Donepezil Mabo 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Donepezilo Mabo 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.
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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.
Leaflet contents
- What Donepezilo Mabo is and what it is used for
- Before you take Donepezilo Mabo
- How to take Donepezilo Mabo
- Possible side effects
- How to store Donepezilo Mabo
- Contents of the pack and other information
1. What Donepezilo Mabo is and what it is used for
Donepezilo Mabo belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezilo Mabo is used to treat the symptoms of dementia in people diagnosed with Alzheimer's disease of mild to moderately severe degree. It is used only in adult patients.
2. Donepezil Mabo
Do not take Donepezil Mabo:
- if you are allergic (hypersensitive) to donepezil hydrochloride, to related substances (piperidine derivatives), or to any of the other components of Donepezil Mabo
(see section 6, Additional information).
Take special care with Donepezil Mabo:
Check whether any of the warnings listed below apply or have previously applied to you. Inform your doctor:
- If you are scheduled for surgery requiring general anesthesia. Donepezil hydrochloride may intensify muscle relaxation during anesthesia.
- If you have had a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
- If you have had a heart condition called "QT interval prolongation" or a history of certain abnormal heart rhythms known as torsade de pointes, or if anyone in your family has "QT interval prolongation".
- If you have low levels of magnesium or potassium in your blood.
- If you have ever had stomach or duodenal ulcers, or if you are taking a certain type of painkiller (non-steroidal anti-inflammatory drugs, known as NSAIDs). Your doctor will monitor your symptoms.
- If you have difficulty urinating. Your doctor will monitor your symptoms.
- If you have ever had seizures. Donepezil hydrochloride may trigger a new seizure. Your doctor will monitor your symptoms.
- If you suffer from asthma or another chronic lung disease. Your symptoms may worsen.
- If you have ever had liver problems. No studies have been conducted; therefore, there is no information available on the safe use of donepezil hydrochloride in patients with severe liver problems.
- If your doctor has informed you that you have an intolerance to certain sugars, for example, lactose.
Use of other medicines
Other medicines may be affected by donepezil hydrochloride. Conversely, they may affect the action of donepezil hydrochloride. It may interact with:
In particular, it is important to inform your doctor if you are taking any of the following types of medicines:
- medicines for heart rhythm disorders, e.g., amiodarone or sotalol
- medicines for depression, e.g., citalopram, escitalopram, amitriptyline, fluoxetine
- medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone
- medicines for bacterial infections, e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
- antifungal medicines, such as ketoconazole
- other medicines for Alzheimer's disease, e.g., galantamine
- painkillers or arthritis treatments, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
- anticholinergic medicines, e.g., tolterodine
- anticonvulsants, e.g., phenytoin, carbamazepine
- medicines for heart disease, e.g., quinidine, beta-blockers (propranolol and atenolol)
- muscle relaxants, e.g., diazepam, succinylcholine
- general anesthetics
herbal remedies and over-the-counter medicines
Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.
Taking Donepezil Mabo with food and drinks
Alcohol may reduce the effect of donepezil hydrochloride. Therefore, be cautious when using alcohol together with donepezil hydrochloride.
Pregnancy and breastfeeding
There is insufficient data to evaluate the safety of donepezil hydrochloride during breastfeeding. You must not breastfeed while taking donepezil.
Consult your doctor or pharmacist before using any medicine.
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.
Additionally, Donepezil Mabo may cause fatigue, dizziness, and muscle cramps, and if affected, you should not drive or operate machinery.
Donepezil Mabo contains lactose
This medicine 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 Donepezilo Mabo
Follow exactly the administration instructions for Donepezilo Mabo given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Inform the doctor or pharmacist of the name of the person responsible for your care. This person will help you take the medicine as prescribed.
The strength of the tablet you take may change, depending on how long you have been taking the medicine and on your doctor's recommendation.
The usual dose is one film-coated Donepezilo Mabo 5 mg tablet (5 mg of donepezil hydrochloride) each night. After one month, your doctor may instruct you to take two film-coated Donepezilo Mabo 5 mg tablets (10 mg of donepezil hydrochloride) each night. If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezilo Mabo in the morning. The maximum recommended dose is 10 mg per night.
No dose adjustment is required if you have kidney problems.
If you have mild or moderate liver problems, your doctor must gradually and carefully adjust the dose according to your needs. If you have severe liver problems, you must be more cautious with Donepezilo Mabo (see section 2, "Before taking Donepezilo Mabo"). If you have an unexplained liver disease, your doctor may decide to completely discontinue treatment with donepezil hydrochloride.
This medicine is not recommended for use in children and adolescents (under 18 years of age).
How to take it: Take the Donepezilo tablet by mouth, with a glass of water, at night, before going to bed.
Your doctor will tell you how long you should continue taking the tablets. You should visit your doctor at regular intervals so that your treatment can be reviewed and your symptoms assessed.
If you take more Donepezilo Mabo 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 taken.
Do not take a larger number of tablets than you should. If you take more donepezil than you should, symptoms such as nausea, vomiting, salivation (excessive saliva), sweating, slow heart rate (bradycardia), low blood pressure (hypotension), breathing difficulties (respiratory depression), muscle weakness (collapse), and involuntary muscle contractions (seizures) may occur, as well as increased muscle weakness, a potentially fatal condition.
If you have taken more tablets than you should, contact your doctor or pharmacist immediately.
If you forget to take Donepezilo Mabo
Do not take a double dose to make up for a missed dose. Skip the missed dose and take the next tablet at your usual dose the next day. If you forget to take your medicine for more than one week, call your doctor before taking any more medicine.
If you stop taking Donepezilo Mabo
Do not stop treatment with your tablets, even if you feel well, unless your doctor tells you to.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Donepezil Mabo may have adverse effects, although not everyone experiences them.
Adverse effects may be:
- very common (may affect more than 1 in 10 people taking donepezil hydrochloride);
- common (may affect up to 1 in 10 people taking donepezil hydrochloride);
- uncommon (may affect up to 1 in 100 people taking donepezil hydrochloride);
- rare (may affect up to 1 in 1,000 people taking donepezil hydrochloride);
- very rare (may affect up to 1 in 10,000 people taking donepezil hydrochloride).
Additional investigations
Uncommon: slight increase in serum levels of a certain muscle enzyme (creatine kinase).
Heart (cardiac disorders)
Uncommon: slow heart rate (bradycardia).
Rare: certain disorders in the heart's conduction system causing an abnormal heart rhythm (sinoatrial block, atrioventricular block).
Frequency not known: Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "prolongation of the QT interval", rapid and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition known as torsade de pointes.
Nervous system disorders
Common: fainting (syncope), dizziness, inability to sleep (insomnia).
Uncommon: seizures.
Rare: uncontrolled movements of the body or face (extrapyramidal symptoms).
Stomach and intestines (gastrointestinal disorders)
Very common: diarrhoea, nausea.
Common: vomiting, abdominal discomfort.
Uncommon: internal bleeding (gastrointestinal haemorrhage), ulcers (gastric and duodenal ulcers).
Frequency not known (cannot be estimated from available data): Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways bending of the body and head).
Kidney (renal and urinary disorders)
Common: urinary incontinence.
Skin (skin and subcutaneous tissue disorders)
Common: skin rash, itching (pruritus).
Muscles (musculoskeletal and connective tissue disorders)
Common: muscle cramps.
Nutrition (metabolism and nutrition disorders)
Common: loss of appetite (anorexia).
Infections (infections and infestations)
Common: common cold.
Traumatic injuries, poisonings and procedural complications
Common: accidents.
General (general disorders and administration site conditions)
Very common: headache.
Common: fatigue, pain.
Liver (hepatobiliary disorders)
Rare: liver dysfunction, including hepatitis.
Mental (psychiatric disorders)
Common: imagining things that are not real (hallucinations), agitation, aggressive behaviour.
Frequency not known (cannot be estimated from available data): increased libido, hypersexuality.
Your doctor may decide to reduce the dose or stop treatment to manage these adverse effects.
Reporting of adverse effects
If you experience any 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 through 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 Mabo
Keep out of the reach and sight of children.
Do not use Donepezil Mabo after the expiry date stated on the blister and outer carton, following EXP. The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE 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 Donepezilo Mabo
- 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:
Monohydrate lactose
Corn starch
Microcrystalline cellulose
Hydroxypropylcellulose
Magnesium stearate
Film coating:
10 mg:
Hypromellose
Titanium dioxide (E171)
Propylene glycol
Povidone (K25)
Yellow iron oxide (E172)
Appearance of Donepezilo Mabo 10 mg and contents of the pack
Donepezilo Mabo 10 mg film-coated tablets are yellow, round, biconvex, film-coated tablets.
This medicine is available in blisters of 7, 14, 28, 30, 50, 56, 60, 84, 98, 100, 112 or 120 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
MABO-FARMA S.A.
Calle Vía de los Poblados 3,
Building 6, 28033, Madrid,
Spain.
Manufacturer
Infarmade S.L
C/ Torre de los Herberos nº 35
Pol. Ind. “Carretera de la Isla”
41703 Dos Hermanas
Seville
Or
NETPHARMALAB CONSULTING SERVICES
Carretera de Fuencarral 22, Alcobendas, 28108, Madrid
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain: Donepezilo Mabo 10 mg Film-coated tablets
This summary of product characteristics was approved in October 2022
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/.