Skip to Content

UK Edition. Click here for US version.

DONEPEZIL HYDROCHLORIDE 1MG/ML ORAL SOLUTION

Active substance(s): DONEPEZIL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Donepezil Hydrochloride 1 mg/ml Oral Solution
For use in adults
Donepezil hydrochloride
You and your caregiver should read all of this leaflet carefully before you start taking this
medicine, because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any of the side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet (see section 4).
What is in this leaflet
1. What Donepezil Hydrochloride 1 mg/ml Oral Solution is and what it is used for
2. What you need to know before you take Donepezil Hydrochloride 1 mg/ml Oral Solution
3. How to take Donepezil Hydrochloride 1 mg/ml Oral Solution
4. Possible side effects
5. How to store Donepezil Hydrochloride 1 mg/ml Oral Solution
6. Contents of the pack and other information

1. What Donepezil Hydrochloride 1 mg/ml 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 1 mg/ml Oral Solution is for use in adult patients only.

2. What you need to know before you take Donepezil
Hydrochloride 1 mg/ml Oral Solution
Do not take Donepezil Hydrochloride 1 mg/ml Oral Solution:
if you are allergic to donepezil hydrochloride, or to piperidine derivatives, or any of the
other ingredients of this medicine listed in section 6



Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil Hydrochloride 1 mg/ml Oral
Solution if you have ever had:
1









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
inherited intolerance of a sugar known as fructose

Also tell your doctor if you are pregnant or think you might be pregnant.
Children and adolescents
Donepezil Hydrochloride 1 mg/ml Oral Solution is not recommended for use in children and
adolescents below the age of 18 years.
Other medicines and Donepezil Hydrochloride 1 mg/ml 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 sometimes in the
future if you continue to take Donepezil Hydrochloride 1 mg/ml Oral Solution. This is because
these medicines may weaken or strengthen the effects of Donepezil Hydrochloride 1 mg/ml
Oral Solution.
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 (propranolol and atenolol)
muscle relaxants e.g. diazepam, succinylcholine
general anaesthetic
medicines obtained without a prescription e.g. herbal remedies.

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 1 mg/ml Oral
Solution. This is because Donepezil Hydrochloride 1 mg/ml Oral Solution may affect the
amount of anaesthetic needed.
Donepezil Hydrochloride 1 mg/ml 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 1 mg/ml 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 1 mg/ml Oral Solution with food, drink and alcohol
2

Food will not influence the effect of Donepezil Hydrochloride 1 mg/ml Oral Solution.
Donepezil Hydrochloride 1 mg/ml Oral Solution should not be taken with alcohol because
alcohol may change its effect.
Pregnancy, breast-feeding and fertility
Donepezil Hydrochloride 1 mg/ml Oral Solution should 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.
Donepezil Hydrochloride 1 mg/ml Oral Solution contains sorbitol, methyl
parahydroxybenzoate and sodium metabisulphite.
This medicine contains:
• sorbitol (E 420) – if you have been told by your doctor that you have intolerance to
some sugars, contact your doctor before taking this medicinal product. Sorbitol is a
source of fructose. A 5 ml dose of Donepezil Hydrochloride 1 mg/ml Oral Solution
supplies 1.25 g of sorbitol and a 10 ml dose of Donepezil Hydrochloride 1 mg/ml Oral
Solution supplies 2.5 g of sorbitol.
• methyl parahydroxybenzoate (E 218) which may cause allergic reactions (possibly
delayed).
• sodium metabisulphite (E 223) which may rarely cause hypersensitivity reactions and
bronchospasm.

3. How to take Donepezil Hydrochloride 1 mg/ml
Oral Solution
How much Donepezil Hydrochloride 1 mg/ml Oral Solution should you take?
Usually, you will start by taking 5 ml every night. After one month, your doctor may tell you to
take 10 ml every night. To take a 5 ml dose pour the liquid into the dosing spoon to the line of
5 ml. To take a 10 ml dose pour the liquid into the dosing spoon to the line of 10 ml. The
amount of Donepezil Hydrochloride 1 mg/ml Oral Solution 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 10 ml 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.

3

Route and method of administration
Donepezil Hydrochloride 1 mg/ml Oral Solution should be taken orally in the evening just prior
to retiring.
For how long should you take Donepezil Hydrochloride 1 mg/ml 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 take more Donepezil Hydrochloride 1 mg/ml 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 1 mg/ml 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.
If you stop taking Donepezil Hydrochloride 1 mg/ml Oral Solution
Do not stop taking Donepezil Hydrochloride 1 mg/ml Oral Solution unless told to do so by your
doctor. If you stop taking Donepezil Hydrochloride 1 mg/ml Oral Solution the benefits of your
treatment will gradually fade away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 by people taking Donepezil Hydrochloride
1 mg/ml Oral Solution.
Tell your doctor if you have any of these effects while you are taking Donepezil Hydrochloride
1 mg/ml 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.
• 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 (probably affecting fewer than 1 in 1,000)


stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort
(indigestion) felt between the navel and the breast bone (probably affecting fewer than
in 100)



bleeding in the stomach or intestines. This may cause you to pass black tar like stools or
visible blood from the rectum (probably affecting fewer than 1 in 100)

4



seizures (fits) or convulsion (probably affecting fewer than 1 in 100)



fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder
called “Neuroleptic Malignant Syndrome) (probably affecting fewer than 1 in 10,000
people)
Muscle weakness, tenderness or pain and particularly, if at the same time, you feel
unwell, have a high temperature or have dark urine. They may be caused by an
abnormal muscle breakdown which can be life threatening and lead to kidney problems
(a condition called rhabdomyolysis).



Very common side effects (probably affecting more than 1 in 10):
• diarrhoea
• feeling or being sick
• headaches
Common side effects (probably affecting up to 1 in 10)
• 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 (probably affecting fewer than 1 in 100)
• slow heart beat
Rare side effects (probably affecting fewer than 1 in 1,000)
• stiffness, shaking or uncontrollable movement especially of the face and tongue but also
of the limbs.
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 via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Donepezil Hydrochloride 1 mg/ml
Oral Solution

5








Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions.
Once the bottle is opened, use within 2 months. You may find it helpful to write the date
you first opened the bottle in the space provided on the bottle label.
Do not use this medicine after the expiry date which is stated on the label after EXP. The
expiry date refers to the last day of that month.
If your doctor tells you to stop taking your medicine, you should return any you have not
used to your pharmacist.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Donepezil Hydrochloride 1 mg/ml Oral Solution contains?
The active substance is donepezil hydrochloride.
• 5 ml of Donepezil Hydrochloride 1 mg/ml Oral Solution contain 5 mg of donepezil
hydrochloride
• 10 ml of Donepezil 1 mg/ml Oral Solution contain 10 mg of donepezil hydrochloride
• Each 5 ml dose contains 1.25 g of sorbitol.
The other ingredients are sorbitol solution (E 420), hydroxyethyl cellulose, sodium benzoate
(E 211), methyl parahydroxybenzoate (E 218), propylene glycol (E 1520), sodium
metabisulphite (E 223), strawberry flavour, HCI sol 10 %, purified water.
What Donepezil Hydrochloride 1 mg/ml Oral Solution looks like and contents of the pack?
Donepezil Hydrochloride 1 mg/ml Oral Solution is a clear colourless liquid with a strawberry
flavour.
Donepezil Hydrochloride 1 mg/ml Oral Solution is available in one strength of 1 mg/ml and is
supplied in bottles of 150 ml. The package also includes a 10 ml dosing spoon with intermediate
graduations of 5 and 10 ml.
Marketing Authorisation Holder
Lamda Laboratories SA
59 Ioannou Metaxa Street
Karellas
Koropi
GR-19400
Greece
Manufacturer
Rafarm SA
Thesi Pousi-Xatzi
Agiou Louka Street
Paiania Attikis
GR-19002
Greece
For any information about this medicinal product, please contact the Marketing Authorisation
Holder, details provided above.

6

This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom
Donepezil Hydrochloride 1 mg/ml oral solution
Germany
Donepezilhydrochlorid Lamda 1 mg/ml Lösung zum Einnehmen
This leaflet was last revised in 03/2016.

7

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide