Donepezil Aurobindo

Package leaflet: Information for the user

Donepezil Aurobindo 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 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Donepezil Aurobindo (donepezil hydrochloride) 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 its breakdown.
It is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderate Alzheimer's disease. Symptoms include increasing memory loss, confusion, and changes in behaviour. As a result, patients suffering from Alzheimer's disease find it increasingly difficult to carry out their normal daily activities.
Donepezil Aurobindo is intended for use only in adult patients.

2. What you need to know before taking Donepezil Aurobindo

Do not take Donepezil Aurobindo:

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

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

• stomach or duodenal ulcers
• epileptic seizures or convulsions
• a heart condition (irregular or very slow heartbeat)
• asthma or other long-term lung diseases
• liver problems or hepatitis
• difficulty passing urine or mild kidney disease

You should also inform your doctor if you are pregnant or think you may be pregnant.

Children and adolescents
Donepezil Aurobindo is not recommended for use in children and adolescents (under 18 years of age).

Other medicines and Donepezil Aurobindo
Inform 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 on your own. This also applies to medicines you might take in the future while continuing to take Donepezil Aurobindo, as all these medicines may weaken or strengthen the effects of Donepezil Aurobindo.

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, e.g. aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as 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 anaesthesia
• over-the-counter medicines, e.g. herbal remedies

If you are about to undergo surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking Donepezil Aurobindo, as your medicine may affect the amount of anaesthetic required.

Donepezil Aurobindo can be used in patients with renal disease or mild to moderate hepatic impairment. Inform your doctor if you have kidney or liver disease. Patients with severe hepatic impairment must not take Donepezil Aurobindo.

Inform your doctor or pharmacist about the name of the person who takes care of you. This person will help you take the medicine as prescribed.

Donepezil Aurobindo with food, drinks and alcohol
Food does not affect the action of Donepezil Aurobindo.
Donepezil Aurobindo must not be taken with alcohol, as alcohol may alter its effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Donepezil Aurobindo 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, your medicine may cause tiredness, dizziness, and muscle cramps. If you experience these effects, do not drive or operate machinery.

Donepezil Aurobindo contains lactose
Donepezil Aurobindo film-coated tablets contain lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Donepezil Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.

How much Donepezil Aurobindo should you take?
Usually, treatment starts with 5 mg (one white tablet) taken every evening. After one month, your doctor may instruct you to take 10 mg (one yellow tablet) every evening.
The tablet strength you take may change depending on how long you have been taking the medicine and on your doctor's recommendation. The maximum recommended dose is 10 mg every evening.
Do not change the dose on your own without consulting your doctor.

How to take the medicine
Swallow the Donepezil Aurobindo tablet with a glass of water in the evening before going to bed.

Use in children and adolescents
Donepezil Aurobindo is not recommended for use in children and adolescents (under 18 years of age).

If you take more Donepezil Aurobindo than you should
If you take more medicine than you should, contact your doctor or the nearest Emergency Department immediately. Take this leaflet and any remaining tablets with you.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slowed heartbeat, low blood pressure (dizziness or lightheadedness when standing up), breathing difficulties, loss of consciousness, and epileptic seizures or convulsions.

If you forget to take Donepezil Aurobindo
If you forget to take a tablet, take the recommended dose the next day at the usual time. Do not take a double dose to make up for the forgotten dose.
If you forget to take your medicine for more than one week, call your doctor before restarting treatment.

If you stop taking Donepezil Aurobindo
Do not stop taking the tablets unless your doctor advises you to do so. If you stop taking Donepezil Aurobindo, the benefits of treatment will gradually disappear.
If you have any questions about using this medicine, consult your doctor or pharmacist.

How long should you take Donepezil Aurobindo?
Your doctor or pharmacist will tell you how long you should continue taking the tablets. You will need to visit your doctor periodically to review your treatment and assess your symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported in patients taking Donepezil Aurobindo.
Tell your doctor if you experience any of these side effects while taking Donepezil Aurobindo.

Serious side effects:
You must inform your doctor immediately if you notice any of the serious side effects listed below.
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, and dark-coloured urine (may affect up to 1 in 1,000 people)
• Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion) between the navel and the breastbone (may affect up to 1 in 100 people)
• Bleeding in the stomach or intestines. This may cause dark stools or visible rectal bleeding (may affect up to 1 in 100 people)
• Seizures or convulsions (may affect up to 1 in 10,000 people)
• Fever with muscle rigidity, sweating, or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people)
• Weakness, tenderness or muscle pain, particularly if you also feel unwell, have 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 known as rhabdomyolysis)

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

• Diarrhoea
• Feeling unwell
• Headache

Common side effects (may affect up to 1 in 10 people):
Muscle cramps
Fatigue
Difficulty sleeping (insomnia)
Common cold
Loss of appetite
Hallucinations (seeing or hearing things that are not real)
Unusual dreams including nightmares
Agitation
Aggressive behaviour
Fainting
Dizziness
Uncomfortable feeling in the stomach
Skin rash
Itching
Incontinence
Pain
Accidents (patients may be more prone to falls and accidental injuries)

Uncommon side effects (may affect up to 1 in 100 people):
Slow heart rate
Excessive salivation

Rare side effects (may affect up to 1 in 1,000 people):
Stiffness, tremor, and uncontrollable movements, mainly 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 the following website: http://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 Aurobindo

Keep this medicine out of the sight and reach of children.
Blister: Store in the original packaging to protect the medicine from moisture.
HDPE bottle: Keep the bottle tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the label, carton and blister after "EXP.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Donepezil Aurobindo contains
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:
Tablet core: monohydrate lactose, pregelatinized starch (maize starch), microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and magnesium stearate.
Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171), iron oxide yellow (E172) (only for 10 mg tablets).

Description of the appearance of Donepezil Aurobindo and package contents
Film-coated tablets
Donepezil Aurobindo 5 mg film-coated tablets
White to off-white, round, biconvex, film-coated tablets, marked with 'X' on one side and '11' on the other.
Donepezil Aurobindo 10 mg film-coated tablets
Yellow, round, biconvex, film-coated tablets, marked with 'X' on one side and '12' on the other.

Donepezil Aurobindo tablets are available in blister packs and in bottles.
Pack sizes:
Blister packs: 14, 28, 50, 56 and 98 tablets.
HDPE bottle: 30, 250 and 1000 tablets.
Not all pack sizes may be marketed.

Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (Varese)
Italy

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta

Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD.
United Kingdom

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Donepezil Aurobindo
France DONEPEZIL ARROW 5 mg / 10 mg film-coated tablet
Germany Donepezil Aurobindo 5 mg / 10 mg Filmtabletten
Italy Donepezil Aurobindo
Malta Donepezil hydrochloride 5 mg / 10 mg film-coated tablets
Portugal Donepezilo Orua
Spain DONEPEZILO AUROBINDO 5 mg / 10 mg film-coated tablets
Sweden Donepezil Aurobindo
United Kingdom Donepezil hydrochloride 5 mg / 10 mg film-coated tablets