Package Leaflet: Information for the User

Donepezil Sandoz 10 mg Film-Coated Tablets

donepezil hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Donepezilo belongs to a group of medications called cholinesterase inhibitors. Donepezilo increases the levels in the brain of a substance related to memory (acetylcholine), by decreasing the rate of breakdown of this substance.

Donepezilo is used for the treatment of thesymptoms of dementiain individuals diagnosed withAlzheimer's diseaseof mild to moderately severe. Symptoms include increased loss of memory, confusion, and changes in behavior. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their daily activities.

Donepezilo is used only in adult patients.

Do not take Donepezilo Sandoz

if you areallergicto:

• donepezil hydrochloride, or
• to piperidine derivatives, which are similar substances to donepezil, or
• soy, peanuts, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezilo Sandoz.

If you experience any of the following problems, you or your caregiver must inform yourdoctor or pharmacist.

• stomach or duodenal ulcers,
• crises (attacks) or convulsions,
• heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction),
• a heart condition called “prolongation of the QT interval” or a history of certain abnormal heart rhythms called Torsade de Pointes, or if someone in your family has “prolongation of the QT interval”,
• low levels of magnesium or potassium in the blood,
• asthma or other chronic lung problems,
• liver problems or hepatitis,
• difficulty urinating or mild kidney disease.

Inform your doctor also if you are pregnant or think you may be pregnant.

Other medications and Donepezilo Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This includes medications that your doctor has not prescribed but that you have purchased at a pharmacy. This also includes medications that you may need to take in the future if you continue to take donepezil. This is because these medications may weaken or enhance the effects of donepezil.

Inform your doctor especially if you are taking any of the following types of medications:

• other medications to treat Alzheimer's disease, e.g., galantamine,
• analgesics or treatments for arthritis, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium,
• anticholinergic medications, e.g., tolterodine,
• antibacterial medications (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin),
• antifungal medications e.g., ketoconazole,
• antidepressants (e.g., citalopram, escitalopram, amitriptyline, fluoxetine),
• antipsychotics (e.g., pimozide, sertindole, ziprasidone),
• anticonvulsants e.g., phenytoin, carbamazepine,
• medications for heart rhythm problems (e.g., amiodarone, sotalol),
• medications for heart disease (e.g., quinidine, beta-blockers (propranolol and atenolol)),
• muscle relaxants e.g., diazepam, succinylcholine,
• general anesthesia,
• over-the-counter medications e.g., herbal remedies.

If you are to undergo surgery that requires general anesthesia, inform your doctor and the anesthesiologist that you are taking donepezil. This is because this medication may affect the amount of anesthetic needed.

Donepezil may be used in patients with mild to moderate kidney or liver disease. Inform your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take donepezil.

Inform your doctor or pharmacist of the name of your caregiver. Your caregiver will help you take your medication as prescribed.

Taking Donepezilo Sandoz with food, drinks, and alcohol

Food will not affect the effect of donepezil. Donepezil should not be taken with alcohol as alcohol may modify its effect.

Pregnancy, breastfeeding, and fertility

Donepezil should not be taken while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery. Do not engage in these activities unless your doctor indicates it is safe to do so.

This medication may cause fatigue, dizziness, and muscle cramps, mainly at the beginning of treatment and when increasing the dose. If you experience these effects, do not drive or operate machinery.

Donepezilo Sandoz contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The recommended dose is:

Adults and elderly

• Initial dose: 1/2 tablet every night.
• After one month: possible increase to 1 tablet every night.
• Maximum dose: 1 tablet every night.

Do not modify the dose on your own without consulting your doctor.

Patients with renal dysfunction

You can take the usual dose as described above. No adjustment is required.

Patients with mild to moderate hepatic dysfunction

Your doctor will check your tolerance to donepezil before increasing the dose.

Patients with severe renal dysfunction

Your doctor will decide if this medication is suitable for you.

Administration form

Take your coated tablets at night before going to bed, regardless of meals. Swallow the tablet with a glass of water.

If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Sandoz in the morning.

Treatment duration

Your doctor or pharmacist will tell you for how long you need to continue taking your tablets. You may need to visit your doctor from time to time to review your treatment and evaluate your symptoms.

If you take more Donepezil Sandoz than you should

DO NOT take more than 10 mg of donepezil per day.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you cannot contact your doctor, go to the nearest emergency service. Always carry your tablets and packaging with you so that the doctor knows you are taking them.

The symptoms of overdose include feeling or being sick, drooling, sweating, decreased heart rate, low blood pressure (dizziness or fainting when standing up), breathing difficulties, loss of consciousness, and tremors or seizures.

If you forget to take Donepezil Sandoz

If you forget to take a tablet, take only one tablet the next day at the usual time. Do not take a double dose to compensate for the missed doses.

If you forget to take your medication for more than a week, consult your doctor before resuming the medication.

If you interrupt treatment with Donepezil Sandoz

Do not stop treatment with this medication unless your doctor tells you to. If you stop taking donepezil, the treatment benefits will gradually disappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported by people taking donepezil. Inform your doctor if you experience any of these side effects during treatment with donepezil.

Severe side effects:

You should inform your doctor immediately if you notice the following severe side effects mentioned. You may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (affecting between 1 and 10 out of 10,000 users),
• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (affecting between 1 and 10 out of 1,000 users),
• Bleeding in the stomach or intestines. This may cause you to have black, tar-like stools or visible blood from the rectum (affecting between 1 and 10 out of 1,000 users),
• Dizziness (attacks) or convulsions (affecting between 1 and 10 out of 1,000 users),
• Fever with muscle stiffness, sweating, or a decrease in level of consciousness (which may be symptoms of a condition called "Neuroleptic Malignant Syndrome" (affecting fewer than 1 out of 10,000 users),
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or your urine is dark-colored. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis).

The estimated frequency of side effects is as follows:

Very common,may affect more than 1 in 10 patients:

• Diarrhea,
• Nausea,
• Headache.

Common,may affect between 1 and 10 in 100 patients:

• Muscle cramps,
• Tiredness,
• Difficulty sleeping (insomnia),
• Common cold,
• Loss of appetite,
• Hallucinations (seeing or hearing things that are not there),
• Strange and disturbing dreams,
• Restlessness,
• Aggressive behavior,
• Fainting,
• Dizziness,
• Vomiting,
• Uncomfortable stomach sensation,
• Rash,
• Itching,
• Pain,
• Urinary incontinence,
• Accidents (patients may be more prone to falls and accidental injuries).

Uncommon, may affect up to 1 in 100 patients:

• Decreased heart rate,
• Mild increase in muscle enzyme creatinine kinase in blood tests.

Rare, may affect up to 1 in 1,000 patients:

• Tremors, stiffness, or uncontrolled movements, especially of the face and tongue, but also of the limbs,
• Alterations in heart conduction.

Frequency not known(cannot be estimated from available data)

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval",
• Fast and irregular heart rhythm, fainting that may be symptoms of a potentially fatal condition called Torsade de Pointes,
• Increased libido, hypersexuality,
• De Quervain syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Do not use this medication 6 months after the first opening of the plastic bottle.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Donepezilo Sandoz 10 mg

The active ingredient is donepezil hydrochloride.

Each film-coated tablet contains 10 mg of donepezil hydrochloride.

The other components are:

Core of the tablet:microcrystalline cellulose,lactose monohydrate, cornstarch,magnesium stearate.

Film coating of the tablet:polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, soy lecithin, yellow iron oxide (E 172).

Appearance of the product and contents of the package

Donepezilo Sandoz 10 mg are yellow, round, film-coated tablets (diameter 9 mm) with a notch.The tablet can be divided into equal doses.

Donepezilo Sandoz is available in:

• Blisteres. Package sizes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 100x1 or 120 film-coated tablets.
• Plastic bottles with a screw cap. Package sizes of 100 or 250 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek S.A.

Ul. Domaniewska 50 C

02-672 Warsaw

Poland

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

S.C. Sandoz, S.R.L

Str.Livezeni nr.7 A

RO-540472 Targu-Mures

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:Donepezil HCl Sandoz 10mg – Filmtabletten

Belgium:Donepezil Sandoz 10 mg filmomhulde tabletten

Czech Republic:Donepezil Sandoz 10mg potahované tablety

Denmark:Donepezil Sandoz

France:DONEPEZIL Sandoz 10 mg, comprimé pelliculé

Greece:Pezale

Italy:DONEPEZIL SANDOZ

Norway:Donepezil Sandoz

Portugal:DONEPEZILO SANDOZ

Sweden:Donepezil Sandoz

United Kingdom

(Northern Ireland): Donepezil Hydrochloride 10 mg Film-coated Tablets

Last revision date of this leaflet:December 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/