Label: information for the user

Donepezilo pensa 5mg film-coated tablets

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 for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

6. Contents of the pack and additional informationl

Donepezilo belongs to a group of medications known as cholinesterase inhibitors: it 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 for the treatment of mild to moderately severe symptoms of Alzheimer's disease. Symptoms include increased memory loss, confusion, and changes in behavior.

Remember:Inform your doctor about your caregivers.

Do not takeDonepezilo Pensa

• If you are allergic to hydrochloride of donepezilo, to piperidina derivatives or to any of the other components of this medication (included in section 6).

- If you are pregnant, think you might be pregnant or are breastfeeding

Warnings and precautions

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

The treatment with donepezilo 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 Donepezilo Pensa if you have or have had:

• Had stomach ulcers or intestinal ulcers at any time
• Often take analgesics or treatment for rheumatism (pain or inflammation around bones, joints or muscles): taking these medications at the same time as donepezilo may increase the risk of developing stomach or intestinal ulcers.
• Had seizures at any time
• Cardiac condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• Cardiac 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
• Has asthma or other chronic lung disease
• Has difficulty urinating
• Had liver problems or hepatitis at any time
• Is going to undergo surgery that requires general anesthesia. You must inform the anesthesiologist that you are taking donepezilo.

You should avoid taking Donepezilo Ranbaxy with other inhibitors of acetylcholinesterase and other agonists or antagonists of the cholinergic system.

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

Children:

Donepezilo is not recommended for children

Other medications and Donepezilo Pensa

Inform your doctor if you are using, have used recently or might have to use any other medication, even those purchased without a prescription.

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

- Other medications for Alzheimer's disease, for example, galantamine.

- Analgesics or treatment for arthritis, for example, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.

• Antifungal medications, such as ketoconazole.
• Cardiac medications, for example, quinidine, beta-blockers (propranolol and atenolol).
• Anticonvulsants, for example, phenytoin, carbamazepine.

- Anticholinergic medications, for example, tolterodine.

- Muscle relaxants, for example, succinylcholine, diazepam.

- General anesthetic.

- Medications for cardiac rhythm problems, for example, amiodarone or sotalol.

- Medications for depression, for example, fluoxetine, citalopram, escitalopram, amitriptyline.

- Medications for psychosis, for example, pimozide, sertindole or ziprasidone.

- Medications for bacterial infections, for example, rifampicin, clarithromycin, erythromycin, levofloxacin, moxifloxacin.

- Medications purchased without a prescription, for example, herbal remedies.

In case of surgery with general anesthesia, you must inform your doctor that you are taking Donepezilo Pensa as this may affect the amount of anesthetic needed. Donepezilo Pensa can be used in patients with mild to moderate renal or hepatic disease. Inform your doctor if you have any kidney or liver disease. Patients with severe liver disease should not take Donepezilo Pensa.

Taking Donepezilo Pensa with food, drink and alcohol

Taking Donepezilo Pensa with alcohol may alter the absorption of this medication.

You should avoid drinking alcohol while taking donepezilo, as this may reduce the effect of donepezilo.

Pregnancy, breastfeeding and fertility

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

Do not take donepezilo if you are pregnant or think you might be pregnant.

Do not take donepezilo if you are breastfeeding.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Donepezilo may cause fatigue, dizziness, drowsiness and muscle cramps, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or operate machinery.

Donepezilo Pensa contains lactose

Donepezilo Pensa contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

You should take donepezil once a day orally with a glass of water at night, immediately before going to bed.

The dose you take may vary depending on the time you have been taking the medication and what your doctor recommends. You will usually start taking 5mg each night. After a month, your doctor may indicate that you take 10mg each night. The maximum recommended dose is 10mg 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 or moderate liver disease (a disease that affects the liver) or kidney disease (a disease that affects the kidney), you can take Donepezil Pensa. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease 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 Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

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

If you forgot to take Donepezil Pensa

If you forgot to take a dose, take the missed dose as soon as you remember, unless it is almost time for your next dose.

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

If you interrupt treatment with 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 other questions about the use of this medication, ask your doctor or pharmacist.

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

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

Common side effects(seen in at least1 in 100 patients) are: 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)are: convulsions, slow heart rate, gastrointestinal bleeding, gastric and duodenal ulcers, excessive salivation, and abnormal levels of 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, stiffness, or uncontrollable movements of the face and tongue, as well as the limbs.

Frequency not knowna

• Changes in cardiac activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that may be a symptom of a potentially life-threatening condition known as torsade 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 experience these serious side effects. You may need urgent medical treatment.

• Fever with muscle rigidity, sweating, or decreased level of consciousness (a condition called "Neuroleptic Malignant Syndrome")
• Weakness, muscle sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. This can 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, convulsions, or brief episodes of fainting, consult your doctor as you may need to reduce the dose or stop treatment.

Severe side effects

Consult your doctor immediately if you experience these severe 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 discomfort, fever, pruritus, 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 (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, tar-like stools or visible blood from the rectum (≥1/1,000 to <1).
• Dizziness (attacks) or convulsions (≥1/1,000 to <1)

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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.

Do not use Donepezilo Pensa after the expiration date that appears on the box. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications.This will help protect the environment.

Composition of Donepezilo Pensa 5 mg

• The active ingredient is hydrochloride of donepezilo. Each tablet contains 5.26 mg of hydrochloride of donepezilo, equivalent to 5 mg of donepezilo.
• The other components are: the tablet core contains lactose monohydrate, cornstarch without gluten, hydroxypropylcellulose (E-463), microcrystalline cellulose (E-460ii), carboxymethylstarch sodium, 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 content of the packaging

Donepezilo Pensa 5 mg are film-coated tablets, biconvex, circular, yellow in color, and with the text “RC25” on one side. The 5 mg tablets are available in packaging sizes of: 28 tablets and clinical packaging of 50 tablets.

Donepezilo Pensa 10 mg is also available in packaging sizes of 28 tablets and clinical packaging of 50 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Last review date of this leaflet: September 2022

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