Donepezil Alter 5 mg film-coated tablets EFG: detailed information

Brand name Donepezil Alter 5 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

DONEPEZIL HYDROCHLORIDE · 5 mg

Prescription type Hospital Diagnosis

ATC code

N06D N06DA N06DA02

Registration number 74175

Manufacturer Laboratorios Alter S.A.

Donepezil Alter 5 mg film-coated tablets EFG tablets, film-coated

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Donepezilo Alter is and what it is used for
2. What you need to know before taking Donepezil Alter
3. How to take Donepezilo Alter
4. Possible adverse effects
5. Storage of Donepezil Alter
6. Additional Information

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Alter 5 mg film-coated 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 must not be given 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 such effects are not listed in this leaflet.

Leaflet contents:

What Donepezil Alter is and what it is used for
What you need to know before taking Donepezil Alter
How to take Donepezil Alter
Possible adverse effects
How to store Donepezil Alter
Contents of the pack and other information

1. What Donepezilo Alter is and what it is used for

Donepezilo Alter contains the active substance donepezil hydrochloride.

Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases levels in the brain of a substance related to memory (acetylcholine), by reducing the rate at which this substance breaks down.

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

2. What you need to know before taking Donepezil Alter

Do not take Donepezil Alter:

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

Warnings and precautions

Consult your doctor before starting Donepezil Alter 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)
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
seizures
asthma or chronic lung disease
difficulty urinating or mild kidney disease

You should avoid taking Donepezil Alter together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.

Other medicines and Donepezil Alter:

Tell 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 treating 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 for treating 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 are undergoing surgery under general anaesthesia, you must inform your doctor that you are taking Donepezil Alter, as this may affect the amount of anaesthetic required.

Donepezil Alter may 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 impairment must not take Donepezil Alter.

Taking Donepezil Alter with food, drinks, and alcohol:

This medicine should be taken with a glass of water.

Donepezil Alter must 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Do not take Donepezil Alter if you are pregnant.

You must not take Donepezil Alter if you are breastfeeding your child.

Driving and using machines:

Your illness 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 Alter may cause fatigue, dizziness, somnolence, and muscle cramps, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

This medicine contains lactose.

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

3. How to take Donepezilo Alter

Follow exactly the dosing instructions for donepezil as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Donepezil is administered orally.

Treatment with donepezil starts with one 5 mg tablet taken once daily with water, 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/day.

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

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

Use in children

The use of donepezil is not recommended in children.

If you take more Donepezilo Alter than you should:

If you have taken more donepezil than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medication and the amount taken.

Symptoms of overdose may include nausea (feeling sick), vomiting (being sick), 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 Donepezilo Alter:

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

If you stop taking Donepezilo Alter:

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

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

4. Possible adverse effects

Like all medicines, Donepezilo Alter may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported in people taking Donepezilo Alter.

Contact your doctor if you experience any of these effects during treatment with Donepezilo Alter.

Serious adverse effects:

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

Liver damage, for example, hepatitis. Symptoms of hepatitis include nausea or vomiting (feeling sick or being sick), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), and dark urine (affects between 1 and 10 in every 10,000 people).
Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the sternum (affects between 1 and 10 in every 1,000 people).
Bleeding in the stomach or intestines. This may cause black, tarry stools or visible rectal bleeding (affects between 1 and 10 in every 1,000 people).
Dizziness (syncope) or seizures (affects between 1 and 10 in every 1,000 people).
Fever with muscle rigidity, sweating, and decreased level of consciousness (may be symptoms of a disorder called "Neuroleptic Malignant Syndrome") (affects fewer than 1 in every 10,000 patients).
Muscle weakness, tenderness, or pain, especially 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 called rhabdomyolysis).

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

Very common: may affect more than 1 in 10 patients:

Diarrhea
Malaise
Headache

Common: may affect between 1 and 10 in every 100 patients:

Cold
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 between 1 and 10 in every 1,000 patients:

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

Rare: may affect between 1 and 10 in every 10,000 patients:

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

Frequency not known (cannot be estimated from available data):

Increased libido, hypersexuality
Pisa syndrome (a condition involving involuntary muscle contractions with abnormal lateral flexion of the body and head)
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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaRAM.es.

5. Storage of Donepezil Alter

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

This medicine does not require any special storage conditions.

Do not use donepezil after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Donepezil Alter 5 mg tablets

The active substance is donepezil. Each tablet contains 5 mg of donepezil hydrochloride.
The other components are: Core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethyl potato starch, colloidal silicon dioxide, and magnesium stearate. Coating: Opadry White.

Appearance of the medicinal product and contents of the pack

Donepezil Alter 5 mg are film-coated tablets, round, biconvex, and white in colour.

They are available in packs containing 28 or 56 tablets.