Donepezil Flas Sandoz 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Donepezilo Flas Sandoz 5 mg orodispersible tablets EFG

Donepezilo Flas Sandoz 10 mg orodispersible tablets EFG

donepezil hydrochloride

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

Leaflet contents

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

1. What Donepezilo Flas Sandoz is and what it is used for

Donepezilo Flas Sandoz belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezilo increases levels in the brain of a substance related to memory (acetylcholine) by slowing down the breakdown of acetylcholine.

Donepezilo Flas Sandoz is used to treat the symptoms of dementia in patients diagnosed with Alzheimer's disease, from mild to moderately severe. Symptoms include increasing memory loss, confusion, and behavioural changes. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their daily activities.

Donepezilo Flas Sandoz is used only in adult patients.

2. What you need to know before starting Donepezilo Flas Sandoz

Do not take Donepezilo Flas Sandoz

if you are allergic to

• donepezil hydrochloride, or
• piperidine derivatives, which are similar to donepezil, or
• any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Donepezilo Flas Sandoz. If you have any of the following conditions, you or your caregiver should inform your doctor or pharmacist:

• stomach or duodenal ulcers,
• spasms (attacks) or seizures (donepezil may cause seizures),
• a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction),
• a heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has "QT interval prolongation",
• low levels of magnesium or potassium in the blood,
• asthma or other long-term lung disorders,
• liver disorders or hepatitis,
• difficulty urinating or mild kidney disease.

Tell your doctor if you are pregnant or think you might be pregnant.

Other medicines and Donepezilo Flas Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This includes medicines not prescribed by your doctor but purchased over-the-counter. It also includes medicines you may need to take occasionally in the future while continuing donepezil treatment. This is because these medicines may weaken or increase the effects of donepezil.

Tell your doctor especially if you are taking any of the following types of medicines:

• other medicines for Alzheimer's disease, e.g., galantamine,
• painkillers or medicines for arthritis, e.g., aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac,
• anticholinergic medicines, e.g., tolterodine,
• medicines for bacterial infections, e.g., clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin,
• antifungal medicines, e.g., ketoconazole,
• medicines for depression, e.g., citalopram, escitalopram, amitriptyline, fluoxetine,
• medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone,
• anticonvulsants, e.g., phenytoin, carbamazepine,
• medicines for heart rhythm disorders, e.g., amiodarone, sotalol,
• medications for heart conditions, e.g., quinidine, beta-blockers (propranolol and atenolol),
• muscle relaxants, e.g., diazepam, succinylcholine,
• general anesthesia,
• over-the-counter medicines, e.g., herbal remedies.

If you are undergoing surgery requiring general anesthesia, you must inform your doctor and anesthetist that you are taking donepezil. This is because the medicine may affect the amount of anesthetic required.

Donepezil can be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor first if you have had liver or kidney problems. Patients with severe hepatic impairment should not take donepezil.

Inform your doctor or pharmacist of your caregiver's name. Your caregiver will help you take your medicine exactly as prescribed.

Taking Donepezilo Flas Sandoz with food, drinks, and alcohol

Food does not affect the action of donepezil.

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

Pregnancy, breastfeeding, and fertility

Donepezil should not be taken during breastfeeding.

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

Driving and using machines

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

This medicine may cause fatigue, dizziness, and muscle cramps, particularly at the beginning of treatment and during dose increases. If this happens, you should not drive or operate machinery.

Donepezilo Flas Sandoz contains aspartame and sodium

This medicine contains 8.4 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; therefore, it is essentially “sodium-free”.

3. How to take Donepezil Flas Sandoz

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist. The recommended dose is:

Adults and elderly patients

Donepezil Flas Sandoz 5 mg orodispersible tablets

• Initial dose: 1 orodispersible tablet each night.
• After one month: possible increase to 2 orodispersible tablets each night.
• Maximum dose: 2 orodispersible tablets each night.

Donepezil Flas Sandoz 10 mg orodispersible tablets

• Initial dose: 5 mg each night; for this dosage, this medicine cannot be used. Donepezil Flas Sandoz 5 mg is available to initiate treatment.
• After one month: possible increase to 1 orodispersible tablet each night.
• Maximum dose: 1 orodispersible tablet each night.

Do not change your dose on your own without consulting your doctor.

Patients with renal impairment

You may take the usual dose as described above. No adjustment is required.

Patients with mild to moderate hepatic impairment

Your doctor will assess your tolerance to donepezil before increasing your dose.

Patients with severe renal impairment

Your doctor will decide whether donepezil is suitable for you. Patients with severe renal impairment should not take donepezil.

Method of administration

Take your orodispersible tablets at night before going to bed, regardless of meals. Place the tablet on your tongue, where it will rapidly disintegrate before swallowing, with or without water, according to your preference.

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

Duration of treatment

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

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

If you take more Donepezil Flas Sandoz than you should

DO NOT take more than 10 mg of donepezil hydrochloride per day.

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

Always take the orodispersible tablets, this leaflet, and/or the packaging with you to the hospital so the doctor knows what you have taken.

Symptoms of overdose include feeling or being sick, salivation, sweating, slow heart rate, low blood pressure (dizziness or fainting upon standing), breathing difficulties, loss of consciousness, and spasms (seizures) or convulsions.

If you forget to take Donepezil Flas Sandoz

If you forget to take an orodispersible tablet, take only one orodispersible tablet the next day 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, consult your doctor before resuming the medicine.

If you stop taking Donepezil Flas Sandoz

Do not stop taking the orodispersible tablets without your doctor's instruction. If treatment is interrupted, the beneficial effects may gradually decrease.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects:

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

• Liver damage, e.g., hepatitis. Symptoms of hepatitis include feeling unwell or sick, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-coloured urine (may affect up to 1 in 1,000 people),
• Stomach or duodenal ulcer. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (may affect up to 1 in 100 people),
• Bleeding from the stomach or intestines. This may cause black-coloured stools or blood in the stools (may affect up to 1 in 100 people),
• Spasms (attacks) or seizures (may affect up to 1 in 100 people),
• Fever with muscle rigidity, sweating, or decreased level of consciousness. These are symptoms of 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 fever, or have dark-coloured urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (may affect up to 1 in 10,000 people).

Other adverse effects that may occur:

Very common – may affect more than 1 in 10 people

• Diarrhoea,
• Nausea (feeling sick),
• 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 are not real),
• Strange dreams and nightmares,
• Agitation,
• Aggressive behaviour,
• Fainting,
• Dizziness,
• 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,
• Slight increase in the enzyme creatine kinase in blood tests.

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,
• Changes in heart rhythm.

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 disorder known as torsade de pointes,
• Increased libido, hypersexuality,
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal bending of the body and head to one side).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Flas Sandoz

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

Do not use this medicine after the expiry date stated on the packaging, blister, or label of the plastic bottle, following CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Do not use this medicine more than 6 months after first opening the plastic bottle.

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

6. Contents of the pack and other information

Composition of Donepezilo Flas Sandoz 5 mg

• The active substance is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.
• The other components are: aspartame (E951), sodium croscarmellose, magnesium stearate, mannitol (E421), microcrystalline cellulose, mint flavour, anhydrous colloidal silica, and monohydrate zinc sulfate.

Composition of Donepezilo Flas Sandoz 10 mg

• The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: aspartame (E951), sodium croscarmellose, yellow iron oxide (E172), magnesium stearate, mannitol (E421), microcrystalline cellulose, mint flavour, anhydrous colloidal silica, and monohydrate zinc sulfate.

Appearance of the product and contents of the pack

Donepezilo Flas Sandoz 5 mg orodispersible tablets are white, round, flat tablets with the mark "5" engraved on one side and smooth on the other.

Donepezilo Flas Sandoz 10 mg orodispersible tablets are yellowish, slightly mottled, round, flat tablets with the mark "10" engraved on one side and smooth on the other.

The orodispersible tablets are packed in Alu/PVC/ACLAR blisters contained in a cardboard box or in HDPE bottles with a PP screw cap.

Pack sizes:

Blister: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, or 120 orodispersible tablets.

Bottles: 100 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Salutas Pharma GmbH
Otto Von Guericke Allee 1
39179 Barleben
Germany

or

LEK, S.A.
Ul Domaniewska 50 C
PL 02-672 Warsaw
Poland

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Austria: Donepezil HCl Sandoz 5 mg – Schmelztabletten
Donepezil HCl Sandoz 10 mg – Schmelztabletten

Belgium: Donepezil Sandoz 5 mg orodispergeerbare tabletten
Donepezil Sandoz 10 mg orodispergeerbare tabletten

Czech Republic: DONEPEZIL SANDOZ DISTAB 10 mg tablety dispergovatelné v ústech

France: DONEPEZIL SANDOZ 10 mg, comprimé orodispersible

Sweden: Donepezil Sandoz 5 mg munsönderfallande tablett
Donepezil Sandoz 10 mg munsönderfallande tablett

United Kingdom
(Northern Ireland): Donepezil 5 mg Orodispersible Tablets
Donepezil 10 mg Orodispersible Tablets

Date of the most recent review of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/