Donepezil Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE USER

Donepezil Sandoz 5 mg film-coated tablets, 10 mg film-coated tablets

Generic medicine
Please read 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:
1 What Donepezil Sandoz is and what it is used for
2 What you need to know before taking Donepezil Sandoz
3 How to take Donepezil Sandoz
4 Possible side effects
5 How to store Donepezil Sandoz
6 Contents of the pack and other information

1. What Donepezil Sandoz is and what it is used for

Donepezil Sandoz belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine.
Donepezil Sandoz is used to treat the symptoms of dementia in patients diagnosed with Alzheimer's disease of mild to moderate severity. Symptoms include increasing memory loss, confusion, and behavioural changes. As a result, people with Alzheimer's disease find it increasingly difficult to carry out their usual daily activities.
Donepezil Sandoz is used only in adult patients.

2. What you need to know before taking Donepezil Sandoz

Do not take Donepezil Sandoz
If you are allergic to

• donepezil hydrochloride
• piperidine derivatives (substances similar to donepezil), or
• soy, peanuts, or any of the excipients in Donepezil Sandoz film-coated tablets (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Donepezil Sandoz
film-coated tablets.
If any of the following conditions apply to you, you or the person caring for you
should inform your doctor or pharmacist

• gastric or duodenal ulcers
• epileptic seizures or convulsions
• heart disease (irregular or very slow heartbeat)
• asthma or other long-term lung diseases
• liver disorders or hepatitis
• difficulty in urination or mild kidney disease

Also inform your doctor if you are pregnant or think you might be pregnant.

Other medicines and Donepezil Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including medicines not prescribed by your doctor but purchased
over-the-counter at a pharmacy. This also applies to medicines you may take occasionally
in the future while continuing to take Donepezil Sandoz. This is because these
medicines may weaken or strengthen the effects of Donepezil Sandoz film-coated tablets.
In particular, inform your doctor if you are taking any of the following types of medicines:

• other medicines for Alzheimer's disease, e.g. galantamine
• painkillers or treatments for arthritis, such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or sodium diclofenac
• anticholinergic medicines, e.g. tolterodine
• antibiotics, e.g. erythromycin, 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 and atenolol)
• muscle relaxants, e.g. diazepam, succinylcholine
• general anaesthetics
• over-the-counter medicines, e.g. herbal remedies

If you are scheduled for surgery requiring a general anaesthetic, you must inform
your doctor and anaesthetist that you are taking Donepezil Sandoz film-coated tablets.
This is because the medicine may affect the amount of anaesthetic required.
Donepezil Sandoz film-coated tablets can be used in patients with mild to moderate
kidney or liver disease. Inform your doctor beforehand if you have liver or
kidney disease. Patients with severe liver disease must not take Donepezil Sandoz film-coated tablets.
Inform your doctor or pharmacist about the name of your caregiver. The caregiver will
help you take the medicine as prescribed.

Donepezil Sandoz with food, drinks and alcohol
Food does not affect the action of Donepezil Sandoz film-coated tablets. Donepezil
Sandoz film-coated tablets should not be taken with alcohol, as alcohol may alter its effect.

Pregnancy, breast-feeding and fertility
Donepezil Sandoz film-coated tablets must not be used during breast-feeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breast-feeding,
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Alzheimer's disease may reduce your ability to drive or operate machinery.
Therefore, you should not perform such activities unless your doctor tells you that you can do so
with a certain degree of safety. This medicine may also cause fatigue, dizziness, and muscle cramps,
especially at the beginning of treatment and when the dose is increased. If you experience these symptoms,
you must not drive or operate machinery.

Donepezil Sandoz contains lactose and maize starch
Donepezil Sandoz contains lactose and maize starch (a source of glucose).
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Donepezil Sandoz

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dosage is described below.
Adults and elderly patients

• Initial dose: 1 film-coated tablet every evening.

• After one month: increase if necessary to 2 film-coated tablets every evening.

• Maximum dose: 2 film-coated tablets every evening.

• Initial dose: ½ film-coated tablet every evening.

• After one month: increase if necessary to 1 film-coated tablet every evening.

• Maximum dose: 1 film-coated tablet every evening.

Do not change the dose without consulting your doctor.
Patients with renal impairment
Use the standard dosage regimen described above. No dose adjustment is required.
Patients with mild to moderate hepatic impairment
Before increasing the dose, your doctor will assess your tolerance to Donepezil Sandoz.
Patients with severe hepatic impairment
Your doctor will decide whether Donepezil Sandoz film-coated tablets are suitable for your condition.
Method of administration
Take the film-coated tablets in the evening, before going to bed, regardless of meals.
Swallow the film-coated tablets with a glass of water.
Duration of treatment
Your doctor or pharmacist will inform you how long you should continue taking the tablets. You should consult your doctor regularly to review the treatment and assess your symptoms.
If you take more Donepezil Sandoz than you should
DO NOT TAKE MORE THAN 10 MG OF DONEPEZIL HYDROCHLORIDE PER DAY.
Inform your doctor immediately if you have taken more than you should. If you cannot contact your doctor, go to the nearest hospital emergency department. Always bring the tablets and the pack with you to the hospital so that the doctor knows what you have taken.
Symptoms of overdose include feeling unwell, excessive salivation, sweating, slow heartbeat, low blood pressure (feeling lightheaded or dizzy when standing), breathing difficulties, loss of consciousness, and epileptic seizures or convulsions.
If you forget to take Donepezil Sandoz
If you forget to take a film-coated tablet, simply take the next one the following day at the usual time. Do not take a double dose to make up for the forgotten dose. If you forget to take the medicine for more than one week, contact your doctor before resuming treatment.
If you stop taking Donepezil Sandoz
Do not stop taking this medicine unless specifically instructed by your doctor. If you discontinue treatment, the beneficial effects of the medicine may gradually decrease.
If you have any further questions about the use of this medicine, consult 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 in people taking Donepezil Sandoz film-coated tablets. Inform your doctor if you experience any of these side effects while taking Donepezil Sandoz film-coated tablets.
Serious side effects:
If you notice any of these serious side effects, you must contact your doctor immediately. You may need urgent medical treatment.

• Liver damage, for example hepatitis. Symptoms of hepatitis include nausea and vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark-coloured urine (affects 1 to 10 people in 10,000)
• Gastric or duodenal ulcers. Symptoms of ulcers include pain and discomfort (indigestion) in the stomach area between the navel and the breastbone (affects 1 to 10 people in 1,000)
• Bleeding in the stomach or intestine. This may cause black, tarry stools or visible bleeding from the rectum (affects 1 to 10 people in 1,000)
• Epileptic seizures or convulsions (affects 1 to 10 people in 1,000)
• Fever with muscle stiffness, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome") (affects fewer than 1 person in 10,000)
• Weakness, muscle weakness (hypotonia), or muscle pain, particularly if you also feel generally unwell, have 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 known as rhabdomyolysis).

The side effects listed by frequency are as follows:
Very common – may affect more than 1 in 10 people:

• Diarrhoea
• Nausea
• Headache

Common – may affect up to 1 in 100 people:

• Muscle cramps
• Tiredness
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite
• Hallucinations (seeing or hearing things that are not really there)
• Abnormal dreams and nightmares
• Agitation
• Aggressive behaviour
• Fainting
• Dizziness
• Feeling of stomach discomfort
• Skin rash
• Itching
• Involuntary urination
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)

Uncommon – may affect up to 1 in 100 people:

• Slow heart rate

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

• Tremor, stiffness, or uncontrollable movements, especially of the face and tongue, but also of the limbs

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:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Donepezil Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging, blister or
bottle label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine more than six months after first opening the plastic bottle.
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 Sandoz Contains
The active substance is donepezil hydrochloride.
Each film-coated tablet contains 5 mg of donepezil hydrochloride.
Each film-coated tablet contains 10 mg of donepezil hydrochloride.
The other components are as follows.
Tablet core
Microcrystalline cellulose
Lactose monohydrate
Maize starch
Magnesium stearate.
Film coating
<5 mg>
Polyvinyl alcohol
Talc
Titanium dioxide (E171)
Macrogol 3350
Soy lecithin.
<10 mg>
Polyvinyl alcohol
Talc
Titanium dioxide (E171)
Macrogol 3350
Soy lecithin
Yellow iron oxide (E172).

Description of the Appearance of Donepezil Sandoz and Pack Contents
Donepezil Sandoz 5 mg appears as white, round film-coated tablets (diameter 7 mm).
Donepezil Sandoz 10 mg appears as yellow, round film-coated tablets (diameter 9 mm) with a breakline. The tablets can be divided into two equal doses.
Donepezil Sandoz is available in:

• Blister packs containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 100x1 or 120 film-coated tablets
• Plastic bottles with screw cap containing 100 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A., Largo U. Boccioni 1, 21040 Origgio (VA)
Responsible Manufacturers for Batch Release
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany;
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany;
LEK S.A., Ul. Domaniewska 50 C, 02-672 Warszawa, Poland;
LEK S.A., Ul. Podlipie 16 C, 95 010 Strykow, Poland;
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia;
Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania