DONEPEZIL RATIO 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil ratio 5 mg film-coated tablets EFG

donepezil, hydrochloride (as monohydrate)

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

1. What is Donepezil ratio and what is it used for
2. What you need to know before you take Donepezil ratio
3. How to take Donepezil ratio
4. Possible side effects
5. Storage of Donepezil ratio
6. Contents of the pack and other information

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

Donepezil (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors.

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

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

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

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

Do not take Donepezil ratio

• if you are allergic to donepezil hydrochloride or 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 breast-feeding.

Tell your doctor if any of these conditions apply to you.

Warnings and precautions

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

• stomach or duodenal ulcers
• seizures or convulsions.
• a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction),
• a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes or if someone in your family has "prolonged QT interval",
• low magnesium or potassium levels 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 Donepezil ratio with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.

Use in children and adolescents

Donepezil ratio is not recommended for children and adolescents under 18 years of age.

Other medicines and Donepezil ratio

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

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

In particular, tell 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 for Alzheimer's disease, e.g., galantamine
• sedatives or treatment for arthritis, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium.
• anticholinergics, e.g., tolterodine.

• anticonvulsants, e.g., phenytoin, carbamazepine
• heart medication, e.g., quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, e.g., diazepam, succinylcholine
• general anesthetics
• over-the-counter medicines, e.g., herbal-based.

If you are going to have an operation that requires general anesthesia, you must inform your doctor and anesthetist that you are taking Donepezil ratio. This is because your medicine may affect the amount of anesthetic needed.

Donepezil ratio can be used in patients with mild to moderate kidney or liver disease.

Tell your doctor if you have kidney or liver disease. Patients with severe liver disease should not take Donepezil ratio.

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

Taking Donepezil ratio with food, drinks, and alcohol

Donepezil ratio should be taken with water.

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

Pregnancy and breast-feeding

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

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

Do not take Donepezil ratio if you are breast-feeding.

Driving and using machines

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

It can also cause tiredness, dizziness, or muscle cramps, mainly at the start of treatment or when the dose is increased. If you experience these effects while taking Donepezil ratio tablets, do not drive or use machines.

Donepezil ratio contains lactose

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

Donepezil ratio contains sodium

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

3. How to take Donepezil ratio

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

Taking the dose of Donepezil ratio

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

The dose of the tablet you take may vary depending on how long you have been taking this medicine 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 medicine. Do not change the dose yourself without your doctor's advice.

How to take your medicine

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

How long to take Donepezil ratio

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

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

Use in children and adolescents

Donepezil ratio is not recommended for children and adolescents (under 18 years of age).

If you take more Donepezil ratio than you should

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

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

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

If you forget to take Donepezil ratio

If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses. If you forget to take your medicine for more than one week, call your doctor before taking more.

If you stop taking Donepezil ratio

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

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

4. Possible side effects

Like all medicines, Donepezil ratio can cause side effects, although not everybody gets them.

People taking Donepezil ratio have reported the following side effects.

Tell your doctor if you experience any of these side effects while taking Donepezil ratio.

Serious side effects:

Consult your doctor immediately if you notice these 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 (may affect up to 1 in 1000 people).
• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion), discomfort between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This can cause your stools to pass from black tar-like color 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 stiffness, sweating, or a decrease in the level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, sensitivity, or muscle pain, particularly if you also feel unwell, have a fever, or have dark urine. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis) (may affect up to 1 in 10,000 people).
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening disorder known as torsades 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,
• Agitation,
• Aggressive behavior,
• Fainting,
• Dizziness,
• Difficulty sleeping (insomnia)
• Vomiting
• Uncomfortable feeling in the stomach,
• 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 uncontrolled 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 can be seen on an electrocardiogram (ECG) called "prolonged QT interval"
• Increased libido, hypersexuality,
• Syndrome of Pisa (a condition that involves involuntary muscle contraction with an abnormal

flexion of the body and head to one side).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed 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 ratio

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil ratio 5 mg film-coated tablets EFG.

• The active substance is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride (as monohydrate).
• The other ingredients are:

Core: corn starch, lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (derived 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 pack

Donepezil ratio 5 mg: film-coated tablets, white or almost white, round, biconvex, marked with "DN 5" on one face.

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

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 under the following names:

Spain Donepezil ratio 5 mg film-coated tablets EFG

This leaflet was approved in January 2023

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/