Donepezil Hydrochloride 5 Mg Film Coated Tablets
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Donepezil hydrochloride 5 mg film-coated tablets Donepezil hydrochloride 10 mg film-coated tablets
You and your caregiver should read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read itagain.
• Ifyou havefurtherquestions, pleaseaskyourdoctororyourpharmacist.
• 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 get serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Donepezil hydrochloride 5/10 mg Film-coated tablets are and what are they usedfor
2. Before you take Donepezil hydrochloride 5/10 mg Film-coated tablets
3. How to take Donepezil hydrochloride 5/10 mg Film-coated tablets
4. Possible side effects
5. How to store Donepezil hydrochloride 5/10 mg Film-coated tablets
6. Further Information
1. What Donepezil hydrochloride 5/10 mg Film-coated tablets are and what are they usedfor
Donepezil hydrochloride 5/10 mg Film-coated tablets belong to a group of medicines called acetylcholinesterase inhibitors.
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 hydrochloride 5/10 mg Film-coated tablets are for use in adult patients only
2. Before you take Donepezil hydrochloride 5/10 mg Film-coated tablets_
Do not take Donepezil hydrochloride 5/10 mg Film-coated tablets if any of the following apply to you
• if you are allergic (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Donepezil hydrochloride 5/10 mg Film-coated tablets listed in section 6. (An allergic reaction may include rash, itching, swelling of face, lips, or hands/feet, or breathing difficulties)
Take special care with Donepezil hydrochloride 5/10 mg Film-coated tablets
Tell your doctor or pharmacist before starting to take Donepezil hydrochloride 5/10 mg Film-coated tables ifyou have or have had
• stomach orduodenal ulcers
• seizures (fits) or convulsions
• a heart condition (irregular or very slow heart beat)
• asthma orotherlong term lung disease
• liverproblemsorhepatitis
• difficulty passing urine or mild kidney disease.
Also tell your doctor if you are pregnant or think you might be pregnant.
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 is because these medicines may weaken or strengthen the effects of Donepezil hydrochloride 5/10 mg Film-coated 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
• 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 hydrochloride 5/10 mg Film-coated tablets. This is because your medicine may affect the amount of anaesthetic needed.
Donepezil hydrochloride 5/10 mg Film-coated 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 liver disease should not take Donepezil hydrochloride 5/10 mg Film-coated tablets
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will helpyou to take your medicine as it is prescribed.
Taking Donepezil hydrochloride 5/10 mg Film-coated Tablets with food and drink
Food will not influence the effect of Donepezil hydrochloride 5/10 mg Film-coated tablets
Donepezil hydrochloride 5/10 mg Film-coated tablets should not be taken with alcohol because alcohol may change its effect.
Pregnancy and breast-feeding
There is no enough evidence of the use of donepezil in pregnant women. The potential risk for humans is unknown. Donepezil should not be used during pregnancy unless clearly necessary.
If you are pregnant, or think you might be pregnant, askyour doctor for advice.
Donepezil hydrochloride 5/10 mg Film-coated tablets must not be used while breastfeeding.
Ask your doctor or 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 tiredness, dizziness and muscle cramp. If you experience any of these effects you must not drive or operate machinery.
Important information about some of the ingredients of Donepezil hydrochloride 5/10 mg Film-coated tablets
This medicine contains lactose. Ifyou have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product
3. How to take Donepezil hydrochloride 5/10 mg Film-coated tablets_
How much Donepezil hydrochloride 5/10 mg Film-coated tablets should you take?
Always take Donepezil hydrochloride 5/10 mg Film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.
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.
Swallow your Donepezil hydrochloride 5/10 mg Film-coated tablet with a drink of water before you go to bed at 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.
For how long should you take Donepezil hydrochloride 5/10 mg Film-coated 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 hydrochloride 5/10 mg Film-coated tablet 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 Emergency department in the hospital 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 hydrochloride 5/10 mg Film-coated 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.
Ifyou forget to take your medicine for more than one week, call your doctor before taking any more medicine.
If you stop taking Donepezil hydrochloride 5/10 mg Film-coated 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 product, askyourdoctoror pharmacist.
4. Possible side effects
Like all medicines, Donepezil hydrochloride 5/10 mg Film-coated tablet(s) can cause side effects, although not everybody gets them.
Tell your doctor if you have any of these effects while you are taking Donepezil hydrochloride 5/10 mg Film-coated tablet(s)
Very serious side effects
If any of the following happen, stop taking Donepezil hydrochloride 5/10 mg Film-coated tablet(s) and tell your doctor immediately, or go to the casualty department at your nearest hospital:
• Allergic reaction to Donepezil hydrochloride 5/10 mg Film-coated tablets (An allergic reaction may include rashes, hives, itching, chest constriction, shortness of breath or swelling of face, lips, hands / feet, fever, fainting)
You may need urgent medical attention or hospitalization
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 (affects 1 to 10 users in 10,000)
• Stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the 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)
• Slow heart rate associated with dizziness, weakness, confusion (affects 1 to 10 users in 10,000)
Tell your physician immediately ifyou notice fever with muscle stiffness, sweating ora lowered level of consciousness (a disorder called "Neuroleptic Malignant Syndrome"), as urgent medical treatment may be needed (affects less than 1 user in 10,000).
otherside effects
Very common side effects /affects more than 1 user in 10):
• diarrhoea
• feeling sick
• headaches
Common side effects (affects 1 to 10 user in 100):
• muscle cramp
• tiredness
• difficulty in sleeping (insomnia)
• the common cold
• loss of appetite (anorexia)
• hallucinations (seeing or hearing things that are not really there)
• agitation
• aggressive behaviour
• fainting
• dizziness
• stomach feeling uncomfortable, being sick (vomiting)
• rash
• itching
• passing urine uncontrollably
• pain
Uncommon side effects (affects 1 to 10 users in
1,000):
• slow heart beat
• accidents (patients may be more prone to falls and accidental injury)
Rare side effects (affects 1 to 10 users in 10,000):
• stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs
Effects on Laboratory test
Minor increase in serum concentration of muscle
creatinine kinase (affects 1 to 10 users in 1,000)
If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Donepezil hydrochloride 5/10 mg Film-coated Tablets_
Keep out of the reach and sight of children.
Do not use Donepezil hydrochloride 5/10 mg Film-coated tablets after the expiry date which is stated on the blister label and the carton label after (Exp). The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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
Donepezil hydrochloride 5/10 mg Film-coated 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 hydrochloride 5/10 mg Film-coated tablets looks 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:
Ranbaxy (UK) Limited Building 4, Chiswick Park,
566 Chiswick High Road,
London, W45YE United Kingdom
Manufacturer:
Ranbaxy Ireland Limited,
Spafield, Cork Road,
Cashel, Co-Tipperary,
Republic of Ireland
This leaflet was last revised in September 2012.
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