PATIENT INFORMATION LEAFLET

Donepezilo Alter 5 mg film-coated tablets

Donepezilo hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it 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 leaflet

Donepezilo Alter contains the active ingredient donepezilo hydrochloride

Donepezilo hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezilo hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the rate of breakdown of this substance.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.The symptoms include increased loss of memory, confusion, and changes in behavior.

Do not takeDonepezilo Alter:

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Donepezilo Alterif you have or have had:

-stomach or duodenal ulcers

-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 torsades de pointes or if someone in your family has «prolongation of the QT interval»

-low levels of magnesium or potassium in the blood

-seizures

-asthma or chronic lung disease

-difficulty urinating or mild kidney disease.

You must avoid taking Donepezilo Alterwithother acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Other medications and Donepezilo Alter:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication and especially if you are taking any of the following medications:

-medications for heart rhythm problems, for example amiodarone or sotalol

-medications for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine

-medications for psychosis, p. e.g. pimozide, sertindole or ziprasidone

-medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin

-antifungal medications, such as ketoconazole

-other medications to treat Alzheimer's disease, for example galantamine

-pain relievers or treatments for arthritis such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.

-quinidine and beta-blockers for treating irregular heartbeats such as propranolol and atenolol

-phenytoin and carbamazepine (for treating epilepsy)

-cholinergic agonists and medications with anticholinergic activity (acting at the central nervous system) such as tolterodine

-succinylcholine, diazepam and other neuromuscular blockers (to produce muscle relaxation)

-general anesthesia

You must inform your doctor that you are taking Donepezilo Alter before undergoing surgery with general anesthesia as this may affect the amount of anesthetic needed.

Donepezilo Alter 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 Alter.

TakingDonepezilo Alterwith food, drinks, and alcohol:

This medication should be taken with a little water.

Donepezilo Alter should not be taken with alcohol as alcohol may modify the effect of this medication.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Do not take Donepezilo Alter if you are pregnant.

You must not takeDonepezilo Alterif you are breastfeeding your child.

Driving and operating machinery:

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Donepezilo Alter may cause fatigue, dizziness, drowsiness, and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

This medication 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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Donepezilo is administered orally.

Treatment with donepezilo starts with a 5 mg tablet, taken once a day with a little water, at night immediately before going to bed. After a month of treatment, your doctor may recommend 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 donepezilo in the morning.

If you have mild or moderate liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can take donepezilo. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should not take donepezilo.

Use in children

Donepezilo is not recommended for use in children.

If you take moreDonepezilo Alterthan you should:

If you have taken more donepezilo than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The symptoms of overdose may include nausea (feeling sick), vomiting (being sick), drooling, sweating, decreased heart rate, low blood pressure (dizziness or lightheadedness when standing up), breathing problems, loss of consciousness, and seizures.

If you forgot to takeDonepezilo Alter:

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Donepezilo Alter

Do not stop treatment with donepezilo 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 donepezilo, ask your doctor or pharmacist.

Like all medications,Donepezilo Alter this medicationmay cause side effects, although not everyone will experience them.

The following side effects have been reported by people taking Donepezilo Alter.

Contact your doctor if you experience any of these side effects during treatment with Donepezilo Alter.

Severe side effects:

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

• Liver damage, for example, hepatitis. The symptoms of hepatitis are nausea or vomiting (feeling or being sick), loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark-colored urine (affects between 1 and 10 in 10,000).

• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (affects between 1 and 10 in 1,000).

• Bleeding in the stomach or intestines. This can cause you to have black, tar-like stools or visible blood from the rectum (affects between 1 and 10 in 1,000).

• Dizziness (attacks) or seizures (affects between 1 and 10 in 1,000).

• Fever with muscle stiffness, sweating, decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (affects fewer than 1 in 10,000 patients)

• Muscle weakness, sensitivity, or 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).

The estimated frequency of side effects is as follows:

Very common: may affect more than 1 in 10 patients:

• Diarrhea
• Uncomfortable feeling
• Headache

Common: may affect between 1 and 10 in 100 patients::

• Cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behavior
• Abnormal dreams and nightmares
• Fainting
• Dizziness
• Difficulty sleeping
• Vomiting
• Abdominal discomfort
• Urinary incontinence

• Rash
• Itching
• Muscle cramps
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect between 1 and 10 in 1,000 patients:

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

Rare: may affect between 1 and 10 in 10,000 patients:

• Extrapyramidal symptoms (such as tremors or stiffness of the hands or legs)
• Alterations in heart conduction
• Liver function alteration, including hepatitis

Frequency not known(cannot be estimated from available data):

• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contraction with abnormal flexion of the body and head to one side)
• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that may be symptoms of a potentially fatal condition called torsade de pointes

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es.

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

This medication does not require special storage conditions.

Do not usedonepeziloafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Donepezilo Alter 5 mg Tablets

• The active ingredient is donepezilo. Each tablet contains 5 mg of donepezilo hydrochloride.
• The other components are:Core:monohydrate lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, and magnesium stearate.Coating:Opadry White.

Appearance of the Product and Contents of the Package

Donepezilo Alter 5 mg are film-coated tablets, round, biconvex, and white in color.

They are presented in packages of 28 or 56 tablets.

Other presentations:

Donepezilo Alter 10 mg film-coated tablets: packages of 28 or 56 tablets.

Holder of the Marketing Authorization and Responsible Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036, Madrid,

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880, Meco (Madrid)

Spain

Last Review Date of this Leaflet:

December 2023

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