PEZIMAX 2 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Pezimax 2 mg/ml Oral Solution

Donepezil, Hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack and other information

1. What Pezimax Oral Solution is and what it is used for
2. What you need to know before you take Pezimax Oral Solution
3. How to take Pezimax Oral Solution
4. Possible side effects
5. Storage of Pezimax Oral Solution
6. Pack contents and further information

1. What Pezimax Oral Solution is and what it is used for

Pezimax Oral Solution contains the active substance Donepezil Hydrochloride.

Donepezil Hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil increases the levels in the brain of a substance related to memory (acetylcholine), by reducing the speed of breakdown 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 increasing memory loss, confusion, and changes in behavior.

As a result, people with Alzheimer's disease have increasing difficulty carrying out their normal daily activities.

Pezimax Oral Solution is for use in adult patients only.

2. What you need to know before you take Pezimax Oral Solution

Do not take Pezimax Oral Solution:

• if you are allergic to Donepezil Hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (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
• seizures or convulsions
• a heart condition (such as irregular heartbeats or very slow heart rate, heart failure, myocardial infarction)
• a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes, or if a family member has "prolonged QT interval"
• low levels of magnesium or potassium in the blood
• asthma or other chronic lung disease
• liver or hepatitis problems
• difficulty urinating or mild kidney disease.

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

Children and adolescents

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

Using Pezimax Oral Solution with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This includes medicines that your doctor has not prescribed but that you have bought yourself in a pharmacy. It also includes medicines that you might take in the future if you continue to take Pezimax. This is because these medicines can weaken or strengthen the effects of Pezimax.

In particular, it is important to tell your doctor if you are taking any of the following 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 treating 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.
• Anticholinergic medicines, such as tolterodine.
• Anticonvulsants, such as phenytoin and carbamazepine.
• Medicines for irregular heartbeats, such as quinidine and beta-blockers, such as propranolol and atenolol.
• Muscle relaxants, such as diazepam, succinylcholine.
• General anesthesia
• Medicines bought without a prescription, such as herbal remedies.

In case of surgical intervention with general anesthesia, you should inform your doctor and anesthetist that you are taking Pezimax Oral Solution. This medicine may affect the amount of anesthetic needed.

Pezimax Oral Solution can 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 medicine.

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

Taking Pezimax Oral Solution with food, drink, and alcohol

Food does not affect the effect of Pezimax Oral Solution.

Pezimax Oral Solution should not be taken with alcohol, as alcohol may change the effect of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Pezimax Oral Solution during breastfeeding.

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.

Pezimax Oral Solution may cause tiredness, dizziness, and muscle cramps. If you experience these effects, do not drive or use machines.

Pezimax Oral Solution contains sorbitol, sodium benzoate, sodium metabisulfite, methylparahydroxybenzoate, propylene glycol, and ethanol.

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

This medicine contains 1.0 mg of sodium benzoate and 122.2 mg of propylene glycol in each ml.

This medicine contains sodium metabisulfite. It can rarely cause severe hypersensitivity reactions and bronchospasm.

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

This medicine contains 499.8 mg of sorbitol in each ml.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars, or 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 medicine.

This medicine contains 0.0002% ethanol (alcohol), this small amount corresponds to 0.0027 mg per ml.

3. How to take Pezimax Oral Solution

How much Pezimax Oral Solution should you take

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Initially, the recommended dose is 2.5 ml (or 5 mg), each night before bedtime. After one month of treatment, your doctor may indicate an increase in the dose to 5 ml (or 10 mg) each night before bedtime.

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

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

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

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

How to take the medicine

Pezimax Oral Solution should be taken orally, at night, before bedtime.

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

Only the spoon provided in each box should be used.

After taking your dose, wash the dosing spoon 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 you take more Pezimax Oral Solution than you should

If you have taken more Pezimax Oral Solution than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

Symptoms of overdose may include feeling sick, drooling, sweating, decreased heart rate, low blood pressure (dizziness or fainting when standing up), breathing problems, loss of consciousness, and convulsions.

If you forget to take Pezimax Oral Solution

Do not take a double dose to make up for forgotten doses.

If you forget to take Pezimax Oral Solution for more than one week, consult your doctor before taking this medicine again.

If you stop taking 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 medicine, ask your doctor or pharmacist.

How long you should take Pezimax Oral Solution

Your doctor or pharmacist will tell you how long you should continue to take this medicine.

You should consult your doctor regularly to review your treatment and assess your symptoms.

4. Possible side effects

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

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

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

Serious side effects:

You should inform your doctor immediately if you notice any of the following serious side effects, 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 malaise, 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 sternum (may affect up to 1 in 100 patients).
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (may affect up to 1 in 100 patients).
• Dizziness (seizures) 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, especially if you also feel unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle breakdown, which can be life-threatening 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
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect up to 1 in 100 patients

• Decreased heart rate
• Increased salivation

Rare: may affect up to 1 in 1,000 patients

• Stiffness, tremors, or uncontrolled movements, especially of the face and tongue, but also of the limbs.

Frequency not known: cannot be estimated from the available data

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolonged QT interval"
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as 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 of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pezimax Oral Solution

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Pack contents and further information

Composition of Pezimax 2 mg/ml Oral Solution

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

• The other ingredients are: liquid sorbitol 70% (non-crystallizable) (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 pack contents

Pezimax 2 mg/ml Oral Solution is a clear, colorless solution with a strawberry flavor and odor.

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 pack should be used.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 – Sant Joan Despí

Barcelona

Spain

Manufacturer

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 under the following names:

Date of the last revision of this leaflet: October 2022

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