Donepezil Sandoz 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Donepezil Sandoz 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Donepezil Sandoz is and what it is used for
- What you need to know before taking Donepezil Sandoz
- How to take Donepezil Sandoz
- Possible side effects
- How to store Donepezil Sandoz
- Contents of the pack and other information
1. What Donepezil Sandoz is and what it is used for
Donepezil 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.
Donepezil is used to treat the symptoms of dementia in people diagnosed with Alzheimer's disease of mild to moderate severity. Symptoms include increasing memory loss, confusion, and changes in behaviour. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their daily activities.
Donepezil is used only in adult patients.
2. What you need to know before taking Donepezil Sandoz
Do not take Donepezil Sandoz
if you are allergic to:
- donepezil hydrochloride, or
- piperidine derivatives, which are substances similar to donepezil, or
- soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you start taking Donepezil Sandoz.
If you have any of the following conditions, you or your caregiver should inform your doctor or pharmacist:
- stomach or duodenal ulcers,
- seizures (fits) or convulsions,
- heart disease (such as irregular or very slow heartbeat, heart failure, myocardial infarction),
- a heart condition called “prolongation of the QT interval” or a history of certain abnormal heart rhythms known as Torsade de Pointes, or if someone in your family has “prolongation of the QT interval”,
- low levels of magnesium or potassium in the blood,
- asthma or other chronic lung problems,
- liver problems or hepatitis,
- difficulty urinating or mild kidney disease.
Tell your doctor if you are pregnant or think you might be pregnant.
Other medicines and Donepezil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This includes medicines your doctor has not prescribed but that you have bought from a pharmacy. It also includes medicines you may need to take occasionally in the future while continuing to take donepezil. This is because these medicines may weaken or increase the effects of donepezil.
Tell your doctor especially if you are taking any of the following types of medicines:
- other medicines for Alzheimer's disease, e.g., galantamine,
- painkillers or treatments for arthritis, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac,
- anticholinergic medicines, e.g., tolterodine,
- antibiotics for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin),
- antifungal medicines, e.g., ketoconazole,
- medicines for depression (e.g., citalopram, escitalopram, amitriptyline, fluoxetine),
- medicines for psychosis (e.g., pimozide, sertindole, ziprasidone),
- anticonvulsants, e.g., phenytoin, carbamazepine,
- medicines for heart rhythm problems (e.g., amiodarone, sotalol),
- medicines for heart disease, e.g., quinidine, beta-blockers (propranolol and atenolol),
- muscle relaxants, e.g., diazepam, succinylcholine,
- general anaesthesia,
- over-the-counter medicines, e.g., herbal remedies.
If you are going to have surgery requiring general anaesthesia, you must tell your doctor and anaesthetist that you are taking donepezil. This is because this medicine may affect the amount of anaesthetic needed.
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 your caregiver's name. Your caregiver will help you take your medicine as prescribed.
Taking Donepezil Sandoz with food, drinks and alcohol
Food will not affect the action of donepezil. Donepezil should not be taken with alcohol, as alcohol may alter its effect.
Pregnancy, breast-feeding and fertility
Donepezil should not be taken during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Your illness may affect your ability to drive or operate machinery. You should not perform these activities unless your doctor tells you it is safe to do so.
This medicine may cause fatigue, dizziness and muscle cramps, mainly at the beginning of treatment and when the dose is increased. If you experience these effects, you should not drive or operate machinery.
Donepezil Sandoz contains lactose.
If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Donepezil Sandoz
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. The recommended dose is:
Adults and elderly
- Initial dose: 1/2 tablet each night.
- After one month: possible increase to 1 tablet each night.
- Maximum dose: 1 tablet each night.
Do not change the dose on your own without consulting your doctor.
Patients with renal impairment
You may take the usual dose as described above. No dose adjustment is required.
Patients with mild to moderate hepatic impairment
Your doctor will assess your tolerance to donepezil before increasing your dose.
Patients with severe renal impairment
Your doctor will decide whether this medicine is suitable for you.
Method of administration
Take your coated tablets at night before going to bed, regardless of meals. Swallow the tablet with a glass of water.
If you experience abnormal dreams, nightmares or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Sandoz in the morning.
Duration of treatment
Your doctor or pharmacist will tell you how long you should continue taking your tablets. You may need to visit your doctor from time to time to review your treatment and assess your symptoms.
If you take more Donepezil Sandoz than you should
DO NOT take more than 10 mg of donepezil per day.
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.
If you cannot contact your doctor, go to the nearest emergency service. Always bring the tablets and the packaging with you so the doctor knows what you are taking.
Symptoms of overdose include feeling or being sick, drooling, sweating, slowed heart rate, low blood pressure (fainting or dizziness when standing up), breathing problems, loss of consciousness, and tremors or seizures.
If you forget to take Donepezil Sandoz
If you forget to take a tablet, take only one tablet the next day at the usual time. Do not take a double dose to make up for forgotten doses.
If you forget to take your medicine for more than one week, consult your doctor before resuming the medicine.
If you stop taking Donepezil Sandoz
Do not stop treatment with this medicine 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.
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. Inform 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 any of the serious adverse effects listed below. You may require urgent medical treatment.
- Liver damage, e.g., hepatitis. Symptoms of hepatitis include feeling sick or being unwell, loss of appetite, malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark-colored urine (occurs in 1 to 10 out of 10,000 users),
- Stomach or duodenal ulcer. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (occurs in 1 to 10 out of 1,000 users),
- Bleeding in the stomach or intestine. This may cause black, tarry stools or visible rectal bleeding (occurs in 1 to 10 out of 1,000 users),
- Dizziness (syncope) or seizures (occurs in 1 to 10 out of 1,000 users),
- Fever with muscle rigidity, sweating, or decreased level of consciousness (may be symptoms of a condition known as "Neuroleptic Malignant Syndrome") (occurs in fewer than 1 out of 10,000 users),
- Muscle weakness, tenderness, 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).
The estimated frequency of occurrence of adverse effects is as follows:
Very common – may affect more than 1 in 10 patients:
- Diarrhea,
- Nausea,
- Headache.
Common – may affect 1 to 10 in 100 patients:
- Muscle cramps,
- Fatigue,
- Difficulty sleeping (insomnia),
- Common cold,
- Loss of appetite,
- Hallucinations (seeing or hearing things that are not really there),
- Strange dreams and nightmares,
- Agitation,
- Aggressive behavior,
- Fainting,
- Dizziness,
- Vomiting,
- Feeling of stomach discomfort,
- Skin rash,
- Itching,
- Pain,
- Urinary incontinence,
- Accidents (patients may be more prone to falls and accidental injuries).
Uncommon – may affect up to 1 in 100 patients:
- Slowing of the heart rate,
- Slight increase in the blood enzyme creatine kinase (CK).
Rare – may affect up to 1 in 1,000 patients:
- Tremors, rigidity, or uncontrolled movements, especially of the face and tongue, but also of the limbs,
- Disturbances in cardiac conduction.
Frequency not known (cannot be estimated from available data):
- Changes in heart activity detectable on an electrocardiogram (ECG), known as "QT interval prolongation",
- Fast, irregular heartbeat and 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 lateral flexion of the body and head).
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 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 Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after CAD/EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25 °C.
Do not use this medicine more than 6 months after first opening the plastic bottle.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Donepezil Sandoz 10 mg
The active substance is donepezil hydrochloride.
Each film-coated tablet contains 10 mg of donepezil hydrochloride.
The other components are:
Tablet core: microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate.
Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, soybean lecithin, yellow iron oxide (E 172).
Appearance of the product and contents of the pack
Donepezil Sandoz 10 mg are yellow, round, film-coated tablets (9 mm in diameter) with a score line. The tablet can be divided into equal doses.
Donepezil Sandoz is available in:
- Blister packs: pack sizes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 100x1 or 120 film-coated tablets.
- Plastic bottles with screw caps: pack sizes of 100 or 250 film-coated tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Lek S.A.
Ul. Domaniewska 50 C
02-672 Warsaw
Poland
or
Lek Pharmaceuticals d.d.
Verovškova, 57
SLO-1526 Ljubljana
Slovenia
or
S.C. Sandoz, S.R.L
Str.Livezeni nr.7 A
RO-540472 Targu-Mures
Romania
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Donepezil HCl Sandoz 10mg – Filmtabletten
Belgium: Donepezil Sandoz 10 mg filmomhulde tabletten
Czech Republic: Donepezil Sandoz 10mg potahované tablety
Denmark: Donepezil Sandoz
France: DONEPEZIL Sandoz 10 mg, comprimé pelliculé
Greece: Pezale
Italy: DONEPEZIL SANDOZ
Norway: Donepezil Sandoz
Portugal: DONEPEZILO SANDOZ
Sweden: Donepezil Sandoz
United Kingdom (Northern Ireland): Donepezil Hydrochloride 10 mg Film-coated Tablets
Date of the most recent revision of this leaflet: December 2022
Detailed 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/