Donepezil Doc Generici

Package leaflet: Information for the user

DONEPEZIL DOC Generici 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Please read 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 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.

Contents of this leaflet:

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

1. WHAT DONEPEZIL IS AND WHAT IT IS USED FOR

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil increases the levels in the brain of a substance (acetylcholine) which is important for memory,
by slowing down the breakdown of acetylcholine.
Donepezil is used for the symptomatic treatment of mild to moderate Alzheimer's dementia.
.
The symptoms include increasing memory loss, confusion and changes in behaviour.
As a consequence, people suffering from Alzheimer's disease have increasing difficulties in carrying out a normal life.
Donepezil must only be used in adult patients.

2. WHAT YOU SHOULD KNOW BEFORE TAKING DONEPEZIL DOC Generici

Do not take DONEPEZIL DOC Generici

• If you are allergic to donepezil hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to medicines containing piperidine derivatives. Do not start taking this medicine if any of the conditions listed above apply to you. If you are unsure, talk to your doctor or pharmacist before taking DONEPEZIL DOC Generici.

Warnings and precautions
Ask your doctor or pharmacist for advice before taking this medicine if you have or have had:

• gastric or duodenal ulcer
• epileptic seizures or convulsions
• a heart condition (irregular or very slow heartbeat)
• asthma or other chronic lung disease
• any liver problems or hepatitis
• difficulty passing fluids (urine) or mild kidney disease

Also inform your doctor if you are pregnant or think you might be pregnant.
If any of the conditions described above apply to you (or if you are unsure), consult your doctor or pharmacist before taking DONEPEZIL DOC Generici.
Other medicines and DONEPEZIL DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medications for Alzheimer's disease, e.g. galantamine
• analgesics or medicines for arthritis such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or sodium diclofenac
• anticholinergic drugs, e.g. tolterodine
• antibiotics, e.g. erythromycin or rifampicin
• antifungal medicines, e.g. ketoconazole
• antidepressants, e.g. fluoxetine
• anticonvulsants, e.g. phenytoin, carbamazepine
• medicines for heart conditions, e.g. quinidine, beta-blockers (propranolol, atenolol)
• muscle relaxants, e.g. diazepam, succinylcholine
• general anaesthetics
• over-the-counter medicines, e.g. herbal remedies

Tell your doctor that you are taking DONEPEZIL DOC Generici if you are planning to undergo surgery. This may affect the amount of anaesthetic required.
DONEPEZIL DOC Generici can be used in patients with mild to moderate renal or hepatic impairment. Inform your doctor beforehand if you have renal or hepatic impairment. Patients with severe hepatic impairment must not take DONEPEZIL DOC Generici.
Tell your doctor or pharmacist the name of the person who cares for you. This caregiver will help you take the medicine as prescribed.
If any of the conditions listed above apply to you (or if you are unsure), speak to your doctor or pharmacist before taking DONEPEZIL DOC Generici.
DONEPEZIL DOC Generici with food, drinks and alcohol
Food does not affect the effectiveness of DONEPEZIL DOC Generici.
DONEPEZIL DOC Generici must not be taken with alcohol, as alcohol may alter its effects.
Pregnancy, breastfeeding and fertility
Do not take DONEPEZIL DOC Generici if you are breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery, and you should not engage in these activities unless your doctor has confirmed it is safe for you to do so. In addition, this medicine may cause fatigue, dizziness, and muscle cramps. Do not drive or operate machinery if you experience these effects.
DONEPEZIL DOC Generici contains lactose. If your doctor has informed you that you cannot tolerate or digest certain sugars (have an intolerance to certain sugars), consult your doctor before taking this medicine.

3. HOW TO TAKE DONEPEZIL DOC Generici

Always take this medicine exactly as your doctor has told you. If you have any doubts, you must
consult your doctor or pharmacist.
Taking the medicine

• Take this medicine before going to sleep.
• The tablets should be swallowed whole with water.

How much to take:
Usually, treatment starts with 5 mg (one white tablet) taken every evening. After one month, your doctor may
tell you to take 10 mg (one yellow tablet) every evening.
Swallow your DONEPEZIL DOC Generici tablet with a glass of water before going to sleep at night.
The dosage of the tablet you take may change depending on how long you have been on treatment and your
doctor's advice. The maximum recommended dose is 10 mg every evening.
Always follow your doctor’s or pharmacist’s instructions on how and when to take your medicine.
Do not change the dose without first consulting your doctor.
Use in children and adolescents
DONEPEZIL DOC Generici must not be taken by children or adolescents.
How long should you take DONEPEZIL DOC Generici?
Your doctor or pharmacist will tell you how long you should continue taking the tablets.
You will need to visit your doctor periodically to have your treatment reviewed and your symptoms checked.
If you stop taking DONEPEZIL DOC Generici
Do not stop taking the tablets unless your doctor tells you to. If you stop taking
DONEPEZIL DOC Generici, the benefits of treatment will gradually disappear.
If you take more DONEPEZIL DOC Generici than you should
DO NOT take more than one tablet per day. Call your doctor immediately if you have taken more than
you should. If you cannot contact your doctor, go immediately to the Emergency Department of the
nearest hospital. Always take the tablets and the packaging with you to the hospital, so that the doctor
knows what has been taken.
Symptoms of overdose include nausea and vomiting, salivation, sweating, slowing of the heartbeat,
low blood pressure (feeling of light-headedness or dizziness when standing up), breathing difficulties,
loss of consciousness, and epileptic or convulsive seizures.
If you forget to take DONEPEZIL DOC Generici
If you forget to take a tablet, simply take one tablet at the usual time the next day. Do not take a double
dose to make up for the forgotten tablet.
If you forget to take the medicine for more than one week, call your doctor before restarting treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported in people taking this medicine.
Inform your doctor if you experience any of these adverse reactions while taking DONEPEZIL DOC Generici.

Serious adverse reactions
If you notice any of these serious adverse reactions, you must immediately report them to your doctor. You may require urgent medical treatment.

• Liver damage, e.g. hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, dark-coloured urine (occurs in 1–10 out of 10,000 users).
• Stomach or duodenal ulcers. Symptoms of stomach ulcers include pain and discomfort (indigestion) between the navel and the breastbone (occurs in 1–10 out of 1,000 users).
• Bleeding in the stomach or intestine. This may cause black, tarry stools or visible blood from the rectum (occurs in 1–10 out of 1,000 users).
• Epileptic seizures or convulsions (occurs in 1–10 out of 1,000 users).
• If you develop fever with muscle rigidity, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome"), you must immediately consult a doctor, as urgent medical treatment may be necessary.

Very common adverse reactions (affect more than 1 in 10 patients):

• Diarrhoea
• Nausea
• Headache

Common adverse reactions (affect less than 10 in 100 patients):

• Muscle cramps
• Fatigue
• Inability to sleep (insomnia)
• Common cold – loss of appetite
• Hallucinations (seeing, hearing or sensing things that are not real)
• Unusual dreams including nightmares
• Feeling of restlessness
• Aggressiveness
• Fainting
• Dizziness
• Feeling of stomach discomfort
• Malaise (vomiting)
• Rash
• Itching
• Loss of bladder control
• Pain
• Accidents (patients may be more prone to falls or injuries)

Uncommon adverse reactions (affect 1 to 10 in 100 patients):

• Slowing of the heart rate

Rare adverse reactions (affect 1 to 10 in 1,000 patients):

• Rigidity, tremor or uncontrollable movements, especially of the face and tongue, but also of the limbs.

If you experience any adverse reaction, tell your doctor or pharmacist.
This includes any adverse reaction not listed in this leaflet.
Your doctor may decide to reduce your dose or discontinue treatment.

5. HOW TO STORE DONEPEZIL DOC Generici

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton, blister, and bottle after the word 'EXP'.
The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What DONEPEZIL DOC Generici contains

• The active substance is donepezil hydrochloride. Each 5 mg tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil. Each 10 mg tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
• The excipients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose (E464), talc (E553b), polyethylene glycol 8000, and titanium dioxide (E171). The 10 mg tablets also contain yellow iron oxide (E172).

Description of the appearance of DONEPEZIL DOC Generici and pack sizes

• The 5 mg tablets are white to almost white, round, biconvex tablets with the imprint 'APO' on one side and 'DO' above '5' on the other.
• The 10 mg tablets are pale yellow to yellow, round, biconvex tablets with the imprint 'APO' on one side and 'DO' above '10' on the other.
• The 5 mg tablets are available in blisters of 28 and 30 tablets and in bottles of 30 and 100 tablets.
• The 10 mg tablets are available in blisters of 28, 30, 56, and 98 tablets and in bottles of 30 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici Srl – Via Turati, 40 – 20121 Milan - Italy
Manufacturer:
Apotex Nederland B.V. - Archimedesweg 2 - 2333 CN Leiden - The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Donepezil Apotex 5/10 mg film-coated tablets
Czech Republic: Apo-Donepezil 5/10 mg coated tablets
Italy: Donepezil DOC Generici
Luxembourg: Donepezil Apotex 5/10 mg
Poland: Apo-Doperil
Portugal: Donepezilo Apotex
Spain: Donepezilo Apotex 5/10 mg film-coated tablets
April 2013