Consumer medicine information

Aridon APN 5, 10

Donepezil hydrochloride

BRAND INFORMATION

Brand name

Aridon APN

Active ingredient

Donepezil hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Aridon APN 5, 10.

ARIDON APN 5, 10

ARIDON APN 5, 10

 Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

 1. Why am I using ARIDON APN?

ARIDON APN contains the active ingredient donepezil hydrochloride. ARIDON APN is used to treat mild, moderate and severe Alzheimer's disease, also called dementia of the Alzheimer's type.

For more information, see Section 1. Why am I using ARIDON APN? in the full CMI.

 2. What should I know before I use ARIDON APN?

Do not use if you have ever had an allergic reaction to ARIDON APN or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ARIDON APN? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with ARIDON APN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

 4. How do I use ARIDON APN?
  • The usual starting dose is one ARIDON APN 5 mg tablet each day
  • After one month, your doctor will assess your response and may increase your dose to one ARIDON APN 10 mg tablet each day.

More instructions can be found in Section 4. How do I use ARIDON APN? in the full CMI.

 5. What should I know while using ARIDON APN?

Things you should do
  • Remind any doctor or dentist you visit that you are using ARIDON APN.
Things you should not do
  • Do not stop taking your medicine or change the dosage without checking with your doctor first.
Driving or using machines
  • ARIDON APN may cause fatigue, dizziness and muscle cramps, especially at the start of treatment.
  • Be careful driving or operating machinery until you know how ARIDON APN affects you.
  • Alzheimer's disease may affect your ability to drive or operate machinery.
  • Ask your doctor whether it is safe for you to continue to drive or operate machinery.
Looking after your medicine
  • Keep your tablets in their blister pack until it is time to take them.
  • Keep your tablets in a cool, dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using ARIDON APN? in the full CMI.

 6. Are there any side effects?

Common side effects include heartburn, indigestion, stomach pain, headache, dizziness, difficulty in sleeping, unusual tiredness, feeling sick, diarrhoea, vomiting, loss of appetite, weight loss, bruising, muscle cramps, joint pain, tingling or numbness of the hands or feet, depression, unusual dreams, agitation, aggressive behaviour, difficulty in urinating or passing urine more often.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

ARIDON APN 5, 10

Active ingredient(s): donepezil hydrochloride (doe-knee-pra-zeal hi-dro-claw-ride)

 Consumer Medicine Information (CMI)

This leaflet provides important information about using ARIDON APN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ARIDON APN.

Where to find information in this leaflet:

1. Why am I using ARIDON APN?
2. What should I know before I use ARIDON APN?
3. What if I am taking other medicines?
4. How do I use ARIDON APN?
5. What should I know while using ARIDON APN?
6. Are there any side effects?
7. Product details

 1. Why am I using ARIDON APN?

ARIDON APN contains the active ingredient donepezil hydrochloride. ARIDON APN is an acetylcholinesterase inhibitor. They are thought to work by increasing the level of a chemical called acetylcholine in the brain.

ARIDON APN is used to treat mild, moderate and severe Alzheimer's disease, also called dementia of the Alzheimer's type. ARIDON APN will not cure the disease, but should help your memory and improve your ability to think more clearly.

 2. What should I know before I use ARIDON APN?

Warnings

Do not use ARIDON APN if:

  1. you are allergic to donepezil hydrochloride, piperidine derivatives, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
  1. the expiry date on the pack has passed
  2. the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • have any allergies to any other medicines, foods, preservatives or dyes
  • have any other medical conditions, including
    - heart problems (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
    - a heart condition called ‘prolonged QT interval’ or a history of certain abnormal heart rhythms called Torsade de Pointes or if anyone in your family have ‘prolonged QT interval’
    - low levels of magnesium or potassium in your blood
    - stomach problems, particularly gastric or duodenal ulcer
    - seizures or fits
    - asthma or obstructive lung disease
    - loss of memory or other mental capacity due to stroke or blood vessel problems
    - tendencies toward aggressive behaviour.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Children

ARIDON APN is not recommended for use in children.

The safety and effectiveness of ARIDON APN in children has not been established.

 3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with ARIDON APN and affect how it works.

Tell your doctor or pharmacist if you are taking any medicines for any other condition, including

  • any other medicine for dementia
  • medicines used to relieve stomach cramps or spasms, Parkinson's disease or travel sickness
  • medicines used to relax muscles
  • medicines used in general anaesthesia
  • anti-fungal medicines e.g. ketoconazole
  • medicines for bacterial infections e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
  • dexamethasone, a corticosteroid medicine
  • medicines for heart rhythm problems e.g. amiodarone, sotalol
  • medicines for depression e.g. citalopram, escitalopram, amitriptyline, fluoxetine
  • medicines for psychosis e.g. pimozide, sertindole, ziprasidone
  • medicines used to treat
    - difficulty in passing urine
    - arthritis, pain or inflammation known as non-steroidal anti-inflammatory drugs (NSAIDs)
    - high blood pressure or fast heartbeat
    - asthma
    - diarrhoea
    - epilepsy - carbamazepine, phenobarbitone or phenytoin.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ARIDON APN.

 4. How do I use ARIDON APN?

How much to take

  • the usual starting dose for ARIDON APN is one 5 mg tablet each day.
  • after 1-month, your doctor will assess your response and may increase your dose to one ARIDON APN 10 mg tablet each day.
  • depending on your condition and how you react to the medicine, your doctor may ask you to take a different dose.

Follow the instructions provided with the medicine. Do not exceed the recommended dosage.

When to take / use ARIDON APN

  • Take your medicine every night just before you go to bed.
  • Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How to take ARIDON APN

  • Swallow the tablets whole with a full glass of water.
  • ARIDON APN can be taken with or without food.
  • Continue taking your medicine for as long as your doctor tells you.
  • This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
  • It may take several weeks for your medicine to take effect, so do not be discouraged if you do not see an improvement straight away.

If you forget to use ARIDON APN

If you forget to take a tablet, just take one tablet the following day at the usual time then continue as normal.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you forget to take your medicine for more than 1-week, call your doctor before taking any more.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much ARIDON APN

If you think that you have used too much ARIDON APN, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

 5. What should I know while using ARIDON APN?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using ARIDON APN.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you should not do

Do not take this medicine to treat any other complaints unless your doctor says to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or change the dosage without checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ARIDON APN affects you.

This medicine may cause fatigue, dizziness and muscle cramps especially at the start of treatment or if the dose is increased. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

In addition, Alzheimer's disease may affect your ability to drive or operate machinery. Ask your doctor whether it is safe for you to continue to drive or operate machinery.

Looking after your medicine

Keep your tablets in their blister pack until it is time to take them.

If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool, dry place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

 6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Less serious side effectsWhat to do
  • heartburn, indigestion, or stomach pain
  • headache or dizziness
  • difficulty in sleeping
  • unusual tiredness
  • feeling sick, diarrhoea, vomiting,
  • loss of appetite, weight loss
  • bruising
  • muscle cramps, joint pain
  • tingling or numbness of the hands or feet
  • depression, unusual dreams
  • agitation, aggressive behaviour
  • difficulty in urinating or passing urine more often
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • seeing, feeling or hearing things that are not there
  • trembling and shaking of the hands and fingers, shuffling walk and stiffness of the arms and legs
  • severe upper stomach pain, often with nausea, vomiting and fever
  • changes in the heart activity which can be seen on an electro-cardiogram (ECG) called ‘prolonged QT interval’
  • fast irregular heartbeat, fainting which could be the symptoms of a life-threatening condition known as Torsade de Pointes
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very serious side effects

Very serious side effectsWhat to do
  • any breathing difficulties
  • sudden signs of allergy such as rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing.
  • vomiting blood or material that looks like coffee grounds
  • black sticky bowel motions (stools)
  • convulsions or fits
  • weakness, shortness of breath, yellowing of the skin, dark brown urine and stomach pain
  • sudden increase in body temperature, sweating, muscle stiffness, or altered consciousness (awareness of oneself and ones surrounding)
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

 7. Product details

This medicine is only available with a doctor's prescription.

What ARIDON APN contains

Active ingredient
(main ingredient)		donepezil hydrochloride
Other ingredients
(inactive ingredients)
  • lactose monohydrate
  • maize starch
  • microcrystalline cellulose
  • hyprolose
  • magnesium stearate
  • OPADRY Complete Film-coating system OY-38951 White (ARTG no. 106399 [5mg tablet only]
  • OPADRY Complete Film-coating system 03B32654 Yellow (ARTG 106398) [10mg tablet only]
Potential allergensContains sugars as lactose.

Do not take this medicine if you are allergic to any of these ingredients.

What ARIDON APN looks like

ARIDON APN 5 mg: White to off-white, round, bevelled edge, biconvex, film coated tablets with inscription "5" on one side and plain on other side. (AUST R 167193)

ARIDON APN 10 mg: Yellow, round, biconvex, film coated tablets with inscription "10" on one side and plain on other side. (AUST R 167190)

ARIDON APN are presented in blister packs containing 28 tablets.

Who distributes ARIDON APN

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in November 2023

Published by MIMS December 2023

BRAND INFORMATION

Brand name

Aridon APN

Active ingredient

Donepezil hydrochloride

Schedule

S4

 

1 Name of Medicine

Donepezil hydrochloride.

2 Qualitative and Quantitative Composition

Donepezil hydrochloride is a specific and reversible inhibitor of the enzyme acetylcholinesterase.
Aridon APN tablets come in two strengths and contain either 5 mg or 10 mg of donepezil hydrochloride.
Excipients with known effect. Contains sugars as (lactose).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Aridon APN 5 are white to off-white, round, bevelled edge, biconvex, film coated tablets with inscription "5" on one side and plain on other side.
Aridon APN 10 are yellow, round, biconvex, film coated tablets with inscription "10" on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterised by severe nausea, vomiting, miosis, lacrimation, salivation, sweating, flushing, bradycardia, involuntary urination and/or defecation, bronchospasm, increased bronchial secretions, respiratory depression, collapse and convulsions/seizures. Hypotension following overdose could be severe leading to cardiovascular collapse or shock. Abdominal pain, diarrhoea, increased micturition, diaphoresis, vertigo, fasciculations, tremors, agitation, lethargy, syncope and coma may occur. Various dysrhythmias, primarily heart block, may theoretically occur due to cholinergic effects. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Due to its high degree of selectivity for AChE in the CNS and less peripheral selectivity, overdoses would be expected to exhibit more CNS-related symptomatology, including extrapyramidal effects.
Overdoses of 45 mg and 50 mg in two elderly patients resulted in minimal effects, predominately gastrointestinal, and in one case persistent bradycardia (HR in the 40's) both with uneventful recoveries.
As in any case of overdose, general supportive measures should be utilised. Cholinesterase activity may be depressed and should be monitored in plasma (pseudocholinesterase) and red blood cells. Monitor ECG following significant exposures. Monitor pulse oximetry and/or arterial blood gases and obtain a chest radiograph in patients with pulmonary symptoms. Tertiary anticholinergics such as atropine may be used as an antidote for donepezil hydrochloride overdosage. Intravenous atropine sulphate titrated to effect is recommended: an initial dose of 1.0 to 2.0 mg IV with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated charcoal is most effective when administered within one hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. It is not known whether donepezil and/or its metabolites can be removed by dialysis (haemodialysis, peritoneal dialysis, or haemofiltration). Emesis is not recommended because of the potential for CNS depression and seizures.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

It has been demonstrated that Alzheimer's disease is associated with a relative decrease in the activity of the cholinergic system in the cerebral cortex and other areas of the brain. Studies suggest that donepezil hydrochloride exerts its therapeutic effect by enhancing cholinergic function in the central nervous system. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of acetylcholinesterase.

5.3 Preclinical Safety Data

Genotoxicity. Donepezil was not mutagenic in reverse mutation assays in bacteria or in the mouse lymphoma forward mutation assay in vitro. Donepezil did not induce unscheduled DNA synthesis in rat primary hepatocyte cultures following oral dosing of the animals. In the chromosome aberration test in cultures of Chinese hamster lung cells, some clastogenic effects were observed. Donepezil was not clastogenic in the in vivo mouse micronucleus test.
Carcinogenicity. No evidence of carcinogenicity was found in long-term studies in mice and rats with dietary dosing of donepezil resulting in peak plasma concentrations of up to 17 times and 6-19 times, respectively, that in humans at the recommended clinical dose of 10 mg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane.
Chemical structure. Chemical name: (RS)-1-benzyl-4- [5,6-dimethoxy-1-indanon)-2-yl] -methylpiperidine hydrochloride.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDONEPE.gif Molecular formula: C24H29NO3HCl.
Molecular weight: 415.96.
CAS number. 120011-70-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ARIAPNST.gif