DONEPEZILO 5 mg Film-Coated Tablets

2. What you need to know before taking Donepezil Kern Pharma

Do not take Donepezil Kern Pharma

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

Warnings and precautions

• Before starting treatment with Donepezil Kern Pharma, you should inform your doctor if you have or have a history of stomach ulcers, heart disease, seizures, asthma, chronic pulmonary disease, or difficulty urinating.
• In case of surgery with general anesthesia, you should inform your doctor that you are taking Donepezil.
• The use of Donepezil is not recommended in children.
• You should avoid taking Donepezil 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 torsades de pointes, or if a family member has "prolongation of the QT interval"
• Low levels of magnesium or potassium in the blood

Children and adolescents

The use of donepezil is not recommended in children.

Use of Donepezil 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, 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 (with action on the central nervous system).
• 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, sertindole, ziprasidone), medications for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin).

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

Use of Donepezil Kern Pharma with food, beverages, and alcohol

This medication should be taken with a little water.

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

Pregnancy, breastfeeding, and fertility

Do not take Donepezil if you are pregnant.

Do not take Donepezil if you are breastfeeding your child.

Driving and using machines

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

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

3. How to take Donepezil Kern Pharma

Follow your doctor's instructions for taking Donepezil Kern Pharma exactly. Consult your doctor or pharmacist if you have any doubts.

Donepezil Kern Pharma is administered orally.

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

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

If you have mild or moderate liver impairment (a disease that affects the liver) or renal impairment (a disease that affects the kidneys), you may follow a similar dosing schedule as indicated above.

If you take more Donepezil Kern Pharma than you should

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

If you forget to take Donepezil Kern Pharma

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medications, Donepezil Kern Pharma may cause adverse effects, although not all people experience them. The estimated frequency of their occurrence is as follows:

The most common adverse effects that may affect at least 1 in 10 patients are:

• Diarrhea
• Nausea
• Headache

Common adverse effects that may affect more than 1 in 100 but less than 1 in 10 patients are:

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

Uncommon adverse effects that may affect more than 1 in 1,000 but less than 1 in 100 patients are:

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

Rare adverse effects that may affect less than 1 in 1,000 patients are:

• Extrapyramidal symptoms (such as tremors or rigidity of the hands or legs)
• Alterations in cardiac conduction
• Alteration of liver function, including hepatitis

Adverse effects with unknown frequency:

• Changes in cardiac activity that can be observed in an electrocardiogram (ECG) called "prolongation of the QT interval"
• Rapid and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes
• Increased libido, hypersexuality
• Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)

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

Severe adverse effects:

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

• Weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark in color. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis).

5. Storage of Donepezil Kern Pharma

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

No special storage conditions are required.

Do not use Donepezil Kern Pharma after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Donepezil Kern Pharma

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

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

Appearance of the product and package contents

White, round, biconvex, flat film-coated tablets.

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

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this prospectus:November 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.