Donepex

Package leaflet: Information for the patient

Donepex, 5 mg, film-coated tablets
Donepex, 10 mg, film-coated tablets
Donepezil hydrochloride
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents

1. What Donepex is and what it is 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 Donepex is and what it is used for

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

2. Important information before using Donepex

When not to use Donepex

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

Warnings and precautions
Special caution is required:

• in patients with heart diseases: sick sinus syndrome or supraventricular conduction disorders (sinoatrial block, atrioventricular block);
• in patients with urinary tract or genital disorders (with difficulties in passing urine);
• in patients with peptic ulcer of the stomach or duodenum;
• in patients with seizures;
• in patients with asthma or other chronic lung diseases;
• in patients with liver disease or history of hepatitis;
• in patients scheduled for surgery or dental procedures. The patient should inform the physician that they are taking Donepex;
• in patients taking antipsychotic medications. Consult a physician, even if the above warnings relate to conditions occurring in the past.

Before starting treatment with Donepex, discuss with a doctor or pharmacist if the patient:

• has or has had heart disorders (such as irregular or very slow heartbeat, heart failure, myocardial infarction);
• has or has had a heart condition known as "prolonged QT interval", or previously diagnosed certain rhythm disorders called torsade de pointes tachycardia, or has a family history of "prolonged QT interval";
• has or has had low blood levels of magnesium or potassium.

Donepex with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
It is particularly important to inform your doctor if you are 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 to treat 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 to treat joint inflammation, e.g. acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium 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. diazepam, succinylcholine;
• general anaesthetics;
• over-the-counter medicines, e.g. herbal preparations.

Patients scheduled for anaesthesia should inform their doctor that they are taking Donepex.
Donepex with food, drink and alcohol
Food does not affect the absorption of the medicine.
Alcohol should not be consumed during treatment with Donepex.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor or pharmacist before using this medicine.
The use of Donepex during pregnancy is contraindicated. Women taking Donepex should not breastfeed.
Driving and operating machinery
Donepex has a minor or moderate effect on the ability to drive or operate machinery.
Dementia in Alzheimer's disease may impair the ability to drive or operate machinery. In addition, Donepex may cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment or after dose increase. The physician will assess whether patients with Alzheimer's disease taking Donepex may continue driving or operating machinery.
Donepex contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Donepex

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult
your doctor or pharmacist.
Use in adults, including elderly patients
The starting dose is 5 mg once daily. The 5 mg daily dose should be continued for at least one month,
allowing the doctor to assess the effectiveness of treatment. After clinical evaluation following one
month of therapy with 5 mg daily, the doctor may increase the dose 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 sleeping (see section 4), the doctor
may advise taking Donepex in the morning instead.
If you feel that the effect of Donepex is too strong or too weak, consult your doctor.
Use in children
Donepex is not recommended for use in children.
Use in patients with renal impairment
Patients with impaired renal function may follow a similar dosing regimen as patients with normal
renal function.
Use in patients with hepatic impairment
In patients with mild to moderate hepatic impairment, dose escalation should be based on individual
tolerance. There is no available data on the use of Donepex in patients with severe hepatic
impairment.
Taking more Donepex than recommended
If you take more Donepex than recommended, inform your doctor immediately or go to the nearest
hospital. Symptoms suggesting overdose may include: severe nausea, vomiting, salivation, excessive
sweating, bradycardia (slowing of the heart rate), 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.
If you miss a dose of Donepex
Take the missed dose as soon as possible, unless it is almost time for your next scheduled dose. In
that case, take the next dose at the regular time. Do not take a double dose to make up for a missed
dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions:
If any of the following serious adverse reactions occur, consult a doctor immediately, as immediate medical intervention may be necessary:

• Liver function disorders, 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 no more 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 no more than 1 in 100 patients);
• Bleeding from the stomach or intestines. This may cause black, tarry stools or the presence of blood from the rectum (Frequency: uncommon, may occur in no more than 1 in 100 patients);
• Seizures or convulsions (Frequency: uncommon, may occur in no more than 1 in 100 patients);
• Fever with muscle rigidity, sweating, or reduced level of consciousness (a condition known as neuroleptic malignant syndrome) (Frequency: very rare, may occur in less than 1 in 10,000 patients);
• Weakness, tenderness, or muscle pain, especially when accompanied by malaise, high temperature, or dark urine. These symptoms may be caused by 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 less than 1 in 10,000 patients);
• Rapid, irregular heartbeat, fainting, which 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 affect more than 1 in 10 patients):

• Diarrhoea
• Nausea
• Headache

Common adverse reactions (may affect up to 1 in 10 patients):

• Common cold
• Loss of appetite
• Hallucinations, unusual dreams, including nightmares, restlessness, aggressive behaviour
• Fainting, dizziness, insomnia
• Vomiting, gastric disturbances
• Rash, itching
• Muscle cramps
• Urinary incontinence
• Fatigue, pain
• Accidents

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Bradycardia (slowing of heart rate)
• Slight increase in blood creatine kinase muscle activity

Rare adverse reactions (may affect up to 1 in 1,000 patients):

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

Frequency unknown (cannot be estimated from available data):

• Changes in heart function visible on ECG known as "QT interval prolongation"
• 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 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, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Donepex

Keep this medicine out of 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 stated month.
Store in the original packaging.
Do not use this medicine if you notice any damage to the packaging or signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Donepex contains

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

Core composition: microcrystalline cellulose, lactose monohydrate, maize starch, hypromellose, magnesium stearate.
Coating composition: Opadry HP White (polyethylene glycol, titanium dioxide (E171), talc, polyvinyl alcohol), quinoline yellow lake (E104).

Each Donepex 10 mg coated tablet contains 10 mg of donepezil hydrochloride.

• Other ingredients are:
  Core composition: microcrystalline cellulose, lactose monohydrate, maize starch, hypromellose, magnesium stearate.
  Coating composition: Opadry HP White (polyethylene glycol, titanium dioxide (E171), talc, polyvinyl alcohol).

What Donepex looks like and contents of the pack
Donepex 5 mg is yellow, round, biconvex coated tablets.
Donepex 10 mg is white, round, biconvex coated tablets.
Pack sizes: 28 tablets of 5 mg or 10 mg in a polyethylene container with a polypropylene cap, featuring a tamper-evident ring and a desiccant inside the container, or in PVC/PVDC/Aluminium blisters, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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

For further information on this medicine, please contact the Marketing Authorisation Holder:
Celon Pharma S.A.
ul. Ogrodowa 2A, Kiełpin
05-092 Łomianki
tel.: (22) 75-15-933,
e-mail: [email protected]

To protect the medicine from unauthorised access and from children, the container cap is equipped with a tamper-evident ring and a child-resistant closure mechanism.
Please follow the instructions in the diagrams below to correctly open the container:
 PUSH DOWN FIRMLY  WHILE PUSHING DOWN, TURN THE CAP HALF A TURN