DARIZOL 10 mg. 28 tablets
DARIZOL belongs to a group of medicines called acetylcholinesterase inhibitors.
DARIZOL used to treat the symptoms of dementia (a disorder of rational behavior) in people with established mild to moderate Alzheimer's disease (chronic mental illness).
DARIZOL is intended for use only in adults.
2. BEFORE YOU TAKE DARIZOL
Do not take DARIZOL:
If you are allergic (hypersensitive) to donepezil hydrochloride or any of the other ingredients of Darizol. An allergic reaction may be recognized as a rash, itching, swollen face, swollen lips or shortness of breath. If this happens to you, ask your doctor;
If you are pregnant or think you may be pregnant or breast-feeding.
If you suffer from any of the following illnesses tell your doctor as soon as possible:
Ulcers of the stomach or duodenum;
Epilepsy or if you have ever had seizures (seizures) or convulsion;
Heart disease, including changes in heart beat (irregular or very slow heart rhythm);
Bronchial asthma (dyspnea, difficulty breathing) or other chronic lung disease;
Kidney disease or urinary tract.
Important information about some of the ingredients of DARIZOL
DARIZOL contains aspartame (E 951), a source of phenylalanine. May be harmful for people with phenylketonuria.
This medicine contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars (eg. Lactose), contact him before taking this medicine.
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Be sure to tell your doctor if you are taking any of these medicines together with the use of DARIZOL:
other drugs for Alzheimer's disease, such as galantamine;
painkillers or treatment of arthritis, for example acetylsalicylic acid, nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium;
anticholinergic drugs, such as tolterodine;
antibiotics, for example erythromycin, rifampicin;
antifungal drugs such as ketoconazole;
muscle relaxants eg diazepam, succinylcholine;
anti-depressants, such as fluoxetine;
anticonvulsants (medications used in preventing the emergence of different types of seizures) eg. phenytoin, carbamazepine;
medicines for cardiac pacemakers, for example quinidine, beta-blockers;
medicines obtained without a prescription, such as drugs of plant origin and others.
If you are having surgery that requires general anesthesia (anesthesia) you should inform your doctor and anesthetist that you are taking DARIZOL. This is necessary because your medicine may be reacted with an anesthetic.
DARIZOL can be used in patients with kidney disease or mild to moderate hepatic disease. Tell your doctor if you have kidney or liver disease. Patients with severe liver disease should not take DARIZOL.
Taking DARIZOL with food and drink
DARIZOL taken with a glass of water after the tablet is dissolved on the tongue. The food has no influence on the intake of this medicine. Alcohol consumption should be restricted when taking DARIZOL since alcohol can reduce plasma levels of donepezil.
Pregnancy and lactation
Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medicine if you are pregnant unless you have discussed with your doctor. You should not take this medicine when breast-feeding, because it is likely DARIZOL pass into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive because Alzheimer's disease may impair your ability to drive or operate machinery and should not perform these activities unless your doctor tells you it is safe to do so.
Do not use tools or machines because your medicine can cause fatigue, dizziness and muscle spasm.
3. HOW TO TAKE DARIZOL
Always take DARIZOL just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The usual daily dose at the initiation of treatment is 5 mg every night. After a meat Your doctor may start you to take 10 mg each night. The maximum recommended daily dose is 10 mg each night.
Take your tablet by mouth at bedtime. Put the tablet on the tongue and allow it to dissolve, then swallow with or without water depending on your preference.
The concentration of the tablet that will take may change depending on the length of time that has been taken this medicine and what the doctor will recommend.
You should always follow the advice of your doctor or pharmacist about how and when to take your medicine. Do not change the dose yourself without your doctor's advice. Your doctor or pharmacist will advise you on how long you should continue to take the tablets.
You will need to consult your doctor periodically to assess the treatment and your symptoms.
If you take more than the amount DARIZOL
Do not take more than one tablet a day. If you do, you can get nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure, lightheadedness or dizziness when getting up, breathlessness, collapse and convulsions. Call your doctor immediately or go to the nearest hospital. Always take the tablets and the container with you to the hospital to know the doctor what medicine is taken.
If you forget to take DARIZOL
If you forget to take a tablet, just take one tablet the next day at the usual time. If you forget to take your medicine for more than one week, call your doctor before you start taking this medicine again. Do not take a double dose at the expense of missed tablet.
If you stop taking DARIZOL
Do not stop taking the tablets unless your doctor has told you to do it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, DARIZOL can cause side effects, although not everybody gets them, in most cases they disappear, without having to discontinue the treatment.
Tell your doctor if you experience any of these effects and if they are too uncomfortable for you.
Patients taking DARIZOL have reported the following adverse reactions:
Serious side effects
You should tell your doctor immediately if you notice the below mentioned serious side effects. It may be necessary and urgent medical treatment:
liver damage, for example hepatitis. Symptoms of hepatitis are feeling that you are sick, loss of appetite, feelings of malaise, fever, itching, yellowing of skin and eyes, dark colored urine (probably affecting less than 1 in 1000);
ulcers of the stomach or duodenum. The symptoms of ulcers are stomach pain and discomfort around the navel and behind the sternum (probably affecting less than 1 in 100);
bleeding in the stomach or intestines. This can lead to a black tarry stools or visible blood from the rectum (probably affecting less than 1 in 100);
seizures (fits) or convulsions (probably affecting less than 1 in 100).
Very common side effects - affects 1 in 10:
feeling that you are sick;
Common side effects - affects 1 to 10 patients in 100:
loss of appetite;
hallucinations (seeing or hearing things that are not real);
Uncommon side effects - affects 1 to 10 patients in 1000:
Rare side effects - affects 1 to 10 patients in 1000:
stiffness or uncontrollable movement especially of the face and tongue, as well as the extremities.
If any of the side effects get worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DARIZOL
This medicine does not require any special storage conditions.
Keep out of reach of children.
Do not use DARIZOL after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of in 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 is DARIZOL
DARIZOL 10 mg tablets, orodispersible: The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride.
All tablets contain the following ingredients: polacrilin potassium, microcrystalline cellulose, lactose monohydrate, anhydrous monosodium citrate, aspartame (E951), croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hydrochloric acid, purified water.