Prospect: information for the user

Donepezilo Flas Pharma Combix 5 mg buccal dispersible tablets EFG

Donepezilo,hydrochloride

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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.Storage of Donepezilo Flas Pharma Combix

6.Contents of the package and additional information

Donepezilo FlasPharmaCombix(hdonepezilo hydrochloride) belongs to a group of medications called acetylcholinesterase inhibitors. Donepezilo hydrochloride increases the levels in the brain of a substance related to memory (acetylcholine), by decreasing the rate of breakdown of this substance.

It is used for the treatment of mild to moderately severe symptoms of Alzheimer's disease. Symptoms include increased loss of memory, confusion, and changes in behavior.

Do not take Donepezilo Flas Pharma Combix

• If you are allergic to hydrochloride of donepezilo, to derivatives of piperidina, or to any of the other components of this medication (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:

• History of stomach or duodenal ulcers.
• Heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• Convulsions.
• Asthma or chronic lung disease.
• Difficulty urinating or mild kidney disease.
• 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.

You must avoid taking this medication with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Taking Donepezilo Flas Pharma Combix with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication and especially if you are taking any of the following 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, or ziprasidone.
• Medications for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin.
• Antifungal medications, such as ketoconazole.
• Other medications for Alzheimer's disease, for example galantamine.
• Analgesics or treatments for arthritis such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or diclofenac sodium.
• Quinidine and beta-blockers for treating irregular heartbeats such as propranolol and atenolol.
• Phenytoin and carbamazepine (for treating epilepsy).
• Cholinergic agonists and medications with anticholinergic activity (acting at the central nervous system) such as tolterodine.
• Succinylcholine, diazepam, and other neuromuscular blockers (for producing muscle relaxation).
• General anesthesia.

In case of surgical intervention with general anesthesia, you must inform your doctor that you are taking donepezilo tablets because this may affect the amount of anesthetic needed.

Donepezilo tablets 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 tablets.

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

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

Donepezilo tablets should not be taken with alcohol as alcohol may modify the effect of this medication.

Pregnancy, breastfeeding, and fertility

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

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

Do not take donepezilo tablets if you are breastfeeding your child.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not do so unless your doctor tells you it is safe to do so. Donepezilo tablets may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Donepezilo Flas Pharma Combix contains aspartame

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

Donepezilo Flas Pharma Combix contains glucose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Treatment with donepezilo buccodispersible tablets begins with a 5 mg tablet, taken once a day, at night, immediately before bedtime. After a month of treatment, your doctor may recommend an increase in dosage to 10 mg, taken once a day and 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 taking Donepezilo Flas Pharma Combix in the morning.

If you have mild or moderate liver disease (a disease that affects the liver) or renal insufficiency (a disease that affects the kidneys), you can take donepezilo buccodispersible tablets. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should not take donepezilo buccodispersible tablets.

Use in children

Donepezilo buccodispersible tablets are not recommended for use in children.

If you take more Donepezilo Flas Pharma Combix than you should

If you have taken more donepezilo buccodispersible tablets than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Symptoms of overdose may include feeling sick, drooling, sweating, decreased heart rate, low blood pressure (dizziness or lightheadedness when standing up), breathing problems, loss of consciousness, and seizures.

If you forget to take Donepezilo Flas Pharma Combix

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

If you interrupt treatment with Donepezilo Flas Pharma Combix

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

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

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

The following side effects have been reported by people taking donepezil buccal tablets.

Consult your doctor if you experience any of these side effects during treatment with donepezil buccal tablets.

Severe side effects:

You must inform your doctor immediately if you notice any of the following severe side effects mentioned, as you may need urgent medical treatment.

• Liver damage, for example, hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).
• Ulcers in the stomach or 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 intestine. This may cause you to have black, tar-like stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Dizziness (attacks) or convulsions (may affect up to 1 in 100 people).
• Fever with muscle stiffness, decreased level of consciousness (may be symptoms of a condition 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 a fever, or your urine is dark-colored. This may be due to abnormal muscle destruction that can be fatal and cause kidney problems (a condition known as rhabdomyolysis).

The estimated frequency of side effects is as follows:

Very common: may affect more than 1 in 10 people

• Diarrhea
• Discomfort
• Headache

Common: may affect up to 1 in 10 people

• Common cold
• Loss of appetite
• Hallucinations
• Agitation
• Aggressive behavior
• 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

• Convulsions
• Decreased heart rate (bradycardia)
• Gastrointestinal bleeding, ulcers in the stomach and duodenum (a part of the intestine)
• Increased levels of a type of enzyme (creatine kinase muscle) in the blood

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

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Alterations in heart conduction
• Liver function alteration, including hepatitis

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 that may be symptoms of a potentially fatal condition known as torsade de pointes
• Syndrome of Pisa (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)
• Increased libido, hypersexuality.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist. Even if it is a possible side effect that does not appear in this leaflet, you can also report it directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the case after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition of Donepezilo FlasPharmaCombix

• The active ingredient is hydrochloride of donepezilo. Each tablet contains5 mg of hydrochloride of donepezilo.
• The other components are:Celulosa microcristalina (E460i), colloid anhydrous silica,crospovidone (Type A),aspartame (E951),sucralose (E955),peppermint aroma (natural aromas, cornstarch from maize, modified maize starch (E1454), pulegona), strawberry aroma (identical natural aromas, natural aromas, cornstarch from maize and propylene glycol (E1520)), mannitol (E421),stearate fumarate and sodiumystearate magnesium (E470b).

Appearance of the product and contents of the package

Donepezilo FlasPharmaCombix5 mg is presented in buccal dispersible tablets, that is, they dissolve in the mouth. The tablets are whiteornearly white, round, with beveled edges, smooth on both faces.

Donepezilo FlasPharmaCombix5 mg buccal dispersible tablets are presented in Alu/Alu blister packs. Each package contains 28 or 56 buccal dispersible tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Combix, S.L.U.

C/Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

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

Last review date of this leaflet:November 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/.