Donepezil Pensa 5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Donepezilo pensa 5 mg film-coated tablets EFG
Donepezil hydrochloride
Read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- 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.
Contents of this leaflet:
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What Donepezilo Pensa is and what it is used for
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What you need to know before taking Donepezilo Pensa
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How to take Donepezilo Pensa
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Possible adverse effects
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How to store Donepezilo Pensa
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Contents of the pack and other information
1. What Donepezilo Pensa is and what it is used for
Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors: it increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the rate at which this substance is broken down.
It is used to treat the symptoms of mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behaviour.
2. What you need to know before taking Donepezilo Pensa
Remember: You must inform your doctor who your caregivers are.
Do not take Donepezilo Pensa
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If you are allergic to donepezil hydrochloride, to piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6).
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If you are pregnant, think you might be pregnant, or are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Donepezilo Pensa.
Treatment with donepezil should only be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease.
Consult your doctor or pharmacist before starting to take Donepezilo Pensa if you have or have had:
- A history of stomach or intestinal ulcers.
- Frequently take painkillers or treatments for rheumatism (pain or inflammation around bones, joints, or muscles): taking these medicines together with donepezil may increase the risk of developing stomach or intestinal ulcers.
- A history of seizures.
- 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 torsades de pointes, or if someone in your family has "prolongation of the QT interval".
- Low levels of magnesium or potassium in the blood.
- Have asthma or another chronic lung disease.
- Have difficulty urinating.
- Have had liver problems or hepatitis.
- Are scheduled to undergo surgery requiring general anesthesia. You must inform the anesthesiologist that you are taking donepezil.
You should avoid taking Donepezilo Ranbaxy together with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
The individual effect of donepezil cannot be predicted; therefore, the effect of treatment should be regularly evaluated by your doctor.
Children:
Donepezil is not recommended for use in children.
Other medicines and Donepezilo Pensa
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
In particular, it is important that you inform your doctor if you are taking any of the following types of medicines:
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Other medicines for Alzheimer's disease, for example, galantamine.
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Painkillers or treatments for arthritis, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac.
- Antifungal medicines, such as ketoconazole.
- Medications for heart disease, for example quinidine, beta-blockers (propranolol and atenolol).
- Anticonvulsants, for example, phenytoin, carbamazepine.
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Anticholinergic medicines, for example tolterodine.
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Muscle relaxants, for example, succinylcholine, diazepam.
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General anesthetics.
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Medicines for heart rhythm disorders, for example amiodarone or sotalol.
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Medicines for depression, for example fluoxetine, citalopram, escitalopram, amitriptyline.
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Medicines for psychosis, for example pimozide, sertindole, or ziprasidone.
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Medicines for bacterial infections, for example rifampicin, clarithromycin, erythromycin, levofloxacin, moxifloxacin.
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Medicines obtained without a prescription, for example, herbal remedies.
If undergoing surgery with general anesthesia, you must inform your doctor that you are taking Donepezilo Pensa, as this may affect the amount of anesthetic required. Donepezilo Pensa 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 Donepezilo Pensa.
Taking Donepezilo Pensa with food, drink, and alcohol
Taking Donepezilo Pensa with alcohol may alter the absorption of this medicine.
You should avoid drinking alcohol while being treated with donepezil, as it could reduce the effect of donepezil.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take donepezil if you are pregnant or think you might be pregnant.
Do not take donepezil if you are breastfeeding.
Driving and using machines
Your medical condition may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor has advised you that it is safe to do so. Donepezil may cause fatigue, dizziness, drowsiness, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.
Donepezilo Pensa contains lactose
Donepezilo Pensa contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Donepezil Pensa
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The usual dose is described below.
You should take donepezil once daily by mouth with a glass of water at night, just before going to bed.
Your dose may vary depending on how long you have been taking the medicine and on your doctor's advice. Usually, you will start by taking 5 mg each night. After one month, your doctor may instruct you to take 10 mg each night. The maximum recommended dose is 10 mg each night.
If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Pensa in the morning.
Both you and your caregivers should be aware of your doctor's instructions.
If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may take Donepezil Pensa. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment (liver disease) must not take Donepezil Pensa.
Use in children:
The use of donepezil is not recommended in children.
If you take more Donepezil Pensa than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
Symptoms of overdose may include dizziness, salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.
If you forget to take Donepezil Pensa
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for forgotten doses.
If you stop taking Donepezil Pensa
Do not stop treatment with Donepezil Pensa unless instructed by your doctor. If you stop taking Donepezil Pensa, the benefits of treatment will gradually disappear.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Very common adverse effects (≥1/10) are: Diarrhea, nausea, headache.
Common adverse effects (seen in at least 1 in every 100 patients) are: Dizziness, insomnia, fatigue, fainting, hallucinations, agitation, aggressive behavior, abnormal dreams and nightmares, tiredness, pain, loss of appetite, digestive disorders such as diarrhea, nausea and vomiting, incontinence, muscle cramps, skin rash, itching, colds, and accidents.
Uncommon adverse effects (≥1/1,000 to <1/100) are: Seizures, slow heart rate, gastrointestinal bleeding, gastric and duodenal ulcers, hypersalivation, and abnormal levels of the substance creatine kinase in the blood.
Rare adverse effects (≥1/10,000 to <1/1,000) are: Liver disorders including hepatitis, heart problems such as abnormal heart rhythm, as well as symptoms such as tremor, rigidity, or involuntary movements of the face and tongue, and of the limbs.
Frequency not known
- Changes in heart activity that may be observed on an electrocardiogram (ECG), known as "prolongation of the QT interval"
- Fast and irregular heartbeat, fainting which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.
- Increased libido, hypersexuality.
- Pisa syndrome (a condition involving involuntary muscle contractions with abnormal flexion of the body and head to one side).
Very rare and serious adverse effects
Contact your doctor immediately if you experience these serious adverse effects. You may require urgent medical treatment.
- Fever with muscle rigidity, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome")
- Muscle weakness, tenderness or pain, particularly if you also feel unwell, have a fever, or your urine is dark-colored. This may be due to abnormal muscle breakdown which can become life-threatening and lead to kidney problems (a condition called rhabdomyolysis).
If you experience hallucinations, agitation, aggressive behavior, seizures, or brief episodes of fainting, you should consult your doctor, as you may need to reduce the dose or stop treatment.
Serious adverse effects
Contact your doctor immediately if you experience these serious adverse effects. You may require urgent medical treatment:
- Liver damage, for example, hepatitis. Symptoms of hepatitis include being or feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (≥1/10,000 to <1/1,000).
- Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (≥1/1,000 to <1/100).
- Bleeding in the stomach or intestines. This may cause black, tarry stools or visible rectal bleeding (≥1/1,000 to <1/100).
- Dizziness (attacks) or seizures (≥1/1,000 to <1/100).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 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 Pensa
Keep this medicine out of the sight and reach of children.
Do not use Donepezil Pensa after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Donepezil Pensa 5 mg
- The active substance is donepezil hydrochloride. Each tablet contains 5.26 mg of donepezil hydrochloride, equivalent to 5 mg of donepezil.
- The other components are: the tablet core contains lactose monohydrate, gluten-free corn starch, hydroxypropylcellulose (E-463), microcrystalline cellulose (E-460ii), sodium carboxymethylstarch, magnesium stearate (E-572). The film coating contains: talc (E-553b), macrogol, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172).
Appearance of the product and contents of the pack
Donepezil Pensa 5 mg are film-coated tablets, biconvex, circular, yellow in colour, with the characters “RC25” on one side. The 5 mg tablets are available in pack sizes of: 28 tablets and clinical pack of 50 tablets.
Donepezil Pensa 10 mg is also available in pack sizes of 28 tablets and clinical pack of 50 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer
Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp,
The Netherlands
Date of the most recent review of this leaflet: September 2022
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/