Donepezil Hydrochloride 5 Mg Film-Coated Tablets
20 mm |
◄-——>k-
150 mm 130 mm
>
>
PACKAGE LEAFLET: INFORMATION FOR THE USER Donepezil hydrochloride 5 mg /10 mg film-coated Tablets
Donepezil hydrochloride
UJ
UJ
o
3
3
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 medieine-has been prescribed-for-yeu only: 0a 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.
Donepezil hydrochloride film-coated Tablets will be referred to as Donepezil Tablets in this leaflet. What is in this leaflet:
1. What Donepezil Tablets are and what are they used for
% "What yoimeed tD"knowt)e1bre"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 hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil Tablets are used to treat the symptoms lof dementia In people d ragnosed as- having nil Id To moderately severe Alzheimer's disease.
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 similar medicines (known as piperidine derivatives) or to any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking
Donepezil Tablets:
• if you are going to have an operation that requires you to have a general anaesthetic. Donepezil may exaggerate muscle relaxation during anaesthesia.
• if you have or ever had a heart problem (specifically the sick sinus syndrome or a comparable condition). Donepezil may slow down your heart rate.
• if you ever had stomach or duodenal ulcers
or if you use a certain type of painkiller ~ "(Non-Steroldal“Anti-1nflamTnatoTy Drags-NSAIDs, e.g. diclofenac). Concurrent use may lead to an increased risk of stomach or duodenal ulcers. Your doctor will monitor your symptoms (such as pain of the stomach or the intestinum).
• if you have difficulty passing urine. Your doctor will monitor your symptoms.
• if you ever had a seizure. Donepezil may cause a new seizure. Your doctor will monitor your symptoms
• medicines used to control heart rhythm (quinidine), antifungal medicines (ketoconazole and itraconazole), specific types of antibiotics (erythromycin) and medicines used for the treatment of depressioq (selective serotonin-reuptake inhibitors, SSRIs,
_ _ _ such as fluoxetine).These, medicinesucan___
intensify the effect of donepezil.
• medicines used for the treatment of tuberculose (rifampicin), medicines used to treat epilepsy (phenytoin and carbamazepine) These medicines can reduce the effect of Donepezil Tablets.
• medicines used as short-term muscle relaxation in anaesthesia and intensive care (succinylcholine) and certain blood pressure lowering medicines (beta blockers). The effect of both medicines is increased.
“ • “6ther“me“dicTries that act Wsame“way as donepezil (such as galantamine or rivastigmine), and some medicines for diarrhoea, Parkinson’s disease or asthma (agonists or antagonists of the cholinergic system).
• general anaesthetics.
• painkillers or treatment for arthritis such as acetylsalicylic acid, non-steroidal anti-inflammatory (NSAID) medicines such as ibuprofen, or diclofenac.
- DoirepezilTbbletswitlrfood, drink antf alcohol
Do not drink any alcohol during treatment with; donepezil because alcohol may reduce its effectiveness.
Pregnancy, breast-feeding and fertility
Donepezil Tablets should not be used breastfeeding.
If you are pregnant or breastfeeding, think you! may be pregnant or are planning to have a baby,! ask your doctor for advice before taking this! medicine.
~ Driving arid-usingmachTries
Donepezil has a minor or moderate influence on the ability to drive and use machines.
Alzheimer's disease may impair your ability tq drive or use machinery and you must not carry out; these activities, unless your doctor tells you that it is safe to do so.
Also, Donepezil Tablets can cause fatigue^ dizziness and muscle cramp, mainly at the start of treatment or after a dose increase.
If you are affected, do not drive or operate
- machinery.
Donepezil Tablets contains 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. How to take Donepezil Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tell the doctor or pharmacist the name of your
while
If you ever had extrapyramidal symptoms------caregiver. Your caregiver will help you take your
(uncontrolled movements of the body or face). Donepezil may induce or exacerbate extrapyramidal symptoms.
• if you have asthma or other long term lung disease. Your symptoms could get worse.
• if you ever had any liver problems (as your dose may need to be adjusted).
Donepezil Tablets 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 Jiver .disease .should _ _ product are avaHabje. not take Donepezil Tablets.
Children and adolescents Donepezil Tablets is not recommended for children and adolescents below the age of 18 years.
Other medicines and Donepezil Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Other medicines may be affected by donepezil.
They, in turn, may affect how well donepezil works.
medicine as it is prescribed.
The recommended dose is:
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 maximum recommended dose is 10 mg donepezil hydrochloride each night.
For doses not realisable/practicable with this strength other strengths of this medicinal
Do not alter the dose yourself without your doctor's advice.
No dosage adjustment is required if you have kidney problems.
If you have liver problems, your dose may need to be adjusted to your needs by your doctor (see section 2, What you need to know before you take Donepezil Tablets).
Take your Donepezil Tablets with a drink of water at night before you go to bed
^Donepezil can-interactwith;----------------This mediemelsnot-recommended-fer use-in
E
E
o
■*a-
E
E
o
■'f
E
E
o
E
E
o
E
E
o
E
E
o
E
E
o
E
E
o
' E E o
Children and-adolescents (younger than TS years).
Your doctor will tell you how long you should Continue to take your tablets. You will need to $ee your doctor from time to time to review your [treatment and assess your symptoms. Do not stop taking the tablets unless your doctor advises you to.
[If you take more Donepezil Tablets than you -should---------------------------
bo not take more tablets than you should. If you fake more donepezil than you should, you may Experience symptoms such as severe nausea, Vomiting, secretion of saliva (salivation),
Sweating, slow heartbeat (bradycardia), low [blood pressure (hypotension), breathing [difficulties (respiratory depression), collapse, involuntary contraction of muscles (convulsion) and increased muscle weakness. Call your doctor immediately. If you cannot contact your doctor, contact the local hospjtal Accident and
[Emergency department at once. Take the tablets [and the carton with you to the hospital, so that [the doctor knows what has been taken.
[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 for a forgotten tablet.
!|f you forget to take your tablets for more than one week, call your doctor before taking any [more.
If you stop taking Donepezjl Tablets
[Do not stop treatment without talking to your doctor first, even if you feel better.
[If you have any further questions on the use of [this product, ask your doctor or pharmacist.
A. Possible side effects [Like all medicines, this medicine can cause side Effects, although not everybody gets them. In [most cases, these go away without having to [stop treatment.
[iSerious side effects:
Vbu .must tell your-doctoc 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 (indigeation)_felt between the .navel andthe_ _ 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).
fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome") (affects less than 1 user In 10,000)________
falls ancTaccidentarinjiiry)
Uncommon (affects 1 to 10 users in 1,000):
• slow heart beat
Rare (affects 1 to 10 users In 10,000):
• 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 ineludes-any-possible side----
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: 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 Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle/blister and the cuter carton cfter Exp: The-exprry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicine 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 contain
The active substance Ts“donepezil hydrochloride.4 Each 5mg tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil, and each 10mg tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil.
The other ingredients are:
Tablet core: Lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate. Film-coating: hypromellose, macrogol 400, titanium dioxide
(E171}. A-celorant ealled yellow-iron-oxide----
(E172) is also present in the 10mg tablet.
What Donepezil Tablets look like and contents of the pack Donepezil 5 mg Tablets are white round biconvex film-coated tablets marked 'DNP' on one side and '5' on the other, whereas Donepezil 10 mg Tablets are yellow round biconvex film-coated tablets marked 'DNP' on one side and '10' on the other.
The medicinal product is available in cartons of 7:28,30,-50,56,-60; 84,-98-or 4 20 film-coated tablets, and in bottles of 28,30 or 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer:
Dr. Reddy's Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 OLD
Distributed by Lupin (Europe) Limited Victoria Court, Bexton Road, Knutsford, Cheshire WA16 OPF
Very common (affects more than 1 user in 10): diarrhoea
nausea or feeling sick headaches.
Common (affects 1 to 10 users in 100): muscle cramps tiredness
difficulty in sleeping (insomnia) the common cold loss of appetite
hallucinations. (seeing_orJiearing_things. that. are not really there) unusual dreams including nightmares agitation
aggressive behaviour fainting dizziness
stomach feeling uncomfortable rash itching
passing urine uncontrollably pain
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Donepezil-HCI beta 5 mg & 10 mg Filmtabletten
Italy: Donepezil Dr. Reddy's 5 mg & 10 mg
compresse rivestite con film UK: Donepezil hydrochloride 5 mg &
10 mg film-coated Tablets Romania: Aldemiz 5 mg & 10mg, comprimate ________Jilraate___________________
This leaflet was last revised in May 2013
PL 08553/0313 and 08553/0314
accidents (patients may be more prone to
. OQQDOQQDQ