Donepezil Hydrochloride 5 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Donepezil hydrochloride 5 mg film-coated tablets
(Donepezil Hydrochloride)
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
OWhat Donepezil hydrochloride 5 mg film-coated tablets is and what it is used for © Before you take Donepezil hydrochloride 5 mg film-coated tablets ©How to take Donepezil hydrochloride 5 mg film-coated tablets ©Possible side effects
©How to store Donepezil hydrochloride 5 mg film-coated tablets ©Further information
O WHAT DONEPEZIL HYDROCHLORIDE 5 MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Donepezil hydrochloride 5 mg film-coated tablets (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat the symptoms of dementia (disorder of rational behaviour) in people diagnosed as having mild to moderately severe Alzheimer's disease (a chronic mental disease). It is for use only in adult patients.
© BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE 5 MG FILM- COATED TABLETS Do not take Donepezil hydrochloride 5 mg film-coated tablets
You must not take Donepezil hydrochloride 5 mg film-coated tablets if:
• you are allergic to donepezil hydrochloride, or to piperidine derivatives, or to any of the ingredients used in the formulation
• you are pregnant, think you might be pregnant or are breast feeding
Take special care with Donepezil hydrochloride 5 mg film-coated tablets
Tell your doctor or pharmacist if:
• you have ever had stomach or duodenal ulcers
• you have ever had a seizure
• you have a heart condition
• you have asthma (dyspnoea) or other long term lung disease
• you have ever had any liver problems or hepatitis (inflammation of the liver)
• you have difficulty passing urine
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Always tell your doctor or pharmacist if you are using or receiving any of the following medicines in addition to Donepezil hydrochloride 5 mg film-coated tablets:
• pain killers or treatment for arthritis
• antibiotics or anti-fungal medicines (drugs destroying or inhibiting the growth of fungi)
• muscle relaxants
• anti-depressants (medicines against mental depressions)
• anticonvulsants (medicines used in prevention of the occurrence of several types of seizures)
• medication for a heart condition.
If you are going to have an operation that requires you to have a general anaesthetic (narcosis) you should tell your doctor and the anaesthetist that you are taking Donepezil hydrochloride 5 mg film-coated tablets.
Taking Donepezil hydrochloride 5 mg film-coated tablets with food and drink
Donepezil hydrochloride 5 mg film-coated tablets should be taken with liquid (a glass of water). Food does not have any effect on this medication. Alcohol consumption should be restricted when taking donepezil, as alcohol may reduce the levels of donepezil.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are breast feeding, do not use Donepezil hydrochloride 5 mg film-coated tablets. Ask your doctor or your pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive because 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. Do not use any tool or machine because your medicine can cause fatigue, dizziness and muscle cramp and if affected you must not drive or operate machinery.
Important information about some of the ingredients of Donepezil hydrochloride 5 mg film-coated tablets
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
© HOW TO TAKE DONEPEZIL HYDROCHLORIDE 5 MG FILM-COATED TABLETS
Always take Donepezil hydrochloride 5 mg film-coated tablets exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure. Take your Donepezil hydrochloride 5 mg film-coated tablets tablet by mouth with a drink of water at night before you go to bed. 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 will recommend. Usually, you will start by taking 5 mg every night. After one month, your doctor may tell you to take 10 mg every night. The maximum recommended dose is 10 mg each night. You should 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. 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 hydrochloride 5 mg film-coated tablets than you should
Do not take more than one tablet each day. If you do, you may experience nausea, vomiting, salivation, sweating, bradycardia, hypotension, difficulty in breathing, collapse and convulsion. Call your doctor immediately or contact the local hospital. Always 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 hydrochloride 5 mg film-coated tablets
If you forget to take a tablet, just take one tablet the following day at the usual time. If you forget to take your medicine for more than one week, call your doctor before taking any more medicine. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Donepezil hydrochloride 5 mg film-coated tablets
Do not stop taking the tablets unless told to do so by your doctor. If you have any further question on the use of this product, ask your doctor or your pharmacist. O POSSIBLE SIDE EFFECTS
Like all medicines, Donepezil hydrochloride 5 mg film-coated tablets can have side effects, although not everybody gets them. In most cases these go away without having to stop treatment. Tell your doctor if you have any of these effects and if they are too uncomfortable for you.
Serious side effects:
You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.
• Fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called "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). Patients taking Donepezil hydrochloride 5 mg film-coated tablets have also reported the following side effects:
Very common (estimated frequency is more than 1 person out of 10)
• diarrhoea
• nausea
• headaches
vomiting
abdominal disturbances
rash
itching
muscle cramp urinary incontinence fatigue pain
Common (estimated frequency is less than 1 person out of 10 but more than 1 out of 100)
• insomnia (difficulty in sleeping) •
• accidents
Uncommon (estimated frequency is less than 1 person out of 100 but more than 1 out of 1000)
• seizures
• gastrointestinal haemorrhage
• slow heart beat
• stomach and duodenal ulcers
• minor increase in serum concentration of muscle creatine kinase
Rare (estimated frequency is less than 1 person out of 1000 but more than 1 out of 10000)
• liver disorders including hepatitis
• shaking
• sino-atrial block, atrioventricular block
• stiffness or uncontrollable movement especially of the face and tongue but also of the limbs
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
@ HOW TO STORE DONEPEZIL HYDROCHLORIDE 5 MG FILM-COATED TABLETS
Do not store above 30°C. Keep out of the reach and sight of children. Do not use Donepezil hydrochloride 5 mg film-coated tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask yor pharmacist how to dispose of medicines no longer required. These measures will help to protect the enviroment.
0 FURTHER INFORMATION
What Donepezil hydrochloride 5 mg film-coated tablets contains
The active substance in Donepezil hydrochloride 5 mg film-coated tablets is donepezil hydrochloride.
Each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil free base.
The other ingredients are:
Tablet core: Lactose Monohydrate, Maize starch, Hydroxypropyl cellulose, Microcrystalline cellulose, Magnesium Stearate Film-coating: HPMC 2910/Hypromellose 5 cP (E464), Titanium dioxide (E171), Propylene Glycol, Talc What Donepezil hydrochloride 5 mg film-coated tablets looks like and contents of the pack
White, round film-coated tablets with a diameter of 7.5 mm approximately.
Packs: 28 tablets.
Marketing Authorisation Holder:
Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor, P.C. 1060, Nicosia, Cyprus Manufacturer:
SymPhar Sp. z o.o., ul. Wtoska 1,00-777 Warsaw, Poland Specifar S.A. 1,28 Octovriou str.123 51 Ag. Varvara Athens, Greece
This leaflet was last revised in 10/2015 A0018/O/PIL/A1
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Donepezil Hydrochloride Product: 5 mg FC Tablets |
Printing Colours: | Black |
Non-Printing Colours: | Profile |
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MA Holder: Activase |
Final Preparation Date For Submission: 05/10/2015 | ||
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PL No.: 28444/0018 |
Packing Site Technical Approval: 00/00/0000 Authority Approval Date: 00/00/0000 Latest Implementation Deadline: 00/00/0000 | ||
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Pack Size: - |
Dimensions: 170 x 245 mm | ||
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Livery: Activase |
Created By: DTawde | ||
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Manufacturer: -Market: UK Component: Leaflet |
Artwork Code: A0018/O/PIL/A1 Bar Code: - Font Type: Swiss 721 CN BT Font Size: 6.75 pt |
Print Proof Approval: 00/00/0000 | |