1. What Dementile is and what it is used for  
Dementile (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 down the break down of acetylcholine.
It is used to treat the symptoms of dementia in people diagnosed as having mild and moderately severe Alzheimer’s disease. The symptoms include increasing memory loss, confusion and behavioural changes.
As a result, sufferers of Alzheimer’s disease find it more and more difficult to carry out their normal daily activities. 
Dementile is for use in adult patients only.

2. Before you take Dementile 
Do not take Dementile
If you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Dementile.
Take special care with Dementile
Tell your doctor or pharmacist before starting to take Dementile if you have or have had:
- Stomach or duodenal ulcers.
- Seizures (fits) or convulsions.
- A heart condition (irregular or very slow heart beat).
- Asthma or other long term lung disease.
- Liver problems or hepatitis.
- Difficulty passing urine or mild kidney disease.
- Cardiovascular conditions: Sick sinus syndrome or other supraventricular cardiac conduction condition, such as sinoatrial or atrioventricular block. 
There have been reports of syncope and seizures. In investigating such patients, the possibility of heart block or long sinusal pauses should be considered. There have also been post-marketing reports of QTc interval prolongation and Torsade de Pointes.
Pay attention if you have pre-existing or family history of QTc prolongation, if you have been treated with drugs affecting the QTc interval, or if you are with relevant preexisting cardiac disease (e.g. uncompensated heart failure, recent myocardial infarction, bradyarrhythmias), or electrolyte disturbances (hypokalaemia, hypomagnesaemia). Clinical monitoring (ECG) may be required.
Also tell your doctor if you are pregnant or think you might be pregnant.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine. This includes medicines that your doctor has not prescribed for you but which you have bought yourself from a chemist/pharmacist. It also applies to medicines you may take sometime in the future if you continue to take Dementile. This is because these medicines may weaken or strengthen the effects of Dementile.
Especially tell your doctor if you are taking any of the following types of medicines:
- Other Alzheimer’s disease medicines, e.g. galantamine.
- Pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen, or diclofenac sodium.
- Anticholinergics medicines, e.g. tolterodine.
- Antibiotics e.g. erythromycin, rifampicin.
- Anti-fungal medicine e.g. ketoconazole.
- Anti-depressants e.g. fluoxetine.
- Anticonvulsants e.g. phenytoin, carbamazepine.
- Medication for a heart condition e.g. quinidine, beta-blockers (propanolol and atenolol).
- Muscle relaxants e.g. diazepam, succinylcholine.
- General anaesthetic.
- Medicines obtained without a prescription e.g. herbal remedies.
- Class IA antiarrhythmics (e.g. quinidine).
- Class III antiarrhythmics (e.g. amiodarone, sotalol).
- Other antipsychotics (e.g. phenothiazine derivatives, sertindole, pimozide, ziprasidone).
- Certain antibiotics (e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin).
If you are going to have an operation that requires you to have a general anaesthetic, you should tell your doctor and the anaesthetist that you are taking Dementile. This is because your medicine may affect the amount of anaesthetic needed.
Dementile can be used in patients with kidney disease or mild to moderate liver disease. Tell your doctor first if you have kidney or liver disease. Patients with severe liver disease should not take Dementile.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed. 
Taking Dementile with food and drink
Food will not influence the effect of Dementile.
Dementile should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
Dementile should not be used while breastfeeding.
If you are pregnant, or think you might be pregnant, ask your doctor for advice before taking any medicine.
Driving and using machines
Alzheimer’s disease may impair your ability to drive or operate machinery and you must not perform these activities unless your doctor tells you that it is safe to do so.
Also, your medicine can cause tiredness, dizziness and muscle cramp. If you experience any of these effects you must not drive or operate machinery.
Important information about some of the ingredients of Dementile
This medicine contains lactose. If you have been told
by your doctor that you have intolerance to some sugars, you should contact your doctor before taking Dementile.

3. How to take Dementile
How much Dementile should you take?
Usually, you will start by taking 5 mg every night. After one month, your doctor may tell you to take 10 mg every night.
Swallow your Dementile tablet with a drink of water before you go to bed at night.
The tablet strength you will take may change depending on the length of time you have been taking the medicine and on what your doctor recommends. The maximum recommended dose is 10 mg each night.
Always follow your doctor’s, or pharmacist’s advice about how and when to take your medicine.
Do not alter the dose yourself without your doctor’s advice. 
For how long should you take Dementile?
Your doctor or pharmacist will advise you on how long you should continue to take your tablets. You will need to see your doctor from time to time to review your treatment and assess your symptoms.
If you stop taking Dementile 
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Dementile, the benefits of your treatment will gradually fade away.
If you take more Dementile than you should
Do not take more than one tablet each day. Call your doctor immediately if you take more than you should.
If you cannot contact your doctor, contact the local hospital Accident and Emergency department at once. Always take the tablets and the carton with you to the hospital so that the doctor knows what has been taken.
Symptoms of overdosing include feeling and being sick, drooling, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.
If you forget to take Dementile
If you forget to take a tablet, just take one 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 one week, call your doctor before taking any more medicine. 

4. Possible side effects
Like all medicines, Dementile can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Donepezil hydrochloride.
Tell your doctor if you have any of these effects while you are taking Dementile.
Serious side effects:
You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.
- Liver damage e.g. hepatitis. The symptoms of hepatitis are feeling or being sick, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine (affects 1 to 10 users in 10,000).
- Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (affects 1 to 10 users in 1,000).
- Bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (affects 1 to 10 users in 1,000).
- Seizures (fits) or convulsions (affects 1 to 10 users in 1,000).
Very common side effects (affects more than 1 user in 10):
- Diarrhea.
- Feeling or being sick.
- Headaches.
Common side effects (affects 1 to 10 users in 100):
- Muscle cramp.
- Tiredness.
- Difficulty in sleeping (insomnia).
- The common cold.
- Loss of appetite.
- Hallucinations (seeing or hearing things that are not really there).
- Unusual dreams including nightmares.
- Agitation.
- Aggressive behaviour.
- Fainting.
- Dizziness.
- Stomach feeling uncomfortable.
- Rash.
- Itching.
- Passing urine uncontrollably.
- Pain.
- Accidents (patients may be more prone to falls and accidental injury).
Uncommon side effects (affects 1 to 10 users in 1,000):
- Bradycardia.
Rare side effects (affects 1 to 10 users in 10,000):
- Stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs,Sino-atrial block, Atrioventricular block.
Unknown frequency (frequency cannot be measured based on the avalible data):
- Polymorphic ventricular tachycardia including Torsade de Pointes; Electrocardiogram QT interval prolonged.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 
 

5. How to store Dementile 
Keep out of rech of children.
Store below 30°C.
Shelf life: 3 years from production date imprinted on
the carton.
Do not use beyond the expiry date or if the product shows any sign of detern.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help to protect the environment.