Donepezil Sandoz 5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Donepezil Sandoz 5 mg film-coated tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
Leaflet contents:
- 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 related to memory (acetylcholine), by slowing down the breakdown of this substance.
Donepezil is used for the treatment of symptoms of dementia in people diagnosed with Alzheimer's disease of mild to moderate severity. The symptoms include increasing memory loss, confusion, and behavioural changes. 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
- soya, peanuts, or any of the other components 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 heartbeats, heart failure, myocardial infarction),
- a heart condition called “prolonged QT interval” or a history of certain abnormal heart rhythms known as Torsade de Pointes, or if someone in your family has “prolonged QT interval”,
- low levels of magnesium or potassium in the blood,
- asthma or other chronic lung problems,
- liver problems or hepatitis,
- difficulty passing urine or mild kidney disease.
Tell your doctor if you are pregnant or think you might be pregnant.
Other medicines and Donepezil Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This includes medicines not prescribed by your doctor but purchased from a pharmacy. It also includes medicines you may need to take occasionally in the future while continuing 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,
- medicines 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 undergoing surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking donepezil. This is because this medicine may affect the amount of anaesthetic 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 the name of your caregiver. 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 must 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 tiredness, dizziness, and muscle cramps, especially at the beginning of treatment and when the dose is increased. If you experience these effects, you should not drive or use machinery.
Donepezil Sandoz contains lactose.
If your doctor has informed you of 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 tablet each night.
- After one month: possible increase to 2 tablets each night.
- Maximum dose: 2 tablets 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 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, stating the medication and 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 upon standing), breathing difficulties, 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 medication.
If you stop taking Donepezil Sandoz
Do not stop treatment with this medicine unless instructed by your doctor. 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 following 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, discomfort, fever, itching, yellowing of the skin and eyes, and dark-coloured urine (occur 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 (occur in 1 to 10 out of 1,000 users),
- Bleeding in the stomach or intestine. This may cause black, tar-like stools or visible rectal bleeding (occur in 1 to 10 out of 1,000 users),
- Dizziness (attacks) or seizures (occur in 1 to 10 out of 1,000 users),
- Fever with muscle stiffness, sweating, or decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (occurs in fewer than 1 out of 10,000 users),
- Weakness, sensitivity, or muscle pain, particularly if accompanied by feeling unwell, fever, or dark-coloured 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:
- Diarrhoea,
- 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 behaviour,
- 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 muscle enzyme creatine kinase in blood tests.
Rare – may affect up to 1 in 1,000 patients:
- Tremors, stiffness, or uncontrolled movements, especially of the face and tongue, but also of the limbs,
- Cardiac conduction disturbances.
Frequency not known (cannot be estimated from available data):
- Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation",
- 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 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 they are possible adverse effects 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 which is 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Donepezil Sandoz 5 mg
The active substance is donepezil hydrochloride.
Each film-coated tablet contains 5 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, soy lecithin.
Appearance of the product and contents of the pack
Donepezil Sandoz 5 mg are white, round, film-coated tablets (7 mm in diameter).
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 certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
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 Târgu-Mureș
Romania
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Donepezil HCl Sandoz 5mg – Filmtabletten
Belgium: Donepezil Sandoz 5 mg filmomhulde tabletten
Denmark: Donepezil Sandoz
France: DONEPEZIL Sandoz 5 mg, comprimé pelliculé
Greece: Pezale
Italy: DONEPEZIL SANDOZ
Norway: Donepezil Sandoz
Portugal: DONEPEZILO SANDOZ
Sweden: Donepezil Sandoz
United Kingdom (Northern Ireland): Donepezil Hydrochloride 5 mg film-coated tablets
Date of the most recent review of this leaflet: December 2022
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/