DONEPEZIL QUALIGEN 10 mg FILM-COATED TABLETS

2. What you need to know before taking Donepezil Qualigen

Do not take Donepezil Qualigen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezil Qualigen

Consult your doctor or pharmacist before starting to take 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 called torsades de pointes, or if a family member has "prolongation of the QT interval",
• asthma or other chronic lung disease,
• liver problems or hepatitis,
• difficulty urinating or mild kidney failure,
• low magnesium or potassium levels in the blood.

Tell 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 medications and Donepezil Qualigen

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

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

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

• other medications for Alzheimer's disease, such as galantamine
• pain relievers or arthritis treatment, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium, anticholinergics, such as tolterodine.
• anticonvulsants, such as phenytoin and carbamazepine,
• medications for heart disease, such as quinidine and beta-blockers (propranolol and atenolol),
• general anesthetics,
• muscle relaxants, such as succinylcholine, diazepam,
• over-the-counter medications, such as herbal remedies

In the event of surgery with general anesthesia, you should inform your doctor that you are taking donepezil. This is because the medication may affect the amount of anesthesia needed.

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

Taking Donepezil Qualigen with food, drinks, and alcohol

Food does not interfere with the effect of donepezil.

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines:

Your illness 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, especially at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Donepezil Qualigen contains lactose and sodium.

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

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

3. How to take Donepezil Qualigen

Follow your doctor's instructions for taking this medication exactly. If you have any questions, consult your doctor or pharmacist. Initially, the recommended dose is 5 mg (one white tablet) every night before bedtime. After one month, your doctor may instruct you to take 10 mg (one yellow tablet) every night before bedtime.

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

Donepezil Qualigen is administered orally.

Adults and elderly patients

Treatment with Donepezil 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 one month of treatment, your doctor may instruct you to increase the dose to 10 mg, once a day, at night, before bedtime. The maximum recommended dose is 10 mg/day.

Do not change the dose without consulting your doctor first.

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 symptom assessment.

If you take more Donepezil Qualigen than you should

Contact your doctor or a hospital immediately if you have taken too much Donepezil Qualigen. Bring the tablets, this package 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 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 forgotten doses. Take your usual dose the next day at the usual time.

If you forget to take your medication for more than one week, consult your doctor before taking the medication again.

If you stop taking Donepezil Qualigen:

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

Serious side effects:

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

• Liver disorders, such as hepatitis. The symptoms of hepatitis are nausea, vomiting, loss of appetite, general malaise, fever, itching, yellow skin and eyes, and dark urine (may affect up to 1 in 1,000 people).
• Stomach and duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people)
• Gastrointestinal bleeding. The symptoms are black, tarry 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 feel unwell, have a fever, or dark urine. This can be due to abnormal muscle destruction, which can be life-threatening and cause kidney problems (a condition called 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 reduction in dose or discontinuation of treatment.
• dizziness, drowsiness, difficulty sleeping
• vomiting, abdominal disorders
• skin 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):

• seizures
• slow heartbeat
• 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):

• 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 can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening condition called torsades de pointes
• Increased libido, hypersexuality.
• Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Donepezil Qualigen

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

Do not use this medication after the expiration date stated on the packaging after EXP. 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Donepezil Qualigen

• The active ingredient is donepezil hydrochloride. Each film-coated tablet contains 10 mg of donepezil hydrochloride.
• The other ingredients (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 package contents

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

Donepezil Qualigen 10 mg film-coated tablets are available in one package size, containing 28 tablets, with a blister pack formed by PVC/PVdC with an aluminum foil on the back.

Marketing authorization holder and manufacturer

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 last revision of this package leaflet: October 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/