Package Leaflet: Information for the user

Donepezil hydrochloride film-coated tablets EFG 5 mg

donepezil, hydrochloride(as monohydrate)

Read this leaflet carefully before you start taking this medicine because 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

- If you get any side effects, talk to your doctor or pharmacist. See section 4

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

2. What you need to know before you start taking Donepezil hydrochloride

3. How to take Donepezil hydrochloride

4. Possible side effects

5. Storage of Donepezil hydrochloride

6. Contents of the pack and additional information

Donepezilo (donepezil hydrochloride) belongs to a group of medications called cholinesterase inhibitors.

Donepezil hydrochloride increases the levels in the brain of a substance (acetylcholine) involved inmemory function by reducing the breakdown of acetylcholine.

It is used to treat the symptoms of dementia in individuals diagnosed with mild to moderately severe Alzheimer's disease.

The symptoms include increased loss of memory, confusion, and changes in behavior. As a result, patients with Alzheimer's find it increasingly difficult to carry out their normal daily activities. It is for use only in adult patients.

Do not take Donepezilo ratio

- if you are allergic to donepezil hydrochloride or derivatives of piperidina or to any of the other components of this medication (listed in section 6).

- if you are pregnant, think you may be pregnant or are breastfeeding.

Inform your doctor if any of these situations affect you.

Warnings and precautions

Consult with your doctor or pharmacist before taking Donepezilo ratio if you have or have had:

- stomach or duodenal ulcer

- an attack 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 called 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 other long-term lung diseases

- liver problems or hepatitis

- difficulty urinating or mild kidney disease,

Also inform your doctor if you are pregnant or think you may be pregnant.

You should avoid taking Donepezilo ratio with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Use in children and adolescents

Donepezilo ratio is not recommended for children and adolescents under 18 years.

Other medications and Donepezilo ratio

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

This includes medications that your doctor has not prescribed but that you have purchased from a pharmacist. It also applies to medications that you may take in the future if you continue to take Donepezilo ratio. This is because these medications may weaken or strengthen the effects of Donepezilo ratio.

Especially, inform your doctor if you are taking any of the following medications:

• medications for heart rhythm problems, for example amiodarone or sotalol
• medications for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• medications for psychosis, for example pimozide, sertindole or ziprasidone
• medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medications, such as ketoconazole

- other medications for Alzheimer's disease, for example galantamine

- sedatives or treatment for arthritis, for example Aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.

- anticholinergics, for example Tolterodina.

- anticonvulsants, for example Phenobarbital, carbamazepine

- medication for a heart condition, for example quinidine, beta-blockers (propranolol and atenolol)

- muscle relaxants, for example Diazepam, succinylcholine

- general anesthetics

- over-the-counter medications, for example, plant-based.

If you are going to undergo surgery that requires general anesthesia, you must inform your doctor and the anesthesiologist that you are taking Donepezilo ratio. This is because your medication may affect the amount of anesthetic needed.

Donepezilo ratio may be used in patients with mild to moderate kidney or liver disease.

Inform your doctor that you have kidney or liver disease. Patients with severe liver disease should not take Donepezilo ratio.

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

Taking Donepezilo ratio with food, drinks, and alcohol

Donepezilo ratio should be taken with water.

You should not drink alcohol while taking Donepezilo ratio because alcohol may change its effect.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Do not take Donepezilo ratio if you are breastfeeding your child.

Driving and using machines

Alzheimer's disease may affect your ability to drive or use machinery. Do not drive or use tools or machinery unless your doctor tells you it is safe to do so.

It may also cause fatigue, dizziness or muscle cramps mainly at the beginning of treatment or when the dose is increased. If you experience these effects while taking Donepezilo ratio tablets, you should not drive or use machinery.

Donepezilo ratio contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Donepezilo ratio contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Donepezilo ratio Dose Taking

You will generally start taking 5 mg (one white tablet) each night before going to sleep. After a month, your doctor may tell you to take 10 mg (one yellow tablet) each night before going to sleep. If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezilo in the morning.

The dose of the tablet you take may vary depending on how long you have been taking this medication and what your doctor recommends. The maximum recommended dose is 10 mg each night. Always follow the advice of your doctor or pharmacist on how and when to take your medication. Do not modify the dose yourself without consulting your doctor.

How to Take Your Medication

Swallow your tablet with a little water at night before going to bed.

How Long to Take Donepezilo ratio

Your doctor or pharmacist will advise you on how long you should continue taking the tablets.

You need to visit your doctor from time to time to review your treatment and evaluate your symptoms.

Use in Children and Adolescents

Donepezilo ratio is not recommended for use in children and adolescents (under 18 years old).

If You Take More Donepezilo ratio Than You Should

Contact your doctor or the nearest hospital immediately if you take more medication than you should.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or visit the hospital or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Bring the tablets and the packaging to the hospital, so the doctor will know what you have taken.

The symptoms of overdose include nausea (sensation of illness) and vomiting (illness), drooling, sweating, decreased heart rate, low blood pressure (dizziness or dizziness when standing up), breathing problems, loss of consciousness, and seizures or convulsions.

If You Forget to Take Donepezilo ratio

If you forget to take your medication, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses. If you forget to take your medication for more than a week, call your doctor before taking more.

If You Interrupt Treatment with Donepezilo ratio

Do not stop taking the tablets unless your doctor has told you to.If you stop taking Donepezilo ratio, the benefits of treatment will gradually disappear.

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

Like all medications, Donepezilo ratio may produce adverse effects, although not all people will experience them.

People taking Donepezilo ratio have reported the following adverse effects.

Inform your doctor if you experience any of these effects while taking Donepezilo ratio.

Severe adverse effects:

Consult your doctor immediately if you notice these adverse effects mentioned. You may need urgent medical treatment.

• Liver damage, for example, hepatitis. Hepatitis symptoms are feeling or illness, loss of appetite, general discomfort, fever, itching, yellow discoloration of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).

• Stomach or duodenal ulcers. Ulcer symptoms are stomach pain and discomfort (indigestion), general discomfort between the navel and sternum (may affect up to 1 in 100 people).

• Bleeding in the stomach or intestines. This may cause your stools to turn from tar-black to visible blood in the rectum (may affect up to 1 in 100 people).

• Seizures or convulsions (may affect up to 1 in 100 people)

• Fever with muscle rigidity, sweating, or a decrease in level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).

•Muscle weakness, sensitivity, or pain, particularly if you are feeling unwell, have a fever, or have dark-colored urine. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition called rhabdomyolysis)(may affect up to 1 in 10,000 people).

• Rapid and irregular heart rate, fainting spells that may be symptoms of a potentially fatal condition known as torsade de pointes.

Very common (may affect more than 1 in 10 people)

• Diarrhea,

• Feeling unwell,

• Headache,

Common (may affect up to 1 in 10 people)

• Common cold,

• Loss of appetite,

• Hallucinations (seeing or hearing things that are not real),

• Unusual dreams and nightmares,

• Restlessness,

• Aggressive behavior,

• Fainting,

• Dizziness,

• Insomnia (difficulty sleeping)

• Vomiting

• Uncomfortable stomach sensation,

• Rash,

• Itching,

• Muscle cramps

• Urinary incontinence

• Fatigue,

• Pain,

• Accidents (patients more prone to falls and accidents).

Uncommon (may affect up to 1 in 100 people)

• Decreased heart rate

Rare (may affect up to 1 in 1,000 people)

• Tremors, stiffness, or uncontrollable movements, especially of the face and tongue but also of the limbs.

Frequency not known:cannot be estimated from available data

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

•Increased libido, hypersexuality,

•Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side).

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:

https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after theabbreviation CAD. 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 the packaging andmedicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and medicines you no longer need. By doing so, youwill help protect the environment.

Composition of Donepezilo ratio 5 mg film-coated tablets.

- The active ingredient is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride (as monohydrate).

- The other components are:

Core: maize starch, lactose monohydrate, microcrystalline cellulose, carboxymethylstarch sodium (type A) (from potato), anhydrous colloidal silica, magnesium stearate.

Coating: lactose monohydrate, hypromellose 15cp, titanium dioxide (E-171) and macrogol 4000.

Appearance of the product and contents of the packaging

Donepezilo ratio 5 mg: film-coated tablets, white or almost white, round, biconvex, marked with “DN 5” on one side.

Film-coated tablets are supplied in blister packs of 7, 28, 30, 50, 56, 60, 84, 90, 98 and 120 film-coated tablets.

Film-coated tablets are supplied in calendar blister packs of 7, 28, 56, 84 or 98 film-coated tablets.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80. 31-456, Cracow

Poland

or

PLIVA CROATIA LIMITED (PLIVA KRVATSKA D.O.O.)

Prilaz Baruna Filipovica, 25

10000 Zagreb, Croatia

or

Merckle GmbH

Ludwig-Merckle-Str. 3,

89143 Blaubeuren

Germany

This medicine is authorized in the Member States of the European Economic Area with the following names:

SpainDonepezilo ratio 5 mg film-coated tablets EFG

This leaflet was approved in January 2023

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