Donepezil Stada 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Donepezil Stada 10 mg film-coated 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 must not be given to other people, even if they have the same symptoms as you, because it may 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:
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What Donepezil Stada is and what it is used for
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What you need to know before taking Donepezil Stada
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How to take Donepezil Stada
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Possible side effects
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How to store Donepezil Stada
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Contents of the pack and other information
1. What Donepezilo Stada is and what it is used for
Donepezilo Stada belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels in the brain of a substance involved in memory (acetylcholine), by reducing the rate at which this substance is broken down.
Donepezilo Stada is used to treat the symptoms of dementia in people with Alzheimer's disease of mild to moderate severity. The symptoms include increasing memory loss, confusion, and behavioural changes. As a result, it becomes increasingly difficult for patients with Alzheimer's disease to carry out their daily activities.
Donepezil is indicated only for adult patients.
2. What you need to know before starting Donepezilo Stada
Do not take Donepezilo Stada:
- if you are allergic to donepezil hydrochloride or similar medicines (known as “piperidine 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 if you have or have had:
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stomach or duodenal ulcers
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seizures or epilepsy
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a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
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a heart condition called “prolonged QT interval” or a history of certain abnormal heart rhythms known as Torsades de Pointes, or if anyone in your family has “prolonged QT interval”
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asthma or another chronic lung disease
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liver problems or hepatitis
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difficulty urinating or mild kidney disease
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low levels of magnesium or potassium in the blood
Also inform your doctor if you are pregnant or think you might be pregnant.
Children and adolescents
Donepezil is not indicated for use in children and adolescents (individuals under 18 years of age).
Other medicines and Donepezilo Stada
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those without a prescription. This also includes medicines you may take in the future while continuing to take donepezil. This is because these medicines may weaken or strengthen the effects of donepezil.
It is particularly important to inform your doctor if you are taking any of the following types of medicines:
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medicines for heart rhythm problems, for example, amiodarone or sotalol
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medicines for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine
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medicines for psychosis, for example, pimozide, sertindole, ziprasidone
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medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
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antifungal medicines, such as ketoconazole
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other medicines for Alzheimer's disease, such as galantamine
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painkillers or treatments for arthritis, for example, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or sodium diclofenac
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anticholinergics, such as tolterodine
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anticonvulsants, such as phenytoin and carbamazepine
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medicines for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)
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muscle relaxants, such as diazepam, succinylcholine
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general anaesthesia
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over-the-counter medicines, such as herbal remedies
If you undergo surgery with general anaesthesia, you must inform your doctor and anaesthetist that you are taking donepezil, as your medicine may affect the amount of anaesthesia required.
Donepezil may be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not take donepezil.
Inform your doctor or pharmacist of the name of the person responsible for your care. This person will help you take your medicine as directed.
Taking Donepezilo Stada with food, drinks and alcohol
Food does not interfere with the effect of this medicine.
Donepezil should not be taken with alcohol because alcohol may alter its effects.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There is insufficient experience regarding the use of donepezil in pregnant women. Do not take donepezil if you are pregnant or planning to become pregnant, unless your doctor considers it absolutely necessary, having taken into account the clinical benefit/ risk balance for you.
Available data are insufficient to assess the safety of donepezil during breastfeeding. You should not breastfeed while taking donepezil.
Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery, and you should not engage in these activities unless your doctor tells you it is safe to do so.
In addition, this medicine may cause tiredness, dizziness and muscle cramps. If you experience any of these symptoms, you should not drive or operate machinery.
Donepezilo Stada contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Donepezil Stada
How much Donepezil Stada to take
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Recommended dose:
You will usually start by taking 5 mg of donepezil hydrochloride each night before going to bed.
After one month, your doctor may instruct you to take 1 film-coated tablet (10 mg of donepezil hydrochloride) each night before going to bed.
The strength of the tablet you take may change depending on how long you have been taking the medicine and your doctor's recommendation.
The maximum recommended dose is 1 film-coated tablet (10 mg of donepezil hydrochloride) each night.
For doses that cannot be administered with this formulation, other strengths of this medicine are available.
Always follow your doctor's or pharmacist's instructions on how and when to take this medicine.
Do not change your dose on your own without consulting your doctor.
Dose adjustment is not necessary if you have kidney problems.
If you have mild to moderate liver problems, your doctor may need to adjust your dose. If you have severe liver problems, you must not take donepezil (see section 2. "Warnings and precautions"). If you have unexplained liver disease, your doctor may decide to completely discontinue your treatment with donepezil.
How to take this medicine
Take your tablet with a glass of water at 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 in the morning.
Use in children and adolescents
This medicine is not recommended for children and adolescents (under 18 years of age).
If you take more Donepezil Stada than you should
Contact your doctor or the nearest hospital emergency department immediately if you take more medicine than you should. Take this leaflet and the remaining tablets with you.
Symptoms of overdose include, among others, feeling unwell or vomiting, drooling, sweating, slow heartbeat, low blood pressure (dizziness or lightheadedness when standing), breathing difficulties, loss of consciousness, and seizures or fits.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested.
If you forget to take Donepezil Stada
If you forget to take a tablet, take the next dose at the usual time.
Do not take a double dose to make up for forgotten doses.
If you have forgotten to take your medicine for more than one week, consult your doctor before taking any more medicine.
If you stop taking Donepezil Stada
Do not stop taking the tablets unless your doctor tells you to. If you stop taking donepezil, the benefits of treatment will gradually disappear.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
How long you should take Donepezil Stada
Your doctor or pharmacist will advise you on how long you should take these tablets. You will need to visit your doctor periodically 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 by people taking donepezil.
Contact your doctor if you experience any of these effects during treatment with donepezil.
Serious adverse effects:
You must inform your doctor immediately if you notice the following serious adverse effects. You may require urgent medical treatment.
- Liver disorder, such as hepatitis. Symptoms of hepatitis include nausea (feeling sick), 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).
- Stomach and duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (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 rigidity, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
- Muscle weakness, sensitivity, or pain, particularly if accompanied by feeling unwell, fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
- Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as Torsade de Pointes (frequency cannot be estimated from available data).
Other adverse effects
Very common (may affect more than 1 in 10 people):
- Diarrhea
- Nausea (feeling of discomfort)
- Headache
Common (may affect up to 1 in 10 people):
- Common cold
- Vomiting (feeling of discomfort)
- Abdominal discomfort
- Muscle cramps
- Fatigue
- Fainting
- Dizziness
- Difficulty sleeping (insomnia)
- Pain
- Loss of appetite
- Itching
- Rash
- Hallucinations (seeing or hearing things that are not really there)
- Unusual dreams, including nightmares
- Agitation
- Aggressive behavior
- Urinary incontinence
- Accidents (patients may be more prone to falls and accidental injuries)
Uncommon (may affect up to 1 in 100 people):
- Slow heartbeat
- Increased salivation
Rare (may affect up to 1 in 1,000 people):
- Stiffness, tremor, or uncontrollable movements, especially of the face and tongue, as well as the limbs (extrapyramidal symptoms)
Not known (frequency cannot be estimated from available data):
- Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
- Increased libido, hypersexuality
- Pisa syndrome (a condition involving involuntary muscle contraction with abnormal lateral flexion of the body and head).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Donepezil Stada
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you have any doubts, 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 Donepezilo Stada
- The active substance is donepezil hydrochloride.
Each film-coated tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
- The other components are:
Tablet core:
Anhydrous lactose
Pregelatinized corn starch
Dibasic calcium phosphate dihydrate
Talc
Magnesium stearate
Anhydrous colloidal silica
Tablet coating:
Hypromellose
Hydroxypropylcellulose
Talc
Titanium dioxide (E171)
Yellow iron oxide (E172)
Appearance of Donepezilo Stada and contents of the pack
Film-coated tablets, yellow, round, biconvex, 9.1 mm in diameter.
Packs containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 120, 126, 154, 182, 196 film-coated tablets in PVC/Aluminum blisters.
HDPE bottle (100 ml) with polypropylene closure and integrated silica gel desiccant containing 250 film-coated tablets, for pharmacy-only dispensing in unit doses.
Only some pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio Stada, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]
Manufacturer
Clonmel Healthcare Ltd.
Waterford Road, Clonmel,
Co. Tipperary
Ireland
or
- A. Eurogenerics N.V.
Heizel Esplanade Heysel b 22,
B-1020 Brussels
Belgium
or
STADA Arzneimittel AG
Stadastr. 2-18,
61118 Bad Vilbel
Germany
or
STADA Arzneimittel GmbH
Muthgasse 36/2,
A-1190 Wien
Austria
This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
AT Donepezil STADA 10 mg Filmtabletten
BE Donepezil EG 10 mg filmomhulde tabletten
DE Donepezil STADA 10 mg Filmtabletten
DK Donepezil STADA
ES Donepezilo Stada 10 mg comprimidos recubiertos con película EFG
FR Donepezil EG 10 mg comprimés pelliculés
HU Donestad 10 mg filmtabletta
LU Donepezil EG 10 mg comprimés pelliculés
PL Donestad
PT Donepezilio Ciclum
RO Donepezil STADA 10 mg comprimate filmate
SE Donepezil STADA 10 mg filmdragerade tabletter
Date of the most recent review of this package leaflet: May 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/)