Alzancer ODT 10 mg. 28 tablets

1. What Alzancer ODT is and what it is used for
Alzancer ODT contains the active substance donepezil hydrochloride. Alzancer 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 changes in behaviour. As a result, people with Alzheimer's disease find it increasingly difficult to carry out their normal daily activities.

Alzancer ODT is for use in adults only.

2. What you need to know before you take Alzancer ODT
Do not take Alzancer ODT
if you are allergic to donepezil hydrochloride, piperidine derivatives or any of the other ingredients of this medicine (listed in section 6);
Warnings and precautions
Talk to your doctor or pharmacist before taking Alzancer ODT if you have or have ever had:

a stomach or duodenal ulcer;
fits or seizures;
heart disease (irregular or slow heartbeat);
asthma or other long-term 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
Alzancer ODT is not recommended for use in children and adolescents (under 18 years of age).

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

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

other medicines for Alzheimer's disease, e.g. galantamine;

painkillers or arthritis treatments, e.g. aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or diclofenac sodium;
anticholinergic medicines, e.g. tolterodine;
antibiotics, e.g. erythromycin, rivampicin;
antifungal medicines, e.g. ketoconazole;
antidepressants, e.g. fluoxetine;
anticonvulsants, e.g. phenytoin, carbamazepine;
heart medicines, e.g. quinidine, beta-blockers (propanolol and atenolol);
muscle relaxants, e.g. diazepam, succinylcholine;
general anaesthetics;
medicines obtained without a prescription, e.g. herbal products.
If you are going to have an operation that requires a general anaesthetic, you should tell your doctor and the anaesthetist that you are taking Alzancer ODT. This is because your medicine may affect the amount of anaesthetic needed.

Alzancer 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 Alzancer ODT.

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

Alzancer ODT with food, drink and alcohol
Food does not affect the effect of Alzancer ODT.
Alzancer ODT should not be taken with alcohol because alcohol can change its effect.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Alzancer ODT should not be taken during breast-feeding.

Driving and using machines
Alzheimer's disease may impair your ability to drive or use machines and you should not do these activities unless your doctor tells you it is safe.
Your medicine may also cause tiredness, dizziness and muscle cramps. If this happens, you should not drive or use machines.

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

Alzancer ODT contains sorbitol (E420), a source of fructose. If you have hereditary fructose intolerance, a rare genetic disease, 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 hereditary fructose intolerance or if you cannot take sugary foods or drinks,
if you feel sick, vomit or experience unpleasant sensations such as stomach bloating, abdominal cramps or diarrhoea.

Alzancer ODT contains sodium metabisulphite (E 223), which in rare cases may cause severe hypersensitivity reactions and bronchospasm.

Alzancer ODT contains mannitol (E421) and may have a mild laxative effect.

For a full list of excipients, see Contents of the pack and other information below.

3. How to take Alzancer ODT
How much Alzancer ODT you should take
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended starting dose is 5 mg each evening at bedtime. After one month, your doctor may tell you to take 10 mg each evening at bedtime. The dose you take may change depending on the duration of treatment and your doctor's recommendations.
The maximum recommended dose is 10 mg, every evening.

Always follow your doctor or pharmacist's instructions on how and when to take your medicine. Do not change your dose without consulting your doctor.

How to take your medicine
Take your Alzancer ODT tablet by mouth before going to bed. Place the tablet on your 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 Alzancer ODT is not recommended in children and adolescents (under 18 years of age).

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

Symptoms of overdose may include nausea and vomiting, salivation, sweating, slow heart rate, low blood pressure (fainting or dizziness when standing up), difficulty breathing, loss of consciousness and seizures or fits.

If you forget to take Alzancer 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 forgotten dose.
If you forget to take your medicine for more than a week, call your doctor before taking the tablets.

If you stop taking Alzancer ODT
Do not stop taking the tablets unless your doctor tells you to. If you stop taking Alzancer ODT, the benefit of your treatment will gradually disappear.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

How long you should take Alzancer ODT
Your doctor or pharmacist will advise you on how long you should take your tablets. You should see your doctor regularly to review 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 Alzancer ODT.

If you experience any of these effects while taking Alzancer ODT, tell your doctor.

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

Liver damage, such as hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, feeling generally 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 include 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 from the rectum (may affect up to 1 in 100 people).
Seizures or fits (may affect up to 1 in 100 people).
Fever accompanied by muscle stiffness, sweating or changes in consciousness (a condition called ‘neuroleptic malignant syndrome’) (may affect up to 1 in 10,000 people).
Muscle weakness, tenderness or pain, especially if you also feel unwell, have a high temperature or dark urine. This may 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 (affecting more than 1 in 10 people):
diarrhoea;
nausea;
headache.
Common possible side effects (may affect between 1 in 10 and 1 in 100 patients):
muscle stiffness;
tiredness;
difficulty falling asleep (insomnia);
cold;
loss of appetite;
hallucinations (seeing or hearing things that are not there);
unusual dreams, including nightmares;
agitation;
aggressive behaviour;
feeling sick;
dizziness;
stomach discomfort;
rash;
uncontrolled urination;
pain;
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 people):
stiffness, shaking or uncontrolled movements, especially of the face and tongue, but also of the limbs.

5. How to store Alzancer ODT
Keep out of the reach and sight of children.
Store in the original package.
Store below 25°C.

Do not use this medicine after the expiry date which is stated on the carton/blister/label after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Alzancer ODT contains
The active substance is: donepezil hydrochloride. Each Alzancer ODT 10 mg tablet contains 10 mg donepezil hydrochloride.
The other ingredients are:
Mannitol
Sorbitol
Crospovidone
Sodium metabisulphite (E223)
Silicon dioxide, colloidal anhydrous
Silicon dioxide, colloidal aqueous
Aspartame (E951)
Sodium stearyl fumarate
Magnesium stearate
What Alzancer ODT looks like and contents of the pack
Alzancer ODT 10 mg orodispersible tablets are white, round tablets with the inscription “ALZ” on one side and “10” on the other side with a diameter of 9.4 mm, packed in aluminium/aluminium blisters. One blister contains 7 tablets.

Orodispersible tablet is a technical term for a tablet that dissolves directly in the mouth, making it easy to swallow.

Pack size: 28 tablets (1 pack/ 4 blisters).

 

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