Donepezil Hydrochloride 2mg/Ml Oral Solution
B. PACKAGE LEAFLET
Package leaflet: Information for the user
Donepezil Hydrochloride 2mg/ml Oral Solution
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 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 Oral solution is and what it is used for
2. What you need to know before you take Donepezil Oral Solution
3. How to take Donepezil Oral Solution
4. Possible side effects
5. How to store Donepezil Oral Solution
6. Contents of the pack and other information
1. What Donepezil Oral Solution is and what it is used for
• Donepezil Hydrochloride 2 mg/ml Oral Solution (referred to in this leaflet as Donepezil Oral Solution) contains the active ingredient Donepezil Hydrochloride. It belongs to a group of medicines called acetylcholinesterase inhibitors. These work by slowing the breakdown of acetylcholine (a substance in the brain involved in memory function).
• Donepezil Oral solution 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 Oral Solution is for use in adult patients only.
2. What you need to know before you take Donepezil Oral Solution Do NOT take Donepezil Oral Solution:
- if you are allergic to (hypersensitive) 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 Oral Solution if you have ever had:
• a heart condition (irregular or very slow heart beat)
• stomach or duodenal ulcers
• difficulty passing urine or mild kidney disease
• seizures (fits) or convulsions
• asthma or other long term lung disease
• liver problems or hepatitis
• inherited intolerance of a sugar known as fructose
• This medicine can be used in patients with kidney disease or mild to moderate liver disease. You must tell your doctor if you have kidney or liver disease. Patients with severe liver disease should not take this medicine.
• 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 Oral Solution. This is because your anaesthetist may have to adjust the amount of anaesthetic you are given.
Children and adolescents
Donepezil Oral Solution is not recommended for use in children.
Other medicines and Donepezil Oral Solution
• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription, including herbal remedies. You should tell your doctor because other medicines can alter the effectiveness of Donepezil Oral Solution.
In particular you must tell your doctor or pharmacist if you are taking any of the following medicines:
• other medicines used to treat Alzheimer e.g. galantamine or rivastigmine
• pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen or diclofenac sodium
• anticholinergic medicines used to treat a variety of conditions such as asthma, incontinence, stomach cramps, incontinence and Parkinson’s disease e.g. tolterodine
• antibiotics e.g. erythromycin, rifampicin
• medicines used to treat fungal infections e.g. ketoconazole
• anti-depressants e.g. fluoxetine
• medicines used to treat seizures (fits) known as 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 (see warnings and precautions subsection)
Donepezil Oral Solution with food, drink and alcohol
• Donepezil Oral Solution should not be taken with alcohol because the alcohol may reduce this medicine’s effectiveness.
Pregnancy and breast-feeding
• This medicine should not be used during pregnancy. 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
• This medicine should not be used whilst breastfeeding.
Driving and using machines
• Alzheimer’s disease may affect your ability to drive or operate machinery safely and you must not do either of these activities unless your doctor tells you that it is safe for you to do so.
• This medicine can cause tiredness, dizziness and muscle cramp. Even if your doctor has advised that you can continue to drive or operate machinery, if you experience any of these effects you must not drive or operate machinery.
Donepezil Oral Solution contains E420 (sorbitol) E218 and E223
This medicine contains:
• sorbitol (E420) - if you have been told by your doctor that you have an intolerance to some sugars (e.g. fructose), contact your doctor before taking this medicinal product.
• methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed)
• sodium metabisulphite (E223) which may rarely cause hypersensitivity reactions and bronchospasm
3. How to take Donepezil Oral Solution
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• The recommended starting dose is 2.5ml (equivalent to 5mg donepezil hydrochloride)
• After the first month your doctor will review your treatment and may increase your dose to 5ml each day(equivalent to 10mg donepezil hydrochloride)
• The maximum recommended daily dose is 5ml (equivalent to 10mg donepezil hydrochloride)
Directions for use
• Unless otherwise prescribed by your doctor you should take this medicine just before bedtime
• Use the dosage spoon supplied in the carton with this medicine
• Measure out the amount of medicine prescribed for you using either the 2.5ml or 5ml dosage line marked on the spoon and then swallow it, (remember to clean the spoon after use)
• This medicine is not affected by food which means this medicine can be taken with food or a bedtime
drink if required (but not alcohol)
If you take more Donepezil Oral Solution than you should
• If you take more of this medicine than you have been prescribed consult your doctor or seek medical advice immediately. If possible, show them the bottle and this leaflet so they know what you have taken.
• Symptoms of an overdose 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 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, talk to your doctor before you start taking this medicine again
If you stop taking Donepezil Oral Solution
• Your doctor will continue to prescribe you this medicine for as long as you are benefiting from it
• Do not stop taking this medicine unless told to do so by your doctor.
• If you stop taking Donepezil 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 this medicine.
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 (may affect up to 1 in 1,000 people)
• stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (may affect up to 1 in 100 people)
• bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (may affect up to 1 in 100 people)
• seizures (fits) or convulsion (affects fewer than 1 in 100)
• fever with muscle stiffness, sweating or a lowered level of consciousness ( a disorder called “Neuroleptic Malignant Syndrome) (may affect up to 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).
Tell your doctor if you have any of the following side effects while you are taking this medicine
Very common side effects (may affect more than 1 in 10 people):
• diarrhoea
• feeling sick
• headaches
Common side effects (may affect up to 1 in 10 people)
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia)
• the common cold
• loss of appetite
• hallucinations (seeing or hearing things that are not really there)
• agitation
• aggressive behaviour
• fainting
• dizziness
• being sick
• stomach feeling uncomfortable
• rash
• itching
• passing urine uncontrollably
• pain
• accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (may affect up to 1 in 100 people)
• slow heart beat
Rare side effects (may affect up to 1 in 1,000 people)
• stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs.
• unusual (abnormal) heart beat
You should tell your doctor if you notice any other side effects not listed in this leaflet while you are taking Donepezil Hydrochloride 2mg/ml 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 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 Oral solution
• 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 do not store above 25 °C and use within 2 months.
• Do not use this medicine after the expiry date that 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 pharmacy
• Do not throw away any medicines via wastewater or household waste. 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 Oral Solution contains
• The active substance is donepezil hydrochloride. Each 5ml dose contains 10mg of the active ingredient Donepezil Hydrochloride.
Each 5 ml dose contains 2.5 g of sorbitol.
The other ingredients are sorbitol 70 % solution (E 420), hydroxyethyl cellulose, sodium benzoate (E 211), methyl parahydroxybenzoate (E 218), propylene glycol (E 1520), sodium metabisulphite (E 223), strawberry flavour, HCl sol 10 % and purified water.
What Donepezil Oral Solution looks like and contents of the pack
Donepezil Oral Solution is a clear colourless liquid with a strawberry smell and flavour Donepezil Oral Solution is available in one strength of 2mg/ml and is supplied in a 150ml amber glass bottle with a child resistant cap.
Each carton contains one 150ml bottle and one 5ml dosing spoon.
Marketing Authorisation Holder
Colonis Pharma Limited Hanover Place, 8 Church Road Royal Tunbridge Wells, Kent TN1 1JP, United Kingdom
Manufacturer
Rafarm SA,
Thesi Pousi-Xatzi,
Agiou Louka,
Paiania Attiki,
TK19002,
T0 37,
Greece
Marketed and Distributed by
Quantum Pharmaceutical Hobson Industrial Estate Burnopfield, County Durham NE16 6EA, United Kingdom