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Alzancer ODT 5 mg. 28 tablets

Product Code: Alzancer ODT 5 mg. 28 tablets
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What Alzanzer ODT is and what it is used for
Alzanzer ODT contains the active substance donepezil hydrochloride. Alzanzer ODT (donepezil hydrochloride) belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance in the brain (acetylcholine) that is involved in memory by slowing down the breakdown of acetylcholine.

It is used to treat the symptoms of dementia in people diagnosed with mild to moderate Alzheimer's disease. These symptoms include increasing memory loss, confusion, and behavioral changes. As a result, Alzheimer's sufferers find it increasingly difficult to carry out their normal daily activities.

Alzanzer ODT is for use in adult patients only.

2. What you need to know before you take Alzanzer ODT
Do not take Alzanzer ODT:
if you are allergic to donepezil hydrochloride, to 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 Alzanzer ODT if you have or have had:

stomach or duodenal ulcer;
seizures or convulsions;
heart disease (irregular or slow heartbeat),
asthma or other long-standing lung disease;
liver problems or hepatitis;
difficulty urinating or mild kidney disease.
Also tell your doctor if you are pregnant or think you may be pregnant.

Children and adolescents
Alzanzer ODT is not recommended for use in children and adolescents (under 18 years of age).

Other medicines and Alzanzer ODT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This also applies to medicines you may take in the future if you continue to take Alzanzer ODT, because these medicines may weaken or increase the effect of Alzanzer ODT.

Tell your doctor if you are taking any of the following medicines:

other medicines for Alzheimer's disease, eg galantamine;
pain relievers or arthritis treatments, eg aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac sodium;
anticholinergic drugs, eg tolterodine;
antibiotics, eg erythromycin, rivampicin;
an antifungal medicine, e.g. Ketaconazole;
antidepressants, eg fluoxetine;
anticonvulsants, eg phenytoin, carbamazepine;
medicines for heart disease, eg quinidine, beta-blockers (propanolol and atenolol);
muscle relaxants, eg diazepam, succinylcholine;
General anesthesia;
medicines obtained without a prescription, e.g. herbal products.
If you have to undergo an operation that requires the administration of general anesthesia, you must tell your doctor and the anesthesiologist that you are taking Alzanzer ODT. This is because your medication can affect the amount of anesthetic needed.

Alzanzer ODT can be taken by patients with kidney disease or mild to moderate liver impairment. Tell your doctor if you have kidney or liver disease. Patients with severe liver disease should not take Alzanzer ODT.

Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you take your medicine as prescribed.

Alzanzer ODT with food, drink and alcohol
Food does not affect the effect of Alzanzer ODT.
Alzanzer ODT 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 this medicine. Alzanzer ODT should not be used during breast-feeding.
Driving and using machines
Alzheimer's disease may impair your ability to drive or operate machinery, and you should not do these activities unless your doctor has told you it is safe.
Your medicine may also cause tiredness, dizziness, and muscle cramps. If this happens, you should not drive or operate machinery.

Important information about some of the ingredients of Alzanzer ODT
Alzanzer ODT contains aspartame (E951), a source of phenylalanine. It can be harmful for people with phenylketonuria. It can harm you if you have phenylketonuria, a rare genetic disorder in which phenylalanine builds up because the body can't excrete it properly.

Alzanzer ODT contains sorbitol (E420), a source of fructose. If you have hereditary fructose intolerance, a rare genetic disorder, you should not be given this medicine. Patients with hereditary fructose intolerance cannot break down the fructose contained in this medicine, which may cause serious side effects. You should tell your doctor before you are given this medicine if you have a hereditary intolerance to fructose or if you cannot take sweet foods or drinks, for
How to take your medicine
Take your Alzanzer ODT tablet by mouth at bedtime. Place the tablet on the tongue and wait for it to dissolve, then swallow with or without water depending on your preference.

Use in children and adolescents
The use of Alzanzer ODT is not recommended in children and adolescents (under 18 years of age).

If you have taken more Alzanzer ODT than you should
In case you have taken more than the required dose, contact your doctor immediately or go to the emergency department of the nearest hospital. Take this leaflet and the remaining tablets with you.

Overdose symptoms may include nausea and vomiting, drooling, sweating, slow heart rate, low blood pressure (fainting or lightheadedness when standing up), difficulty breathing, loss of consciousness, and seizures or convulsions.

If you forget to take Alzanzer ODT
If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you forget to take your medicine for more than a week, call your doctor before taking tablets.

If you have stopped taking Alzanzer ODT
Do not stop taking the tablets unless your doctor tells you to. If you stop taking Alzanzer ODT, the benefit of your treatment will gradually wear off. If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

How long should you use Alzanzer ODT?
Your doctor or pharmacist will advise you how long you should take your tablets. You should see your doctor periodically to assess your treatment and 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 Alzanzer ODT.

If you experience any of these reactions while taking Alzanzer ODT, let us know
Your doctor.

Serious side effects:

You should tell your doctor immediately if you experience any of the following serious side effects. You may need emergency treatment.

Liver damage, eg hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, feeling unwell, fever, itching, yellowing of the skin and eyes and dark urine (may affect up to 1 in 1,000 people).
Stomach or duodenal ulcers. Symptoms of an ulcer are stomach pain and discomfort felt between the navel and the breastbone (may affect up to 1 in 100 people).
Bleeding from the stomach and/or intestines. This may cause black stools or clear blood to be passed from the rectum (may affect up to 1 in 100 people).
Fits or fits (may affect up to 1 in 100 people)
Fever with muscle stiffness, sweating or changes in consciousness (a condition called 'neuroleptic malignant syndrome') (may affect up to 1 in 10,000 people)
Weakness, tenderness or pain in the muscles, especially if you are unwell at the same time, have a high temperature or dark urine. This can be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a disease called rhabdomyolysis) (may affect up to 1 in 10,000 people).
Other side effects:

Very common side effects (affecting more than 1 in 10 people):

Common possible side effects (may affect between 1 in 10 and 1 in 100 patients):

muscle cramps;
difficulty falling asleep (insomnia);
a cold;
loss of appetite;
hallucinations (seeing or hearing things that are not there);
unusual dreams, including nightmares;
aggressive behavior;
feeling sick;
stomach discomfort;
uncontrolled urination;
accidents (patients may be prone to falls and accidental injury).
Uncommon possible side effects (may affect between 1 in 100 and 1 in 1,000 patients):

slow heart rate;
excessive salivation.
Rare possible side effects (may affect between 1 in 1,000 and 1 in 10,000 patients):

stiffness, tremors or uncontrolled movements, especially of the face and tongue, but also of the limbs.
5. How to store Alzanzer ODT
Keep out of the reach of children.
To be stored in the original
To be stored below 25°C.

Do not use this medicine after the expiry date which is stated on the carton/blister/label 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. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Alzanzer ODT contains
The active substance is: donepezil hydrochloride. Each Alzanzer ODT 5 mg tablet contains 5 mg donepezil hydrochloride.
The other ingredients are:
Sodium metabisulphite (E223)
Silica, colloidal anhydrous
Silica, colloidal aqueous
Aspartame (E951)
Sodium stearyl fumarate
Magnesium stearate
What Alzanzer ODT looks like and contents of the pack
Alzanzer ODT 5 mg orodispersible tablets are white, round tablets debossed with "ALZ" on one side and "5" on the other side, 8 mm in diameter, packed in aluminum/aluminum blisters. One blister contains 7 tablets.

An orodispersible tablet is a technical term for a tablet that directly dissolves in the mouth, thus being easily swallowed.

Package size: 28 tablets (1 package / 4 blisters).


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