Summary of Product Characteristics: Information for the User

Donepezilo Flas Stada 5 mg Buccal Tablets EFG

Donepezilo Flas Stada 10 mg Buccal 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 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. See section 4

Table of Contents

1. What Donepezilo Flas Stada is and what it is used for
2. What you need to know before you start taking Donepezilo Flas Stada
3. How to take Donepezilo Flas Stada
4. Possible side effects
5. Storage of Donepezilo Flas Stada
6. Contents of the pack and additional information

Donepezilo Flas Stada(donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase 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.

It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include an increase in memory loss, confusion, and changes in behavior. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their daily activities.

Donepezilois only for use in adult patients.

Do not take Donepezilo Flas Stada:

• if you are allergic to donepezil hydrochloride, similar medications (known as piperidine derivatives), or 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 Flas Stada, especially if you have or have had::

• • stomach or duodenal ulcers
• a seizure or convulsion
• a heart condition (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.
• asthma or other chronic lung disease
• liver problems or hepatitis
• difficulty urinating or mild kidney disease

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

Children and Adolescents

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

Other Medications and Donepezilo Flas Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This also includes medications that your doctor has not prescribed but that you have acquired at the pharmacy. It also applies to medications that you may take in the future if you continue to take donepezilo.This is because these medications may weaken or strengthen the effects ofdonepezilo.

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
• antifungal medications, for example,ketoconazole

• other medications for Alzheimer's disease, for example,galantamine
• analgesics or treatment for arthritis, for example,acetylsalicylic acid, nonsteroidal anti-inflammatory drugs (NSAIDs) such asibuprofen or diclofenac sodium
• anticholinergic medications, for example,tolterodine
• anticonvulsants (medications used to prevent the occurrence of various types of seizures), for example,phenytoin, carbamazepine
• medications for heart disease, for example,quinidine, beta blockers(propranolol and atenolol)
• muscle relaxants, for example,diazepam, succinylcholine
• general anesthesia
• over-the-counter medications, for example,herbal remedies

If you are to undergo surgery that requires general anesthesia, you must inform your doctor and anesthesiologist that you are takingdonepezilo. This is because the medication may affect the amount of anesthetic needed.

Donepezilo may be used in patients with mild to moderate kidney or liver disease. Inform your doctor if you have kidney or liver disease. Patients with severe liver disease should not takedonepezilo.

Inform your doctor or pharmacist about the name of your caregiver. Your caregiver will help you takeyour medication as prescribed.

Donepezilo Flas Stada with Food, Drinks, and Alcohol

This medication does not affect the effect of food..Donepezilo should not be taken with alcohol,because alcohol may change its effects.

Pregnancy and Breastfeeding

Donepeziloshould not be used during breastfeeding. If you are pregnant or in the breastfeeding period, think you may be pregnant, or intend to become pregnant, consult your doctor before taking this medication.

Driving and Operating Machinery

Alzheimer's disease may affect the ability to drive or operate machinery and should not be performed unless your doctor indicates it is safe to do so.

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

Donepezilo Flas Stada contains Aspartame, Lactose, and Sodium

Aspartame

Donepezilo Flas Stada 5 mg

This medication contains 5mg of aspartame in each 5 mg buccal dispersible tablet.

Donepezilo Flas Stada 10 mg

This medication contains 10mg of aspartame in each 10 mg buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per buccal dispersible tablet; it is essentially “sodium-free”.

How much donepezil should I take?

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Normally, you will start taking 5 mg each night before going to bed. After a month, your doctor may recommend that you take 10 mg every night before going to bed.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil in the morning.

The dosage of the tablets you will take may change depending on the length of time you have been taking the medication and what your doctor recommends.

The maximum recommended dose is 10 mg per night.

Always follow the advice of your doctor or pharmacist about how and when to take the medication.

Do not adjust the dose on your own without consulting your doctor.

How to take donepezil?

The tablet should be placed on the tongue and should be allowed to disintegrate before swallowing, with or without water according to your preference.

Use in children and adolescents

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

If you take more Donepezil Flas Stada than you should

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

The symptoms of overdose include, 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 Donepezil Flas 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 Donepezil Flas Stada

Do not stop taking the tablets unless your doctor tells you to do so,If you interrupt treatment withdonepezil, the benefits of your treatment may disappear gradually.

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

For how long should I take donepezil?

Your doctor or pharmacist will advise you on how long you should continue taking your tablets. You will need to visit your doctor from time to time to review your treatment and evaluate your symptoms.

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

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

Inform 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 mentioned. You may need urgent medical treatment.

• Liver disorders, for example, hepatitis. The symptoms of hepatitis are nausea (feeling sick), vomiting, loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (rare: may affect up to 1 in 1,000 people).
• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (infrequent: may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This may cause your stools to be tar-like or visible blood in the rectum (infrequent: may affect up to 1 in 100 people).
• Spasms (attacks) or convulsions (infrequent: may affect up to 1 in 100 people).
• Fever with muscle rigidity, sweating, or decreased level of consciousness (a condition known as Neuroleptic Malignant Syndrome) (very rare: may affect up to 1 in 10,000 people).
• Muscle weakness, sensitivity, or pain, particularly if you are feeling unwell, have a fever, or your urine is dark-colored. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition known as rhabdomyolysis) (may affect up to 1 in 10,000 people).
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially fatal condition known as Torsade de Pointes (the frequency cannot be estimated from the available data).

Other side effects

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

• Diarrhea
• Nausea (feeling sick)
• Headaches

Common (may affect up to 1 in 10 people)

• Muscle cramps
• Tiredness
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that do not exist)
• Unusual dreams, including nightmares
• Restlessness
• Aggressive behavior
• Fainting
• Dizziness
• Vomiting (feeling sick)
• Discomfort in the stomach
• Rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Infrequent (may affect up to 1 in 100 people)

• Slow heart rate
• Excessive salivation

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

• Rigidity, agitation, or uncontrollable movements, especially of the face and tongue, but also of the limbs

Unknown (the frequency cannot be estimated from the available data)

• Changesin heart activity that can be observed on an electrocardiogram (ECG) known as “prolongationof 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 the 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, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Donepezilo Flas Stada

• The active ingredient of Donepezilo Flas Stada is donepezil hydrochloride.

Each Donepezilo Flas Stada 5 mg tablet contains 5 mg of donepezil hydrochloride.

Each Donepezilo Flas Stada 10 mg tablet contains 10 mg of donepezil hydrochloride.

• The other components are:

potassium polacrilex, microcrystalline cellulose, anhydrous lactose monohydrate (spray-dried), anhydrous citric acid, aspartame (E951), sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the package

Donepezilo Flas Stada 5 mg are white to almost white, round, flat, beveled-edge tablets, marked with the '5' on one face and smooth on the other face.

Donepezilo Flas Stada 10 mg are white to almost white, round, flat, beveled-edge tablets, marked with the '10' on one face and smooth on the other face.

Packaging:

Blister packs of7, 10 or 14 tablets.

Packaging sizes:

10, 14, 28, 30, 56, 98, 126, 154 and 196 buccal dispersible tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Genepharm S.A

18th Km Marathonos Avenue,

153 51 Pallini Attikis

Greece

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

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

Germany:Donepezilhydrochlorid AL 5/10 mg Schmelztabletten

Spain:Donepezilo Flas STADA 5/10 mg buccal dispersible tablets EFG

Last review date of thisleaflet: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/