Donepezil Mabo 5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Donepezil Mabo 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 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 serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents
- What Donepezil Mabo is and what it is used for
- Before you take Donepezil Mabo
- How to take Donepezil Mabo
- Possible side effects
- How to store Donepezil 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 known as acetylcholinesterase inhibitors.
Donepezilo Mabo is used to treat the symptoms of dementia in people with a diagnosis of Alzheimer's disease ranging from mild to moderately severe. It is used only in adult patients.
2. Before taking Donepezilo Mabo
Do not take Donepezilo Mabo:
- if you are allergic (hypersensitive) to donepezil hydrochloride, to related substances (piperidine derivatives), or to any of the other components of Donepezilo Mabo.
(see section 6, Additional information).
Take special care with Donepezilo 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 anaesthesia. Donepezil hydrochloride may exaggerate muscle relaxation during anaesthesia.
- 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 known as «QT interval prolongation» or a history of certain abnormal heart rhythms called 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 cause 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. In turn, they may affect the action of donepezil hydrochloride. This medicine may interact with:
In particular, it is important that you inform your doctor if you are taking any of the following types of medicines:
- medicines for heart rhythm problems, for example amiodarone or sotalol
- medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
- medicines for psychosis, e.g. pimozide, sertindole or ziprasidone
- medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
- antifungal medicines, such as ketoconazole
- other medicines for Alzheimer's disease, for example, galantamine
- painkillers or treatment for arthritis, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
- anticholinergic medicines, e.g. tolterodine
- anticonvulsants, e.g., phenytoin, carbamazepine
- medication for heart disease, for example quinidine, beta-blockers (propranolol and atenolol)
- muscle relaxants, e.g., diazepam, succinylcholine
- general anaesthetics
medicines obtained without a prescription, for example, herbal remedies
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Taking Donepezilo 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 breast-feeding
There are insufficient data available to assess the safety of donepezil hydrochloride during breast-feeding. You must not breast-feed 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 tells you it is safe to do so.
In addition, Donepezilo Mabo may cause fatigue, dizziness, and muscle cramps, and if affected, you should not drive or use machines.
Donepezilo Mabo contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Donepezilo Mabo
Follow exactly the dosing instructions for Donepezilo Mabo provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
Inform the doctor or pharmacist about the name of the person responsible for your care. This person will help you take the medication as prescribed.
The strength of the tablet you take may change depending on how long you have been taking the medication and on your doctor's recommendation.
The usual dose is one Donepezilo Mabo 5 mg film-coated tablet (5 mg of donepezil hydrochloride) taken every night. After one month, your doctor may instruct you to take two Donepezilo Mabo 5 mg film-coated 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 will need to carefully and gradually adjust your dose according to your individual needs. If you have severe liver problems, you must exercise greater caution when taking 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.
The use of this medicine is not recommended in children and adolescents (under 18 years of age).
How to take it: Take the Donepezilo tablet orally, 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 regularly 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 medication and the amount taken.
Do not take more tablets than prescribed. If you take more donepezil than you should, symptoms such as nausea, vomiting, salivation, 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 life-threatening 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 following day. If you forget to take your medication for more than one week, call your doctor before taking any more medication.
If you stop taking Donepezilo Mabo
Do not stop treatment with your tablets, even if you feel well, unless your doctor instructs you to do so.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Donepezilo 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: mild increase in serum levels of a certain muscle enzyme (creatine kinase).
Heart (cardiac disorders)
Uncommon: slow heart rate (bradycardia).
Rare: certain heart conduction disorders causing arrhythmia (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.
Nerves (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 bending of the body and head to one side).
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.
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 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 Mabo
Keep out of the reach and sight of children.
Do not use Donepezil Mabo after the expiry date stated on the blister and the 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 mentioned month.
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 located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Information for the user
Composition of Donepezilo Mabo
- The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
- The other components are:
Tablet core:
Monohydrate lactose
Corn starch
Microcrystalline cellulose
Hydroxypropylcellulose
Magnesium stearate
Film coating:
Hypromellose
Macrogol 400
Titanium dioxide (E171)
Appearance of Donepezilo Mabo 5 mg and pack contents
Donepezilo Mabo 5 mg film-coated tablets are white, 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 some 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 European Economic Area member states under the following names:
Spain: Donepezilo Mabo 5 mg film-coated tablets EFG.
This leaflet was last approved in October 2022
Detailed and up-to-date 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/