DONEPEZIL HYDROCHLORIDE 10MG FILM COATED TABLETS
Active substance: DONEPEZIL HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Donepezil hydrochloride 5mg film-coated tablets Donepezil hydrochloride 10mg 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: 1. What Donepezil hydrochloride is and what it is used for 2. Before you take Donepezil hydrochloride 3. How to take Donepezil hydrochloride 4. Possible side effects 5. How to store Donepezil hydrochloride 6. Further information 1. WHAT DONEPEZIL HYDROCHLORIDE IS AND WHAT IT IS USED FOR 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. 2. BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE Do not take Donepezil hydrochloride if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives or any of the other ingredients of the tablets. Take special care with Donepezil hydrochloride if you have ever had stomach or duodenal ulcers if you have ever had a seizure if you have a heart condition if you have asthma (dyspnoea) or other long term lung disease if you have ever had any liver problems or hepatitis (inflammation of the liver) if you have difficulty passing urine. Taking Donepezil hydrochloride with food and drink Donepezil hydrochloride 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. Ask your doctor or your pharmacist 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 fatigue, dizziness and muscle cramps and if affected you must not drive or operate machinery. Important information about some of the ingredients of Donepezil hydrochloride This medicine 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 HYDROCHLORIDE Always take Donepezil hydrochloride 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 tablet by mouth with a drink of water at night before you go to bed. 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. This especially applies to: medicines to treat pain and inflammation such as NSAIDs antibiotics such as erythromycin and rifampicin anti-fungal medicines (medicines destroying or inhibiting the growth of fungi) such as ketoconazole and itraconazole muscle relaxants such as succinylcholine anti-depressants (medicines against mental depressions) such as fluoxetine anticonvulsants (medicines used in prevention of the occurrence of several types of seizures) such as phenytoin and carbamazepine medication for heart condition or high blood pressure such as quinidine other medicines that act the same way as donepezil (such as galantamine or rivastigmine) and some medicines for asthma. 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. 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 than you should Do not take more than one tablet each day. If you accidentally take too many tablets, the following symptoms may appear: nausea, vomiting, excess production of saliva, sweating, slow heart beat, low blood pressure, difficulty in breathing, muscle weakening, faint and fits (body shakes uncontrollably). 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.
10008 PC 217
If you forget to take Donepezil hydrochloride If you forget to take your medicine, but remember to take it after a short time, take that days dose as usual. However, if a long delay has occurred (e.g. all day), skip that dose and take the next dose the next day at the usual time and skip the forgotten dose. Do not take a double dose to make up for a forgotten tablet. If you stop taking Donepezil hydrochloride Do not stop taking the tablets unless told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or your pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Donepezil hydrochloride 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. Patients taking Donepezil hydrochloride have reported the following side effects: Very common side effects (estimated frequency is more than 1 person out of 10) diarrhoea nausea headache. Common side effects (estimated frequency is less than 1 person out of 10 but more than 1 out of 100) common cold abdominal disturbances loss of appetite rash hallucinations itching agitation muscle cramps aggressive behaviour urinary incontinence fainting fatigue dizziness pain insomnia (difficulty in sleeping) accident vomiting. Uncommon side effects (estimated frequency is less than 1 person out of 100 but more than 1 out of 1000) seizures abdominal bleeding slow heart beat stomach and duodenal ulcers minor increase in serum concentration of muscle creatinine kinase. Rare side effects (estimated frequency is less than 1 person out of 1000 but more than 1 out of 10000) shaking liver disorders including hepatitis stiffness or uncontrollable movement especially of the face and tongue but also of the limbs sinoatrial block, atrioventricular block. 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.
5. HOW TO STORE DONEPEZIL HYDROCHLORIDE Keep out of the reach and sight of children. Do not store above 30C. Do not use Donepezil hydrochloride tablets after the expiry date which is stated on the blisters and the carton after. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Donepezil hydrochloride contains The active substance in these tablets is donepezil hydrochloride. 5mg: Each tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil free base. 10mg: Each tablet contains 10 mg of donepezil hydrochloride, equivalent to 9.12 mg of donepezil free base. The other ingredients are: Tablet core: Lactose Monohydrate, Maize starch, Hydroxypropylcellulose, Cellulose, Microcrystalline, Magnesium Stearate. Film-coating: Hypromellose (E464), Titanium dioxide (E171), Propylene Glycol, Talc. What Donepezil hydrochloride looks like and contents of the pack 5mg: White, round film-coated tablets with a diameter of 7.5 mm approximately. 10mg: White, round film-coated tablets with a diameter of 9.3 mm approximately bearing a breakline on one side. The tablet can be divided into equal halves. Pack sizes: 28, 56, 98 tablets. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: Alet Pharmaceuticals S.A. 26 Aidiniou Str., Haidari, 12461Athens, Greece Manufacturer: Specifar S.A. 1, 28 Octovriou str., Ag. Varvara 123 51 Athens, Greece This leaflet was last prepared in 12/2011.
10008 PC 217
Donepezil hydrochloride 5mg film-coated tablets Donepezil hydrochloride 10mg 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: 1. What Donepezil hydrochloride is and what it is used for 2. Before you take Donepezil hydrochloride 3. How to take Donepezil hydrochloride 4. Possible side effects 5. How to store Donepezil hydrochloride 6. Further information 1. WHAT DONEPEZIL HYDROCHLORIDE IS AND WHAT IT IS USED FOR 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. 2. BEFORE YOU TAKE DONEPEZIL HYDROCHLORIDE Do not take Donepezil hydrochloride if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives or any of the other ingredients of the tablets. Take special care with Donepezil hydrochloride if you have ever had stomach or duodenal ulcers if you have ever had a seizure if you have a heart condition if you have asthma (dyspnoea) or other long term lung disease if you have ever had any liver problems or hepatitis (inflammation of the liver) if you have difficulty passing urine. Taking Donepezil hydrochloride with food and drink Donepezil hydrochloride 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. Ask your doctor or your pharmacist 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 fatigue, dizziness and muscle cramps and if affected you must not drive or operate machinery. Important information about some of the ingredients of Donepezil hydrochloride This medicine 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 HYDROCHLORIDE Always take Donepezil hydrochloride 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 tablet by mouth with a drink of water at night before you go to bed. 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. This especially applies to: medicines to treat pain and inflammation such as NSAIDs antibiotics such as erythromycin and rifampicin anti-fungal medicines (medicines destroying or inhibiting the growth of fungi) such as ketoconazole and itraconazole muscle relaxants such as succinylcholine anti-depressants (medicines against mental depressions) such as fluoxetine anticonvulsants (medicines used in prevention of the occurrence of several types of seizures) such as phenytoin and carbamazepine medication for heart condition or high blood pressure such as quinidine other medicines that act the same way as donepezil (such as galantamine or rivastigmine) and some medicines for asthma. 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. 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 than you should Do not take more than one tablet each day. If you accidentally take too many tablets, the following symptoms may appear: nausea, vomiting, excess production of saliva, sweating, slow heart beat, low blood pressure, difficulty in breathing, muscle weakening, faint and fits (body shakes uncontrollably). 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.
10008 PC 217
If you forget to take Donepezil hydrochloride If you forget to take your medicine, but remember to take it after a short time, take that days dose as usual. However, if a long delay has occurred (e.g. all day), skip that dose and take the next dose the next day at the usual time and skip the forgotten dose. Do not take a double dose to make up for a forgotten tablet. If you stop taking Donepezil hydrochloride Do not stop taking the tablets unless told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or your pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Donepezil hydrochloride 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. Patients taking Donepezil hydrochloride have reported the following side effects: Very common side effects (estimated frequency is more than 1 person out of 10) diarrhoea nausea headache. Common side effects (estimated frequency is less than 1 person out of 10 but more than 1 out of 100) common cold abdominal disturbances loss of appetite rash hallucinations itching agitation muscle cramps aggressive behaviour urinary incontinence fainting fatigue dizziness pain insomnia (difficulty in sleeping) accident vomiting. Uncommon side effects (estimated frequency is less than 1 person out of 100 but more than 1 out of 1000) seizures abdominal bleeding slow heart beat stomach and duodenal ulcers minor increase in serum concentration of muscle creatinine kinase. Rare side effects (estimated frequency is less than 1 person out of 1000 but more than 1 out of 10000) shaking liver disorders including hepatitis stiffness or uncontrollable movement especially of the face and tongue but also of the limbs sinoatrial block, atrioventricular block. 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.
5. HOW TO STORE DONEPEZIL HYDROCHLORIDE Keep out of the reach and sight of children. Do not store above 30C. Do not use Donepezil hydrochloride tablets after the expiry date which is stated on the blisters and the carton after
10008 PC 217
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
