ARICEPT 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is Aricept and what is it used for
3. Important information before taking Aricept
   1. When not to take Aricept
   2. Warnings and precautions
   3. Children and adolescents
   4. Aricept and other medicines
   5. Taking Aricept with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
4. How to take Aricept
   1. Taking Aricept in children and adolescents
   2. Taking Aricept in patients with kidney and liver problems
   3. Taking more Aricept than prescribed
   4. Missing a dose of Aricept
   5. Stopping Aricept treatment
5. Possible side effects
   1. If you experience any of the following side effects, contact your doctor.
   2. Aricept
6. How to store Aricept
7. Contents of the pack and other information
   1. What Aricept contains
   2. What Aricept looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet: 10/2022

Package Leaflet: Information for the Patient

Aricept, 5 mg, film-coated tablets
Aricept, 10 mg, film-coated tablets
Donepezil hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Aricept and what is it used for

Aricept contains the active substance donepezil hydrochloride, which belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil works by slowing down the breakdown of acetylcholine, increasing its concentration in the brain.
Acetylcholine is important for memory function.
Aricept is used to treat the symptoms of mild to moderate Alzheimer's disease. Symptoms include increasing memory loss, disorientation, and changes in behavior.
Aricept can be used by adult patients.

2. Important information before taking Aricept

When not to take Aricept

If you are allergic to donepezil hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Aricept, discuss with your doctor or pharmacist if any of the following apply to you:
stomach or duodenal ulcer;
seizures;
heart problems (such as irregular or very slow heart rate, heart failure, heart attack, sick sinus syndrome, or atrioventricular block);
a heart condition called "prolonged QT interval" or a history of certain heart rhythm disorders called torsades de pointes;
low magnesium or potassium levels in the blood;
asthma or other long-term lung diseases;
liver disease or a history of liver inflammation;
urinary tract problems (with difficulty urinating);
taking antipsychotic medicines.
You should also tell your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

Aricept is not recommended for use in children and adolescents (under 18 years).

Aricept and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Tell your doctor if you are taking any of the following medicines:

• medicines for irregular heartbeats, such as amiodarone, sotalol
• medicines for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• antipsychotic medicines, such as pimozide, sertindole, ziprasidone
• medicines for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, such as ketoconazole, itraconazole
• other medicines for Alzheimer's disease, such as galantamine
• painkillers or medicines for arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs, such as ibuprofen, diclofenac
• anticholinergic medicines, such as tolterodine
• antiepileptic medicines, such as phenytoin, carbamazepine
• medicines for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as tetrazepam, diazepam, suxamethonium
• general anesthetics
• over-the-counter medicines, such as herbal remedies.

If you are going to have surgery that requires general anesthesia, tell your doctor that you are taking Aricept. Aricept may affect the amount of anesthetic needed.
Aricept can be used in patients with kidney problems and mild to moderate liver problems. Tell your doctor if you have kidney or liver problems. Patients with severe liver problems should not take Aricept.

Taking Aricept with food, drink, and alcohol

Food does not affect the action of the medicine.
Do not drink alcohol while taking Aricept, as alcohol may change the effect of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Aricept if you are pregnant. Women taking Aricept should not breastfeed.

Driving and using machines

Alzheimer's disease may affect your ability to drive or use machines. Do not drive or use machines until your doctor has told you it is safe to do so.
Aricept may also cause drowsiness, dizziness, and muscle cramps. If you experience any of these effects, do not drive or use machines.
Aricept contains lactose monohydrate.Patients with intolerance to some sugars should contact their doctor before taking Aricept.

3. How to take Aricept

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended starting dose is 5 mg, one white tablet, taken in the evening. After one month, your doctor may increase the dose to 10 mg, one yellow tablet, taken in the evening.
Swallow the tablet with water, in the evening before going to bed.
If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may advise you to take Aricept in the morning.
The dose of Aricept may be changed depending on the duration of treatment and your doctor's advice.
The maximum recommended daily dose is 10 mg. Do not change the dose without consulting your doctor.

Taking Aricept in children and adolescents

Aricept is not recommended for use in children and adolescents under 18 years.

Taking Aricept in patients with kidney and liver problems

Patients with kidney problems may take the same dose as patients with normal kidney function.
In patients with mild to moderate liver problems, the dose may be increased according to individual tolerance. There is no data on the use of Aricept in patients with severe liver problems.

Taking more Aricept than prescribed

If you take more Aricept than prescribed, contact your doctor or go to the nearest hospital immediately. Bring this leaflet and the medicine pack with you.
Signs of overdose may include: severe nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure, respiratory depression, and seizures. It is also possible to experience progressive muscle weakness, which can lead to death in the case of respiratory muscle weakness. Depending on the symptoms, your doctor will provide appropriate treatment.

Missing a dose of Aricept

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have missed taking Aricept for more than one week, consult your doctor before taking the medicine again.

Stopping Aricept treatment

Do not stop taking Aricept unless your doctor tells you to. After stopping treatment, the benefits of the medicine will gradually disappear.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aricept can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Aricept.

If you experience any of the following side effects, contact your doctor.

Aricept

Severe side effects:
If you experience any of the following severe side effects, seek medical help immediately.

• liver problems, including hepatitis. Signs of hepatitis include nausea or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (Frequency: rare, may occur in less than 1 in 1,000 patients).
• stomach or duodenal ulcers. Signs of ulcers include stomach pain and discomfort in the upper abdomen (Frequency: uncommon, may occur in less than 1 in 100 patients).
• bleeding from the stomach or intestines. This may cause black, tarry stools or blood in the stool (Frequency: uncommon, may occur in less than 1 in 100 patients).
• seizures or convulsions (Frequency: uncommon, may occur in less than 1 in 100 patients).
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called neuroleptic malignant syndrome) (Frequency: very rare, may occur in less than 1 in 10,000 patients).
• weakness, tenderness, or pain in the muscles, especially if accompanied by feeling unwell, high temperature, or dark urine. These symptoms may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (Frequency: very rare, may occur in less than 1 in 10,000 patients).
• fast, irregular heartbeat, fainting, which may be signs of a life-threatening condition called torsades de pointes (Frequency: unknown, cannot be estimated from available data).

Other side effects include:
Very common side effects (may occur in more than 1 in 10 patients):

• diarrhea,
• nausea
• headache

Common side effects (may occur in less than 1 in 10 patients):

• muscle cramps
• fatigue
• sleep problems (insomnia)
• cold
• loss of appetite
• hallucinations (delusions)
• unusual dreams, including nightmares
• agitation
• aggressive behavior
• fainting
• dizziness
• stomach problems, vomiting
• rash
• itching
• urinary incontinence
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon side effects (may occur in less than 1 in 100 patients):

• bradycardia (slow heart rate)
• mild increase in muscle enzyme levels in the blood
• increased salivation

Rare side effects (may occur in less than 1 in 1,000 patients):

• extrapyramidal symptoms (movement disorders, such as: muscle stiffness, reduced facial expressions, slow movements, restlessness, involuntary muscle contractions, and involuntary movements, especially of the face and tongue, but also of the hands and feet)
• atrioventricular block (heart problems)

Unknown frequency (cannot be estimated from available data):

• changes in heart function visible on an ECG called "prolonged QT interval"
• increased libido, hypersexuality
• a condition called "torticollis" (involuntary muscle contraction leading to abnormal twisting of the head and neck)

Reporting side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Aricept

Keep the medicine out of the 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 month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aricept contains

• The active substance is donepezil hydrochloride. Aricept is available in two strengths. One film-coated tablet of Aricept contains either 5 mg or 10 mg of donepezil hydrochloride.
• The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, purified water. The coating of the 5 mg tablet contains: hydroxypropyl methylcellulose, talc, macrogol 8000, titanium dioxide. The coating of the 10 mg tablet contains: hydroxypropyl methylcellulose, talc, macrogol 8000, titanium dioxide, yellow iron oxide.

What Aricept looks like and contents of the pack

Aricept 5 mg is a white, round, biconvex film-coated tablet with "Aricept" engraved on one side and "5" on the other.
Aricept 10 mg is a yellow, round, biconvex film-coated tablet with "Aricept" engraved on one side and "10" on the other.
The pack contains 28 film-coated tablets in aluminum/PVC blisters in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
Manufacturer:
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France
For more information, contact the representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet: 10/2022

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the website: 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.