PATIENT INFORMATION LEAFLET

Donepezilo Durban 10mg film-coated tablets

Hydrochloride of donepezilo

Please read this leaflet carefully before you start to take 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. Do not pass it on to others even if their symptoms are the same. It may harm them.

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

1.What is Donepezilo Durban and what it is used for

2.What you need to know before taking Donepezilo Durban

3.How to take Donepezilo Durban

4.Possible side effects

5.Storage of Donepezilo Durban

6.Contents of the pack and additional information

Donepezilo 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 rate 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.

Donepezilo Durban is indicated only for adult patients.

Do not take Donepezilo Durban

• If you are allergic to hydrochloride donepezilo, piperidina derivatives, or any of the components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacistbefore starting to take Donepezilo Durban if you have or have had:

• stomach or duodenal ulcers
• seizures or attacks
• 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 disease
• liver problems or hepatitis
• difficulty urinating or mild kidney disease

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

Children and adolescents

Donepezilo Durban is not indicated for use in children and adolescents (young people over 18 years old).

Other medications and Donepezilo Durban

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication including over-the-counter medications.

This also includes medications you may take in the future if you continue taking Donepezilo Durban. This is because these medications may weaken or enhance the effects of Donepezilo Durban tablets.

It is particularly important to inform your doctor if you are taking any of the following types of 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, ziprasidone
• medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungals, such as ketoconazole
• other medications for Alzheimer's disease, such as galantamine

• painkillers 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
• medications for heart disease, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• general anesthesia
• over-the-counter medications, such as herbal remedies

In the event of surgery withgeneral anesthesia, you must inform your doctor and anesthesiologist that you are taking donepezilo, as your medication may affect the amount of anesthesia needed.

Donepezilo 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 Donepezilo Durban.

Inform your doctor or pharmacist of the name of the person responsible for your care. This person will help you take your medication as directed.

Taking Donepezilo Durban with food, drinks, and alcohol

Foods do not interfere with the effect of donepezilo.

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

Pregnancy, breastfeeding, and fertility

Donepezilo Durban should not be taken during breastfeeding.

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

Do not take Donepezilo Durban if you are breastfeeding.

Driving and operating machinery

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

Additionally, your medication may cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, you should not drive or operate machinery.

Donepezilo Durban contains lactose

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

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

The initial recommended dose is 5mg (one white tablet) taken each night before bedtime. After a month, your doctor may instruct you to take 10mg (one yellow tablet) each night before bedtime.

If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donepezilo Durban in the morning.

The concentration of the tablet you take may change over time as you continue taking the medication and based on your doctor's recommendations. The maximum recommended dose is 10mg each night.

Do not change the dose without consulting your doctor.

Swallow your Donepezilo Durban with water before bedtime.

Use in children and adolescents

Donepezilo Durban is not recommended for use in children and adolescents (individuals under 18 years of age).

If you take more Donepezilo Durban than you should

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

The symptoms of overdose include, among others, feeling unwell or vomiting, drooling, sweating, slow heart rate, low blood pressure (dizziness or lightheadedness when standing), respiratory problems, loss of consciousness, and seizures or attacks.

If you forget to take Donepezilo Durban

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

If you interrupt treatment with Donepezilo Durban

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

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

How long should I take Donepezilo Durban

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

Like all medications, Donepezilo Durban may cause side effects, although not everyone will experience them.

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

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

Severe side effects:

You must immediately inform your doctor if you notice any of the following severe 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 discomfort, fever, itching, yellowing of the skin and eyes, and dark urine (may affect up to 1 in 1,000 people).
• Ulcers of the stomach and duodenum. The symptoms of ulcers are stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestines. This may cause black, tarry stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Convulsions or seizures (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 are also feeling unwell, have a fever, or your urine is dark. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition known as rhabdomyolysis). (may affect up to 1 in 10,000 people).

Contact your doctor immediately if you notice any of these severe side effects.

Other side effects:

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

• Diarrhea
• Nausea
• Headaches

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

• Muscle cramps
• Tiredness
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that are not really there)
• Unusual dreams, including nightmares
• Agitation
• Aggressive behavior
• Fainting
• Dizziness
• Discomfort in the stomach
• Rashes
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and injuries)

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

• Slow heart rate
• Excessive salivation

Rare (may affect up to 1 in 10,000 people):

• Rigidity, tremor, or uncontrollable movements, especially of the face and tongue, and 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 heart rate, fainting, which may be symptoms of a potentially fatal 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)

Reporting side effects:

If you experience any type of side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website: www.notificaRAM.es.

Do not store above 30?C.

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

Do not take Donepezilo Durban after the expiration date printed on the blister. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Donepezilo Durban

The active ingredient is donepezilo hydrochloride. The 10 mg tablet contains 10 mg of donepezilo hydrochloride.

The other excipients are:

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

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

Appearance of the product and contents of the package

10 mg tablets: The donepezilo 10 mg tablets are film-coated, yellow, round, biconvex tablets with the imprint "ML88" on one side and smooth on the other.

The packages contain 28, 56, and 98 film-coated tablets. Some package sizes may not be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2047 10 El Ejido ALMERÍA. Spain

Responsible 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.

Polígono Mocholi

C/Noain, 1

31110 NOAIN (NAVARRA)

SPAIN

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

This medicinal product is authorized in the Member States of the EEA with the following names

United KingdomDonepezil hydrochloride 10 mg Film-coated tablet

GermanyDonepezilhydrochlorid Macleods 10 mg Filmtabletten

ItalyMemac 10 mg film-coated tablets

SpainDonepezilo Durban 10 mg film-coated tablets

This leaflet was revised in November 2022