PATIENT INFORMATION LEAFLET

Donepezilo Qualigen 10 mg film-coated tabletsEFG

Donepezilo hydrochloride

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

2. What you need to know before you start taking Donepezilo Qualigen

3. How to take Donepezilo Qualigen

4. Possible side effects

5. Storage of Donepezilo Qualigen

6. Contents of the pack and additional information

Donepezilo Qualigen belongs to a group of medications called cholinesterase inhibitors. Donepezilo increases brain levels of a substance (acetylcholine), involved in memory, by reducing the degradation of acetylcholine.

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

Do not take Donepezilo Qualigen

If you areallergictodonepezilo hydrochloride or to piperidina derivatives or to any of the other components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezilo Qualigen

Consult your doctor or pharmacist before starting to take Donepezilo Qualigen if you have or have had:

• stomach or duodenal ulcers,
• attacks 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 called torsade de pointes or if someone in your family has «prolongation of the QT interval»,
• asthma or other 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

Donepezilo Qualigen is not recommended for use in children and adolescents under 18 years.

Other medications and Donepezilo Qualigen

Inform your doctor or pharmacist if you are using, have used recently or may need to use another medication.

Especially, it is important to inform your doctor if you are taking any of the following types of medications:

• medications for heart rhythm problems, for example amiodarone or sotalol
• medications for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• medications for psychosis, p. e.g. pimozide, sertindol or ziprasidone
• medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole

• other medicationsagainst Alzheimer's disease, e.g. galantamine
• analgesics or treatment of arthritis, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodiumanticholinergics, e.g tolterodina.
• anticonvulsants e.gphenytoin and carbamazepine,
• medicationsfor a heart conditione.g. quinidine and beta-blockers (propranolol and atenolol),
• general anesthetics,
• muscle relaxants e.g.succinylcholine, diazepam,
• over-the-counter medications, e.g,herbal remedies

In case of surgical intervention with general anesthesia, you must inform your doctor that you are taking donepezilo. This is because the medication may affect the amount of anesthesia needed.

Donepezilo may be used in patients with renal insufficiency or mild to moderate liver disease. Inform your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take donepezilo.

Taking Donepezilo Qualigen with food, drinks, and alcohol

Food does not interfere with the effect of donepezilo.

Do not drink any alcohol during treatment with Donepezilo Qualigen film-coated tablets, as it may modify the effectiveness of the medication.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

If you are breastfeeding, do not take this medication.

Driving and operating machinery:

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so.

Donepezilo may cause dizziness and somnolence, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Donepezilo Qualigen contains lactose and sodium.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist. The initial recommended dose is 5 mg (one white tablet) every night before bedtime. After a month, your doctor may recommend taking 10 mg (one yellow tablet) every night before bedtime.

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

Donepezilo Qualigen is administered orally.

Adults and elderly patients

The treatment with Donezepilo Qualigen starts with a 5 mg tablet, taken once a day, at night, before bedtime.

Swallow the tablets with the help of a glass of water at night before bedtime.

After a month of treatment, your doctor may recommend an increase in the dose to 10 mg, once a day, at night, before bedtime. The maximum recommended dose is 10 mg/day.

Do not modify the dose without consulting your doctor beforehand.

How long should you take Donepezilo Qualigen?

Your doctor will decide the duration of treatment.

You will need to visit your doctor periodically for treatment review and symptom evaluation.

If you take more Donepezilo Qualigen than you should

Contact your doctor or a hospital immediatelyif you have taken too much Donepezilo Qualigen.Bring with you the coated tablets, this leaflet and/or the packaging to show the doctor what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The signs of an overdose include nausea, vomiting, salivation, sweating, slow heart rate, low blood pressure, respiratory depression, loss of consciousness, and seizures or convulsions.

If you forgot to take Donepezilo Qualigen:

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

If you forget to take your medication for more than a week, consult your doctor before resuming the medication.

If you interrupt the treatment with Donepezilo Qualigen:

Do not stop taking the coated tablets without your doctor's indication. If treatment is interrupted, the positive results may decrease gradually.

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Severe side effects:

Inform your doctor immediately if you experience any of the following severe side effects, which may require urgent medical treatment.

• Liver disorders, including hepatitis. Symptoms of hepatitis are nausea, vomiting, loss of appetite, general discomfort, fever, itching, yellow skin and eyes, and black urine (may affect up to 1 in 1,000 people).
• Stomach and duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
• Gastrointestinal bleeding. Symptoms are black, tar-like stools or blood in the rectum (may affect up to 1 in 100 people).
• Seizures or convulsions (may affect up to 1 in 100 people).
• Weakness, sensitivity, or muscle pain, particularly if you are also feeling unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction, which can be fatal and cause kidney problems (a condition known as rhabdomyolysis).

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

• Diarrhea.
• Nausea (dizziness).
• 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 resolve with a dose reduction or discontinuation of treatment.
• Dizziness, dizziness, difficulty sleeping
• Vomiting, abdominal disorders
• Rash, itching
• Muscle cramps
• Inability to retain urine
• Fatigue, pain
• Accidents (patients may be more prone to falls and accidental injuries)

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

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

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

• Rigidity, tremor, or uncontrolled movements, particularly of the face and tongue, but also of the limbs.
• Cardiac arrest
• Liver disorders, including hepatitis

Frequency not known (cannot be estimated from available data):

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heart rate, fainting, which may be symptoms of a potentially fatal condition known as torsade de pointes
• Increased libido, hypersexuality.
• Torsion dystonia (a condition that involves involuntary muscle contractions with abnormal flexion of the body and head to one side)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Donepezilo Qualigen

• The active ingredient is donepezilo hydrochloride. Each film-coated tablet contains 10 mg of donepezilo 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, and yellow iron oxide (E-172)).

Appearance of the product and content of the container

Donepezilo Qualigen 10 mg is presented in film-coated tablets. The tablets are yellow, round, biconvex, and are engraved with “D10” on one face.

Donepezilo Qualigen 10 mg film-coated tablets are available in a container size, containing 28 tablets and with a blister made of PVC/PVdC with an aluminum foil on the back.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

Niche Generics Ltd

Unit 5, 151 Baldoyle Industrial Estate

Dublin 13

Ireland

Last review date of this leaflet: October 2022

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/