Pezimax 2 mg/ml oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pezimax 2 mg/ml oral solution

Donepezil hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

1. What Pezimax oral solution is and what it is used for
2. What you need to know before taking Pezimax oral solution
3. How to take Pezimax oral solution
4. Possible adverse effects
5. How to store Pezimax oral solution
6. Contents of the pack and other 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 known as acetylcholinesterase inhibitors.

Donepezil increases levels in the brain of a substance involved in memory (acetylcholine), by slowing down the breakdown of this substance.

It is used to treat the symptoms of dementia in patients diagnosed with mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and behavioural changes.

As a result, patients with Alzheimer's disease have increasing difficulty performing their usual daily activities.

Pezimax oral solution is for use in adult patients only.

2. What you need to know before taking Pezimax oral solution

Do not take Pezimax oral solution:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Pezimax oral solution if you have or have had:

• stomach or duodenal ulcer
• 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 known as 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 another chronic lung disease
• liver problems or hepatitis
• difficulty urinating or mild kidney disease.

Talk to your doctor if you are pregnant or think you might be pregnant.

Children and adolescents

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

Taking Pezimax oral solution with other medicines

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

This includes medicines not prescribed by your doctor but which you have purchased on your own at a pharmacy. It also includes medicines you might take in the future while continuing to take Pezimax. This is because these medicines may weaken or strengthen the effects of Pezimax.

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

• Medicines for heart rhythm problems, for example amiodarone or sotalol
• Medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• Medicines for psychosis, e.g. pimozide, sertindole or ziprasidone
• Medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medicines, such as ketoconazole
• Other medicines used to treat Alzheimer's disease, for example galantamine
• Painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• Anticholinergic medicines, such as tolterodine
• Anticonvulsants, such as phenytoin and carbamazepine
• Medicines for heart irregularities, such as quinidine and beta-blockers, such as propranolol and atenolol
• Muscle relaxants, such as diazepam, succinylcholine
• General anaesthesia
• Medicines purchased without a prescription, such as herbal remedies

If you are undergoing surgery with general anaesthesia, you must inform your doctor and anaesthetist that you are taking Pezimax oral solution. This medicine may affect the amount of anaesthetic required.

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

Inform your doctor or pharmacist of your caregiver's name. Your caregiver will help you take your medicine as prescribed.

Taking Pezimax oral solution with food, drink and alcohol

Food does not affect the action of Pezimax oral solution.

Pezimax oral solution should not be taken with alcohol, as alcohol may alter the effect of this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Pezimax oral solution during breast-feeding.

Driving and using machines

Your illness may affect your ability to drive or use machinery, and you should not carry out 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, you should not drive or use machinery.

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. Rarely, this may 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 certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients 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 instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Initially, the recommended dose is 2.5 ml (or 5 mg), taken every night before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 5 ml (or 10 mg) each night before going to bed.

Your dose may change depending on how long you have been taking the medicine or on 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 that you take Pezimax in the morning.

Always follow your doctor’s or pharmacist’s advice 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 going to bed.

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

Only use the spoon provided in each package.

After taking your dose, wash the dosing spoon with water and allow it to air dry.

Use in children and adolescents

The use of Pezimax oral solution is not recommended 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the medicine and the amount taken.

Symptoms of overdose may include feeling unwell, drooling, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Pezimax oral solution

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

If you have forgotten to take Pezimax oral solution for more than one week, consult your doctor before resuming this medicine.

If you stop taking Pezimax oral solution

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

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

How long should you take Pezimax oral solution

Your doctor or pharmacist will advise you on how long you should continue treatment with this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported in people taking Pezimax.

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

Serious adverse effects:

You must inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include feeling sick 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).
• Stomach or duodenal ulcers. Symptoms of ulcers include 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 may cause black, tar-like stools or visible rectal bleeding (may affect up to 1 in 100 patients).
• Dizziness (attacks) or seizures (may affect up to 1 in 100 patients).
• Fever with muscle rigidity, sweating, and decreased level of consciousness (these may be symptoms of a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 patients).
• Weakness, muscle sensitivity, or pain, particularly if you also feel unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle breakdown, which can be fatal and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 patients).

Other adverse 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

• Slowed heart rate
• Excessive salivation

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

• Stiffness, tremors, or uncontrollable 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 may be seen on an electrocardiogram (ECG), known as "QT interval prolongation"
• Fast and irregular heartbeat, fainting which may be symptoms of a potentially life-threatening disorder known as torsade 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 adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the month indicated.

Once the bottle has been opened, use within the following two months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pezimax 2 mg/ml oral solution

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

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

Appearance of the product and contents of the pack

Pezimax 2 mg/ml oral solution is a clear, colourless solution with a strawberry odour and taste.

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

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

Only the dosing cup provided in each package 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review 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/"