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What Dopezal is and what it is used for
Donepezil contains the active substance donepezil hydrochloride. Donepezil (donepezil hydrochloride) belongs to a group of drugs called acetylcholinesterase inhibitors.
Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. Symptoms include progressively increasing memory loss, confusion and behavioral changes. As a result, Alzheimer's sufferers find it increasingly difficult to carry out normal daily activities.
Dopezal is intended for use in adult patients only.
2. What you need to know before you take Dopezal
Do not take Dopezal
if you are allergic to donepezil hydrochloride, piperidine derivatives or to the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Dopezal if you have or have had:
stomach or duodenal ulcers;
seizures or convulsions;
heart disease (such as an irregular or very slow heartbeat, heart failure, myocardial infarction);
a heart disease called 'long QT interval' or certain heart rhythm disorders in the past called 'torsade de pointes', or if someone in your family has a long QT interval;
low levels of magnesium or potassium in the blood;
asthma or other long-term lung disease;
liver problems or hepatitis;
difficulty urinating or mild kidney disease.
Also talk to your doctor if you are pregnant or think you may be pregnant.
Children and adolescents
Dopezal is not recommended for use in children and adolescents (under 18 years of age).
Other medicines and Dopezal
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 from a pharmacy. This also applies to medicines you may take in the future if you continue to take Dopezal. This is because these medicines can weaken or strengthen the effects of Donezal.
In particular, it is important to tell your doctor immediately if you are taking any of the following medicines:
medicines for heart rhythm problems eg amiodarone, sotalol
medicines for depression eg citalopram, escitalopram, amitriptyline, fluoxetine)
medicines for psychosis, eg pimozide, sertindol, ziprasidone
medicines for bacterial infections, eg clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
antifungal medicines, e.g. ketoconazole
other medicines for Alzheimer's disease, eg galantamine
pain relievers or arthritis treatments, eg aspirin, non-steroidal anti-inflammatory (NSAID) medicines such as ibuprofen or diclofenac sodium
anticholinergic drugs, eg tolterodine
anticonvulsants, eg phenytoin, carbamazepine
treatment for heart disease, eg quinidine, beta-blockers (propanolol and atenolol)
muscle relaxants, e.g. diazepam, succinylcholine
over-the-counter medicines, e.g. herbal medicinal products
If you are about to have an operation requiring general anaesthesia, you should tell your anesthesiologist that you are taking Dopezal. This is because your medication may interfere with the anesthesia required.
Donezal can be used in patients with kidney disease or mild to moderate liver disease. Inform your doctor first if you have kidney or liver disease. Patients with severe liver disease should not take Dopezal.
Give your doctor or pharmacist the name of your caregiver. Your caregiver will help you take the medicine as prescribed.
Dopezal with food, drink and alcohol
Food does not affect the effect of Dopezal.
Dopezal should not be taken with alcohol because alcohol can change its effect. Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using any medicine.
Dopezal should not be used during breastfeeding.
Driving and using machines
Alzheimer's disease can impair your ability to drive or operate machinery, and you should not do these activities unless your doctor tells you it is safe to do so.
Also, your medicine may cause fatigue, dizziness, and muscle cramps. If you get any of these effects, you should not drive or use machines.
Dopezal contains lactose
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 Dopezal
How much Dopezal should you take?
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Initially, the recommended dose is 5 mg (one white tablet) every night before going to bed. After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night before going to bed. If you have unusual dreams, nightmares or sleep disturbances (see section 4), your doctor may advise you to take Dopezal in the morning.
The type of tablet you will take may change depending on how long you have been taking the medicine and your doctor's recommendations. The maximum recommended dose is 10 mg every night.
Always follow your doctor's or pharmacist's advice about how and when to take your medicine. Do not change the dose yourself without a prescription from your doctor.
How to take your medicine
Swallow the Dopezal tablet with water before going to bed at night.
Use in children and adolescents
Dopezal is not recommended for use in children and adolescents (under 18 years of age).
If you have taken more Dopezal than you should
Contact your doctor or the nearest emergency department immediately if you have taken more of this medicine than you should. Take this leaflet and the rest of the tablets with you.
Overdose symptoms may include nausea and vomiting, increased salivation » sweating, slow heart rate, low blood pressure (headache or dizziness when standing), trouble breathing, loss of consciousness, and seizures or convulsions.
If you forget to take Dopezal
If you forget to take your medicine, take the next dose at the regular time. Do not take a double dose to make up for a missed tablet.
If you miss taking your medicine for more than a week, call your doctor before you continue taking it.
If you have stopped taking Dopezal
Do not stop taking the tablets unless your doctor tells you to. If you stop taking Dopezal, the benefits of your treatment will gradually decrease.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
How long should you take Dopezal?
Your doctor or pharmacist will tell you how long you should continue taking the tablets. You will need to see your doctor periodically so he can review your treatment and assess your symptoms.
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.
Tell your doctor if you have any of the following symptoms while taking Dopezal.
Serious side effects:
You should inform your doctor immediately if you notice the serious side effects mentioned. Emergency medical treatment may be required.
liver damage, e.g. hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, feeling unwell, fever, itching, yellowing of the skin and eyes, and dark colored urine (may affect up to 1 in 1,000 people);
stomach or duodenal ulcers. Symptoms of an ulcer are stomach pain and discomfort (indigestion) felt between the navel and the breastbone (may affect up to 1 in 100 people);
bleeding in the stomach or intestines. This may present with tarry black stools or visible blood from the rectum (may affect up to 1 in 100 people);
seizures or convulsions (may affect up to 1 in 100 people);
high fever with muscle stiffness, sweating or reduced level of consciousness (a disorder called 'neuroleptic malignant syndrome') (may affect up to 1 in 10,000 people);
muscle weakness, tenderness or pain and especially if you feel unwell at the same time, have a high temperature or your urine is dark in colour. They can be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
Other side effects
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
difficulty falling asleep (insomnia);
loss of appetite;
hallucinations (seeing or hearing things that are not real);
unusual dreams, including nightmares;
unpleasant feeling in the stomach;
accidents (patients may be more prone to falls and accidental injury).
Uncommon side effects (may affect up to 1 in 100 people):
hypersecretion of saliva.
Rare side effects (may affect up to 1 in 1,000 people):
stiffness, tremors or uncontrollable movement, especially of the face and tongue, but also of the limbs.
Not known (frequency cannot be estimated from the available data):
changes in heart activity seen on an electrocardiogram (ECG) called 'QT prolongation'
fast, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as torsade de pointes
increased libido, hypersexuality.
Pisa syndrome (a condition involving uncontrolled muscle contractions with abnormal tilting of the body and head to one side)
5. How to store Dopezal
Keep out of the reach of children.
This medicinal product does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container.
Your pharmacist how to dispose of medicines you no longer use. These help to protect the environment.
6. Contents of the package and additional information
What Dopezal contains
The active substance is donepezil hydrochloride.
Dopezal is available in two strengths:
The 5 mg tablet contains 5 mg donepezil hydrochloride equivalent to 4.56 mg donepezil.
The 10 mg tablet contains 10 mg donepezil hydrochloride equivalent to 9.12 donepezil.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, corn starch, hydroxypropylcellulose, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), talc, macrogol 400 and yellow iron oxide (E 172) (only for the 10 mg tablet).
What Dopezal looks like and contents of the pack
Dopezal 5 mg film-coated tablets are white, round, biconvex film-coated tablets.
Dopezal 10 mg film-coated tablets are yellow, round, biconvex film-coated tablets. Dopezal film-coated tablets are available in packs containing 28 film-coated tablets (2 blisters of 14 tablets each).
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