Donepezil Alter

Patient Information Leaflet

DONEPEZIL ALTER 5 mg film-coated tablets, 10 mg film-coated tablets

Donepezil hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

CONTENTS OF THIS LEAFLET

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

1. What DONEPEZIL ALTER is and what it is used for

DONEPEZIL ALTER (donepezil hydrochloride) belongs to a group of antidementia medicines known as acetylcholinesterase inhibitors.
Donepezil increases the levels in the brain of a substance (acetylcholine) involved in memory function, by slowing its breakdown.
This medicine is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderate Alzheimer's disease. The symptoms of this disease include memory loss, confusion, and changes in behaviour. As a result, people affected by Alzheimer's disease find it increasingly difficult to carry out their normal daily activities.
DONEPEZIL ALTER is indicated only for adult patients.

2. What you need to know before taking DONEPEZIL ALTER

Do not take DONEPEZIL ALTER

• if you are allergic to donepezil hydrochloride, to similar substances (piperidinic derivatives), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking DONEPEZIL ALTER.
In particular, be cautious and inform your doctor before starting treatment with
DONEPEZIL ALTER if you have or have had:

• stomach lesions (stomach or duodenal ulcers), especially if you are being treated with other non-steroidal anti-inflammatory drugs “NSAIDs” (See section “Other medicines and DONEPEZIL ALTER”);
• convulsive spasms (involuntary muscle movements) or seizures;
• a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction), especially if you have certain heart diseases (sino-atrial node disease, supraventricular conduction disorders such as atrioventricular or sinoatrial block);
• a heart condition called “prolonged QT interval” or a history of specific heart rhythm abnormalities known as torsade de pointes, or if someone in your family has a “prolonged QT interval”;
• low levels of magnesium or potassium in the blood;
• asthma or other chronic lung diseases;
• liver problems or hepatitis;
• difficulties in passing urine or mild kidney disorders.

If you are due to undergo surgery requiring general anaesthesia, inform your
doctor and anaesthetist that you are taking DONEPEZIL ALTER. This is because the
medicine may affect the amount of anaesthetic required.
If you experience fever with muscle stiffness, sweating, or reduced level of consciousness
(a condition called "neuroleptic malignant syndrome"), consult a doctor immediately, as treatment may need to be discontinued or urgent medical treatment may be required (See section “Possible side effects”).
Do not take this medicine if you have rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, as DONEPEZIL ALTER contains lactose.
Children
The use of DONEPEZIL ALTER is not recommended in children.
Other medicines and DONEPEZIL ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, be cautious and inform your doctor if you are taking any of the
following medicines:

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

DONEPEZIL ALTER with food, drinks and alcohol
Do not take DONEPEZIL ALTER with alcohol, as alcohol may alter its effect.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take DONEPEZIL ALTER during pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
Avoid taking DONEPEZIL ALTER during breastfeeding.
Driving and using machines
Donepezil may have a slight or moderate effect on the ability to drive and use machines. Alzheimer's disease itself may impair your ability to drive or operate machinery, and you should not engage in these activities unless your doctor has advised you that it is safe. In addition, this medicine may cause fatigue, dizziness, and muscle cramps. If you experience any of these symptoms, you should not drive or operate machinery.
DONEPEZIL ALTER contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take DONEPEZIL ALTER

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Swallow the DONEPEZIL ALTER tablet with water in the evening before going to bed.
The recommended starting dose is one 5 mg tablet every evening.
After one month, your doctor may instruct you to take 10 mg (one 10 mg tablet) every evening.
The maximum recommended dose is 10 mg every evening.
The dosage of the tablet you take may vary depending on when you started taking the medicine and according to the recommendations of the specialist doctor managing your treatment. Do not change the dose without consulting your doctor.
Inform your doctor or pharmacist about the name of the person assisting you. This person will help you take the medicine as prescribed.
Regularly consult your doctor so that your treatment and symptoms can be periodically evaluated.
If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may advise you to take Donepezil Alter in the morning.

Use in patients with liver or kidney problems (impaired hepatic and renal function)
DONEPEZIL ALTER may be used in patients with mild or moderate kidney or liver disease. However, patients with severe liver disease must not take DONEPEZIL ALTER.

If you take more DONEPEZIL ALTER than you should
Symptoms of overdose may include:

• nausea and vomiting;
• salivation;
• sweating;
• slowed heart rate (bradycardia);
• low blood pressure (mild confusion or dizziness upon standing);
• breathing difficulties (respiratory depression);
• loss of consciousness (collapse) and seizures or convulsions;
• muscle weakness which, if affecting the respiratory muscles, may lead to death.

In case of overdose, always bring the tablets and the packaging with you so that the doctor can determine how much medicine has been taken.
Your doctor will determine the appropriate treatment to manage symptoms in case of overdose.
If you have taken or ingested an excessive amount of this medicine, seek immediate medical attention at your doctor’s office or the nearest hospital.

If you forget to take DONEPEZIL ALTER
If you forget to take a tablet, take it the following day at your usual time.
Do not take a double dose to make up for the missed dose.
If you have forgotten to take the medicine for more than one week, inform your doctor before taking any further medicine.

If you stop taking DONEPEZIL ALTER
Do not stop treatment unless instructed by your doctor. If you discontinue treatment with DONEPEZIL ALTER, the benefits will gradually disappear.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone gets them.
The following side effects may occur:

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

• diarrhoea
• nausea
• headache

Common side effects (may affect more than 1 in 100 people and less than 1 in 10 people):

• muscle cramps
• tiredness
• difficulty sleeping (insomnia)
• unusual dreams, especially nightmares
• cold symptoms
• loss of appetite (anorexia)
• hallucinations (seeing or hearing things that do not really exist)
• agitation
• aggressive behaviour
• fainting
• dizziness
• stomach discomfort, abdominal discomfort
• vomiting
• skin rash
• itching
• involuntary loss of urine
• pain
• accidents (patients may be more prone to falling and accidentally injuring themselves)

Uncommon side effects (may affect more than 1 in 1,000 people and less than 1 in 100 people):

• slow heart rate
• stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and a feeling of stomach discomfort (indigestion) between the navel and the breastbone
• bleeding in the stomach or intestines. This may result in passing black, tarry stools or bright red blood from the rectum
• seizures or convulsions
• slight increase in a substance in the blood called creatine kinase
• convulsions

Rare side effects (may affect more than 1 in 10,000 people and less than 1 in 1,000 people):

• stiffness, tremors or involuntary movements, especially of the face and tongue, but also of the arms and legs (extrapyramidal symptoms)
• heart rhythm disorders (sinoatrial block, atrioventricular block)
• liver damage, e.g. hepatitis. Symptoms of hepatitis include nausea and vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark urine.

If the patient develops fever with muscle stiffness, sweating, or reduced level of consciousness (a disorder called "neuroleptic malignant syndrome"), they must consult a doctor immediately, as urgent medical treatment may be required.

Side effects with unknown frequency (frequency cannot be determined from the available data):

• Changes in heart activity that can be observed on an electrocardiogram (ECG), known as "prolonged QT interval"
• Fast and irregular heartbeat and fainting, which could be symptoms of a life-threatening condition called torsade de pointes
• increased libido, hypersexuality
• Pisa syndrome (a condition causing involuntary muscle contractions with abnormal sideways bending of the body and head)

Serious side effects:
If you notice any of the following serious side effects, inform your doctor immediately.
You may require urgent medical treatment.

• Weakness, muscle weakness or muscle pain, especially if you also feel unwell, have a high fever, or dark urine. These symptoms could be caused by abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (a condition called rhabdomyolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DONEPEZIL ALTER

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 carton after
"Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. Package contents and other information

What DONEPEZIL ALTER contains
DONEPEZIL ALTER 5 mg film-coated tablets

• The active substance is donepezil hydrochloride. Each tablet contains 5 mg of donepezil hydrochloride.
• The other components are: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, sodium glycolate starch Type A, colloidal silicon dioxide; magnesium stearate. The film coating contains: hydroxypropylmethylcellulose, titanium dioxide "E171", talc, macrogol 400.

DONEPEZIL ALTER 10 mg film-coated tablets

• The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
• The other components are: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, sodium glycolate starch Type A, colloidal silicon dioxide; magnesium stearate. The film coating contains: hydroxypropylmethylcellulose, titanium dioxide "E171", talc, macrogol 400.

Description of the appearance of DONEPEZIL ALTER and contents of the pack
White 5 mg and 10 mg film-coated tablets, available in packs of 28 tablets.
Marketing Authorization Holder and Manufacturer
LABORATORI ALTER S.r.l. – Via Egadi 7 – 20144 Milan
Manufacturer
Laboratorios Alter S.A., C/Mateo Inuria 30, 28036 Madrid, Spain
This patient information leaflet was last approved on