Patient Information Leaflet

Aricept, 5 mg, film-coated tablets
Aricept, 10 mg, film-coated tablets
Donepezil hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

What Aricept is and what it is used for
Important information before taking Aricept
How to take Aricept
Possible side effects
How to store Aricept
Contents of the pack and other information

1. What Aricept is and what it is used for

Aricept contains donepezil hydrochloride as the active substance, which belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil increases the concentration of acetylcholine in the brain by slowing its breakdown.
Acetylcholine is important for memory function.
Aricept is indicated for the symptomatic treatment of mild to moderate dementia in Alzheimer's disease. Symptoms of the disease may include increasing memory loss, feelings of disorientation, and changes in behaviour.
Aricept may be used in adult patients.

2. Important information before using Aricept

When not to use Aricept
If the patient is allergic to donepezil hydrochloride or to derivatives of piperidine, or
to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Aricept, discuss with your doctor or pharmacist if any of the following situations apply to the patient:

peptic ulcer disease of the stomach or duodenum;
seizures or epilepsy;
heart disorders [such as irregular or very slow heartbeat, heart failure,
myocardial infarction, sick sinus syndrome, or supraventricular conduction disorders (sinoatrial block, atrioventricular block)];
a heart condition known as "prolonged QT interval", previously diagnosed
certain rhythm disorders called torsade de pointes, or a personal or family history of "prolonged QT interval";
low blood levels of magnesium or potassium;
asthma or other chronic lung diseases;
liver disease or history of hepatitis;
urinary tract disorders (with difficulty in passing urine);
use of antipsychotic medicines.

You should also inform your doctor if the patient is pregnant or suspects she may be pregnant.

Children and adolescents
Aricept is not indicated for use in children and adolescents (under 18 years of age).

Aricept with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Inform your doctor if the patient is taking any of the following medicines:

medicines used to treat heart rhythm disorders, e.g. amiodarone, sotalol
medicines used to treat depression, e.g. citalopram, escitalopram, amitriptyline, fluoxetine
antipsychotic medicines, e.g. pimozide, sertindole, ziprasidone
medicines used for bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
antifungal medicines, e.g. ketoconazole, itraconazole
other medicines used in Alzheimer's disease, e.g. galantamine
painkillers or medicines used for joint inflammation, e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs such as ibuprofen, diclofenac
anticholinergic medicines, e.g. tolterodine
antiepileptic medicines, e.g. phenytoin, carbamazepine
medicines used for heart conditions, e.g. quinidine, beta-blockers (propranolol and atenolol)
muscle relaxants, e.g. tetrazepam, diazepam, succinylcholine
general anaesthetics
over-the-counter medicines, e.g. herbal remedies

If the patient is scheduled for surgery requiring general anaesthesia, inform the doctor that the patient is taking Aricept. Aricept may affect the amount of anaesthetic required.

Aricept may be used in patients with kidney disease and mild to moderate liver impairment. Inform your doctor about any kidney or liver problems. Patients with severe liver impairment should not take Aricept.

Taking Aricept with food, drink and alcohol
Food does not affect the action of this medicine.
Do not drink alcohol while taking Aricept, as alcohol may alter the effect of the medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Use of Aricept during pregnancy is contraindicated. Women taking Aricept should not breastfeed.

Driving and using machines
Dementia in Alzheimer's disease may impair the ability to drive or operate machinery. Therefore, these activities should not be performed until the doctor has assessed that it is safe for the patient to do so.
Additionally, Aricept may cause fatigue, dizziness, and muscle cramps. If any of these effects occur, the patient should not drive or operate machinery.

Aricept contains lactose monohydrate. Patients with intolerance to certain sugars should consult their doctor before taking Aricept.

3. How to use Aricept

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended starting dose is 5 mg, one white tablet, taken in the evening. After one month,
the doctor may increase the dose to 10 mg, one yellow tablet, taken in the evening.
The tablet should be taken with water in the evening before going to bed.
If the patient experiences unusual dreams, nightmares or difficulty sleeping (see section 4),
the doctor may recommend taking Aricept in the morning.
The dose of Aricept used may vary depending on the duration of treatment and the recommendations
of the treating physician.
The maximum recommended daily dose is 10 mg. Do not change the dose without consulting
your doctor.
Use in children and adolescents
Aricept is not recommended for use in children and adolescents under 18 years of age.
Use in patients with renal or hepatic impairment
Patients with impaired renal function may follow a similar dosing regimen as patients with normal
renal function.
In patients with mild to moderate hepatic impairment, dose escalation should be based on individual
tolerance. There is no data available on the use of Aricept in patients with severe hepatic impairment.
Taking more Aricept than recommended
If you take more Aricept than recommended, contact your doctor immediately or go to the nearest
hospital. Bring this leaflet and the medicine’s packaging with you.
Symptoms of overdose may include: severe nausea, vomiting, salivation, excessive sweating,
bradycardia (slowing of the heart), hypotension, respiratory depression, collapse and seizures.
Progressive muscle weakness may also occur, which could lead to death if respiratory muscles are
affected. Depending on the symptoms present, the doctor will initiate appropriate treatment.
Missed dose of Aricept
If a dose is missed, take the next dose at the usual time. Do not take a double dose to make up for
a missed dose.
If Aricept has not been taken for longer than one week, contact the treating physician before
resuming treatment.
Stopping the medicine
Do not stop taking Aricept unless advised by your doctor. After stopping treatment, the benefits of
the medicine will gradually disappear over time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported in patients taking Aricept.
If any of the following adverse reactions occur while taking Aricept,
you should contact your doctor.
Severe adverse reactions:
If any of the following severe adverse reactions occur, you should seek immediate medical advice,
as urgent medical treatment may be required.

Liver dysfunction, including hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-coloured urine (Frequency: rare, may occur in fewer than 1 in 1,000 patients).
Gastric or duodenal ulcers. Symptoms of ulcers include abdominal pain and discomfort in the upper abdomen (Frequency: uncommon, may occur in fewer than 1 in 100 patients).
Bleeding from the stomach or intestines. This may cause passage of black, tarry stools or the presence of blood from the rectum (Frequency: uncommon, may occur in fewer than 1 in 100 patients).
Seizures or convulsions (Frequency: uncommon, may occur in fewer than 1 in 100 patients).
Fever with muscle stiffness, sweating, or reduced level of consciousness (a condition called neuroleptic malignant syndrome) (Frequency: very rare, may occur in fewer than 1 in 10,000 patients).
Weakness, tenderness, or muscle pain, especially if accompanied by malaise, high temperature, or dark-coloured urine. These symptoms may be due to abnormal breakdown of muscle cells, which can be life-threatening and lead to kidney dysfunction (a condition called rhabdomyolysis) (Frequency: very rare, may occur in fewer than 1 in 10,000 patients).
Fast or irregular heartbeat, fainting – these may be symptoms of a potentially life-threatening condition called torsade de pointes (Frequency unknown: cannot be estimated from available data).

Other adverse reactions include:
Very common adverse reactions (may occur in more than 1 in 10 patients):

Diarrhoea
Nausea
Headache

Common adverse reactions (may occur in fewer than 1 in 10 patients):

Muscle cramps
Fatigue
Sleep disturbances (insomnia)
Common cold
Loss of appetite
Hallucinations (false perceptions)
Unusual dreams, including nightmares
Restlessness
Aggressive behaviour
Fainting
Dizziness
Stomach discomfort, vomiting
Rash
Itching
Urinary incontinence
Pain
Accidents (patients may be more prone to falls and accidental injuries)

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):

Bradycardia (slowing of the heartbeat)
Slight increase in blood levels of creatine kinase (a muscle enzyme)
Increased salivation

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):

Extrapyramidal symptoms (movement disorders of the nervous system such as: muscle rigidity, reduced facial expression, slowed movements, motor restlessness, involuntary muscle contractions, and involuntary movements, especially of the face and tongue, but also of the hands and feet)
Sinoatrial block, atrioventricular block (heart conduction disorders)

Frequency unknown (cannot be estimated from available data):

Changes in heart function seen on ECG known as "prolongation of the QT interval"
Increased libido, hypersexuality
"Leaning Tower of Pisa" sign (involuntary muscle contraction causing abnormal twisting of the body and head to one side)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aricept

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Store below 30ºC.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Aricept contains

The active substance is donepezil hydrochloride. Two strengths of tablets are available. One coated tablet of Aricept contains either 5 mg or 10 mg of donepezil hydrochloride.
The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, purified water. The coating of the 5 mg film-coated tablet contains: hydroxypropylmethylcellulose, talc, polyethylene glycol 8000, titanium dioxide. The coating of the 10 mg film-coated tablet contains: hydroxypropylmethylcellulose, talc, polyethylene glycol 8000, titanium dioxide, yellow iron oxide.

What Aricept looks like and contents of the pack
Aricept 5 mg is white, round, biconvex, film-coated tablets, embossed with the inscription
"Aricept" on one side and "5" on the other.
Aricept 10 mg is yellow, round, biconvex, film-coated tablets, embossed with the inscription
"Aricept" on one side and "10" on the other.
Pack contains 28 film-coated tablets in blisters made of Aluminium/PVC, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Manufacturer:
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France
For further information, please contact the representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00
Detailed and up-to-date information on this product is available by scanning the QR code
located on the outer packaging using a mobile device. The same information is also available at the URL: https://www.pfizer.pl/ulotka-aricept and on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://www.urpl.gov.pl.