Donepezil Hydrochloride 5 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Donepezil hydrochloride 5 mg Film-coated tablets Donepezil hydrochloride 10 mg Film-coated tablets
The medicine will be referred to as Donepezil tablets throughout the remainder of the leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
• Keep this leaflet. You may need to read it again.
• If you have any furtherquestions, 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 tablets are and what they are used for
2. What you need to know before you take Donepezil tablets
3. How to take Donepezil tablets
4. Possible side effects
5. How to store Donepezil tablets
6. Contents of the pack and other information
1. What Donepezil tablets are and what they are used for
Donepezil tablets contain the active substance donepezil and tablets belong 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.
Donepezil tablets are for use in adult patients only.
2. What you need to know before you take Donepezil tablets_
Do not take Donepezil tablets
• if you are allergic to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of face, lips, or hands/feet, or breathing difficulties.
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil tablets if you have or have had:
• stomach or duodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow heart beat)
• asthma orotherlong term lung disease
• liver problems or hepatitis. Donepezil tablets can be used in patients with mild to moderate liver disease. No data are available to recommend the use of donepezil tablets in severe liver disease.
• difficulty passing urine or kidney disease. However, Donepezil tablets can be used in patients with kidney disease.
• any involuntary or abnormal movements of the tongue, face or body (extrapyramidal symptoms). Donepezil may induce or exacerbate extrapyramidal symptoms.
Children and adolescents.
Donepezil tablets are not recommended for use in children and adolescents.
Other medicines and Donepezil tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 tablets. This is because these medicines may weaken or strengthen the effects of Donepezil tablets.
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. acetylsalicylic acid, non-steroidal antiinflammatory (NSAID) drugs such as ibuprofen, or diclofenac sodium
• anticholinergics medicines, e.g. tolterodine
• antibiotics e.g. erythromycin, rifampicin
• anti-fungal medicine e.g. ketoconazole, itraconazole
• 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
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 tablets. This is because your medicine may affect the amount of anaesthetic needed.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as prescribed.
Donepezil tablets with food, drink and alcohol
Food will not influence the effect of Donepezil tablets.
Donepezil tablets should not be taken with alcohol because alcohol may reduce its effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Donepezil tablets should not be used while breastfeeding.
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 tablets contains lactose
Donepezil tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HowtotakeDonepezilTablets_
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much Donepezil tablets should you take?
Usually, you will start by taking 5 mg of donepezil hydrochloride every night. After one month, your doctor may tell you to take 10 mg of donepezil hydrochloride every 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.
Children and adolescents.
This medicine is not recommended for use in children and adolescents.
Taking yourmedicine
Oral use
Swallow your Donepezil tablet with a drink of water before you go to bed at night.
For how long should you take Donepezil tablets?
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 take more Donepezil tablets 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 Donepezil tablets
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 fora forgotten tablet.
If you forget to take your medicine for more than one week, call your doctor before taking any more medicine.
If you stop taking Donepezil tablets
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil hydrochloride tablets, the benefits of your treatment will gradually fade away.
If you have any further questions on the use of this medicine, askyourdoctororpharmacist.
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 tablets.
Tell your doctor if you have any of these effects while you are taking Donepezil tablet(s)
Serious side effects
You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.
Uncommon (may affect up to 1 in 100 people):
• Seizures (fits) or convulsions
• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breastbone
• Bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum
Rare (may affect up to 1 in 1000 people):
• Slow heart rate associated with dizziness, weakness, confusion
• 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
Very rare (may affect up to 1 in 10,000 people):
• Fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome")
• 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)
Other side effects
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 (anorexia)
• hallucinations (seeing or hearing things that are not really there)
• unusual dreams including nightmares
• agitation
• aggressive behaviour
• fainting
• dizziness
• stomach feeling uncomfortable, being sick (vomiting)
• 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
• minor increase in serum concentration of muscle creatine kinase
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
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. Howto store Donepezil tablets_
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
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 tablets contains
The active substance is donepezil hydrochloride:
5mg
Each tablet contains 5mg donepezil hydrochloride, equivalent to 4.56mg of donepezil.
10mg
Each tablet contains 10mg donepezil hydrochloride, equivalent to 9.12 mg donepezil.
The other ingredients are: Core- Lactose monohydrate, Maize starch, Hydroxypropyl cellulose, Microcrystalline cellulose, Sodium starch glycolate (type A), Magnesium stearate. Coating- Opadry yellow contains Hypromellose 5cP (E464), Titanium dioxide (E171), Macrogol 400, Talc, Iron Oxide Yellow (E172)
What Donepezil tablets look like and contents of the pack
Donepezil hydrochloride 5mg Film-coated tablets are yellow coloured, circular, biconvex film coated tablets debossed with 'RC25' on one side
Donepezil hydrochloride 10mg Film-coated tablets are yellow coloured, capsule shaped film coated tablets debossed with 'RC' & '26' on either side of the score line.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Product is available in blister packs of:
5 mg: 7, 28, 30, 56, 98, and 100 film-coated tablets
10 mg: 28, 30, 56, 98, and 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited 5th floor, Hyde Park, Hayes 3
11 Millington Road Hayes, UB34AZ United Kingdom
Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue87
2132JHHoofddorp
The Netherlands
TerapiaSA 124 Fabricii Street 400632, Cluj Napoca Romania
This leaflet was last revised in October 2016.
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