DONEPEZIL SANDOZ 5 mg FILM-COATED TABLETS

Introduction

Prospectus: information for the user

Donepezil Sandoz 5 mg film-coated tablets EFG

Read the entire prospectus carefully before starting to take this medication, 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 medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What is Donepezil Sandoz and what is it used for
2. What you need to know before starting to take Donepezil Sandoz
3. How to take Donepezil Sandoz
4. Possible side effects
5. Storage of Donepezil Sandoz
6. Package contents and additional information

1. What is Donepezil Sandoz and what is it used for

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

Donepezil is used for the treatment of symptoms of dementiain people diagnosed with Alzheimer's diseaseof mild to moderate severity. The symptoms include increased memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their daily activities.

Donepezil is used only in adult patients.

2. What you need to know before starting to take Donepezil Sandoz

Do not take Donepezil Sandoz

if you are allergicto:

• donepezil hydrochloride, or
• piperidine derivatives, which are substances similar 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 Donepezil Sandoz.

If you have any of the following problems, you or your caregiver should inform your doctor or pharmacist.

• stomach or duodenal ulcers,
• seizures 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 a family member has "prolongation of the QT interval",
• low levels of magnesium or potassium in the blood,
• asthma or other chronic pulmonary problems,
• liver or hepatitis problems,
• difficulty urinating or mild kidney disease.

Tell your doctor if you are pregnant or think you may be pregnant.

Other medications and Donepezil Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, 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 occasionally in the future if you continue to take donepezil. This is because these medications can weaken or increase the effects of donepezil.

Tell your doctor especially if you are taking any of these types of medications:

• other medications for treating Alzheimer's disease, e.g., galantamine,
• analgesics or treatments for arthritis, e.g., aspirin, non-steroidal anti-inflammatory medications (NSAIDs) such as ibuprofen or diclofenac sodium,
• anticholinergic medications, e.g., tolterodine,
• medications for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin),
• antifungal medications, e.g., ketoconazole,
• medications for depression (e.g., citalopram, escitalopram, amitriptyline, fluoxetine),
• medications for psychosis (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 going to undergo surgery that requires general anesthesia, you should inform your doctor and anesthesiologist that you are taking donepezil. This is because this medication can affect the amount of anesthetic needed.

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

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

Taking Donepezil Sandoz with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Donepezil should not be taken during 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 using machines

Your illness may affect your ability to drive or use machines. You should not engage in these activities unless your doctor indicates that it is safe to do so.

This medication can cause fatigue, dizziness, and muscle cramps, mainly at the start of treatment and when increasing the dose. If you experience these effects, you should not drive or use machinery.

Donepezil Sandoz 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 Sandoz

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again. The recommended dose is:

Adults and elderly

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

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

Patient with renal dysfunction

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

Patient with mild to moderate hepatic dysfunction

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

Patient with severe renal dysfunction

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

Method of administration

Take your 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.

Duration of treatment

Your doctor or pharmacist will tell you 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 assess 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 Toxicology 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 the tablets and packaging with you so that the doctor knows you are taking donepezil.

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

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 make up for forgotten doses.

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

If you stop taking Donepezil Sandoz

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

Serious side effects:

You should inform your doctor immediately if you notice any of the following serious side effects. You may need urgent medical treatment.

• liver damage, e.g., hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, discomfort, fever, itching, yellowing of the skin and eyes, and darkening of the 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 sternum (affecting between 1 and 10 out of 1,000 users),
• bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (affecting between 1 and 10 out of 1,000 users),
• seizures or convulsions (affecting between 1 and 10 out of 1,000 users),
• fever with muscle stiffness, sweating, or a decrease in the level of consciousness (which can be symptoms of a condition called "Neuroleptic Malignant Syndrome" (affecting less than 1 out of 10,000 users)),
• weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or have dark urine. This can be due to an abnormal destruction of muscle that can be fatal and cause kidney problems (a disease called rhabdomyolysis).

The estimated frequency of occurrence 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 out of 100 patients:

• muscle cramps,
• fatigue,
• difficulty sleeping (insomnia),
• common cold,
• loss of appetite,
• hallucinations (seeing or hearing things that are not really there),
• abnormal dreams and nightmares,
• agitation,
• aggressive behavior,
• fainting,
• dizziness,
• vomiting,
• uncomfortable stomach,
• skin 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 creatine 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,
• changes 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",
• rapid and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as Torsade 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).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Donepezil Sandoz

Keep this medication out of sight and reach of children.

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

Do not store above 25 °C.

Do not use this medication more than 6 months after opening the plastic bottle.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection 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 Sandoz 5 mg

The active ingredient is donepezil hydrochloride.

Each film-coated tablet contains 5 mg of donepezil hydrochloride.

The other components are:

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

Coating of the tablet:polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, soy lecithin.

Appearance of the product and package contents

Donepezil Sandoz 5 mg are white, round, film-coated tablets (diameter 7 mm).

Donepezil Sandoz is available in:

• Blister packs. 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.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek S.A.

Ul. Domaniewska 50 C

02-672 Varsovia

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 medication 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 5mg – Filmtabletten

Belgium: Donepezil Sandoz 5 mg filmomhulde tabletten

Denmark: Donepezil Sandoz

France: DONEPEZIL Sandoz 5 mg, comprimé pelliculé

Greece: Pezale

Italy: DONEPEZIL SANDOZ

Norway: Donepezil Sandoz

Portugal: DONEPEZILO SANDOZ

Sweden: Donepezil Sandoz

United Kingdom (Northern Ireland): Donepezil Hydrochloride 5 mg film-coated tablets

Date of last revision of this prospectus:December 2022

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