Active ingredient
- donepezil hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0223.
Donepezil Hydrochloride 1mg/1ml Oral Solution
Package leaflet: Information for the user
Donepezil Hydrochloride 1mg/1ml Oral Solution
You and your caregiver should read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
What is in this leaflet:
1. What Donepezil Hydrochloride 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Donepezil Hydrochloride 1mg/1ml Oral Solution
3. How to take Donepezil Hydrochloride 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Donepezil Hydrochloride 1mg/1ml Oral Solution
6. Contents of the pack and other information
1. What Donepezil Hydrochloride 1mg/1ml Oral Solution is and what it is used for
Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat the symptoms of dementia in people diagnosed as having mild to 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.
Donepezil Hydrochloride 1mg/1ml Oral Solution is for use in adult patients only.
2. What you need to know before you take Donepezil Hydrochloride 1mg/1ml Oral Solution
Do not take Donepezil Hydrochloride 1mg/1ml Oral Solution:
Warnings and precautions:
Talk to your doctor or pharmacist before taking Donepezil Hydrochloride 1mg/1ml Oral Solution if you have ever had:
Also tell your doctor if you are pregnant or think you might be pregnant.
Children and adolescents
Donepezil Hydrochloride 1mg/1ml Oral Solution is not recommended for use in children and adolescents (younger than 18 years of age).
Other medicines and Donepezil Hydrochloride 1mg/1ml Oral Solution
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 Donepezil Hydrochloride 1mg/1ml Oral Solution. This is because these medicines may weaken or strengthen the effects of Donepezil Hydrochloride 1mg/1ml Oral Solution.
Especially tell your doctor if you are taking any of the following types of medicines:
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 Donepezil Hydrochloride 1mg/1ml Oral Solution. This is because Donepezil Hydrochloride 1mg/1ml Oral Solution may affect the amount of anaesthetic needed.
Donepezil Hydrochloride 1mg/1ml Oral Solution 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 Donepezil Hydrochloride 1mg/1ml Oral Solution.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
Donepezil Hydrochloride 1mg/1ml Oral Solution with food, drink and alcohol
Food will not influence the effect of Donepezil Hydrochloride 1mg/1ml Oral Solution.
Donepezil Hydrochloride 1mg/1ml Oral Solution should not be taken with alcohol because alcohol may change its effect.
Pregnancy, breast-feeding and fertility
Donepezil Hydrochloride 1mg/1ml Oral Solution must not be used while breastfeeding. If you are pregnant, think you might be pregnant or are planning to have a baby, 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 Donepezil Hydrochloride 1mg/1ml Oral Solution.
This medicine contains:
3. How to take Donepezil Hydrochloride 1mg/1ml Oral Solution
How much Donepezil Hydrochloride 1mg/1ml Oral Solution should you take?
Usually, you will start by taking 5ml every night. After one month, your doctor may tell you to take 10ml every night. To take a 5ml dose pour the liquid into the dosing spoon to the line of 5ml. To take a 10ml dose pour the liquid into the dosing spoon to the line of 10ml. The amount of Donepezil Hydrochloride 1mg/1ml you will take may change depending on the length of time you have been taking this medicine and on what your doctor recommends.
The maximum recommended dose is 10ml each night. After taking your dose you should wash the dosing spoon with water and leave to air dry.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not alter the dose yourself without your doctor’s advice.
Route and method of administration
Donepezil Hydrochloride 1mg/1ml Oral Solution should be taken orally in the evening just prior to retiring.
For how long should you take Donepezil Hydrochloride 1mg/1ml Oral Solution?
Your doctor or pharmacist will advise you on how long you should continue to take your medicine. You will need to see your doctor from time to time to review your treatment and assess your symptoms.
If you stop taking Donepezil Hydrochloride 1mg/1ml Oral Solution
Do not stop taking Donepezil Hydrochloride 1mg/1ml Oral Solution unless told to do so by your doctor. If you stop taking Donepezil Hydrochloride 1mg/1ml Oral Solution the benefits of your treatment will gradually fade away.
If you take more Donepezil Hydrochloride 1mg/1ml Oral Solution than you should
DO NOT take more medicine than your doctor has told you to. 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 bottle 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 Donepezil Hydrochloride 1mg/1ml Oral Solution
If you forget to take your medicine, just take your normal dose of medicine the following day at the usual time. Do not take a double dose to make up for a forgotten dose. If you forget to take your medicine for more than one week, call your doctor before taking any more.
4. Possible side effects
Like all medicines, Donepezil Hydrochloride 1mg/1ml Oral Solution can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking Donepezil Hydrochloride 1mg/1ml Oral Solution.
Tell your doctor if you have any of these effects while you are taking Donepezil Hydrochloride 1mg/1ml Oral Solution.
Serious side effects
You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.
Very common side effects (probably affecting more than 1 in 10):
Common side effects (probably affecting up to 1 in 10)
Uncommon side effects (probably affecting fewer than 1 in 100)
Rare side effects (probably affecting fewer than 1 in 1000)
You should tell your doctor if you notice any other side effects not listed in this leaflet while you are taking Donepezil Hydrochloride 1mg/1ml Oral Solution.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of the medicines.
United Kingdom
5. How to store Donepezil Hydrochloride 1mg/1ml Oral Solution
6. Contents of the pack and other information
What Donepezil Hydrochloride 1mg/1ml Oral Solution contains?
The active substance is donepezil hydrochloride.
What does Donepezil Hydrochloride 1mg/1ml Oral Solution look like?
Donepezil Hydrochloride 1mg/1ml Oral Solution is a clear colourless liquid with a strawberry odour.
What is in a pack of Donepezil Hydrochloride 1mg/1ml Oral Solution?
Donepezil Hydrochloride 1mg/1ml Oral Solution is available in one strength of 1mg/1ml and is supplied in bottles of 150ml. The package also includes a 10ml dosing spoon.
Marketing Authorisation Holder
Manufacturer:
1.
or
2.
(alternative manufacturer)
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom Donepezil Hydrochloride 1mg/1ml Oral Solution
Greece Rafazil 1mg/ml oral solution
Cyprus Rafazil 1mg/ml oral solution
This leafiet was last revised in June 2018.
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