DONEPEZIL MABO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Mabo 10 mg Film-Coated Tablets EFG

Donepezil Hydrochloride

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

Keep this package leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to 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 side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What is Donepezil Mabo and what is it used for
2. Before taking Donepezil Mabo
3. How to take Donepezil Mabo
4. Possible side effects
5. Storage of Donepezil Mabo
6. Package Contents and Additional Information

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

Donepezil Mabo belongs to a group of medications called acetylcholinesterase inhibitors.

Donepezil Mabo is used to treat the symptoms of dementia in people with a diagnosis of Alzheimer's diseasethat is mild to moderately severe. It is used only in adult patients.

2. Before Taking Donepezil Mabo

Do not take Donepezil Mabo:

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

(see section 6, Additional Information).

Be cautious with Donepezil Mabo:

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

• If you are going to undergo surgeryin which you will be administered general anesthesia. Donepezil hydrochloride may exaggerate muscle relaxation during anesthesia.
• If you have suffered a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• If you have suffered 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»
• If you have low levels of magnesium or potassium in your blood
• If you have ever suffered from stomach or duodenal ulcers, or if you use a certain type of analgesic(non-steroidal anti-inflammatory drugs, known as NSAIDs). Your doctor will monitor your symptoms.
• If you have difficulty urinating. Your doctor will monitor your symptoms.
• If you have ever suffered from seizures. Donepezil hydrochloride may cause a new seizure. Your doctor will monitor your symptoms.
• If you have asthma or other chronic lung disease. Your symptoms may worsen.
• If you have ever suffered from liver problems. No studies have been conducted; therefore, there is no information available on the safe use of donepezil hydrochloride in patients with severe liver problems. If you have unexplained liver disease, your doctor may decide to stop treatment with donepezil hydrochloride completely.
• 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:

In particular, it is essential that you inform your doctor if you are taking any of the following types of medications:

• medications for heart rhythm problems, such as amiodarone or sotalol
• medications for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• medications for psychosis, such as pimozide, sertindole, or ziprasidone
• medications for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole
• other medications for Alzheimer's disease, such as galantamine
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium
• anticholinergic medications, such as tolterodine
• anticonvulsants, such as phenytoin, carbamazepine
• medications for heart disease, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthetics

medications obtained without a prescription, such as herbal remedies

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

Taking Donepezil Mabo with food and drinks

Alcohol may reduce the effect of donepezil hydrochloride. Therefore, be cautious with the use of alcoholand donepezil hydrochloride at the same time.

Pregnancy and breastfeeding

There is not enough data to evaluate the efficacy of donepezil hydrochloride during breastfeeding. Do not breastfeedwhile taking donepezil.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Additionally, Donepezil Mabo may cause fatigue, dizziness, and muscle cramps, and if you are affected, you should not drive or use machines.

Donepezil Mabo contains lactose

This medication 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 Mabo

Follow your doctor's instructions for taking Donepezil Mabo exactly. Consult your doctor or pharmacist if you have any questions.

Tell your doctor or pharmacist the name of the person in charge of your care. This person will help you take the medication as prescribed.

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

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

No dose adjustment is required if you have kidney problems.

If you have liver problemsthat are mild or moderate, 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 cautious with Donepezil Mabo (see section 2, «Before taking Donepezil Mabo»). If you have unexplained liver disease, your doctor may decide to stop treatment with donepezil hydrochloride completely.

The use of this medication is not recommended in children and adolescents (under 18 years of age).

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

Your doctor will tell you how long you should continue taking the tablets. You should visit your doctor at regular intervals so that they can review your treatment and assess your symptoms.

If you take more Donepezil 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 amount of tablets than you should. If you take more donepezil than you should, you may experience symptoms such as nausea, vomiting, excessive salivation, sweating, slow heart rate (bradycardia), low blood pressure (hypotension), breathing difficulties (respiratory depression), muscle weakness (collapse), and involuntary muscle contractions (seizures), as well as increased muscle weakness, a potentially life-threatening disorder.

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

If you forget to take Donepezil Mabo

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

If you stop taking Donepezil Mabo

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

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

4. Possible side effects

Like all medications, Donepezil Mabo can have side effects, although not everyone will experience them.

Side effects may be:

• very common (may affect more than 1 in 10 people taking donepezil hydrochloride);
• common (may affect up to 1 in 10 people taking donepezil hydrochloride);
• uncommon (may affect up to 1 in 100 people taking donepezil hydrochloride);
• rare (may affect up to 1 in 1,000 people taking donepezil hydrochloride);
• very rare (may affect up to 1 in 10,000 people taking donepezil hydrochloride).

Investigations

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

Heart(cardiac disorders)

Uncommon: slow heart rate (bradycardia).

Rare: certain heart conduction disorders that cause a heart rhythm disorder (sinoatrial block, atrioventricular block).

Frequency not known: 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 life-threatening disorder known as torsades de pointes

Nervous system(nervous system disorders)

Common: fainting (syncope), dizziness, insomnia.

Uncommon: seizures.

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

Gastrointestinal(gastrointestinal disorders)

Very common: diarrhea, nausea.

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

Frequency not known (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 and urinary disorders

Common: urinary incontinence.

Skin and subcutaneous tissue disorders

Common: skin rash, itching (pruritus).

Musculoskeletal and connective tissue disorders

Common: muscle cramps.

Metabolism and nutrition disorders

Common: loss of appetite (anorexia).

Infections and infestations

Common: common cold.

Injury, poisoning, and procedural complicationsCommon: accidents.

General disorders and administration site conditions

Very common: headache.

Common: fatigue, pain.

Hepatobiliary disorders

Rare: liver dysfunction, including hepatitis.

Psychiatric disorders

Common: hallucinations, agitation, aggressive behavior.

Frequency not known (cannot be estimated from available data): increased libido, hypersexuality.

Your doctor may decide to reduce the dose or stop treatment to resolve these side effects.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Mabo

Keep out of the reach and sight of children.

Do not use Donepezil Mabo after the expiration date that appears on the blister pack and on the outer carton, after EXP. 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, 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 Mabo

• The active ingredient is donepezil hydrochloride.

Each film-coated tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.

• The other components are:

Core of the tablet:

Lactose monohydrate

Cornstarch

Microcrystalline cellulose

Hydroxypropylcellulose

Magnesium stearate

Film coating:

10 mg:

Hypromellose

Titanium dioxide (E171)

Propylene glycol

Povidone (K25)

Yellow iron oxide (E172)

Appearance of Donepezil Mabo 10 mg and package contents

Donepezil Mabo 10 mg film-coated tablets are yellow, round, and biconvex.

This medication is available in blister packs of 7, 14, 28, 30, 50, 56, 60, 84, 98, 100, 112, or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados 3, Edificio 6, 28033, Madrid, Spain.

Manufacturer

Infarmade S.L.

C/ Torre de los Herberos nº 35, Pol. Ind. “Carretera de la Isla”, 41703 Dos Hermanas, Sevilla, Spain.

Or

NETPHARMALAB CONSULTING SERVICES, Carretera de Fuencarral 22, Alcobendas, 28108, Madrid, Spain.

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Donepezil Mabo 10 mg film-coated tablets

This package leaflet was approved in October 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/.