Donepezil Krka 10 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Donepezil Krka 10 mg orodispersible tablets EFG
donepezil hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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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 could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Donepezil Krka is and what it is used for
- What you need to know before taking Donepezil Krka
- How to take Donepezil Krka
- Possible side effects
- How to store Donepezil Krka
- 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 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. The 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, piperidinic derivatives, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting Donepezil Krka if you have or have had:
- gastric or duodenal ulcers;
- seizures or convulsions;
- a heart condition (such as irregular or very slow heartbeat, 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 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;
- 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 anaesthetist that you are taking Donepezil Krka. This is because this medicine may affect the amount of anaesthesia required.
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 medicine 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 impair your ability to drive or operate machinery. Therefore, you should not engage in these activities unless your doctor confirms it is safe.
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 properly eliminate it.
- 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 Donepezil Krka
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
How much Donepezil Krka you should take
Initially, the recommended dose is 5 mg taken each night before going to bed.
After one month, your doctor may prescribe 10 mg each night before going to bed.
If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Krka in the morning.
The dose of the tablet you take may change depending on how long you have been taking the medicine and on your doctor's advice. The maximum recommended dose is 10 mg each night.
Always follow your doctor’s or pharmacist’s instructions on how and when to take your medicine.
Do not change the dose yourself without consulting your doctor.
How to take your medicine
Donepezil Krka orodispersible tablets are fragile. Do not press 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 detailed below:
- Hold the blister pack by the edges and separate one cell from the rest of the pack by gently tearing along the perforated line around the cell.
- Pull the edge of the foil until it is completely detached.
- Allow the tablet to fall onto your hand.
- Place the tablet on your tongue as soon as it has been removed 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
Donepezil Krka is not recommended for use in children and adolescents (under 18 years of age).
If you take more Donepezil Krka than you should
Contact your doctor or the nearest hospital emergency department immediately if you take more medicine than prescribed. Always take this leaflet and your tablets with you.
Symptoms of overdose may include nausea (feeling unwell) and vomiting (sickness), drooling, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness when 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 telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Donepezil Krka
If you forget to take your medicine, 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 medicine for more than one week, contact your doctor before taking any more tablets.
If you stop taking Donepezil Krka
Do not stop taking the tablets unless your doctor tells you to. If you stop taking Donepezil Krka, the benefits of treatment will gradually be lost.
If you have any further questions about using this medicine, ask your doctor or pharmacist.
How long you should take Donepezil 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, feeling unwell, fever, itching, yellowing of the skin and eyes, and dark-coloured 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, tarry 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 reduced level of consciousness (a disorder known as "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, which 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 or 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 refers to 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 10.43 mg of donepezil hydrochloride monohydrate, equivalent to 10 mg of donepezil hydrochloride.
- The other components are mannitol (E421), microcrystalline cellulose, low-substituted hydroxypropyl cellulose, banana flavour (maltodextrin, dextrose, sucrose and arabic gum), 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 cartons containing 10, 28, 30, 50, 56, 60, 84, 90, 98 and 100 orodispersible tablets in blisters.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
For further information about this medicinal product, you may contact the local representative of the Marketing Authorisation Holder:
KRKA Farmacéutica, S.L., C/ Anabel Segura, 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Member State Name | Medicinal Product Name |
Czech Republic | Nepla 10 mg orally disintegrating tablets |
Spain | Donepezil Krka 10 mg orodispersible tablets EFG |
Date of the last revision of this leaflet: December 2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).