DONEPEZIL KRKA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet:information for the patient

Donepezil Krka10mg orodispersible tablets EFG

Donepezil hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Donepezil Krka and what is it used for
2. What you need to know before you take Donepezil Krka
3. How to take Donepezil Krka
4. Possible side effects

5 Storage of Donepezil Krka

1. Contents of the pack and further information

1. What is Donepezil Krka and what is it used for

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

Donepezil Krka is used for the treatment of the symptoms of dementia in people diagnosed with mild or moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion, and changes in behavior. As a result, people with Alzheimer's disease have increasing difficulty performing their daily activities.

Donepezil Krka is only used in adult patients.

2. What you need to know before you take Donepezil Krka

Do not takeDonepezil Krka:

• if you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Donepezil Krka if you have or have had:

• stomach or duodenal ulcers;
• seizures or convulsions;
• a heart condition (such as irregular or very slow heartbeats, heart failure, heart attack);
• 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 any lung disease;
• liver problems or hepatitis;
• difficulty urinating or mild kidney disease;

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

Children and adolescents

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

Other medicines andDonepezil Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Also, inform your doctor or pharmacist in the future about any medications you may take if you continue to be treated with Donepezil Krka. This is because these medications can weaken or enhance the effect of Donepezil Krka.

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

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

If you are going to have surgery that requires general anesthesia, you should inform your doctor and anesthesiologist that you are taking Donepezil Krka. The reason is that this medicine may affect the amount of anesthesia needed.

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

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

TakingDonepezil Krkawith food, drinks, and alcohol

Food does not affect the effect of Donepezil Krka.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Do not breastfeed while being treated with Donepezil Krka.

Driving and using machines

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

Additionally, this medicine may cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, do not drive or use machines.

Donepezil Krka contains:

• Aspartame (E951)

This medicine contains 0.75 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

• Glucose (dextrose) and sucrose

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

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

3. How to take Donepezil Krka

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

Amount of Donepezil Krka you should take

Initially, the recommended dose is 5 mg each night before bedtime.

After one month, your doctor may prescribe 10 mg each night before bedtime.

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

The dose of the tablet you will take may change depending on the time you have been taking the medicine 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 medicine.

Do not change the dose yourself without your doctor's advice.

How to take your medicine

Donepezil Krka orodispersible tablets are fragile. They should not be pressed through the aluminum foil of the blister, as this could damage the tablet. Do not handle the tablets with wet hands, as they may disintegrate. Remove a tablet from the blister as follows:

1. Hold the blister by the edges and separate one of the cells from the rest of the blister by gently tearing along the perforated line that marks the cell.
2. Pull the edge of the foil until it is completely separated.
3. Let the tablet fall into your hand.
4. Place the tablet on your tongue immediately after removing it from its packaging.

In a few seconds, the tablet will start to disintegrate in your mouth and can be swallowed with or without water. Your mouth should be empty before placing the tablet on your tongue.

Use in children and adolescents

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

If you take moreDonepezil Krkathan you should

Contact your doctor or the nearest hospital emergency department immediately if you take more medicine than you should. Bring this leaflet and your tablets with you.

Symptoms of overdose may include nausea (feeling sick) and vomiting, drooling, sweating, slow heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and seizures (fits).

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

If you forget to takeDonepezil Krka

If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

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

If you stop takingDonepezil Krka

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

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

How long to take Donepezil Krka

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Tell your doctor if you have any of these side effects while taking Donepezil Krka.

Serious side effects:

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

• liver damage, for example, hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, feeling unwell, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people)
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain, feeling unwell between the navel and the ribs (indigestion) (may affect up to 1 in 100 people)
• bleeding in the stomach or intestine. This can cause black stools (like tar) or visible blood from the rectum (may affect up to 1 in 100 people)
• seizures or fits (may affect up to 1 in 100 people)
• fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people)
• muscle weakness, sensitivity, or pain, especially if you also feel unwell, have a fever, or dark urine. These can be caused by abnormal muscle breakdown, which can be potentially life-threatening and cause kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)

Frequency not known:

• 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 life-threatening disorder known as Torsades 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
• fatigue
• difficulty sleeping (insomnia)
• common cold
• hallucinations (seeing or hearing things that do not really exist)
• abnormal dreams, including nightmares
• agitation
• aggressive behavior
• fainting
• dizziness
• stomach upset
• 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 heartbeat
• excessive salivation

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

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

Frequency not known (cannot be estimated from the 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Store in the original packaging to protect from moisture. This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition ofDonepezil Krka

• The active substance is donepezil hydrochloride.

Each orodispersible tablet contains 10.43 mg of donepezil hydrochloride monohydrate equivalent to 10 mg of donepezil hydrochloride.

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

Appearance ofDonepezil Krkaand contents of the pack

Orodispersible tablets, white and round, with a beveled edge.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

You can obtain further information on this medicine from the representative of the marketing authorization holder:

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:December 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).