DONEPEZIL QUALIGEN 5 mg FILM-COATED TABLETS

2. What you need to know before you take Donepezil Qualigen

Do not take Donepezil Qualigen

If you are allergic to donepezil hydrochloride or piperidine derivatives or any of the other ingredients of this medicine (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 long-term lung disease,
• liver problems or hepatitis,
  • difficulty urinating or mild kidney failure,
  • low levels of magnesium or potassium 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 medicines and Donepezil Qualigen

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

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

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

• other medicines for Alzheimer's disease, such as galantamine
  • painkillers or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium.

• anticholinergics, such as tolterodine.
• anticonvulsants, such as phenytoin and carbamazepine,
• medicines for heart disease, such as quinidine and beta-blockers (propranolol and atenolol),
• general anesthetics,
• muscle relaxants, such as succinylcholine, diazepam,
  • medicines obtained without a prescription, 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 medicine 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 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 have a baby, ask your doctor for advice before taking this medicine.

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

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so.

Donepezil can cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Donepezil Qualigen contains lactose and sodium.

If your doctor has told you that you have an intolerance to some sugars, consult them 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 of administration of this medicine given to you by your doctor. If you are not sure, ask your doctor or pharmacist.

Initially, the recommended dose is 5 mg (one white tablet) every night before bedtime. After one month, your doctor may tell 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 that you take Donepezil Qualigen in the morning.

Donepezil Qualigen is taken orally.

Adults and elderly patients

Treatment with Donepezil Qualigen starts with a 5 mg tablet, taken once daily, 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 tell you to increase the dose to 10 mg, once daily, at night, before bedtime. The maximum recommended dose is 10 mg/day.

Do not change the dose without consulting your doctor first.

How long will you take Donepezil Qualigen?

Your doctor will decide the duration of treatment.

You will need to visit your doctor regularly 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. Take the tablets, this leaflet, and/or the packaging with you 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 medicine 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 medicine for more than one week, consult your doctor before taking the medicine again.

If you stop taking Donepezil Qualigen

Do not stop taking the tablets without talking to your doctor first. If you stop treatment, the positive results of the treatment may gradually decrease.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you get any side effects while taking donepezil.

Serious side effects:

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

• Liver disorders, e.g., 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 also 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, 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 the 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 involving involuntary muscle contraction with abnormal flexion of the body and head to one side)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Donepezil Qualigen

• The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 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 white (polyvinyl alcohol, titanium dioxide (E-171), macrogol (E-1521), talc).

Appearance of the product and pack contents

Donepezil Qualigen 5 mg is presented as film-coated tablets. The tablets are white, round, biconvex, and engraved with "D5" on one face.

Donepezil Qualigen 5 mg film-coated tablets are available in one pack size, containing 28 tablets, and with a blister formed by PVC/PVdC with an aluminum foil on the back.

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 last revision of this leaflet: October 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/