Donepezil Krka 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Donepezil Krka 5 mg orodispersible tablets EFG

donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What Donepezil Krka is and what it is used for
2. What you need to know before taking Donepezil Krka
3. How to take Donepezil Krka
4. Possible side effects
5. How to store Donepezil Krka
6. Contents of the pack and other information

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

Donepezilo Krka contains the active substance donepezil hydrochloride. Donepezilo 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.

Donepezilo Krka is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and behavioural changes. As a result, people with Alzheimer's disease have increasing difficulty performing their usual daily activities.

Donepezilo Krka is only used in adult patients.

2. What you need to know before taking Donepezil Krka

Do not take Donepezil Krka:

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

Warnings and precautions

Talk to 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 known as "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone 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.

You should also consult 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 and Donepezil Krka

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

Also inform them in the future about any medicines you may take while continuing treatment with Donepezil Krka. This is because these medicines may weaken or intensify the effect of Donepezil Krka.

In particular, it is important that you tell 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;
• painkillers or treatments for arthritis, for example: aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac;
• anticholinergic medicines, for example: tolterodine;
• anticonvulsants, for example: phenytoin, carbamazepine;
• medicines for heart conditions, for example: quinidine, beta-blockers (propranolol and atenolol);
• muscle relaxants, for example: succinylcholine;
• general anaesthesia;
• herbal remedies or over-the-counter medicines.

If you are scheduled for surgery requiring general anaesthesia, you must inform your doctor and anaesthesiologist that you are taking Donepezil Krka. This is because this medicine may affect the amount of anaesthesia needed.

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

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

Taking Donepezil Krka with food, drinks and alcohol

Food does not affect the action of Donepezil Krka.

Donepezil Krka should not be taken with alcohol, as alcohol may alter its effect.

Pregnancy, breastfeeding and fertility

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

Do not breastfeed while taking Donepezil Krka.

Driving and using machines

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

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

Donepezil Krka contains:

• Aspartame (E951)

This medicine contains 0.75 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have 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 diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Donepezilo Krka

Always follow exactly the instructions provided by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Amount of Donepezilo Krka you should take

Initially, the recommended dose is 5 mg once daily at bedtime.

After one month, your doctor may prescribe 10 mg once daily at bedtime.

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

Your dose may change depending on how long you have been taking the medicine and your doctor's advice. The maximum recommended dose is 10 mg once daily at bedtime.

Always follow your doctor’s or pharmacist’s instructions on how and when to take your medicine.

Do not change your dose on your own without consulting your doctor.

How to take your medicine

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

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

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

Use in children and adolescents

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

If you take more Donepezilo Krka than you should

Contact your doctor or the nearest hospital emergency department immediately if you take more than the prescribed dose. Always bring this leaflet and your tablets with you.

Symptoms of overdose may include nausea (feeling unwell) and vomiting, excessive salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures (fits).

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service at: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Donepezilo Krka

If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

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

If you stop taking Donepezilo Krka

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

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

How long you should 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 assess your symptoms.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported in people taking Donepezil Krka.

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

Serious adverse effects:

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

• liver damage, for example, hepatitis. Symptoms of hepatitis include nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people)
• gastric or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort between the navel and the 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 rectal bleeding (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, tenderness, or pain, especially if accompanied by feeling unwell, fever, or dark urine. These may be caused by abnormal muscle breakdown that can be potentially fatal and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)

Frequency not known:

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as Torsade de Pointes

Other adverse effects

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

• diarrhoea
• headache

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

• muscle cramps
• tiredness
• difficulty sleeping (insomnia)
• common cold
• hallucinations (seeing or hearing things that are not really there)
• abnormal dreams including nightmares
• agitation
• aggressive behaviour
• fainting
• dizziness
• stomach discomfort
• rash
• urinary incontinence
• pain
• accidents (patients may be more prone to falls or accidental injuries)

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

• slow heartbeat
• increased salivation

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

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

Frequency not known (cannot be estimated from available data)

• increased libido
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways bending of the body and head)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil 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 hydroxypropyl cellulose, banana flavour (maltodextrin, dextrose, sucrose and gum arabic), aspartame (E951), calcium silicate and magnesium stearate.

Appearance of Donepezil Krka and contents of the pack

Orodispersible tablets, white and round, with bevelled edges.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Further information on this medicinal product is available 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 medicinal product is authorized in the European Economic Area Member States under the following names:

Date of the last revision of this leaflet: December 2022

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).