DONEPEZIL KRKA 5 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Donepezil Krka

Do not takeDonepezil 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 take Donepezil Krka if you have or have had:

• gastric or duodenal ulcers;
• seizures or 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 torsades de pointes, or if a family member 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

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

Other medications andDonepezil Krka

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

Also, inform your doctor about any medications you may take in the future 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 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, such as galantamine.
• analgesics or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium.
• anticholinergic medications, such as tolterodine.
• anticonvulsants, such as phenytoin, carbamazepine.
• medications for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol).
• muscle relaxants, such as succinylcholine.
• general anesthesia.
• over-the-counter medications, such as herbal remedies.

If you are going to undergo surgery that requires general anesthesia, you should inform your doctor and anesthesiologist that you are taking Donepezil Krka. The reason is that this medication can 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 the 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 before using this medication.

Do not breastfeed your baby while being treated with Donepezil Krka.

Driving and using machines

Alzheimer's disease can 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 medication can cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, you should not drive or use machines.

Donepezil Krka contains:

• Aspartame (E951)

This medication contains 0.75 mg of aspartame in each tablet.

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

• 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.

3. How to take Donepezil Krka

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, 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 a 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 take may change depending on the time you have been taking the medication and your doctor's recommendations. The maximum recommended dose is 10 mg each night.

Always follow your doctor's or pharmacist's advice on how and when to take your medication.

Do not change the dose yourself without consulting your doctor.

How to take your medication

The orodispersible tablets of Donepezil Krka are fragile. They should not be pressed 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 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 as soon as you have removed it from its packaging.

Within 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 emergency department of the nearest hospital immediately if you take more medication than you should. Bring this leaflet and your tablets with you.

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

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 takeDonepezil Krka

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

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

If you stop takingDonepezil Krka

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

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

How long you should take Donepezil Krka

Your doctor or pharmacist will advise you how long you should 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 medications, this medication can cause side effects, although not everyone 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 (can affect up to 1 in 1,000 people)
• gastric or duodenal ulcers. The symptoms of ulcers are stomach pain, feeling unwell between the navel and the ribs (indigestion) (can affect up to 1 in 100 people)
• bleeding in the stomach or intestine. This can cause black, tar-like stools or visible blood from the rectum (can affect up to 1 in 100 people)
• seizures or convulsions (can affect up to 1 in 100 people)
• fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (can affect up to 1 in 10,000 people)
• muscle weakness, sensitivity, or pain, especially if you also feel unwell, have a fever, or have dark urine. These can be caused by abnormal muscle breakdown, which can be potentially life-threatening and cause kidney problems (a condition called rhabdomyolysis) (can 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"
• rapid and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as Torsade de Pointes

Other side effects

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

• diarrhea
• headache

Common side effects (can 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 (can affect up to 1 in 100 people)

• slow heart rate
• excessive salivation

Rare side effects (can 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 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 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 medication.

5. Storage of Donepezil Krka

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. 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 storage temperature.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofDonepezil Krka

• The active substance is donepezil hydrochloride.

Each orodispersible tablet contains 5.22 mg of donepezil hydrochloride monohydrate, equivalent to 5 mg of donepezil hydrochloride.

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

Appearance ofDonepezil Krkaand package contents

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.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

You can request more information about this medication from 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 under the following names:

Date of the last revision of this leaflet:December 2022

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