Label: Information for the User

Donepezilo Stada 5 mg Film-Coated Tablets

Donepezil Hydrochloride

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only and should not be given 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 label. See section 4.

1. What you need to know before starting Donepezilo Stada

1. How to take Donepezilo Stada

1. Possible side effects

1. Storage of Donepezilo Stada
2. Contents of the pack and additional information

Donepezilo Stada belongs to a group of medications known asacetylcholinesterase inhibitors. Donepezilo increases the levels in the brain of a substance related to memory (acetylcholine), by means of the decrease in the speed of decomposition of this substance.

Donepezilo Stada is used to treat the symptoms of dementia in people withmild to moderately severeAlzheimer's disease. The symptoms include increased loss of memory, confusion, and changes in behavior. As a result, it becomes increasingly difficult for patients with Alzheimer's disease to continue with their daily activities.

Donepezilo is indicated only for adult patients.

Do not take Donepezilo Stada:

- if you are allergic to hydrochloride donepezilo or similar medications (known as “piperidina derivatives”) or to 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 if you have or have had:

• stomach ulcersorduodenal ulcers
• attacksorconvulsions

• acardiac condition(such as irregular or very slow heartbeats, heart failure, myocardial infarction).

• acardiac condition called“prolongation of the QT interval” or a history of certain abnormal heart rhythms calledTorsades de Pointesor ifsomeone in your family has “prolongation of the QT interval”.
• asthmaor otherlong-term lung disease
• liver problemsorhepatitis
• difficulty urinatingormild kidney disease.
• low levels of magnesium or potassiumin the blood.

Also inform your doctor if you are pregnant or think you might be.

Children and adolescents

Donepezilo is not indicated for use in children and adolescents (young people under 18 years old).

Other medications and Donepezilo Stada

Inform your doctor or pharmacist if you are taking, have taken recently or might have to take any other medicationincluding over-the-counter medications. This also includes medications you might take in the future if you continue taking donepezilo. This is because these medications can weaken or enhance the effects of donepezilo.

It is particularly important to inform your doctor if you are taking any of the following types of medications:

• medications for heart rhythm problems, for example,amiodarone or sotalol
• medications for depression, for example,citalopram, escitalopram, amitriptyline, fluoxetine
• medications for psychosis, for example,pimozide, sertindole, ziprasidone
• medications for bacterial infections, for example,clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungals, such as theketoconazole
• other medications for Alzheimer's disease, such asgalantamine

• painkillers or treatment for arthritis, for example,aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), such asibuprofen or diclofenac sodium
• anticholinergics, such astolterodine
• anticonvulsants, such asphenytoin and carbamazepine
• medications for heart disease, such asquinidine, beta blockers(propranolol and atenolol)
• muscle relaxants, such asdiazepam, succinylcholine
• general anesthesia
• over-the-counter medications, such asherbal medications

In the event of surgery withgeneral anesthesia, you must inform your doctor and anesthesiologist that you are taking donepezilo, because your medication may affect the amount of anesthesia needed.

Donepezilo 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 donepezilo.

Inform your doctor or pharmacist of the name of the person responsible for your care. This person will help you take your medication as indicated.

Taking Donepezilo Stada with food, drinks, and alcohol

Foods do not interfere with the effect of this medication.

Donepezilo should not be taken with alcohol because alcohol may alter its effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be, consult your doctor or pharmacist before using this medication.

There are not enough experiences about the use of donepezilo in pregnant women.Do not takedonepezilo if you are pregnantor plan to become pregnant, unless your doctor considers it absolutely necessary, taking into account the clinical benefit-risk balance for you.

The available data are insufficient to evaluate the safety of donepezilo during breastfeeding.Do not breastfeedwhile taking donepezilo.

Driving and operating machinery

Alzheimer's disease may alter your ability to drive or use machinery and you should not perform these activities, unless your doctor tells you it is safe to do so.

Additionally, this medication may causefatigue,dizziness, and muscle cramps.If you experience any of these symptoms, you should not drive or operate machinery.

Donepezilo Stada contains lactose

If your doctor has told you that you have intolerance to certain sugars, consult your doctor before taking this medication.

How much Donepezilo Stada to take

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Usually, you will start taking 1 coated tablet (5 mg of donepezilo hydrochloride) every night before going to bed.

After a month, your doctor may instruct you to take 2 coated tablets (10 mg of donepezilo hydrochloride) every night before going to bed.

The concentration of the tablet you take may change over time and according to your doctor's recommendations.

The maximum recommended dose is 2 coated tablets (10 mg of donepezilo hydrochloride) every night.

Always follow the instructions of your doctor or pharmacist on how and when to take this medication.

Do not alter the dose on your ownwithout consulting your doctor.

No adjustment of the dose is necessary if you havekidney problems.

If you haveliver problemsof mild to moderate intensity, your doctor may need to adjust your dose. If you have severe liver problems, you should not take donepezilo (see section 2. "Warnings and precautions"). If you have an unexplained liver disease, your doctor may decide to completely stop your treatment with donepezilo.

How to take this medication

Take donepezilo with a glass of water at night before going to bed. If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezilo in the morning.

Use in children and adolescents

This medicationis not recommended for children and adolescents (under 18 years).

If you take more Donepezilo Stada than you should

Contact your doctor or the nearest hospital emergency service immediately if you take more medication than you should. Bring this leaflet and any remaining tablets with you.

The symptoms of overdose are, among others, feeling unwell or vomiting, drooling, sweating, slow heart rate, low blood pressure (dizziness or vertigo when standing up), respiratory problems, loss of consciousness, and seizures or attacks.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you forgot to take Donepezilo Stada

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

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

If you interrupt treatment with Donepezilo Stada

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

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

For how long should you take Donepezilo Stada

Your doctor or pharmacist will advise you for how long you should take these tablets. You will need to visit your doctor at regular intervals to review your treatment and assess your symptoms.

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

The following side effects have been reported by people taking donepezil.

Contact 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 any of the following severe side effects. You may need urgent medical treatment.

• liver disorder, such as hepatitis. The symptoms of hepatitis are nausea (feeling sick), vomiting, loss of appetite, general feeling of illness, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people).
• stomach and duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
• bleeding in the stomach or intestines. This can cause black, tarry stools or visible blood from the rectum (may affect up to 1 in 100 people).
• convulsions or seizures (may affect up to 1 in 100 people).

• fever with muscle stiffness, sweating, or a decrease in level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people)
• weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or your urine is dark. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
• rapid and irregular heartbeat, fainting that may be a symptom of a potentially fatal condition called Torsade de Pointes (frequency cannot be estimated from available data).

Other side effects

Very common (may affect more than 1 in 10 people):

• diarrhea
• nausea (feeling sick)
• headache

Common (may affect up to 1 in 10 people):

• common cold
• vomiting (feeling sick)
• abdominal discomfort
• muscle cramps
• fatigue
• fainting
• dizziness
• difficulty sleeping (insomnia)
• pain
• loss of appetite
• itching
• eruption
• hallucinations (seeing or hearing things that are not really there)
• unusual dreams, including nightmares
• agitation
• aggressive behavior
• urinary incontinence
• accidents (patients may be more prone to falls and injuries)

Uncommon (may affect up to 1 in 100 people):

• slow heart rate
• excessive salivation

Rare (may affect up to 1 in 1,000 people):

• stiffness, tremor, or uncontrollable movements, especially of the face and tongue, and limbs (extrapyramidal symptoms)

Unknown (frequency cannot be estimated from available data)

• changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• 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 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 and blister. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Donepezilo Stada

• The active ingredient is donepezilo hydrochloride.

Each film-coated tablet contains 5 mg of donepezilo hydrochloride, equivalent to 4.56 mg of donepezilo.

• The other components are:

Tablet core:

Anhydrous lactose

Pregelatinized cornstarch

Dihydrated calcium hydrogen phosphate

Talc

Magnesium stearate

Anhydrous colloidal silica

Film coating:

Hydroxypropylmethylcellulose

Hydroxypropylcellulose

Talc

Titanium dioxide (E171)

Appearance of Donepezilo Stada and packaging contents

White, round, biconvex film-coated tablets, 7.1 mm in diameter.

PVC/Aluminum blisters containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 120, 126, 154, 182, 196 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Stada Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

or

S. A. Eurogenerics N.V.

Heizel Esplanade Heysel b 22,

B-1020 Brussels

Belgium

or

STADA Arzneimittel AG Stadastr. 2-18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH Muthgasse 36/2,

A-1190 Wien

Austria

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

ATDonepezil STADA 5 mg Filmtabletten

BEDonepezil EG 5 mg filmomhulde tabletten

DEDonepezil STADA 5 mg Filmtabletten

DKDonepezil STADA

ESDonepezilo Stada 5 mg comprimidos recubiertos con película EFG

FRDonepezil EG 5 mg comprimés pelliculés

HUDonestad 5 mg filmtabletta

LUDonepezil EG 5 mg comprimés pelliculés

PLDonestad

PTDonepezilio Stada

RODonepezil STADA 5 mg comprimate filmate

SEDonepezil STADA 5 mg filmdragerade tabletter

Last review date of this leaflet:December 2022

The detailed and updated 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/