DONEPEZIL FLAS PHARMA COMBIX 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Donepezil Flas Pharma Combix 10 mg Orodispersible Tablets EFG

Donepezil, hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Donepezil Flas Pharma Combix and what is it used for
2. What you need to know before taking Donepezil Flas Pharma Combix
3. How to take Donepezil Flas Pharma Combix
4. Possible side effects
5. Storage of Donepezil 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 (hydrochloride of donepezil) belongs to a group of medicines called acetylcholinesterase inhibitors. Hydrochloride of donepezil increases the levels in the brain of a substance related to memory (acetylcholine), by means of decreasing the speed of decomposition of this substance.

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

2. What you need to know before taking Donepezil Flas Pharma Combix

Do not take Donepezil Flas Pharma Combix

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

Warnings and precautions

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

• History of stomach or duodenal ulcer.
• Heart disease (such as irregular or very slow heartbeats, heart failure, myocardial infarction).
• Seizures.
• Asthma or chronic pulmonary 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 torsades de pointes or if someone in your family has "prolongation of the QT interval".
• Low levels of magnesium or potassium in the blood.

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

Taking Donepezil Flas Pharma Combix with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or may have to take any other medicines, especially if you are taking any of the following 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, 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
• analgesics or treatments for arthritis such as aspirin, non-steroidal 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 medicines with anticholinergic activity (with action at the central nervous system level) such as tolterodine
• Succinylcholine, diazepam, and other neuromuscular blockers (for producing muscle relaxation)
• General anesthesia.

In case of surgical intervention with general anesthesia, you should inform your doctor that you are taking donepezil orodispersible tablets, as this may affect the amount of anesthetic needed.

Donepezil orodispersible tablets can 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 donepezil orodispersible tablets.

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

Place the tablet on the tongue and let it 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, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 breast-feeding.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Donepezil orodispersible tablets may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Donepezil Flas Pharma Combix contains aspartame

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

Donepezil Flas Pharma Combix contains glucose

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

3. How to take Donepezil Flas Pharma Combix

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 starts with a 5 mg tablet, taken once a day, at night, immediately before bedtime. After one month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day, at night. The maximum recommended dose is 10 mg per day.

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

If you have mild or moderate liver or kidney disease, you can take donepezil orodispersible tablets. Inform your doctor before starting treatment if you have liver or kidney problems. Patients with severe liver disease should not take donepezil orodispersible tablets.

Use in children

Donepezil orodispersible tablets are not recommended for use in children.

If you take more Donepezil Flas Pharma Combix than you should

If you have taken more donepezil orodispersible tablets than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount used.

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

If you forget to take Donepezil Flas Pharma Combix

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

If you stop taking Donepezil Flas Pharma Combix

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Serious side effects:

You should inform your doctor immediately if you notice any of the following serious side effects, 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 malaise, 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 pain and discomfort in the stomach (indigestion) between the navel and the sternum (may affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This can cause you to have black, tarry stools or visible blood from the rectum (may affect up to 1 in 100 people).
• Dizziness (fits) or seizures (may affect up to 1 in 100 people).
• Fever with muscle stiffness, sweating, 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 have dark-colored urine. This may be due to an abnormal destruction of muscle that can be fatal and cause kidney problems (a condition called "rhabdomyolysis").

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

Very common: may affect more than 1 in 10 people

• Diarrhea
• Nausea
• Headache

Common: may affect up to 1 in 10 people

• 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

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

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

• Extrapyramidal symptoms (such as tremor or rigidity of the hands or feet)
• Alterations in cardiac conduction
• Liver function disorders, 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 heartbeat, fainting that can be symptoms of a potentially fatal disorder known as "torsades de pointes"
• Pisa syndrome (a condition that involves an involuntary contraction of the muscle with an abnormal flexion of the body and head to one side)
• Increased libido, hypersexuality.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Flas Pharma Combix

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

Appearance of the product and contents of the pack

Donepezil Flas Pharma Combix 10 mg is presented in orodispersible tablets, i.e., they dissolve in the mouth. The tablets are yellow to yellowish in color, round, with beveled edges, smooth on both sides.

Donepezil Flas Pharma Combix 10 mg orodispersible tablets are presented in Alu/Alu blister packs. Each pack contains 28 or 56 orodispersible tablets.

Not all 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

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 last revision of this leaflet:November 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.