DONEPEZIL PENSA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

1. Contents of the pack and further information

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

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors: it increases the levels in the brain of a substance related to memory (acetylcholine) by means of decreasing the speed of decomposition of this substance.

It is used for the treatment of the symptoms of Alzheimer's disease of mild to moderately severe. The symptoms include increased loss of memory, confusion, and changes in behavior.

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

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

Do not takeDonepezil Pensa

• If you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other components of this medicine (included in section 6).

• If you are pregnant, think you may be pregnant, or are breast-feeding

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 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 could increase the risk of developing stomach or intestinal ulcers.
• ever had 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
• have difficulty urinating
• have ever had liver problems or hepatitis
• are going to undergo surgery that requires general anesthesia. You must inform the anesthesiologist that you are taking donepezil.

You must avoid taking Donepezil Pensa 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 the doctor.

Children:

Donepezil is not recommended for use in children.

Other medicines and Donepezil Pensa

Tell your doctor if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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 arthritis treatment, 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 succinylcholine, diazepam.
• General anesthetic.
• 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.
• Medicines obtained without a prescription, such as herbal remedies.

In case of surgical intervention with general anesthesia, you must 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 renal or hepatic impairment. Inform your doctor before starting treatment if you have kidney or liver problems. Patients with severe hepatic impairment should not take Donepezil Pensa.

Taking Donepezil Pensa with food, drink, and alcohol

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

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

Pregnancy, breast-feeding, and fertility

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

Do not take donepezil if you are pregnant or think you may be pregnant.

Do not take donepezil if you are breast-feeding.

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

Donepezil Pensa contains lactose

Donepezil Pensa contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Donepezil Pensa

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The normal dose is described below.

You must take donepezil once a day by mouth with a glass of water at night, immediately before going to bed.

The dose you take may vary depending on how long you have been taking the medicine and what your doctor recommends. You will usually start by taking 5 mg each night. After a month, your doctor may tell you to take 10 mg each night. The maximum recommended dose is 10 mg each night.

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

Both you and your caregivers should know the doctor's instructions.

If you have mild to moderate hepatic (liver) or renal (kidney) impairment, you can take Donepezil Pensa. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment should not take Donepezil Pensa.

Use in children:

Donepezil is not recommended for use in children.

If you take more Donepezil Pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include dizziness, 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

If you forget to take a dose, take the forgotten dose as soon as you remember, unless it is time for the next dose.

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

If you stop taking Donepezil Pensa

Do not stop taking Donepezil Pensa unless your doctor tells you to. If you stop taking Donepezil Pensa, the benefits 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) are: dizziness, insomnia, tiredness, 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>

Rare side effects(≥1/10,000 to <1>

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).

Very rare and serious side effects

Consult your doctor immediately if you suffer from these serious side effects. You may need urgent medical treatment.

• Fever with muscle stiffness, sweating, or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome")
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or dark-colored urine. This may be due to abnormal muscle destruction that can be life-threatening 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.

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-colored 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 notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also communicate them 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

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

Do not use Donepezil Pensa after the expiry date stated on the carton. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Donepezil Pensa 5mg

• The active substance is donepezil hydrochloride. Each tablet contains 5.26 mg of donepezil hydrochloride, equivalent to 5 mg of donepezil.
• The other ingredients are: the core of the tablet contains lactose monohydrate, corn starch without gluten, hydroxypropylcellulose (E-463), microcrystalline cellulose (E-460ii), sodium carboxymethylcellulose, magnesium stearate (E-572). The film coating contains: talc (E-553b), macrogol, hypromellose, titanium dioxide (E-171), yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Donepezil Pensa 5 mg are film-coated tablets, biconvex, circular, yellow in color, and with the text "RC25" on one face. The 5 mg tablets are available in pack sizes of: 28 tablets and clinical pack of 50 tablets.

Donepezil Pensa 10 mg is also available in pack sizes of 28 tablets and clinical pack of 50 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

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

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/