Donepezil STADA 5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Donepezil Stada 5 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. 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. It could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 slowing down the breakdown of this substance.
Donepezilo Stada is used to treat the symptoms of dementia in people with Alzheimer's disease ranging from mild to moderately severe. The symptoms include increasing memory loss, confusion, and changes in behaviour. As a result, it becomes increasingly difficult for patients with Alzheimer's disease to continue with 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 to 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 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 “prolongation of the QT interval” or a history of certain abnormal heart rhythms known as Torsades de Pointes, or if anyone in your family has “prolongation of the 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 enhance 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 treatment 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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herbal remedies or over-the-counter medicines, such as herbal-based products
If you undergo surgery under 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 plan 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, taking into account the clinical benefit-risk balance for you.
Available data are insufficient to assess the safety of donepezil during breastfeeding. Breastfeeding is not recommended 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 confirms 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 diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Donepezil Stada
How much Donepezil Stada to take
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.
Recommended dose:
You will usually start by taking 1 film-coated tablet (5 mg of donepezil hydrochloride) each night before going to bed.
After one month, your doctor may instruct you to take 2 film-coated tablets (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 2 film-coated tablets (10 mg of donepezil hydrochloride) each night.
Always follow your doctor’s or pharmacist’s instructions regarding 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 should 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 donepezil 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 instead.
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 than the prescribed amount. Bring this leaflet and any remaining tablets with you.
Symptoms of overdose may 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 convulsions.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 5620420, stating the name of 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 a missed dose.
If you have missed taking your medicine for more than one week, consult your doctor before resuming treatment.
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 in people taking donepezil.
Contact your doctor if you experience any of these effects during treatment with donepezil.
Serious adverse effects:
You should 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, tenderness, or pain, particularly if you also feel unwell, have a fever, or have dark urine. This may be due to abnormal muscle breakdown, which can be fatal and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
- Fast or 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 sick)
- Headache
Common (may affect up to 1 in 10 people):
- Common cold
- Vomiting (feeling sick)
- Abdominal discomfort
- Muscle cramps
- Tiredness
- 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 behaviour
- 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 uncontrolled movements, especially of the face and tongue, as well as 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 "prolongation of the QT interval"
- Increased libido, hypersexuality
- Pisa syndrome (a condition involving involuntary muscle contractions with abnormal bending of the body and head to one side)
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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 containers and medicines should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. 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 donepezil film-coated tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
- The other components are:
Tablet core:
Anhydrous lactose
Pregelatinized corn starch
Dibasic calcium phosphate dihydrate
Talc
Magnesium stearate
Colloidal anhydrous silica
Tablet coating:
Hypromellose
Hydroxypropyl cellulose
Talc
Titanium dioxide (E171)
Appearance of Donepezilo Stada and contents of the pack
Film-coated tablets, white, round and biconvex, 7.1 mm in diameter.
Blister packs of PVC/aluminum containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 120, 126, 154, 182, 196 film-coated tablets.
HDPE bottle (50 ml) with polypropylene closure and integrated silica gel desiccant, containing 250 film-coated tablets, for pharmacy-only dispensing in unit doses.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:
AT Donepezil STADA 5 mg Filmtabletten
BE Donepezil EG 5 mg filmomhulde tabletten
DE Donepezil STADA 5 mg Filmtabletten
DK Donepezil STADA
ES Donepezilo Stada 5 mg comprimidos recubiertos con película EFG
FR Donepezil EG 5 mg comprimés pelliculés
HU Donestad 5 mg filmtabletta
LU Donepezil EG 5 mg comprimés pelliculés
PL Donestad
PT Donepezilio Stada
RO Donepezil STADA 5 mg comprimate filmate
SE Donepezil STADA 5 mg filmdragerade tabletter
Date of the most recent review of this leaflet: May 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)