DONEPEZIL PENSA PHARMA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Donepezil Pensa Pharma 10 mg Orodispersible Tablets EFG

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. See section 4.

Contents of the pack and other information:

1. What is Donepezil Pensa Pharma and what is it used for
2. What you need to know before you take Donepezil Pensa Pharma
3. How to take Donepezil Pensa Pharma
4. Possible side effects
5. Storage of Donepezil Pensa Pharma

Contents of the pack and other information

1. What is Donepezil Pensa Pharma and what is it used for

Donepezil Pensa Pharma belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine) by reducing the rate of breakdown of this substance.

It is used to treat the symptoms of Alzheimer's disease of mild to moderate severity. The symptoms include increased memory loss, confusion, and changes in behavior.

2. What you need to know before you take Donepezil Pensa Pharma

Remember:You must tell your doctor who your caregivers are.

Do not take Donepezil Pensa Pharma:

• If you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezil Pensa.

Treatment with donepezil should only be initiated and supervised by a doctor with experience in the diagnosis and treatment of Alzheimer's disease.

Consult your doctor or pharmacist before starting to take Donepezil Pensa Pharma if you have or have had:

• ever had a stomach ulcer or intestinal ulcer
• frequently take painkillers or treatment for rheumatism (pain or inflammation around bones, joints, or muscles): taking these medicines at the same time as donepezil may increase the risk of developing stomach or intestinal ulcers.
• seizures
• 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 someone in your family has "prolongation of the QT interval"
• low levels of magnesium or potassium in the blood

• have asthma or other chronic lung disease
• liver problems or hepatitis

• have difficulty urinating
• are going to undergo surgery that requires general anesthesia. You should inform your anesthesiologist that you are taking Donepezil Pensa.

You should avoid taking Donepezil Pensa Pharma with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.

The individual effect of donepezil cannot be predicted, therefore the effect of treatment should be regularly evaluated by your doctor.

Children

Donepezil is not recommended for use in children.

Other medicines and Donepezil Pensa Pharma:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription. It also applies to medicines that you are going to take in the future if you continue to take Donepezil Pensa Pharma. This is because these medicines may weaken or strengthen the effects of Donepezil Pensa Pharma.

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

• Other medicines for Alzheimer's disease, such as galantamine
• Painkillers or treatment for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac sodium

• Antifungal medicines, such as ketoconazole
• Medicines for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)

• Anticonvulsants, such as phenytoin, carbamazepine
• Anticholinergic medicines, such as tolterodine
• Muscle relaxants, such as diazepam, succinylcholine
• General anesthetics
• Medicines for heart rhythm problems, such as amiodarone or sotalol
• Medicines for depression, such as fluoxetine, citalopram, escitalopram, amitriptyline
• Medicines for psychosis, such as pimozide, sertindole, or ziprasidone
• Medicines for bacterial infections, such as rifampicin, clarithromycin, erythromycin, levofloxacin, moxifloxacin
• Over-the-counter medicines, such as herbal remedies

In case of surgical intervention with general anesthesia, you should inform your doctor that you are taking Donepezil Pensa, as this may affect the amount of anesthetic needed.

Donepezil Pensa 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 Donepezil Pensa.

Taking Donepezil Pensa Pharma with food and drinks:

Taking Donepezil Pensa Pharma with alcohol may reduce the absorption of this medicine.

You should avoid drinking alcohol while taking donepezil, as it may reduce the effect of donepezil.

Pregnancy, breastfeeding, and fertility:

Donepezil Pensa Pharma should not be used during breastfeeding.

Do not take Donepezil Pensa Pharma if you are pregnant or think you may be pregnant.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

Alzheimer's disease 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.

Also, the medicine may cause drowsiness, dizziness, somnolence, and muscle cramps. If you experience these effects, do not drive or use machines.

3. How to take Donepezil Pensa Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Donepezil Pensa Pharma is administered orally. The tablet should be placed on the tongue where it will disintegrate before swallowing, with or without water, as you prefer.

Usually, treatment is started by taking 5 mg (one white tablet) each night before bedtime. After one month of treatment, your doctor may tell you to increase the dose to 10 mg (one yellow tablet) each night before bedtime. The maximum recommended dose is 10 mg/day.

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

If you have mild or moderate liver or kidney impairment, you may follow a similar dosage regimen as indicated above.

Tell your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver impairment should not take Donepezil Pensa Pharma.

Use in children

Donepezil is not recommended for use in children.

If you take more Donepezil Pensa Pharma than you should:

If you have taken more Donepezil Pensa Pharma than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Always carry the tablets and the packaging with you to show the doctor what you have taken.

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 seizures.

If you forget to take Donepezil Pensa Pharma

Do not take a double dose to make up for a forgotten dose. Take your 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 Pensa Pharma

Do not stop treatment unless your doctor tells you to. If you stop taking Donepezil Pensa Pharma, the beneficial effects of treatment will gradually disappear.

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

4. Possible side effects

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

Very common side effects (≥1/10) are:diarrhea, nausea, headache

Common side effects:(seen in at least 1 in 100 patients): dizziness, insomnia, fatigue, fainting, hallucinations, agitation, aggressive behavior, abnormal dreams, and nightmares, fatigue, pain, loss of appetite, digestive disorders, such as diarrhea, nausea, and vomiting, incontinence, muscle cramps, skin rash, itching, colds, and accidents.

Uncommon side effects:(≥1/1,000 to <1>: seizures, slow heart rate, bleeding in the digestive tract, gastric and duodenal ulcers, excessive salivation, and abnormal levels of the substance creatine kinase in the blood.

Rare side effects ((≥1/10,000 to <1>): are liver disorders including hepatitis, heart problems such as abnormal heart rhythm, as well as symptoms such as tremors, rigidity, or uncontrolled movements of the face and tongue, as well as limbs

Very rare and serious side effects

Consult your doctor immediately if you suffer from any of these effects:

• Fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") as it may require urgent medical treatment
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or dark urine. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis).

If you experience hallucinations, agitation, aggressive behavior, seizures, or brief episodes of fainting, you should consult your doctor as you may need to reduce the dose or stop treatment.

Frequency not known:

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Rapid 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).

Serious side effects:

Consult your doctor immediately if you suffer from these serious side effects. 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 urine (≥1/10,000 to <1>
• Ulcers in the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (≥1/1,000 to <1>
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (≥1/1,000 to <1>
• Fainting (seizures) or convulsions (≥1/1,000 to <1>

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of 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 leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Pensa Pharma

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Pensa Pharma 10 mg Orodispersible Tablets EFG

• The active substance is donepezil hydrochloride. Each orodispersible tablet contains 10 mg of donepezil hydrochloride.
• The other ingredients are: Microcrystalline cellulose, Povidone, Basic butylated methacrylate copolymer, Sodium lauryl sulfate, Stearic acid, Dextrates, Silicified microcrystalline cellulose, Sodium croscarmellose, Sucralose, Magnesium stearate, Synthetic yellow iron oxide (E172).

Appearance of Donepezil Pensa Pharma 10 mg Orodispersible Tablets EFG

Yellow, round, smooth orodispersible tablets with a diameter of approximately 9.0 mm.

Pack contents of Donepezil Pensa Pharma

The orodispersible tablets are supplied in packs of 28, 56, or 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Pharmapath S.A.

28is Oktovriou 1, Agia Varvara,

123 51, Greece

This medicine is authorized in the EEA member states with the following names

ES: Donepezil Pensa Pharma 10 mg Orodispersible Tablets EFG

Date of last revision of this leaflet:September 2022

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