Package Insert: Information for the User

Donepezilo Mabo 10 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1.What isDonepezilo Maboand for what it is used

2.Before taking Donepezilo Mabo

3. How to takeDonepezilo Mabo

4. Possible adverse effects

5. Storage ofDonepezilo Mabo

6. Contents of the package and additional information.

Donepezilo Mabo belongs to a group of medications known as cholinesterase inhibitors.

Donepezilo Mabo is used to treat the symptoms of dementia in individuals with a diagnosis ofmild to moderately severe Alzheimer's disease. It is used only in adult patients.

Do not take Donepezilo Mabo:

- if you are allergic (hypersensitive) to donepezil hydrochloride, related substances (piperidine derivatives) or any of the other components of Donepezilo Mabo.

(see section 6, Additional information).

Be especially careful with Donepezilo Mabo:

Check if any of the warnings in the following list apply or have applied to your case.Inform your doctor:

• If you are to undergo asurgical procedurein which you will be administeredgeneral anesthesia. Donepezil hydrochloride may exaggerate muscle relaxation during anesthesia.
• If you have suffered from a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• If you have suffered from a heart condition called «prolongation of the QT interval» or have a history of certain abnormal heart rhythms called torsade de pointes or if someone in your family has «prolongation of the QT interval»
• If you have low levels of magnesium or potassium in your blood
• If you have ever suffered fromstomach or duodenal ulcers, or if you use a certain type ofanalgesic(non-steroidal anti-inflammatory drugs, known as NSAIDs). Your doctor will monitor your symptoms.
• If you havedifficulty urinating. Your doctor will monitor your symptoms.
• If you have ever suffered fromseizures.Donepezil hydrochloride may cause a new seizure. Your doctor will monitor your symptoms.
• If you suffer fromasthma or other chronic lung disease.Your symptoms may worsen.
• If you have ever suffered fromliver problems.No studies have been conducted; therefore, no information is available about the safe use of donepezil hydrochloride in patients with severe liver problems.
• If your doctor has told you that you have an intolerance to certain sugars, for example, lactose.

Use of other medications

Other medications may be affected by donepezil hydrochloride. They, in turn, may affect the action of donepezil hydrochloride. This may interact with:

Especially, it is essential 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 or ziprasidone
• medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole
• other medications for Alzheimer's disease, for example, galantamine
• analgesics or arthritis treatment, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergic medications, for example, tolterodine
• anticonvulsants, for example, phenytoin, carbamazepine
• medications for heart disease, for example quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, for example, diazepam, succinylcholine
• general anesthetic

over-the-counter medications, for example, herbal remedies

Inform your doctor or pharmacistif you are using or have recently used other medications, including those obtained without a prescription.

Taking Donepezilo Mabo with food and drinks

Alcohol may reduce the effect of donepezil hydrochloride. Therefore, be careful when usingalcoholand donepezil hydrochloride at the same time.

Pregnancy and breastfeeding

No sufficient data are available to evaluate the efficacy of donepezil hydrochloride during breastfeeding.Do not breastfeedwhile taking donepezilo.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Additionally, DonepeziloMabomay causefatigue, dizziness, and muscle crampsand, if you are affected, you should not drive or operate machinery.

Donepezilo Mabo contains lactose

This medication 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 Mabo indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Inform your doctor or pharmacist of the person in charge of your care. This will help them take the medication as prescribed.

The dose of the tablet you take may change, depending on the time you have been taking the medication and what your doctor recommends.

The usual doseis one film-coated tablet of Donepezilo Mabo 5 mg (5 mg of donepezilo hydrochloride) at night. After a month, your doctor may tell you to take two film-coated tablets of Donepezilo Mabo 5 mg (10 mg of donepezilo hydrochloride) at night. If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donepezilo Mabo in the morning. The maximum recommended dose is 10 mg at night.

No dose adjustment is required if you have kidney problems.

If you havemild or moderate liver problems, your doctor will need to adjust the dose gradually and carefully according to your needs. If you have severe liver problems, you should be more careful with Donepezilo Mabo (see section 2, "Before taking Donepezilo Mabo"). If you have an unexplained liver disease, your doctor may decide to completely stop treatment with donepezilo hydrochloride.

This medication is not recommended for children and adolescents (under 18 years old).

How to take it:Take the Donepezilo tablet by mouth, with a sip of water, at night, before going to bed.

Your doctor will tell you for how long you should continue taking the tablets. You should visit your doctor at regular intervals for them to review your treatment and evaluate your symptoms.

If you take more Donepezilo Mabo 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 taken.

Do not take a larger dose than you should. If you take more donepezilo than you should, you may experience symptoms such as nausea, vomiting, salivation, sweating, slow heart rate (bradycardia), low blood pressure (hypotension), breathing difficulties (respiratory depression), muscle weakness (collapse), and involuntary muscle contractions (convulsions), as well as increased muscle weakness, a possibly fatal condition.

If you have taken more tablets than you should, consult your doctor or pharmacist immediately.

If you forget to take Donepezilo Mabo

Do not take a double dose to make up for a missed dose. Skip the missed dose and take the next tablet at the usual dose the next day. If you forget to take your medication for more than a week, call your doctor before taking more medication.

If you interrupt treatment with Donepezilo Mabo

Do not stop taking your tablets, even if you feel well, unless your doctor tells you to.

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

Like all medications, Donepezilo Mabo may have adverse effects, although not all people may experience them.

Adverse effects may be:

• Very common (may affect more than 1 in 10 people taking hydrochloride donepezilo); - Common (may affect up to 1 in 10 people taking hydrochloride donepezilo);
• Uncommon (may affect up to 1 in 100 people taking hydrochloride donepezilo);
• Rare (may affect up to 1 in 1,000 people taking hydrochloride donepezilo);
• Very rare (may affect up to 1 in 10,000 people taking hydrochloride donepezilo).

Additional investigations

Uncommon: minor increase in serum concentration of certain muscle enzyme (creatine kinase).

Heart(cardiac disorders)

Uncommon: slow heart rate (bradycardia).

Rare: certain heart conduction disorders that cause arrhythmia (sinoatrial block, atrioventricular block).

Unknown frequency: changes in cardiac activity that may be observed on an electrocardiogram (ECG) called "prolongation of the QT interval", rapid and irregular heartbeat, fainting that may be a symptom of a potentially life-threatening condition known as torsades de pointes

Nervous system(neurological disorders)

Common: fainting (syncope), dizziness, inability to sleep (insomnia).

Uncommon: seizures.

Rare: uncontrolled body or facial movements (extrapyramidal symptoms).

Stomach and intestines (gastrointestinal disorders).

Very common: diarrhea, nausea.

Common: vomiting, abdominal disorders. Uncommon: internal bleeding (gastrointestinal hemorrhage), ulcers (gastric and duodenal ulcers).

Unknown frequency (cannot be estimated from available data): Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side).

Kidney(renal and urinary disorders)

Common: urinary incontinence.

Skin(skin and subcutaneous tissue disorders)

Common: skin rash, itching (pruritus).

Muscles (musculoskeletal and connective tissue disorders)

Common: muscle cramps.

Food(metabolic and nutritional disorders)

Common: loss of appetite (anorexia).

Infections(infections and infestations)

Common: common cold.

Accidents, poisoning and complications of therapeutic procedures: Common: accidents.

General(general disorders and administration site conditions)

Very common: headache.

Common: fatigue, pain.

Liver(hepatobiliary disorders)

Rare: liver dysfunction, including hepatitis.

Mental(psychiatric disorders)

Common: imagining things that do not exist (hallucinations), agitation, aggressive behavior.

Unknown frequency (cannot be estimated from available data): increased libido, hypersexuality.

The doctor may decide to reduce the dose or stop treatment to resolve these adverse effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of medicinal products for human use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication

Keep out of the reach and sight of children.

Do not use Donepezilo Mabo after the expiration date that appears on the blister pack and on the outer carton, after CAD. The first two digits indicate the month, and the last four digits indicate the year. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition of Donepezilo Mabo

- The active ingredient is donepezilo hydrochloride.

Cada comprimido recubierto con película contiene 10 mg of donepezilo hydrochloride,

equivalente a 9,12 mg of donepezilo.

- The other components are:

Núcleo del comprimido:

Lactose monohydrate

Maize starch

Microcrystalline cellulose

Hydroxypropyl cellulose

Magnesium stearate

Recubierta de película:

10 mg:

Hydroxypropyl methylcellulose

Titanium dioxide (E171)

Propylene glycol

Povidone (K25)

Yellow iron oxide (E172)

Appearance of Donepezilo Mabo 10 mg and content of the container

DonepeziloMabo10 mg Film-coated tablets are yellow, round, biconvex film-coated tablets.

This medicine is presented in blisters of 7, 14, 28, 30, 50, 56, 60, 84, 98, 100, 112 or 120

film-coated tablets.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada (Madrid)

Spain

Responsible for manufacturing

Infarmade S.L

C/ Torre de los Herberos nº 35

Pol. Ind. “Carretera de la Isla”

41703 Dos Hermanas

Sevilla

O

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral 22, Alcobendas, 28108, Madrid

This medicine is authorized in the member states of the European Economic Area with

the following names:

Spain: Donepezilo Mabo 10 mg Film-coated tablets

This leaflet has been approved in October 2022

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