DONEPEZIL FLAS SANDOZ 5 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Donepezil Flas Sandoz

Do not take Donepezil Flas Sandoz

if you are allergicto

• donepezil hydrochloride or
• piperidine derivatives similar to donepezil, or
• any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

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

• stomach or duodenal ulcers,
• seizures or convulsions (donepezil may cause convulsions),
• a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction),
• a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolonged QT interval",
• low levels of magnesium or potassium in the blood,
• asthma or other long-term lung disorders,
• liver or hepatitis disorders,
• difficulty urinating or mild kidney disease.

Tell your doctor if you are pregnant or think you may be pregnant.

Other medications and Donepezil Flas Sandoz

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

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

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

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

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

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

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

Taking Donepezil Flas Sandoz with food, drinks, and alcohol

Food does not affect the effect of donepezil.

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

Pregnancy, breastfeeding, and fertility

Donepezil should not be taken during breastfeeding.

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

Driving and using machines

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

This medication may cause fatigue, dizziness, and muscle cramps, especially during the initial treatment and dose increase. If this happens, you should not drive or use machines.

Donepezil Flas Sandoz contains aspartame and sodium

This medication contains 8.4 mg of aspartame in each orodispersible tablet.

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

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

3. How to take Donepezil Flas Sandoz

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

Adults and elderly patients

Donepezil Flas Sandoz 5 mg orodispersible tablets

• Initial dose: 1 orodispersible tablet each night.
• After 1 month: possible increase to 2 orodispersible tablets each night.
• Maximum dose: 2 orodispersible tablets each night.

Donepezil Flas Sandoz 10 mg orodispersible tablets

• Initial dose: 5 mg each night; for this dosage, this medication cannot be used. Donepezil Flas Sandoz 5 mg is available for initiating treatment.
• After 1 month: possible increase to 1 orodispersible tablet each night.
• Maximum dose: 1 orodispersible tablet each night.

Do not change 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 donepezil before increasing the dose.

Patients with severe renal insufficiency

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

Method of administration

Take your orodispersible tablets at night before bedtime, regardless of meals. Place it on your 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 taking Donepezil Sandoz in the morning.

Duration of treatment

Your doctor or pharmacist will advise you on how long you need to continue taking your tablets.

You will need to visit your doctor from time to time to review your treatment and assess your symptoms.

If you take more Donepezil Flas Sandoz than you should

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

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

Always carry the orodispersible tablets, this leaflet, and/or the packaging 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 seizures or convulsions.

If you forget to take Donepezil Flas Sandoz

If you forget to take an orodispersible tablet, take only one orodispersible tablet the next day at the usual time. Do not take a double dose to make up for forgotten doses.

If you forget to take your medication for more than one week, consult your doctor before taking the medication again.

If you stop taking Donepezil Flas Sandoz

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Serious side effects:

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

• liver damage, e.g., hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and darkening of the 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 sternum (may affect up to 1 in 100 people),
• bleeding from the stomach or intestines. This can cause black stools or blood in stools (may affect up to 1 in 100 people),
• seizures or convulsions (may affect up to 1 in 100 people),
• fever with muscle stiffness, sweating, or a decrease in the level of consciousness. These are the symptoms of a disorder called "Neuroleptic Malignant Syndrome" (may affect up to 1 in 10,000 people),
• weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark. This may be due to an abnormal destruction of muscle that can be fatal and cause kidney problems (a disease called 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,
• fatigue,
• difficulty sleeping (insomnia),
• common cold,
• loss of appetite,
• hallucinations (seeing or hearing things that do not really exist),
• abnormal dreams and nightmares,
• agitation,
• aggressive behavior,
• fainting,
• dizziness,
• stomach upset,
• skin rash,
• itching,
• urinary incontinence,
• pain,
• accidents (patients may be more prone to falls and accidental injuries).

Uncommon, may affect up to 1 in 100 people

• slow heart rate,
• slightly increased creatine kinase enzyme in blood tests.

Rare, may 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 "prolonged QT interval",
• fast and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes,
• increased libido, hypersexuality,
• Syndrome of Pisa (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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Flas Sandoz

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 label of the plastic bottle after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, 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 Flas Sandoz 5 mg

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

Composition of Donepezil Flas Sandoz 10 mg

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

Appearance of the product and package contents

Donepezil Flas Sandoz 5 mg orodispersible tablets are white, round, flat with the mark "5" engraved on one side and smooth on the other.

Donepezil Flas Sandoz 10 mg orodispersible tablets are yellow, slightly speckled, round, flat, with the mark "10" engraved on one side and smooth on the other.

The orodispersible tablets are packaged in Alu/PVC/ACLAR blisters within a cardboard box or in HDPE bottles with a PP screw cap.

Package sizes:

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

Bottles: 100 orodispersible tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under 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

Date of last revision of this leaflet:December 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/