Cogiton odt

Package leaflet: Information for the patient

Cogiton ODT
10 mg, orodispersible tablets
Donepezili hydrochloridum
Read the entire leaflet before starting to take the medicine, because it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific person only. 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 worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Table of contents:

1. What Cogiton ODT is and what it is 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 pack and other information

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

Cogiton ODT contains donepezil hydrochloride as the active substance, which belongs to a group of medicines called acetylcholinesterase inhibitors.
Cogiton ODT is used to treat symptoms of dementia in patients with mild to moderate Alzheimer's disease. Symptoms of the disease include memory loss, disorientation, and changes in behaviour.
As a result, people with Alzheimer's disease find it increasingly difficult to manage normal daily activities.
This medicine is intended for use in adults only.

2. Important information before taking Cogiton ODT

When not to take Cogiton ODT

• if the patient is 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, consult your doctor:

• if the patient has irregular or slow heartbeat (sick sinus syndrome, sinoatrial block, atrioventricular block), because donepezil may slow down heart rate,
• if the patient frequently takes painkillers,
• if the patient has ever been diagnosed with peptic ulcer of the stomach or duodenum,
• if the patient has difficulty urinating or mild kidney disease,
• if the patient has ever had a seizure, because donepezil may provoke another attack,
• if the patient has bronchial asthma or chronic lung disease (e.g. chronic obstructive pulmonary disease),
• if the patient has ever been diagnosed with liver disease.

Treatment with donepezil should only be initiated when continuous monitoring of the patient's medication intake is possible.

Other medicines and Cogiton ODT
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines:

• antifungal medicines (e.g. ketoconazole, itraconazole),
• medicines used for heart conditions (e.g. quinidine, beta-blockers, others),
• painkillers and anti-inflammatory medicines (e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs such as ibuprofen or diclofenac),
• antibiotics (e.g. erythromycin, rifampicin),
• antidepressants (e.g. fluoxetine),
• medicines used for epilepsy (e.g. phenytoin, carbamazepine),
• medicines with muscle-relaxant effects (e.g. diazepam, succinylcholine),
• other medicines used for Alzheimer's disease,
• medicines affecting the cholinergic system (used, among others, to relieve stomach cramps, Parkinson's disease, locomotor disease, and other conditions).

If the patient is scheduled for surgery requiring general anaesthesia (narcosis), he/she must inform the doctor about taking donepezil, as this medicine may enhance the effects of medicines used during anaesthesia.

Cogiton ODT with food, drink and alcohol
Alcohol must not be consumed during treatment with Cogiton ODT. Alcohol may alter the effect of the medicine.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or if the patient plans to become pregnant, consult your doctor or pharmacist before taking this medicine.
Cogiton ODT is contraindicated during pregnancy.
Cogiton ODT must not be used during breastfeeding.

Driving and operating machinery
Alzheimer's disease may impair the ability to drive or operate machinery. These activities must not be performed unless the treating doctor considers them safe.
If fatigue, dizziness, or muscle cramps occur, the patient must not drive or operate machinery.

Cogiton ODT contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, consult 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 the patient has previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Cogiton ODT

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.

Dosage
The initial dose is 5 mg once daily for at least one month. If necessary, the doctor may increase the dose to the maximum recommended dose of 10 mg once daily.

WARNING:
Cogiton ODT, 10 mg, orodispersible tablets are not suitable for initiating treatment, because the tablets cannot be divided.
To initiate treatment, use other orodispersible tablets containing 5 mg of donepezil.

Patients with liver disease
In patients with mild or moderate liver disease, the dose should be increased according to individual patient tolerance. Patients with severe liver disease should not take the medicine due to lack of data on its use in this patient group.

Method of administration
Cogiton ODT tablets should be taken orally, in the evening, just before bedtime.
Place the tablet on the tongue and wait until it dissolves, then swallow it. The tablet may be taken with water.
Orodispersible tablets must not be divided.

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

Use in children
Cogiton ODT must not be used in children.

Taking more than the recommended dose of Cogiton ODT
Do not take a higher dose than prescribed by the treating doctor.
Overdosing on Cogiton ODT may lead to cholinergic crisis (excessive acetylcholine activity), which may manifest as severe nausea, vomiting, excessive salivation, sweating, slowed heart rate, low blood pressure, breathing difficulties, collapse, and convulsions. Progressive muscle weakness may also occur, which may lead to death if respiratory muscles are affected.
In case of accidental overdose of donepezil or accidental ingestion of Cogiton ODT by another adult or child, contact a doctor immediately or go to hospital. Bring the tablets and the carton box with you to show to the doctor.

Missed dose of Cogiton ODT
Do not take a double dose to make up for a missed dose.
Continue treatment according to the prescribed dosing schedule of Cogiton ODT.

Stopping treatment with Cogiton ODT
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
After discontinuation of Cogiton ODT, the beneficial effects of treatment gradually wear off. Do not stop taking Cogiton ODT without consulting your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of adverse reactions is described below:

• very common (in more than 1 in 10 people),
• common (in 1 to 10 in 100 people),
• uncommon (in 1 to 10 in 1,000 people),
• rare (in 1 to 10 in 10,000 people),
• very rare (in fewer than 1 in 10,000 people).

Serious adverse reactions:
If any of the serious adverse reactions listed below occur in the patient, you must immediately inform
the doctor. Immediate treatment may be necessary.

• 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 passing dark-coloured urine (rare);
• stomach or duodenal ulcers. Symptoms include: stomach pain, discomfort (dyspepsia) in the area between the navel and the breastbone (uncommon);
• bleeding from the stomach or intestines. This may present as black, tarry stools or bleeding from the rectum (uncommon);
• seizures (uncommon);
• fever with muscle stiffness, sweating, or reduced level of consciousness (a condition called neuroleptic malignant syndrome), as immediate medical help may be required;
• muscle weakness, tenderness or pain, especially when occurring together with feeling unwell, high fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (very rare).

During treatment with donepezil, the following adverse reactions have also been observed:
Very common:

• diarrhoea,
• nausea,
• headache.

Common:

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

Uncommon:

• slowing of the heartbeat,
• slight increase in the activity of an enzyme called creatine kinase in the blood.

Rare:

• muscle stiffness, tremor, involuntary movements, particularly of the face and tongue, as well as hands and feet (extrapyramidal symptoms),
• heart rhythm disorders (sinoatrial block, atrioventricular block).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Cogiton ODT
Keep out of the 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 and carton.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information
What Cogiton ODT contains

• The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• Other ingredients are: monohydrate lactose, microcrystalline cellulose, crospovidone (type B), colloidal anhydrous silica, sodium croscarmellose, aspartame (E 951), flavouring substance [aromatic substances, maltodextrin (potato), vegetable oil (coconut-palm), modified starch E1450 (corn), triacetin E1518], sodium stearyl fumarate, yellow iron oxide (E 172).

What Cogiton ODT looks like and contents of the pack
Round tablets (10.6 mm), flat on both sides, light beige in colour, with a smooth surface, free from spots and chipping.
The tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium, placed in a cardboard box.
Pack sizes:
7, 28, 30, 56 or 60 tablets

Marketing Authorisation 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
[email protected]

This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:
Poland: Cogiton ODT
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