DONEPEZIL DURBAN 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Durban 10mg 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 Durban and what is it used for
2. What you need to know before you take Donepezil Durban
3. How to take Donepezil Durban
4. Possible side effects
5. Storage of Donepezil Durban
6. Contents of the pack and other information

1. What is DONEPEZIL DURBAN and what is it used for

Donepezil Durban contains Donepezil hydrochloride. It 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 speed of breakdown of this substance.

It is used for the treatment of symptoms of dementia in people diagnosed with mild to moderate Alzheimer's disease. The symptoms include increased loss of memory, confusion, and changes in behavior. As a result, it becomes increasingly difficult for patients with Alzheimer's disease to continue with their daily activities.

Donepezil Durban is indicated only for adult patients.

2. What you need to know before taking DONEPEZIL DURBAN

Do not take Donepezil Durban

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

Warnings and precautions

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

• stomach or duodenal ulcers
• seizures or fits
• 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
• asthma or other long-term lung disease
• liver problems or hepatitis
• difficulty urinating or mild kidney disease

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

Children and adolescents

Donepezil Durban is not indicated for use in children and adolescents (young people over 18 years of age).

Other medicines and Donepezil Durban

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

This also includes medicines that you might take in the future if you continue to take Donepezil Durban. This is because these medicines may weaken or strengthen the effects of Donepezil Durban tablets.

It is particularly important to tell your doctor if you are taking any of the following types of medicines:

• medicines for heart rhythm problems, for example, amiodarone or sotalol
• medicines for depression, for example, citalopram, escitalopram, amitriptyline, fluoxetine
• medicines for psychosis, for example, pimozide, sertindole, ziprasidone
• medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungals, such as ketoconazole
• other medicines for Alzheimer's disease, such as galantamine

• analgesics or treatment for arthritis, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac sodium
• anticholinergics, such as tolterodine
• anticonvulsants, such as phenytoin and carbamazepine
• medicines for heart diseases, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthesia
• over-the-counter medicines, such as herbal medicines

In the event of surgical intervention with general anesthesia, you should inform your doctor and anesthesiologist that you are taking donepezil, as your medicine may affect the amount of anesthesia needed.

Donepezil Durban may 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 Durban.

Tell your doctor or pharmacist the name of the person in charge of your care. This person will help you take your medicine as directed.

Taking Donepezil Durban with food, drinks, and alcohol

Food does not interfere with the effect of donepezil.

Donepezil Durban should not be taken with alcohol because alcohol may alter its effects.

Pregnancy, breastfeeding, and fertility

Donepezil Durban should not be taken during breastfeeding.

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

Do not take Donepezil Durban if you are breastfeeding.

Driving and using machines

Alzheimer's disease may impair your ability to drive or operate machines, so you should not perform these activities unless your doctor tells you it is safe to do so.

Also, your medicine may cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, do not drive or operate machines.

Donepezil Durban contains lactose

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

3. How to take DONEPEZIL DURBAN

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Initially, the recommended dose is 5 mg (one white tablet) each night before bedtime. After one month, your doctor may tell you to take 10 mg (one yellow tablet) each night before bedtime.

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

The concentration of the tablet you take may change depending on the time you have been taking the medicine and what your doctor recommends. The maximum recommended dose is 10 mg each night.

Do not change the dose without consulting your doctor.

Swallow your Donepezil Durban with water before bedtime.

Use in children and adolescents

Donepezil Durban is not recommended for use in children and adolescents (young people under 18 years of age).

If you take more Donepezil Durban than you should

If you have taken more Donepezil Durban than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

The symptoms of overdose are, among others, feeling unwell or vomiting, drooling, sweating, slow heartbeat, low blood pressure (dizziness or fainting when standing), breathing problems, loss of consciousness, and seizures or fits.

If you forget to take Donepezil Durban

If you forget to take your medicine, take it the next day at the usual time. Do not take a double dose to make up for the missed dose.

If you forget to take your medicine for more than one week, consult your doctor before continuing to take the medicine.

If you stop taking Donepezil Durban

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

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

How long will you need to take Donepezil Durban

Your doctor or pharmacist will advise you how long you should take these tablets. You will need to visit your doctor from time to time to review your treatment and assess your symptoms.

4. Possible side effects

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

The following side effects have been reported by people taking Donepezil Durban.

Contact your doctor if you experience any of these side effects during treatment with Donepezil Durban.

Serious side effects:

You should immediately inform your doctor if you notice any of the following serious side effects. You may need urgent medical treatment.

• Liver disorder, such as hepatitis. The symptoms of hepatitis are nausea (feeling or being sick), vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people).
• Stomach and duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This can produce black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Seizures or fits (may affect up to 1 in 100 people).
• Fever with muscle stiffness, sweating, or low level of consciousness (a condition known as "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, which can be life-threatening and cause kidney problems (a condition called rhabdomyolysis). (may affect up to 1 in 10,000 people).

Other side effects:

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

• Diarrhea
• Nausea
• Headache

Common (may affect up to 1 in 10 people):

• Muscle cramps
• Fatigue
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that do not really exist)
• Unusual dreams, including nightmares
• Agitation
• Aggressive behavior
• Fainting
• Dizziness
• Feeling unwell in the stomach
• Rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and injuries from accidents)

Uncommon (may affect up to 1 in 100 people):

• Slow heartbeat
• Excessive salivation

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

• Stiffness, tremor, or uncontrolled movements, especially of the face and tongue, as well as the limbs.

Frequency not known:

• Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting that can be symptoms of a potentially life-threatening condition 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)

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, Website: www.notificaRAM.es.

5. Storage of DONEPEZIL DURBAN

Do not store above 30°C.

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

Do not take Donepezil Durban after the expiry date stated on the blister. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Durban

The active substance is donepezil hydrochloride. The 10 mg tablet contains 10 mg of donepezil hydrochloride.

The other excipients are:

Core:lactose monohydrate, colloidal silicon dioxide, microcrystalline cellulose, pregelatinized maize starch, and magnesium stearate.

Coating:hypromellose (E464), talc (E553b), propylene glycol (E1520), and titanium dioxide (E171), yellow iron oxide (E172)

Appearance ofthe productand contents of the pack

10 mg tablets: The donepezil 10 mg tablets are film-coated, yellow, round, biconvex, with the engraving "ML88" on one face and smooth on the other.

The packs contain 28, 56, and 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Francisco Durban S.A.

Polígono Ind. La Redonda, c/ IX, nº 2 04710 El Ejido ALMERÍA. Spain

Manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020, Poland

IDIFARMA DESARROLLO FARMACÉUTICO, S.L.

Poligono Mocholi

C/Noain, 1

31110 NOAIN (NAVARRA)

SPAIN

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

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

United Kingdom Donepezil hydrochloride 10 mg Film-coated tablet

Germany Donepezilhydrochlorid Macleods 10 mg Filmtabletten

Italy Memac 10 mg compresse rivestite con film

Spain Donepezilo Durban 10 mg comprimidos recubiertos con película

This leaflet was last revised in November 2022