Package Insert: Information for the Patient

Donepezilo Flas Sandoz 5 mg Buccodispersible Tablets EFG

Donepezilo Flas Sandoz 10 mg Buccodispersible Tablets EFG

Donepezil Hydrochloride

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

Donepezilo Flas Sandoz belongs to a group of medicines called cholinesterase inhibitors. Donepezilo increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the speed of acetylcholine breakdown.

Donepezilo Flas Sandoz is used to treatthe symptoms of dementia in patients diagnosed with Alzheimer's disease,mild to moderately severe. Symptoms include increased 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.

Donepezilo Flas Sandoz is only used in adult patients.

Do not take Donepezilo Flas Sandoz

if you areallergicto

• hydrochloride of donepezilo or
• derivatives of piperidina similar to donepezilo, or
• any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor,pharmacist or nurse before starting to take Donepezilo Flas Sandoz. If you have any of the following problems, you or your caregiver must inform yourdoctor or pharmacist.

• stomach ulcers or duodenal ulcers,
• spasms (attacks) or convulsions (donepezilo may cause convulsions),
• 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 torsade 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 long-term lung problems,
• liver problems or hepatitis,
• difficulty urinating or mild kidney disease.

Inform your doctor also if you are pregnant or think you may be pregnant.

Other medications and Donepezilo Flas Sandoz

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

This includes medications that your doctor has not prescribed but that you have bought from a pharmacist. This also includes medications that you may need to take in the future if you continue to take donepezilo. This is because these medications may weaken or increase the effects of donepezilo.

Inform your doctor especially if you are taking any of the following types of medications:

• other medications for Alzheimer's disease, for example, galantamine,
• analgesics or medications for arthritis, for example, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium,
• anticholinergic medications, for example, tolterodina,
• antibacterial medications, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin,
• antifungal medications, for example, ketoconazole,
• medications for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine,
• medications for psychosis, for example, pimozide, sertindole or ziprasidone,
• anticonvulsants, for example, phenytoin, carbamazepine,
• medications for heart rhythm problems, for example, amiodarone, sotalol,
• 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 the anesthesiologist that you are taking donepezilo. This is because the medication may affect the amount of anesthetic needed.

Donepezilo can be used in patients with mild to moderate kidney or liver disease. Inform your doctor first if you have had liver or kidney problems. Patients with severe liver disease should not take donepezilo.

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

Taking Donepezilo Flas Sandoz with food, drinks and alcohol

Food does not affect the effect of donepezilo.

Donepezilo should not be taken with alcohol because alcohol may change its effect.

Pregnancy, breastfeeding and fertility

Donepezilo should not be taken during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machines

Your Alzheimer's disease may affect your ability to drive or operate machines. You should not perform these activities unless your doctor tells you it is safe to do so.

This medication may cause fatigue, dizziness and muscle cramps, particularly during the start of treatment and dose increase. If this happens, you should not drive or operate machines.

Donepezilo Flas Sandoz contains aspartame and sodium

This medication contains 8.4 mg of aspartame in each buccal dispersible tablet.

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.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist. The recommended dose is:

Adults and elderly patients

Donepezilo Flas Sandoz 5 mg buccal tablets

• Initial dose: 1 buccal tablet every night.
• After one month: possible increase to 2 buccal tablets every night.
• Maximum dose: 2 buccal tablets every night.

Donepezilo Flas Sandoz 10 mg buccal tablets

• Initial dose: 5 mg every night, for this dosage, this medication cannot be used. Donepezilo Flas Sandoz 5 mg is available to start treatment.
• After one month: possible increase to 1 buccal tablet every night
• Maximum dose: 1 buccal tablet every night.

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

Patients with renal insufficiency

You can take the usual dose as described above. No adjustment is required.

Patients with mild to moderate hepatic insufficiency

Your doctor will check your tolerance to donepezilo before increasing the dose.

Patients with severe renal insufficiency

Your doctor will decide if donepezilo is suitable for you.Patients with severe renal insufficiency should not take donepezilo.

Administration form

Take your buccal tablets at night before going to bed, regardless of meals. Place it on the tongue where it will rapidly disintegrate before swallowing, with or without water, as you prefer.

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

Treatment duration

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.

If you take more Donepezilo Flas Sandoz than you should

DO NOT take more than 10 mg of donepezilo hydrochloride per day.

If you have taken more Donepezilo Flas Sandoz 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.

Always carry the buccal tablets, this leaflet, and/or the packaging with you to the hospital so that the doctor knows what you have taken.

The symptoms of overdose include feeling or being sick, salivation, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing up), respiratory problems, loss of consciousness, and spasms (attacks) or convulsions.

If you forgot to take Donepezilo Flas Sandoz

If you forget to take a buccal tablet, take only one buccal tablet the next day at the usual time. Do not take a double dose to compensate for the missed doses.

If you forget to take your medication for more than a week, consult your doctor before resuming the medication.

If you interrupt treatment with Donepezilo Flas Sandoz

Do not stop taking the buccal tablets without your doctor's indication. If treatment is interrupted, the positive results may gradually decrease.

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.

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 damage, for example, hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (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 (may affect up to 1 in 100 people),
• Bleeding in the stomach or intestines. This can cause black stools or blood in the stool (may affect up to 1 in 100 people),
• Spasms (attacks) or convulsions (may affect up to 1 in 100 people),
• Fever with muscle stiffness, sweating, or a decrease in level of consciousness. These are the symptoms of a condition called "Malignant Neuroleptic Syndrome" (may affect up to 1 in 10,000 people),
• Weakness, sensitivity, or muscle pain, particularly if you feel unwell, have a fever, or dark-colored urine. This can 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).

Other side effects that may occur:

Very common,may affect more than 1 in 10 people

• Diarrhea,
• Nausea (feeling sick),
• Headache.

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),
• Strange dreams and nightmares,
• Restlessness,
• Aggressive behavior,
• Fainting,
• Dizziness,
• Stomach discomfort,
• Rash,
• Itching,
• Urinary incontinence,
• Pain,
• Accidents (patients may be more prone to falls and accidental injuries).

Uncommonmay affect up to 1 in 100 people

• Slow heart rate,
• Minor increase in creatine kinase enzyme in blood tests.

Raremay affect up to 1 in 1,000 people

• Tremors, stiffness, or uncontrolled movements, especially of the face and tongue, but also of the limbs,
• Changes in heart rhythm.

Frequency not known

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

Reporting of 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 Vigilance 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 and blister or plastic bottle label after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Do not use this medication after 6 months have passed since the first opening of the plastic bottle.

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

Composition of Donepezilo Flas Sandoz 5 mg

• The active ingredient is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.
• The other components are: aspartame (E951), croscarmellose sodium, magnesium stearate, mannitol (E421), microcrystalline cellulose, peppermint flavor, colloidal anhydrous silica, and zinc sulfate monohydrate.

Composition of Donepezilo Flas Sandoz 10 mg

• The active ingredient is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: aspartame (E951), croscarmellose sodium, yellow iron oxide (E172), magnesium stearate, mannitol (E421), microcrystalline cellulose, peppermint flavor, colloidal anhydrous silica, and zinc sulfate monohydrate.

Appearance of the product and contents of the package

The buccal dispersible tablets of Donepezilo Flas Sandoz 5 mg are white, round, flat with the mark "5" engraved on one side and smooth on the other side.

The buccal dispersible tablets of Donepezilo Flas Sandoz 10 mg are yellow, slightly speckled, round, flat, with the mark "10" engraved on one side and smooth on the other side.

The buccal dispersible tablets are packaged in Alu/PVC/ACLAR blisters inside a cardboard package or in HDPE bottles with PP screw cap.

Package sizes:

Blister: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, or 120 buccal dispersible tablets.

Bottle: 100 buccal dispersible tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto Von Guericke Allee 1

39179 Barleben

Germany

or

LEK, S.A.

Ul Domaniewska 50 C

PL 02-672 Warsaw

Poland

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:

Austria:Donepezil HCl Sandoz 5 mg – Schmelztabletten

Donepezil HCl Sandoz 10 mg – Schmelztabletten

Belgium:Donepezil Sandoz 5 mg orodispergeerbare tabletten

Donepezil Sandoz 10 mg orodispergeerbare tabletten

Czech Republic:DONEPEZIL SANDOZ DISTAB 10 mg tablety dispergovatelné v ústech

France:DONEPEZIL SANDOZ 10 mg, comprimé orodispersible

Sweden:Donepezil Sandoz 5 mg munsönderfallande tablett

Donepezil Sandoz 10 mg munsönderfallande tablett

United Kingdom

(Northern Ireland):Donepezil 5 mg Orodispersible Tablets

Donepezil 10 mg Orodispersible Tablets

Last review date of this leaflet:December 2022

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/