Donepezil Qualigen 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Qualigen 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. 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 others, even if they have the same symptoms as you. It may 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.

Leaflet contents:

1. What Donepezil Qualigen is and what it is used for
2. What you need to know before taking Donepezil Qualigen
3. How to take Donepezil Qualigen
4. Possible adverse effects
5. How to store Donepezil Qualigen
6. Contents of the pack and other information

1. What Donepezilo Qualigen is and what it is used for

Donepezilo Qualigen belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases brain levels of a substance (acetylcholine) involved in memory by reducing the breakdown of acetylcholine.

Donepezilo Qualigen is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. Symptoms include memory loss, confusion, and changes in behaviour. As a result, people with Alzheimer's disease find it increasingly difficult to carry out their daily activities.

2. What you need to know before taking Donepezil Qualigen

Do not take Donepezil Qualigen

If you are allergic to donepezil hydrochloride or to piperidine derivatives or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Donepezil Qualigen.

Consult your doctor or pharmacist before starting Donepezil Qualigen if you have or have had:

• stomach or duodenal ulcers,
• seizures or convulsions,
• a heart condition (such as irregular or very slow heartbeats, 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",
• asthma or another long-term lung disease,
• liver problems or hepatitis,
• difficulty urinating or mild renal insufficiency,
• low levels of magnesium or potassium in the blood.

Inform your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

Donepezil Qualigen is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Donepezil Qualigen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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, e.g. galantamine

• painkillers or arthritis treatment, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac, anticholinergics, e.g. tolterodine

• anticonvulsants, e.g. phenytoin and carbamazepine

• medicines for heart disease, e.g. quinidine and beta-blockers (propranolol and atenolol)

• general anaesthetics

• muscle relaxants, e.g. succinylcholine, diazepam

• medicines obtained without a prescription, e.g. herbal remedies

If you are undergoing surgery with general anaesthesia, you must inform your doctor that you are taking donepezil. This is because the medicine may affect the amount of anaesthetic required.

Donepezil can be used in patients with renal impairment or mild to moderate hepatic disease. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic disease should not take donepezil.

Taking Donepezil Qualigen with food, drinks and alcohol

Food does not interfere with the effect of donepezil.

Do not consume any alcohol during treatment with Donepezil Qualigen film-coated tablets, as it may alter the effectiveness of the medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

If you are breastfeeding, you should not take this medicine.

Driving and using machines:

Your condition may affect 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.

Donepezil may cause dizziness and drowsiness, mainly at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

Donepezil Qualigen contains lactose and sodium.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Donepezil Qualigen

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist. Initially, the recommended dose is 5 mg (one white tablet) every night before going to bed. After one month, your doctor may instruct you to take 10 mg (one yellow tablet) every night before going to bed.

If you experience abnormal dreams, nightmares or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Qualigen in the morning.

Donepezil Qualigen is administered orally.

Adults and elderly patients

Treatment with Donepezil Qualigen starts with one 5 mg tablet taken once daily at night before going to bed.

Swallow the tablets with a glass of water at night before going to bed.

After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night before going to bed. The maximum recommended dose is 10 mg/day.

Do not change the dose without first consulting your doctor.

How long should you take Donepezil Qualigen?

Your doctor will decide the duration of treatment.

You will need to visit your doctor periodically for treatment review and assessment of symptoms.

If you take more Donepezil Qualigen than you should

Contact your doctor or a hospital immediately if you have taken too much Donepezil Qualigen. Take the tablets, this leaflet and/or the packaging with you so you can show your doctor what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Signs of an overdose include nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure, respiratory depression, loss of consciousness, and seizures or convulsions.

If you forget to take Donepezil Qualigen:

Do not take a double dose to make up for missed doses. Take your usual dose the next day at the usual time.

If you forget to take your medicine for more than one week, consult your doctor before resuming treatment.

If you stop taking Donepezil Qualigen:

Do not stop taking the film-coated tablets without your doctor's instruction. If treatment is stopped, the beneficial effects may gradually decrease.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Inform your doctor if you experience any of these adverse effects while taking donepezil.

Serious adverse effects:

Tell your doctor immediately if you experience any of the following serious adverse effects. You may require urgent medical treatment.

• Liver disorders, e.g. hepatitis. Symptoms of hepatitis include nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).
• Stomach and duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• Gastrointestinal bleeding. Symptoms include passing black, tar-like stools or rectal bleeding (may affect up to 1 in 100 people).
• Seizures or fits (may affect up to 1 in 100 people).
• Weakness, tenderness, or muscle pain, especially if you also feel unwell, have a fever, or have dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis).

Very common (may affect more than 1 in 10 people):

• Diarrhea.
• Nausea (feeling sick).
• Headache.

Common (may affect up to 1 in 10 people):

• Common cold.
• Loss of appetite.
• Hallucinations (seeing or hearing things that are not real), aggressive behavior, unusual dreams including nightmares, agitation, which may resolve with dose reduction or discontinuation of treatment.
• Dizziness, drowsiness, difficulty sleeping.
• Vomiting, abdominal discomfort.
• Skin rash, itching.
• Muscle cramps.
• Inability to control urination.
• Fatigue, pain.
• Accidents (patients may be more prone to falls and accidental injuries).

Uncommon (may affect up to 1 in 100 people):

• Seizures.
• Slow heart rate.
• Gastrointestinal bleeding, stomach and duodenal ulcers.
• Slight increase in blood levels of the enzyme creatine kinase.

Rare (may affect up to 1 in 1,000 people):

• Stiffness, tremor, or uncontrolled movements, especially of the face and tongue, but also of the limbs.
• Heart block.
• Liver disorders including hepatitis.

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".
• Rapid and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition known as torsade de pointes.
• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways flexion of the body and head).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Qualigen

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 EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Qualigen

• The active substance is donepezil hydrochloride. Each film-coated tablet contains 10 mg of donepezil hydrochloride.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose (E-460), sodium croscarmellose (E-466), magnesium stearate (E-572), and Opadry Yellow (polyvinyl alcohol, titanium dioxide (E-171), macrogol (E-1521), talc, yellow iron oxide (E-172)).

Appearance of the product and contents of the pack

Donepezil Qualigen 10 mg is presented as film-coated tablets. The tablets are yellow, round, biconvex, and marked with "D10" on one side.

Donepezil Qualigen 10 mg film-coated tablets are available in one pack size containing 28 tablets, in a blister made of PVC/PVdC with an aluminum foil backing.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Niche Generics Ltd

Unit 5, 151 Baldoyle Industrial Estate

Dublin 13

Ireland

Date of the most recent revision of this leaflet: 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/