Prospecto: Information for the User

Donepezilo Kern Pharma 5 mg Film-Coated Tablets

Donepezil hydrochloride

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Donepezilo is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

Do not take Donepezilo Kern Pharma

• If you are allergic to hydrochloride donepezilo or any of the components of Donepezilo Kern Pharma.
• If you are pregnant or breastfeeding.

Warnings and precautions

• Before starting treatment with Donepezilo Kern Pharma, you must inform your doctor if you have or have a history of stomach ulcers, heart disease, seizures, asthma, chronic lung disease, or difficulty urinating.
• In the event of surgical intervention with general anesthesia, you must inform your doctor that you are taking Donepezilo.
• Donepezilo is not recommended for use in children.
• You should avoid taking Donepezilo with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
• If you have vascular dementia (loss of brain function due to a series of small strokes).
• A heart condition (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

Children and adolescents

Donepezilo is not recommended for use in children.

Use of Donepezilo Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription and especially if you are taking any of the following medications:

• Ketoconazole and itraconazole (to treat fungal infections).
• Quinidine and beta-blockers (to treat irregular heartbeats).
• Erythromycin (to treat bacterial infections).
• Fluoxetine (to treat depression).
• Rifampicin (to treat bacterial infections and tuberculosis).
• Phenytoin and carbamazepine (to treat epilepsy).
• Cholinergic agonists and medications with anticholinergic activity (acting at the central nervous system level).
• Succinylcholine and other neuromuscular blockers (to produce muscle relaxation).
• Medications for heart rhythm problems (e.g., amiodarone, sotalol, and quinidine).
• Medications for depression (e.g., citalopram, escitalopram, amitriptyline), medications for psychosis (e.g., pimozide, sertindol, ziprasidone), medications for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin).

Taking Donepezilo with alcohol may reduce the absorption of this medication.

Use of Donepezilo Kern Pharma with food, drinks, and alcohol

This medication should be taken with a little water.

Taking Donepezilo with alcohol may reduce the absorption of this medication.

Pregnancy, breastfeeding, and fertility

Do not take Donepezilo if you are pregnant.

Do not take Donepezilo if you are breastfeeding your child.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not engage in these activities unless your doctor tells you it is safe to do so. Donepezilo may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Donepezilo Kern Pharma contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Donepezilo Kern Pharma provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Donepezilo Kern Pharma is administered orally.

Treatment with Donepezilo Kern Pharma starts with a 5 mg tablet, taken once a day with a little water, at night immediately before going to bed. After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, once a day and at night. The maximum recommended dose is 10 mg/day.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donepezilo Kern Pharma in the morning.

If you have mild or moderate liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can follow a similar dosing schedule as indicated above.

If you take more Donepezilo Kern Pharma than you should

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 ingested.

If you forgot to take Donepezilo Kern Pharma

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Donepezilo Kern Pharma may cause side effects, although not everyone will experience them. The estimated frequency of their occurrence is as follows:

The most frequent side effects that may affect at least 1 in 10 patients are:

• Diarrhea
• Nausea
• Headache

The frequent side effects that may affect more than 1 person in 100 but less than 1 in 10 are:

• Common cold
• Loss of appetite
• Hallucinations, agitation, aggressive behavior
• Fainting, dizziness, difficulty sleeping
• Vomiting, abdominal discomfort
• Urinary incontinence
• Rash, itching
• Muscle cramps
• Fatigue, pain
• Accidents

The infrequent side effects that may affect more than 1 person in 1,000 but less than 1 in 100 are:

• Seizures
• Decreased heart rate
• Gastrointestinal bleeding, ulcers in the stomach and duodenum (a part of the intestine)
• Increased levels of a type of enzyme (creatine kinase muscle) in the blood

The rare side effects that may affect less than 1 person in 1,000 are:

• Extrapyramidal symptoms (such as tremors or rigidity of the hands or legs)
• Alterations in heart conduction
• Liver function alteration, including hepatitis

The side effects with unknown frequency:

• Changes in heart activity that can be observed on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially life-threatening condition known as torsade de pointes
• Increased libido, hypersexuality
• Pisa syndrome (a condition that involves an involuntary muscle contraction with an abnormal flexion of the body and head to one side)

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Severe side effects:

Consult your doctor immediately if you experience these severe side effects. You may need urgent medical treatment.

• Weakness, muscle sensitivity or pain, particularly if you also feel unwell, have a fever or your urine is dark in color. This may be due to abnormal muscle destruction that can be life-threatening and cause kidney problems (a condition known as rhabdomyolysis).

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

No special storage conditions are required.

Do not use Donepezilo Kern Pharma after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Composition of Donepezilo Kern Pharma

• The active ingredient is donepezilo hydrochloride. Each tablet contains 5 mg of donepezilo hydrochloride (equivalent to 4.56 mg of donepezilo).

• The other components are: lactose monohydrate, microcrystalline cellulose (E-460i), anhydrous colloidal silica, cornstarch, sodium glycolate starch (potato starch), talc (E-553b), magnesium stearate, polyvinyl alcohol, titanium dioxide (E-171), and polyethylene glycol.

Appearance of the product and content of the packaging

White, round, biconvex, flat-coated tablets.

The tablets are packaged in blisters in boxes of 28 tablets (standard packaging) and 50 tablets (clinical packaging).

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.