DONEPEX 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Donepex, 5 mg, film-coated tablets
3. Donepex, 10 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Donepex and what is it used for
5. Important information before taking Donepex
   1. When not to take Donepex
   2. Warnings and precautions
   3. Donepex with other medicines
   4. Donepex with food, drink, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Donepex contains lactose monohydrate
6. How to take Donepex
   1. Administration in adults, including elderly patients
   2. Administration in children
   3. Administration in patients with renal impairment
   4. Administration in patients with hepatic impairment
   5. Overdose of Donepex
   6. Missed dose of Donepex
7. Possible side effects
   1. Severe side effects:
8. How to store Donepex
   1. Do not use this medicine if you notice damage to the packaging or signs of attempted opening.
9. Contents of the pack and other information
   1. What Donepex contains
   2. What Donepex looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Donepex, 5 mg, film-coated tablets

Donepex, 10 mg, film-coated tablets

Donepezilhydrochloride

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.
• 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Donepex and what is it used for

Donepex contains the active substance donepezil hydrochloride, which is a reversible inhibitor of acetylcholinesterase, the main enzyme that breaks down acetylcholine in the brain.
Donepex is indicated for the symptomatic treatment of mild to moderate Alzheimer's disease.

2. Important information before taking Donepex

When not to take Donepex

• If you are allergic to the active substance, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant.

Warnings and precautions

Particular caution should be exercised:

• in patients with heart diseases: sick sinus syndrome or conduction disorders (sinoatrial block, atrioventricular block);
• in patients with urinary tract disorders (with difficulty urinating);
• in patients with gastric or duodenal ulcer disease;
• in patients with seizure disorders;
• in patients with asthma or other chronic pulmonary diseases;
• in patients with liver disease or a history of hepatitis;
• in patients who are to undergo surgery or dental procedures. The patient should inform the doctor that they are taking Donepex;
• in patients taking antipsychotic medications. You should consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Before starting to take Donepex, you should discuss it with your doctor or pharmacist if you:

• have or have had heart disorders (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
• have or have had a heart rhythm disorder called "prolonged QT interval" or have previously been diagnosed with certain heart rhythm disorders called torsades de pointes or have a family history of "prolonged QT interval";
• have or have had low magnesium or potassium levels in the blood.

Donepex with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
It is especially important to inform your doctor if you are 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 medications, such as pimozide, sertindole, ziprasidone;
• medicines used to treat bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• antifungal medications, such as ketoconazole, itraconazole;
• other medicines used in Alzheimer's disease, such as galantamine;
• painkillers or medicines used to treat arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium;
• anticholinergic medications, such as tolterodine;
• antiepileptic medications, such as phenytoin, carbamazepine;
• medicines used to treat heart diseases, such as quinidine, beta-blockers (propranolol and atenolol);
• muscle relaxants, such as diazepam, succinylcholine;
• general anesthetics;
• over-the-counter medications, such as herbal preparations.

A patient who is to undergo anesthesia should inform the doctor that they are taking Donepex.

Donepex with food, drink, and alcohol

Food does not affect the absorption of the medicine.
During treatment with Donepex, you should not consume alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
Taking Donepex during pregnancy is contraindicated. Women taking Donepex should not breastfeed.

Driving and using machines

Donepex 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, Donepex 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.

Donepex contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Donepex

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Administration in adults, including elderly patients

The initial dose is 5 mg once daily. The 5 mg daily dose should be continued for at least one month to allow the doctor to assess the effectiveness of the treatment. After a clinical assessment of the therapy for one month at a dose of 5 mg daily, the doctor may increase the dose of Donepex to 10 mg once daily. The maximum recommended daily dose is 10 mg.
The tablets should be taken orally, in the evening, just before bedtime.
If the patient experiences unusual dreams, nightmares, or difficulty falling asleep (see section 4), the doctor may recommend taking Donepex in the morning.
If you feel that the effect of Donepex is too strong or too weak, you should consult your doctor.

Administration in children

Donepex is not recommended for use in children.

Administration in patients with renal impairment

Patients with impaired renal function may use a similar dosing regimen as patients with normal renal function.

Administration in patients with hepatic impairment

In patients with mild and moderate hepatic impairment, the dose should be increased according to individual patient tolerance.
There are no data on the use of the medicine in patients with severe hepatic impairment.

Overdose of Donepex

In case of overdose, you should immediately inform your doctor or go to the nearest hospital. Symptoms suggesting overdose may include: severe nausea, vomiting, salivation, excessive sweating, bradycardia (slow heart rate), hypotension, respiratory depression, collapse, and seizures. It is also possible to experience progressive muscle weakness that can lead to death in the case of respiratory muscle weakness. Depending on the symptoms, the doctor will administer the appropriate treatment.

Missed dose of Donepex

You should take the missed dose as soon as possible, unless it is close to the time for the next dose. In this case, you should take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Donepex can cause side effects, although not everybody gets them.

Severe side effects:

If you experience any of the following severe side effects, you should immediately consult your doctor, as you may need urgent medical attention.

• Liver dysfunction, including hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, dark urine (Frequency: rare, may occur in less than 1 in 1,000 patients);
• Gastric or duodenal ulcer disease. Symptoms of ulcers include abdominal pain and discomfort in the upper abdomen (Frequency: uncommon, may occur in less than 1 in 100 patients);
• Gastrointestinal bleeding. It can cause black, tarry stools or the appearance of blood in the rectum (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 muscle pain, especially if accompanied by malaise, high fever, or dark urine. These symptoms may be caused by abnormal muscle cell breakdown, which can be life-threatening and lead to kidney dysfunction (a condition called rhabdomyolysis) (Frequency: very rare, may occur in less than 1 in 10,000 patients);
• Rapid, irregular heartbeat, fainting, which can be symptoms 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):

• Cold
• Anorexia
• Hallucinations, unusual dreams, including nightmares, agitation, aggressive behavior
• Fainting, dizziness, insomnia
• Vomiting, gastrointestinal disorders
• Rash, itching
• Muscle cramps
• Urinary incontinence
• Fatigue, pain
• Accidents

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

• Bradycardia (slow heart rate)
• Slightly increased muscle creatine kinase activity in the blood

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

• Extrapyramidal symptoms (movement disorders of the nervous system, such as: muscle stiffness, facial rigidity, slowed movement, restlessness, involuntary muscle contractions, and involuntary movements)
• Sinoatrial block, atrioventricular block

Unknown frequency (cannot be estimated from available data)

• Changes in heart function visible on the ECG, known as "prolonged QT interval"
• Increased libido, hypersexuality
• Tower of Pisa syndrome (involuntary muscle contraction with abnormal twisting of the body and head to one side).

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 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, you can help provide more information on the safety of this medicine.

5. How to store Donepex

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Store in the original packaging.

Do not use this medicine if you notice damage to the packaging or signs of attempted opening.

Medicines should not be disposed of via wastewater or household waste. Ask your 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 Donepex contains

• The active substance of the medicine is donepezil hydrochloride. Each film-coated tablet of Donepex, 5 mg, contains 5 mg of donepezil hydrochloride.
• Other ingredients are:

core: microcrystalline cellulose, lactose monohydrate, corn starch, hypromellose, magnesium stearate,
coating: Opadry HP White (macrogol, titanium dioxide (E171), talc, polyvinyl alcohol), yellow lake quinoline (E104).
Each film-coated tablet of Donepex, 10 mg, contains 10 mg of donepezil hydrochloride.

• Other ingredients are: core: microcrystalline cellulose, lactose monohydrate, corn starch, hypromellose, magnesium stearate, coating: Opadry HP White (macrogol, titanium dioxide (E171), talc, polyvinyl alcohol).

What Donepex looks like and contents of the pack

Donepex, 5 mg, is a yellow, round, biconvex film-coated tablet.
Donepex, 10 mg, is a white, round, biconvex film-coated tablet.
Available packs: 28 tablets of 5 mg or 10 mg in a polyethylene container with a polypropylene screw cap and a tear-off ring and a desiccant in the container or PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Celon Pharma S.A.
ul. Ogrodowa 2A
05-092 Łomianki/Kiełpin
tel.: (22) 75-15-933,
e-mail: [email protected]

Manufacturer:

Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy
To obtain more detailed information about this medicine, you should contact the marketing authorization holder:
Celon Pharma S.A.
ul. Ogrodowa 2A, Kiełpin
05-092 Łomianki
tel.: (22) 75-15-933,
e-mail: [email protected]
In order to protect the medicine from unauthorized access and children, the packaging cap is equipped with a tear-off ring and a locking mechanism.
You should follow the instructions below to properly open the packaging:
 PRESS THE CAP
 TURN THE PRESSED CAP
HALF A TURN

Date of last revision of the leaflet: