Prospecto:information for the patient

Donepezilo Krka5mg buccodispersible tablets EFG

hydrochloride of donepezilo

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isDonepezilo Krkaand for what it is used

2.What you need to know before starting to takeDonepezilo Krka

3.How to takeDonepezilo Krka

4.Possible adverse effects

5Storage ofDonepezilo Krka

6.Contents of the package and additional information

Donepezilo Krkacontains the active substance donepezil hydrochloride. Donepezilo Krka (donepezil hydrochloride) belongs to a group of medicines called cholinesterase inhibitors. Donepezilo increases the levels of a substance (acetylcholine) in the brain involved in memory function by reducing the breakdown of acetylcholine.

Donepezilo Krkasis used for the treatmentof the symptoms of dementia in those people who have been diagnosedwith mild or moderately severe Alzheimer's disease.The symptoms include an increase in memory loss, confusion, and changes in behavior. As a result, Alzheimer's patients have increasingly greater difficulties in carrying out their normal daily activities.

Donepezilo Krka is only used in adult patients.

Do not takeDonepezilo Krka:

• 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 or pharmacist before starting to takeDonepezilo Krkaif you have or have had:

• gastric or duodenal ulcers;
• episodes or seizures;
• 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 any lung disease;
• liver problems or hepatitis;
• difficulty urinating or mild kidney disease;

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

Children and adolescents

Donepezilo Krka is not recommended for use in children and adolescents (under 18 years of age).

Other medications andDonepezilo Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Inform your doctor or pharmacist equally in the future about any medications you may take while continuing treatment with Donepezilo Krka. This is because these medications may weaken or intensify the effect of Donepezilo Krka.

In particular, it is essential to inform your doctor if you are taking any of the following medications:

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

If you are to undergo a surgical procedure requiring general anesthesia, you must inform your doctor and anesthesiologist that you are taking Donepezilo Krka. This is because this medication may affect the amount of anesthesia needed.

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

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

TakingDonepezilo Krkawith food, drinks, and alcohol

Foods do not affect the effect ofDonepezilo Krka.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, ask your doctor or pharmacist before using this medication.

Do not breastfeed your baby while takingDonepezilo Krka.

Driving and operating machinery

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

Additionally, this medication may cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, you should not drive or operate machinery.

Donepezilo Krka contains:

• Aspartame (E951)

This medication contains 0.75 mg of aspartame in each 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.

• Glucose (dextrose) and sucrose

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Amount of Donepezilo Krka that you should take

The initial recommended dose is 5 mg each night before going to bed.

After a month, your doctor may prescribe 10 mg each night before going to bed.

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

The dose of the tablet you will take may change depending on the time period you have been taking the medication and what your doctor recommends. The maximum recommended dose is 10 mg each night.

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

Do not alter the dose yourself without consulting your doctor.

How to take your medication

Donepezilo Krka tablets are fragile. Do not press them through the aluminum foil of the blister pack, as this could damage the tablet. Do not handle the tablets with wet hands, as they may disintegrate. Remove a tablet from the blister pack as follows:

1. Hold the blister pack by the edges and separate one of the cells from the rest of the blister pack by gently tearing along the perforated line that delimits the cell.
2. Pull the edge of the foil until it is completely separated.
3. Let the tablet fall onto your hand.
4. Deposit the tablet onto your tongue as soon as you have removed it from its packaging.

In a few seconds, the tablet will begin to disintegrate in the mouth and can be swallowed with or without water. The mouth must be empty before depositing the tablet onto the tongue.

Use in children and adolescents

Donepezilo Krka is not recommended for use in children and adolescents (under 18 years old).

If you take moreDonepezilo Krkathan you should

Contact your doctor or the emergency department of the nearest hospital immediately if you take more medication than you should. Carry this leaflet and your tablets with you at all times.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeDonepezilo Krka

If you forget to take your medication, take the next dose at your usual time.Do not take a double dose to compensate for the missed doses.

If you forget to take your medicine for more than a week, call your doctor before taking any more tablets.

If you interrupt treatment withDonepezilo Krka

Do not stop taking the tablets unless your doctor has told you to. If you stop taking Donepezilo Krka, the benefits of treatment will be lost gradually.

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

How long should you take Donepezilo Krka

Your doctor or pharmacist will advise you on how long you should continue taking the tablets.

You will need to see your doctor from time to time to review your treatment and evaluate your symptoms.

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

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

Inform your doctor if you have any of these side effects while taking Donepezilo Krka.

Severe side effects:

Contact your doctor immediately if you notice any of the following severe side effects. You may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, general feeling of 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, feeling of discomfort between the navel and ribs (indigestion) (may affect up to 1 in 100 people)
• Bleeding in the stomach or intestine. This may cause black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 people)
• Convulsions or seizures (may affect up to 1 in 100 people)
• Fever with muscle stiffness, sweating, or decreased level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people)
• Muscle weakness, sensitivity, or pain, and especially if you feel unwell, have a fever, or dark-colored urine. They may be caused by an abnormal muscle rupture that can be potentially fatal and cause kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)

Unknown frequency:

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially fatal condition known as Torsade de Pointes

Other side effects

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

• Diarrhea
• Headache

Common side effects (may affect up to 1 in 10 people)

• Muscle cramps
• Tiredness
• Difficulty sleeping (insomnia)
• Common cold
• Illusions (seeing or hearing things that do not exist)
• Abnormal dreams, including nightmares
• Restlessness
• Aggressive behavior
• Fainting
• Dizziness
• Stomach discomfort
• Rash
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls or accidental injuries)

Uncommon side effects (may affect up to 1 in 100 people)

• Slow heart rate
• Excessive salivation

Rare side effects (may affect up to1 in 1,000 people)

• Rigidity, tremor, or uncontrolled movement, especially of the face and tongue, but also of the limbs (extrapyramidal symptoms)

Unknown frequency (cannot be estimated from available data)

• Increased libido
• 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 national notification system:Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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 usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. This medication does not require any special temperature for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofDonepezilo Krka

• The active ingredient is hydrochloride of donepezilo.

Each buccal dispersible tablet contains 5.22 mg of monohydrate of donepezilo hydrochloride, equivalent to 5 mg of hydrochloride of donepezilo.

• The other components are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, banana flavoring (maltodextrin, dextrose, sucrose, and gum arabic), aspartame (E951), calcium silicate, and magnesium stearate.

Appearance ofDonepezilo Krkaand contents of the packaging

Buccal dispersible tablets, white and round, with a beveled edge.

The tablets are available in blisters of 10, 28, 30, 50, 56, 60, 84, 90, 98, and 100 buccal dispersible tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

For more information about this medication, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura, 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:December 2022

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).