The tablets are packaged in blisters made of OPA/Aluminum/PVC/Aluminum foil, placed in a cardboard box.
Pack sizes:
7, 28, 30, 56, or 60 tablets

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13

• 60-198 Poznań phone: +48 61 66 51 500 fax: +48 61 66 51 505 [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Data of the last update of the leaflet:

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