Label: information for the user

Pezimax 2 mg/ml oral solution

Donepezil hydrochloride

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

Pezimax oral solution contains the active substance hydrochloride of donepezil.

Hydrochloride of donepezil belongs to the group of medicines called acetylcholinesterase inhibitors.

Donepezil increases the levels in the brain of a substance related to memory (acetylcholine), by means of the decrease in the speed of decomposition of this substance.

It is used for the treatment of the symptoms of dementia in patients diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include an increase in memory loss, confusion, and changes in behavior.

As a result, Alzheimer's patients have increasingly greater difficulties in carrying out their normal daily activities.

Pezimax oral solution is for use in adult patients only.

Do not take Pezimax oral solution:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Pezimax oral solution 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"
• low levels of magnesium or potassium in the blood
• asthma or other chronic lung disease
• liver problems or hepatitis
• difficulty urinating or mild kidney disease.

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

Children and adolescents

Do not recommend using Pezimax oral solution in children and adolescents (under 18 years of age).

Use of Pezimax oral solution with other medications

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

This includes medications that your doctor has not prescribed but that you have purchased from a pharmacy. It also includes medications that you may take in the future if you continue to take Pezimax. This is because these medications may weaken or strengthen the effects of Pezimax.

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

• Medications for heart rhythm problems, for example, amiodarone or sotalol
• Medications for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine
• Medications for psychosis, for example, pimozide, sertindol or ziprasidone
• Medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medications, such as ketoconazole
• Other medications to treat Alzheimer's disease, for example, galantamine
• Analgesics or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.
• Anticholinergic medications, such as tolterodine.
• Anticonvulsants, such as phenytoin and carbamazepine.
• Medications for irregular heartbeats, such as quinidine and beta-blockers, such as propranolol and atenolol.
• Muscle relaxants, such as diazepam, succinylcholine.
• General anesthesia
• Over-the-counter medications, such as herbal remedies.

In the event of surgical intervention with general anesthesia, you must inform your doctor and the anesthesiologist that you are taking Pezimax oral solution. This medication may affect the amount of anesthetic needed.

Pezimax oral solution may be used in patients with mild to moderate kidney or liver disease. Inform your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take this medication.

Inform your doctor or pharmacist of the name of your caregiver. Your caregiver will help you take your medication as prescribed.

Taking Pezimax oral solution with food, drink, and alcohol

Foods do not affect the effect of Pezimax oral solution.

Pezimax oral solution should not be taken with alcohol as alcohol may modify the effect of this medication.

Pregnancy, breastfeeding, and fertility

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

Do not take Pezimax oral solution during breastfeeding.

Driving and operating machinery

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

Pezimax oral solution may cause fatigue, dizziness, and muscle cramps. If you experience these effects, do not drive or operate machinery.

Pezimax oral solution contains sorbitol, sodium benzoate, sodium metabisulfite, methylparahydroxybenzoate, propylene glycol, and ethanol.

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

This medication contains 1.0 mg of sodium benzoate and 122.2 mg of propylene glycol per ml.

This medication contains sodium metabisulfite. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

This medication may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate.

This medication contains 499.8 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you that you have a problem with certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains 0.0002% ethanol (alcohol), which corresponds to 0.0027 mg per ml.

How much Pezimax oral solution should I take

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist.In case of doubt,consult your doctor or pharmacist again.

The initial recommended dose is 2.5 ml (or 5 mg), taken each night before going to bed. After a month of treatment, your doctor may recommend increasing the dose to 5 ml (or 10 mg) each night before going to bed.

The dose you take may change depending on the length of time you have been taking the medication or your doctor's recommendations.

The maximum recommended dose is 5 ml (or 10 mg) each night.

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

Always follow the advice of your doctor or pharmacist on how and when to take the medication. Do not change the dose yourself without consulting your doctor.

How to take the medication

Pezimax oral solution should be taken orally, at night, before going to bed.

Measure the prescribed amount of medication using the 2.5 ml or 5 ml dosing line marked on the dropper and then swallow it.

Only the dropper provided in each box should be used.

After taking your dose, wash the dosing dropper with water and let it air dry.

Use in children and adolescents

Pezimax oral solution is not recommended for use in children and adolescents (under 18 years of age).

If I take more Pezimax oral solution than I should

If you have taken more Pezimax oral solutionthan you should, consult your doctor, pharmacist, or callthe Toxicological Information Service, phone: 91 562 04 20,indicating the medication and the amount used.

The symptoms of overdose may include feeling unwell, drooling, sweating, decreased heart rate, low blood pressure (dizziness or lightheadedness when standing up), breathing difficulties, loss of consciousness, and seizures.

If I forget to take Pezimax oral solution

Do not take a double dose to compensate for the missed doses.

If you forget to take Pezimax oral solution for more than a week, consult your doctor before resuming this medication.

If I interrupt the treatment with Pezimax oral solution

Do not stop taking Pezimax oral solution unless your doctor tells you to. If you stop taking Pezimax oral solution, the benefits of treatment will gradually disappear.

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

How long should I take Pezimax oral solution

Your doctor or pharmacist will indicate how long you should continue with this medication treatment.

You will need to consult your doctor periodically to review your treatment and evaluate your symptoms.

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

The following side effects have been reported by people taking Pezimax.

Contact your doctor if you experience any of these side effects during treatment with Pezimax.

Severe side effects:

You must inform your doctor immediately if you notice any of the following severe side effects mentioned, as you may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general discomfort, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 patients).
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 patients).
• Bleeding in the stomach or intestine. This may cause you to have black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 patients).
• Dizziness (attacks) or convulsions (may affect up to 1 in 100 patients).
• Fever with muscle stiffness, sweating, decreased level of consciousness (may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 patients).
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 patients).

Other side effects

Very common: may affect more than 1 in 10 patients

• Diarrhea
• Headache

Common: may affect up to 1 in 10 patients

• Muscle cramps
• Fatigue
• Difficulty sleeping (insomnia)
• Common cold
• Hallucinations (seeing or hearing things that are not real)
• Abnormal dreams and nightmares
• Agitation
• Aggressive behavior
• Fainting
• Dizziness
• Abdominal discomfort
• Rash
• Incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect up to 1 in 100 patients

• Slowed heart rate
• Excessive salivation

Rare: may affect up to 1 in 1,000

• Rigidity, tremors, or uncontrollable movements, especially of the face and tongue, but also of the limbs.

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 may be symptoms of a potentially fatal condition called torsade de pointes
• Increased libido, hypersexuality
• Torticollis (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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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.

This medication does not require special storage conditions.

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

Once the bottle is opened, use within the next two months.

Medications should not be disposed of through drains or in the trash.Deposit empty containers and unused medications at the SIGREcollection point at the pharmacy.In case of doubtask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Pezimax 2 mg/ml oral solution

• The active ingredient is hydrochloride of donepezil. Each ml contains 2 mg of hydrochloride of donepezil, equivalent to 1.824 mg/ml of donepezil base.

• The other components are: liquid sorbitol 70% (non-crystallizing) (E 420), hydroxyethylcellulose, sodium benzoate (E 211), methylparahydroxybenzoate (E 218), propylene glycol (E 1520), sodium metabisulfite (E 223), strawberry flavor (contains propylene glycol and ethanol), 10% hydrochloric acid solution, purified water.

Appearance of the product and contents of the packaging

Pezimax 2 mg/ml oral solution is a transparent and colorless solution with a strawberry odor and taste.

Pezimax 2 mg/ml oral solution is available in 150 ml bottles.

The box also includes a 20 ml dosing cup with intermediate graduations of 2.5 ml, 5 ml, 10 ml, and 15 ml.

Only the dosing cup included in each package should be used.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 – Sant Joan Despí

Barcelona

Spain

Responsible for Manufacturing

RAFARM, S.A.

Thesi Pousi-Xatzi, Agiou Louka,

Paiania, Attiki

19002, Box 37

Greece

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the last review of this leaflet: October 2022

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”