5 mg and 10 mg film-coated tablets 
donepezil hydrochloride

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 in the brain ( acetylcholine ), which is involved in memory function, by delaying the breakdown of acetylcholine .

Donepezil Aurobindo is used to treat the symptoms of dementia in mild to moderate Alzheimer’s disease . These symptoms include increasing memory loss, confusion, and behavioral changes. As a consequence of these symptoms, those suffering from Alzheimer’s disease find it more and more difficult to perform normal daily activities.

Donepezil Aurobindo should only be used by adults.

Donepezil hydrochloride contained in Donepezil Aurobindo may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before taking Donepezil Aurobindo

Do not take Donepezil Aurobindo

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

Warnings and cautions

Talk to your doctor or pharmacist before using Donepezil Aurobindo if you have or have had:

  • gastric ulcer
  • seizures or convulsions
  • any heart disease (irregular or very slow heart rate)
  • asthma or other so-called chronic lung disease
  • any liver disease or hepatitis (hepatitis)
  • difficulty trying to urinate or mild kidney disease

Also tell your doctor if you are pregnant or think you may be pregnant.

Children and young people

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

Other medicines and Donepezil Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to other medicines that you may take at some point in the future if you continue to use Donepezil Aurobindo. This information is important as some other medicines may reduce or increase the effect of Donepezil Aurobindo.

You should be extra careful to tell your doctor if you are taking:

  • other drugs used in Alzheimer’s disease , e.g. galantamine
  • medicines for pain or arthritis , e.g. acetylsalicylic acid , so-called NSAIDs such as ibuprofen or diclofenac
  • anticholinergic drugs, e.g. tolterodine
  • certain antibiotics , e.g. erythromycin, rifampicin
  • drugs against fungal infections, e.g. ketoconazole
  • antidepressant drugs, e.g. fluoxetine
  • medicines for seizures, e.g. phenytoin , carbamazepine
  • drugs for cardiovascular disease, e.g. quinidine , beta blockers (propranolol, atenolol)
  • muscle relaxants, such as diazepam , succinylcholine
  • anesthetics
  • over-the-counter medicines and herbal medicines
    If you plan to be hospitalized for an operation that requires you to be put to sleep, tell your doctor and the doctor performing the operation that you are using Donepezil Aurobindo. This is because Donepezil Aurobindo can affect the amount of anesthetic needed.
    Donepezil Aurobindo can be used in people with renal impairment or with mild to moderate hepatic impairment. Tell your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not use Donepezil Aurobindo.
    Tell your doctor who your guardian is. Your guardian can help you use your medicine according to your doctor’s prescription.

Donepezil Aurobindo with food, drink and alcohol

Food intake does not affect the effect of Donepezil Aurobindo.

You should avoid alcohol as it may affect the effect of Donepezil Aurobindo.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women taking Donepezil Aurobindo should not breast-feed.

Driving and using machines

Alzheimer’s disease can impair your ability to drive or operate machinery. You must therefore first discuss with your doctor if you intend to drive or operate machinery.

It may be that the medicine makes you feel tired and dizzy and that you may have muscle cramps. If you experience any of these symptoms, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Donepezil Aurobindo contains lactose

Donepezil Aurobindo film-coated tablets contain lactose monohydrate . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Donepezil Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

It is common to start treatment by taking a white tablet of 5 mg in the evening. After one month, your doctor may ask you to take a 10 mg yellow tablet instead in the evening.

The tablet strength you should take may change depending on how long you have been taking the medicine and what your doctor recommends. The maximum recommended dose is 10 mg in the evening. Do not change the dose on your own without a prescription from a doctor.

How to use your medicine

Donepezil Aurobindo tablets should be swallowed whole with a glass of water in the evening before going to bed.

Use for children and adolescents

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

If you use more Donepezil Aurobindo than you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital or the Poison Information Center (tel. 112) immediately for risk assessment and advice. Take this leaflet and remaining tablets with you.

Symptoms of overdose include nausea and vomiting, involuntary drooling, sweating, slow heart rate, low blood pressure (dizziness or standing dizziness), difficulty breathing, loss of consciousness and seizures or convulsions.

If you forget to take Donepezil Aurobindo

If you forget to take a tablet, take the next tablet the following day at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you forget to take your medicine for more than a week, call your doctor before taking any more medicines.

If you stop using Donepezil Aurobindo

Do not stop taking the tablets unless your doctor tells you to. If you stop using Donepezil Aurobindo, the benefits of your treatment will gradually disappear.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

How long to use Donepezil Aurobindo

Your doctor or pharmacist will tell you how long to use the tablets. You need to see your doctor regularly for evaluation of your treatment and assessment of your symptoms

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 during treatment with Donepezil Aurobindo.

Tell your doctor if you get any of these side effects while using Donepezil Aurobindo.

Serious side effects:

You must talk to your doctor immediately if you experience any of the following serious side effects . In such cases, you may need immediate medical attention.

  • Liver damage, e.g. liver inflammation ( hepatitis ). Symptoms of hepatitis includenausea or vomiting, loss of appetite, general malaise, fever, itching , yellowing of the skin and whites of the eyes and dark-colored urine (may affect up to 1 in 1,000 people).
  • Gastric ulcer . Symptoms of stomach ulcers can be stomach pain and stomach upset that is felt between the navel and the sternum (may occur in up to 1 in 100 users).
  • Bleeding and ulcers in the gastrointestinal tract. May be manifested by carbon black stools or by clearly visible bleeding from the rectum during toilet visits (may occur in up to 1 in 100 users).
  • Seizures or convulsions (may affect up to 1 in 10,000 people).
  • Fever with muscle stiffness, sweating or decreased consciousness (this is a condition called ‘malignant neuroleptic syndrome’ or ‘neuroleptic malignant syndrome’) (may affect up to 1 in 10,000 people).
  • Muscle weakness, soreness or pain, especially if you also feel sick, have a high fever or dark urine. The symptoms can be caused by an abnormal breakdown of the muscles which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis ).

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

  • diarrhea
  • nausea
  • headache

Common side effects (may affect up to 1 in 10 people):

  • muscle cramps
  • fatigue
  • insomnia (insomnia)
  • cold symptoms
  • loss of appetite
  • hallucinations (seeing or hearing things that do not exist)
  • unusual dreams including nightmares
  • restlessness
  • aggressive behavior
  • fainting
  • dizziness
  • feeling of discomfort in the stomach
  • rash
  • itching
  • difficulty keeping tight (urinary incontinence)
  • pain
  • accident (due to risk of falling)

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

  • slow heart rate
  • overproduction of saliva.

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

  • stiffness, tremors or uncontrolled movements especially of the face and tongue but also in the hands and legs

Reporting of side effects ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Donepezil Aurobindo

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”.

The expiration date is the last day of the specified month.

Blister pack: Store in the original package. Moisture sensitive.

HDPE can: Keep the HDPE can closed tightly. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is donepezil hydrochloride.Donepezil Aurobindo 5 mg film-coated tabletsEach film-coated tablet contains 5 mg donepezil hydrochloride equivalent to 4.56 mg donepezil.Donepezil Aurobindo 10 mg film-coated tabletsEach film-coated tablet contains 10 mg donepezil hydrochloride equivalent to 9.12 mg donepezil.Other ingredients areCore: Lactose monohydrate, starch , pregelatinized (maize), microcrystalline cellulose, hydroxypropylcellulose, low substituted, magnesium stearate.Shell: Hypromellose, macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172) (10 mg only)

What the medicine looks like and contents of the pack

Film-coated tablet.

Donepezil Aurobindo 5 mg film-coated tablets

White to off-white, round, biconvex film-coated tablets with ‘X’ debossed on one side and ’11’ on the other side.

Donepezil Aurobindo 10 mg film-coated tablets

Yellow, round, biconvex film-coated tablets with ‘X’ debossed on one side and ’12’ on the other side.

Donepezil Aurobindo film-coated tablets are available in blister packs and HDPE cans.

Pack sizes:

Blister pack: 14, 28, 50, 56 and 98 tablets

HDPE jar: 30, 250 and 1000 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

UK

or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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