Donepezil Sun

Package leaflet: Information for the patient

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

Generic medicine
The name of the medicine will be referred to as Donepezil tablets throughout the rest of this Package Leaflet
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Donepezil tablets are and what they are used for
2. What you need to know before taking Donepezil tablets
3. How to take Donepezil tablets
4. Possible side effects
5. How to store Donepezil tablets
6. Contents of the pack and other information

1. What Donepezil tablets are and what they are used for

Donepezil tablets contain the active substance donepezil hydrochloride and belong to a group of
medicines called "Acetylcholinesterase inhibitors".
Donepezil increases the levels of a substance (acetylcholine) present in the brain which is involved
in memory function, by slowing down the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people who have been diagnosed with Alzheimer's disease,
ranging from mild to moderately severe. Symptoms include progressive memory loss,
confusion and changes in behaviour. As a result, patients affected by Alzheimer's disease
find it increasingly difficult to carry out their normal daily activities.
Donepezil tablets must only be used in adult patients.

2. What you need to know before taking Donepezil tablets

Do not take Donepezil tablets:

• if you are allergic to donepezil hydrochloride or to piperidine derivatives, or to any of the ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of the face, lips, hands/feet, or difficulty breathing.

Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil tablets if you have or have had:

• stomach or duodenal ulcers
• epileptic seizures or convulsions
• heart problems (irregular or very slow heartbeat)
• asthma or other chronic lung diseases
• liver problems or hepatitis. Donepezil tablets can be used in patients with mild to moderate liver impairment. Patients with severe liver disease must not take Donepezil tablets.
• difficulty urinating or kidney problems. However, Donepezil tablets can be used in patients with kidney problems.
• any involuntary or abnormal movements of the tongue, face, or body (extrapyramidal symptoms). Donepezil tablets may induce or worsen extrapyramidal symptoms.

Children and adolescents
The use of Donepezil tablets is not recommended in children and adolescents.
Other medicines and Donepezil tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and those you might take in the future while continuing treatment with Donepezil tablets.
This is because these medicines may weaken or enhance the effects of Donepezil tablets.
In particular, it is important to inform your doctor if you are taking any of the following types of medicines:

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

If you are due to have surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking Donepezil tablets. This is because the medicine may affect the amount of anaesthetic required.
Inform your doctor or pharmacist about the name of the person assisting you. This person will help you take the medicine as prescribed.
Donepezil tablets with food, drinks and alcohol
Food does not affect the action of Donepezil tablets.
Donepezil tablets must not be taken with alcohol, as alcohol may reduce its effect.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Donepezil tablets must not be used during breastfeeding.
Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery; therefore, you should not perform these activities unless your doctor tells you it is safe to do so.
In addition, this medicine may cause tiredness, dizziness, and muscle cramps. If any of these symptoms occur, you must not drive or operate machinery.
Donepezil tablets contain lactose
Donepezil tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Donepezil tablets

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
How much Donepezil should you take?
Initially, the recommended dose is 5 mg of donepezil hydrochloride every evening. After one month, your doctor
may instruct you to take 10 mg of donepezil hydrochloride every evening.
The tablet strength you take may change depending on the duration of treatment and your doctor’s
recommendations. The maximum recommended dose is 10 mg every evening.
Always follow your doctor’s or pharmacist’s advice on how and when to take this medicine.
Do not change the dose on your own without consulting your doctor.
Use in children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
How to take the medicine
Oral use
Swallow the Donepezil tablet with a glass of water in the evening before going to bed.
If you take more Donepezil tablets than you should
Contact your doctor immediately or go to the nearest hospital emergency department if you take more
medicine than you should. Bring this leaflet and any remaining tablets with you.
Symptoms of overdose may include: nausea, vomiting, excessive salivation, sweating,
slowing of the heartbeat, low blood pressure (dizziness or lightheadedness when standing),
breathing problems, loss of consciousness, and epileptic seizures or convulsions.
If you forget to take Donepezil tablets
If you forget to take your dose, take the next dose at your usual time.
Never take a double dose to make up for a missed tablet.
If you have forgotten to take the medicine for more than one week, contact your doctor before restarting
treatment.
If you stop taking Donepezil tablets
Do not stop taking the tablets unless your doctor tells you to. If you stop taking Donepezil tablets,
the benefit of treatment will gradually disappear.
How long should you take Donepezil tablets?
Your doctor or pharmacist will tell you how long you should continue taking the tablets.
You will need to visit your doctor periodically to monitor your treatment and assess your
symptoms.
If you have any questions about using this medicine, 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 in people taking Donepezil tablets.
Tell your doctor if any of the following side effects occur while you are taking Donepezil tablets.

Serious side effects
You must inform your doctor immediately if you notice any of the following serious side effects. You may need urgent medical treatment.

Uncommon (may affect up to 1 in 100 people):

• Seizures or convulsions
• Stomach or duodenal ulcers. Ulcer symptoms include stomach pain and discomfort (indigestion) between the navel and the breastbone
• Bleeding in the stomach or intestine. This may cause black, tar-like stools or visible rectal bleeding

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

• Slowing of the heartbeat associated with dizziness, weakness, confusion
• Liver damage, for example hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and whites of the eyes (jaundice), and dark-coloured urine

Very rare (may affect up to 1 in 10,000 people):

• High fever with muscle stiffness, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome")
• Muscle weakness, floppiness, or pain, particularly if you also feel unwell, have a high fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown, which can be life-threatening and may lead to kidney problems (a condition called rhabdomyolysis)

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

• Diarrhoea
• Feeling unwell
• Headache

Common: may affect up to 1 in 10 people

• Muscle cramps
• Tiredness
• Difficulty sleeping (insomnia)
• Common cold
• Loss of appetite (anorexia)
• Hallucinations (seeing or hearing things that are not real)
• Unusual dreams including nightmares
• Agitation
• Aggressive behaviour
• Fainting
• Dizziness
• Stomach discomfort, feeling unwell (vomiting)
• Rash
• Itching
• Urinary incontinence
• Pain
• Accidents (patients may be more prone to falls or accidental injuries)

Uncommon: may affect up to 1 in 100 people

• Slowing of the heartbeat
• Mild increases in blood levels of creatine kinase
• Increased salivation

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

• Stiffness, agitation, or uncontrolled 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/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Donepezil tablets

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 blister and 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 tablets contain
The active substance is donepezil hydrochloride:
5 mg
Each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil.
10 mg
Each tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
The other components are:
Core: Lactose monohydrate, maize starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate;
Coating: Opadry yellow containing hypromellose 5cP (E464), titanium dioxide (E171), macrogol 400, talc, yellow iron oxide (E172).

Description of the appearance of Donepezil tablets and contents of the pack
Donepezil Sun 5 mg film-coated tablets are yellow, round, biconvex, film-coated tablets, marked with "RC25" on one side.
Donepezil Sun 10 mg film-coated tablets are yellow, capsule-shaped, film-coated tablets, marked with "RC" and "26" on either side of the breakline.
The breakline is intended only to facilitate breaking for easier swallowing and is not intended for dividing the tablet into equal doses.

The medicine is available in blisters in pack sizes of:
5 mg: 7, 28, 30, 56, 98 and 100 film-coated tablets
10 mg: 28, 30, 56, 98 and 100 film-coated tablets
Not all pack sizes may be marketed.

This medicine is authorised in the European Economic Area member states under the following names:
United Kingdom: Donepezil Hydrochloride 5, 10 mg Film-coated tablets
Greece: CEREBROL 5, 10 mg επικαλυμμένα με λεπτό υμένιο δισκία
Italy: Donezepil Sun
Lithuania: Memofit 5, 10 mg plėvele dengtos tabletės
Sweden: Azepezil 10 mg filmdragerad tablett
Germany: DONEPEZIL-HCL BASICS 5, 10 mg Filmtabletten
Ireland: Donepezil Hydrochloride Ranbaxy 5,10 mg Film Coated Tablets

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries (Europe) B.V.
Polaris Avenue 87
2132 JH
B.V. 1441408 Netherlands
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Galenica AE
4 Eleftherias Str., 145 64 Kifissia
Greece
Terapia S.A.
124 Fabricii Str.
400632 Cluj-Napoca
Romania

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