Summary of Product Characteristics: Information for the User

Donepezilo flas cinfa 5 mg buccodispersible tablets EFG

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 similar symptoms to 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. See section 4.

1.What Donepezilo flas cinfa is and what it is used for

2.What you need to know before you start taking Donepezilo flas cinfa

3.How to take Donepezilo flas cinfa

4.Possible side effects

5.Storage of Donepezilo flas cinfa

6.Contents of the pack and additional information

Donepezilo flas cinfa belongs to a group of medicines called cholinesterase 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 treatment of mild to moderately severe symptoms of Alzheimer's disease. Symptoms include increased memory loss, confusion, and changes in behavior.

Do not take Donepezilo flas cinfa

-If you are allergic to donepezilo hydrochloride, piperidina derivatives, or any of the other components of this medication (listed in section 6)

-If you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezilo flas cinfa, if you have or have had:

• History of 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 torsade 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 should avoid taking donepezilo flas with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists

Children and adolescents

Donepezilo flas is not recommended for use in children.

Taking Donepezilo flas cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially if you are taking any of the following medications:

• Medications for heart rhythm problems, such as amiodarone or sotalol
• Medications for depression, such as citalopram, escitalopram, amitriptyline, fluoxetine
• Medications for psychosis, e.g. pimozide, sertindole, or ziprasidone
• Medications for bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medications, such as ketoconazole
• Other medications for treating Alzheimer's disease, such as galantamine
• Pain relievers or treatments for arthritis, such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• Anticholinergic medications, e.g. tolterodine
• Anticonvulsants, e.g. phenytoin, carbamazepine
• Medications for heart disease, such as quinidine, beta-blockers (propranolol and atenolol)
• Muscle relaxants, e.g. diazepam, succinylcholine
• General anesthetics
• Over-the-counter medications, such as herbal remedies

In the event of surgery with general anesthesia, you should inform your doctor that you are taking donepezilo flas, as this may affect the amount of anesthetic needed.

Donepezilo flas 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 flas.

Taking Donepezilo flas cinfa with food, drinks, and alcohol

Place the tablet on the tongue and let it dissolve. Swallow with or without water.

Donepezilo flas 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take donepezilo flas if you are pregnant or think you may be pregnant.

Do not take donepezilo flas if you are breastfeeding your child.

Driving and operating machinery

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

Donepezilo flas cinfa contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Donepezilo flas cinfa contains sodium.This medication contains less than 23 mg of sodium (1 mmol) per buccal tablet; this is essentially "sodium-free".

Donepezilo flas cinfa contains aspartame (E-951).This medication contains 5 mg of aspartame in each buccal tablet equivalent to 2.80 mg of phenylalanine. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

Take the buccal dispersible tablet in the following way:

Donepezilo flas is administered orally.

1. Do not crush the buccal dispersible tablet

To avoid crushing the buccal dispersible tablet, do not press the alveolus (Figure 1).

1. Separate an alveolus

Each blister contains fourteen alveoli, which are separated by perforations. Separate an alveolus following the perforated lines, where it is indicated “fold” (Figure 2).

1. Remove the foil

Remove the foil carefully, starting from the corner marked with an arrow and where it is indicated “pull here” (Figures 3 and 4).

1. Remove the buccal dispersible tablet

Remove the buccal dispersible tablet with dry hands and place it on the tongue (Figure 5).

The tablet will disintegrate quickly, and once dissolved, it can be swallowed with or without water, according to your preference.

The treatment with donepezilo flas starts with a 5 mg tablet, taken once a day, at night, immediately before going to bed. After a month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day and at night. The maximum recommended dose is 10 mg per day.

If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking donepezilo in the morning.

If you have mild or moderate liver disease (disease affecting the liver) or renal insufficiency (disease affecting 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 and adolescents

Donepezilo flas is not recommended for use in children or adolescents.

If you take more Donepezilo flas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package insert and the packaging of the medication to the healthcare professional.

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

If you forgot to take Donepezilo flas

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Donepezilo flas

Do not stop taking donepezilo unless your doctor indicates it. If you stop taking donepezilo flas, the benefits of treatment will gradually disappear.

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

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 donepezilo flas. Contact your doctor if you have any of these side effects during treatment with donepezilo flas.

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 feeling or being sick, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark urine (very rare side effects (can affect up to 1 in 10,000 patients)).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (rare side effects (can affect up to 1 in 1,000 patients)).
• Bleeding in the stomach or intestine. This can cause you to have black, tar-like stools or visible blood from the rectum (rare side effects (can affect up to 1 in 1,000 patients)).
• Mareos (ataques) or convulsiones (efectos adversos raros (pueden afectar hasta 1 de cada 1,000 pacientes))
• Fever with muscle rigidity, decreased level of consciousness (can be symptoms of a condition known as "Neuroleptic Malignant Syndrome") (very rare side effects (can affect up to 1 in 10,000 patients)).
• Weakness, sensitivity or muscle pain, particularly if you are feeling 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 known as rhabdomyolysis)

The estimated frequency of side effects is as follows:

Very common (can affect more than 1 in 10 patients)

• Diarrhea
• Discomfort
• Headache

Common (can affect up to 1 in 10 patients)

• Cold
• Loss of appetite
• Illusions
• Agitation
• Aggressive behavior
• Abnormal dreams and nightmares
• Fainting
• Dizziness
• Difficulty sleeping
• Vomiting
• Abdominal discomfort
• Incontinence
• Rash
• Itching
• Muscle cramps
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Rare (can affect up to 1 in 100 patients)

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

Rare (can affect up to 1 in 1,000 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)

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially fatal condition 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 type of side effect, 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 the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://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 afterCAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging andmedications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and medications you no longer need. By doing so, you willhelp protect the environment.

Composition of Donepezilo flas cinfa

-The active ingredient is donepezilo hydrochloride. Each buccal dispersible tablet contains 5 mg of donepezilo hydrochloride equivalent to 4.56 mg of donepezilo.

-The other components are: potassium polacrilex, microcrystalline cellulose, lactose monohydrate, anhydrous sodium citrate, aspartame (E-951), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, hydrochloric acid, purified water.

Appearance of the product and contents of the package

Donepezilo flas cinfa is presented in buccal dispersible tablets, which dissolve in the mouth.The buccal dispersible tablets of Donepezilo flas cinfa 5 mg are flat, round, beveled-edged tablets with a white or off-white color, engraved with “5” on one face and flat on the other.

Donepezilo flas cinfa 5 mg is available in PVC/PCTFE (Aclar)/Aluminum blisters and in Aluminum/Aluminum blisters with 28 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Genepharm S.A.

18 Km Marathon Av.15351 Pallini Attikis - Greece

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:October 2022

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74998/P_74998.html

QR code to:https://cima.aemps.es/cima/dochtml/p/74998/P_74998.html