Donepezil Durban 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Durban 5mg film-coated tablets EFG

Donepezil hydrochloride

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, 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 you should not give it to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Donepezilo Durban contains Donepezil hydrochloride. It belongs to a group of medicines called acetylcholinesterase inhibitors.

Donepezil hydrochloride increases levels in the brain of a substance related to memory (acetylcholine), by reducing the rate at which this substance is broken down.

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

Donepezilo 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 components of Donepezil Durban (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 convulsions
• a heart condition (such as irregular or very slow heartbeats, heart failure, myocardial infarction)
• a heart condition called "QT interval prolongation" or a history of certain abnormal heart rhythms known as torsade de pointes, or if someone in your family has "QT interval prolongation"
• low levels of magnesium or potassium in the blood
• asthma or another 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

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

This also includes medicines you may take in the future while continuing to take Donepezil Durban. This is because these medicines may weaken or enhance the effects of Donepezil Durban.

It is particularly important to inform 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

• antifungal medicines, such as ketoconazole

• other medicines 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 sodium diclofenac

• anticholinergics, such as tolterodine

• anticonvulsants, such as phenytoin and carbamazepine

• medicines for heart conditions, such as quinidine, beta-blockers (propranolol and atenolol)

• muscle relaxants, such as diazepam, succinylcholine

• general anesthesia

• over-the-counter medicines, such as herbal remedies

If you undergo surgery requiring general anesthesia, you must inform your doctor and anesthetist that you are taking donepezil, as your medication may affect the amount of anesthesia required.

Donepezil Durban may be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not take Donepezil 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 Donepezil Durban with food, drink, and alcohol

Food does not interfere with the effect of Donepezil Durban.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 machinery; therefore, you should not engage in these activities unless your doctor tells you it is safe to do so.

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

Donepezil Durban contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking Donepezil Durban.

3. How to take DONEPEZILO DURBAN

Always follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

The strength of the tablet you take may change depending on how long you have been taking the medicine and your doctor's recommendation. The maximum recommended dose is 10 mg each night.

Do not change the dose without consulting your doctor.

Swallow your Donepezilo Durban with water before going to bed.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

Symptoms of overdose may include, among others, feeling unwell or vomiting, drooling, sweating, slow heartbeat, low blood pressure (dizziness or lightheadedness when standing), breathing difficulties, loss of consciousness, and seizures or fits.

If you forget to take Donepezilo Durban

If you forget to take your medicine, take it the next day at your 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 resuming treatment.

If you stop taking Donepezilo Durban

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

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 periodically to review your treatment and assess your symptoms.

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

4. Possible adverse effects

Like all medicines, Donepezil Durban may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported in people taking Donepezil Durban.

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

Serious adverse effects:

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

• Liver disorders, such as hepatitis. Symptoms of hepatitis include nausea (feeling sick), vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (may affect up to 1 in 1,000 people).
• Stomach and duodenal ulcers. Symptoms of ulcers include 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 may result in black, tar-like stools or visible rectal bleeding (may affect up to 1 in 100 people).
• Seizures or fits (may affect up to 1 in 100 people).
• Fever with muscle rigidity, sweating, or decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Muscle weakness, tenderness, or pain, particularly if accompanied by feeling unwell, fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).

Other adverse effects

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

• Diarrhoea
• Nausea
• Headaches

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 are not really there)
• Unusual dreams, including nightmares
• Agitation
• Aggressive behaviour
• Fainting
• Dizziness
• Feeling of stomach discomfort
• Skin rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

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

• Slow heart rate
• Increased salivation

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

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

Frequency not known:

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "prolongation of the QT interval"
• Fast and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening condition known as torsade de pointes
• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways bending of the body and head)

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at the 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Pack composition and additional information

Donepezil Durban composition

The active substance is donepezil hydrochloride. The 5 mg tablet contains 5 mg of donepezil hydrochloride.

The other components are:

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

Coating: hypromellose (E464), talc (E553b), propylene glycol (E1520) and titanium dioxide (E171).

Appearance of the product and contents of the pack

5 mg tablets: white to off-white, round, biconvex, film-coated tablets, engraved with “ML89” on one side and smooth on the other.

The packs contain 28, 56, and 98 film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Francisco Durbán S.A.

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

Manufacturers

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 medicinal product is authorized in EEA member states under the following names:

United Kingdom: Donepezil hydrochloride 5 mg Film-coated tablet
Germany: Donepezilhydrochlorid Macleods 5 mg Filmtabletten
Italy: Memac 5 mg compresse rivestite con film
Spain: Donepezilo Durban 5 mg comprimidos recubiertos con película

This leaflet has been reviewed in November 2022