Donepezil Flas Pharma Combix 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

1. What is Donepezil Flas Pharma Combix and what is it used for?

Donepezil Flas Pharma Combix (donepezil hydrochloride) belongs to a group of medicines known as acetylcholinesterase inhibitors. Donepezil hydrochloride increases levels in the brain of a substance related to memory (acetylcholine) by slowing down the breakdown of this substance.

It is used to treat the symptoms of mild to moderately severe Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behaviour.

2. What you need to know before starting to take Donepezilo Flas Pharma Combix

Do not take Donepezilo Flas Pharma Combix

• If you are allergic to donepezil hydrochloride, to piperidine derivatives, or to any of the other components of this medicine (listed in section 6).
• If you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Donepezilo Flas Pharma Combix if you have or have had:

• A history of stomach or duodenal ulcer.
• Heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• Seizures.
• Asthma or chronic lung disease.
• Difficulty urinating or mild kidney disease.
• A heart condition known as "QT interval prolongation" or a history of certain abnormal heart rhythms called torsade de pointes, or if someone in your family has "QT interval prolongation".
• Low levels of magnesium or potassium in the blood.

You should avoid taking this medicine together with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.

Taking Donepezilo Flas Pharma Combix with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

• 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, for example galantamine
• Painkillers or treatments for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, or sodium diclofenac
• Quinidine and beta-blocking medicines used to treat irregular heartbeats such as propranolol and atenolol
• Phenytoin and carbamazepine (for treating epilepsy)
• Cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system) such as tolterodine
• Succinylcholine, diazepam, and other neuromuscular blockers (to produce muscle relaxation)
• General anaesthesia.

If you undergo surgery under general anaesthesia, you must inform your doctor that you are taking donepezil orodispersible tablets, as this may affect the amount of anaesthetic required.

Donepezil orodispersible tablets can 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 disease should not take donepezil orodispersible tablets.

Taking Donepezilo Flas Pharma Combix with food, drinks, and alcohol

Place the tablet on the tongue and allow it to dissolve. Swallow with or without water.

Donepezil orodispersible tablets should not be taken with alcohol, as alcohol may alter the effect of this medicine.

Pregnancy, breastfeeding, and fertility

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

Do not take donepezil orodispersible tablets if you are pregnant or think you may be pregnant.

Do not take donepezil orodispersible tablets if you are breastfeeding your child.

Driving and using machines

Your condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Donepezil orodispersible tablets may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Donepezilo Flas Pharma Combix contains aspartame

This medicine may be harmful to people with phenylketonuria because it contains aspartame, a source of phenylalanine.

Donepezilo Flas Pharma Combix contains glucose

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Donepezil Flas Pharma Combix

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

Donepezil orodispersible tablets are administered orally. The tablet should be placed on the tongue and allowed to dissolve before swallowing, with or without water.

Treatment with donepezil orodispersible tablets is initiated with one 5 mg tablet, taken once daily, at night, immediately before going to bed. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg per day.

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

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may take donepezil orodispersible tablets. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe hepatic impairment (liver disease) must not take donepezil orodispersible tablets.

Use in children

The use of donepezil orodispersible tablets is not recommended in children.

If you take more Donepezil Flas Pharma Combix than you should

If you have taken more donepezil orodispersible tablets 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 used.

Symptoms of overdose may include feeling unwell, salivation, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures.

If you forget to take Donepezil Flas Pharma Combix

Do not take a double dose to make up for missed doses.

If you stop taking Donepezil Flas Pharma Combix

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

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 experiences them.

The following adverse effects have been reported in people taking donepezil orodispersible tablets.

Contact your doctor if you experience any of these effects during treatment with donepezil orodispersible tablets.

Serious adverse effects:

You must inform your doctor immediately if you notice any of the serious adverse effects listed below, as you may require urgent medical treatment.

• Liver damage, for example, hepatitis. Symptoms of hepatitis include feeling sick or being unwell, 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).
• Ulcers in the stomach or duodenum. 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 cause black, tar-like stools or visible rectal bleeding (may affect up to 1 in 100 people).
• Dizziness (attacks) or seizures (may affect up to 1 in 100 people).
• Fever with muscle rigidity and reduced sweating, decreased level of consciousness (these may be symptoms of a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
• Weakness, tenderness, or muscle pain, particularly if you also feel unwell, have fever, or dark urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis).

The estimated frequency of occurrence of adverse effects is as follows:

Very common: may affect more than 1 in 10 people

• Diarrhea
• Malaise
• Headache

Common: may affect up to 1 in 10 people

• Cold symptoms
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behaviour
• Abnormal dreams and nightmares
• Fainting
• Dizziness
• Difficulty sleeping
• Vomiting
• Abdominal discomfort
• Urinary incontinence
• Rash
• Itching
• Muscle cramps
• Fatigue
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon: may affect up to 1 in 100 people

• Seizures
• Slowing of the heart rate (bradycardia)
• Gastrointestinal haemorrhage, stomach and duodenal ulcers (a part of the intestine)
• Increase in a certain type of enzyme (muscle creatine kinase) in the blood

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

• Extrapyramidal symptoms (such as tremor or stiffness in the hands or legs)
• Cardiac conduction disorders
• Liver function abnormalities, including hepatitis

Frequency not known:

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Pharma Combix

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

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezilo FlasPharmaCombix

• The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: microcrystalline cellulose (E460i), anhydrous colloidal silica, crospovidone (Type A), yellow iron oxide (E172), aspartame (E951), sucralose (E955), mint flavour (natural flavours, corn maltodextrin, modified corn starch (E1454), pulegone), strawberry flavour (flavours identical to natural, natural flavours, corn maltodextrin and propylene glycol (E1520)), mannitol (E421), stearic fumarate sodium, and magnesium stearate (E470b).

Appearance of the product and contents of the pack

Donepezilo FlasPharmaCombix 10 mg is presented as orodispersible tablets, i.e. tablets that dissolve in the mouth. The tablets are yellow to pale yellow, round, with bevelled edges, smooth on both sides.

Donepezilo FlasPharmaCombix 10 mg orodispersible tablets are available in Alu/Alu blister packs. Each pack contains 28 or 56 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the most recent revision of this leaflet: November 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/.