Zepanalz 5 mg/10 mg Tablets

The active substance is donepezil hydrochloride. ZEPANALZ 5 mg TABLETS: Each film-coated tablet contains donepezil hydrochloride 5 mg. ZEPANALZ 10 mg TABLETS: Each film-coated tablet contains donepezil hydrochloride 10 mg. The other ingredients of ZEPANALZ TABLETS are hypromellose, lactose monohydrate, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, talc and titanium dioxide. ZEPANALZ 10 mg TABLETS also contains iron oxide yellow.

ZEPANALZ TABLETS belongs to a group of medicines called acetylcholinesterase inhibitors. ZEPANALZ TABLETS are used to treat mild to moderate dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and may cause changes in mood and personality) caused by Alzheimer’s disease.

Do not take ZEPANALZ TABLETS:

• If you are hypersensitive (allergic) to donepezil hydrochloride, piperidine derivatives or any of the other ingredients of ZEPANALZ TABLETS.
• In children – Because the safety and effectiveness of ZEPANALZ TABLETS has not been established in children. ZEPANALZ TABLETS should not be given to children.

Take special care with ZEPANALZ TABLETS:

• The use of ZEPANALZ TABLETS in patients with severe dementia, other types of dementia or other types of memory problems has not been determined.
• Before taking ZEPANALZ TABLETS, tell your doctor if you have or have had:
• “sick sinus syndrome” which may present with symptoms such as chest pain, shortness of breath, dizziness, fatigue, nausea, fainting or a fast heartbeat, or other heart disease.
• gastrointestinal (affecting the stomach and intestines) bleeding, ulcers, or if you are taking non-steroidal anti-inflammatory medicines (NSAIDs).
• seizures (fits) or convulsions.
• asthma or other obstructive lung disease.
• difficulty passing urine.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ZEPANALZ TABLETS.
• If you are recovering from recent bladder or gastrointestinal surgery.

Taking ZEPANALZ TABLETS with food and drink: ZEPANALZ TABLETS can be taken with or without food. Alcohol may change the effect of ZEPANALZ TABLETS as the rate that ZEPANALZ TABLETS is eliminated from your system is increased therefore decreasing the duration that ZEPANALZ TABLETS may work for you.

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ZEPANALZ TABLETS with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice. Always take ZEPANALZ TABLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of ZEPANALZ TABLETS is too strong or too weak, talk to your doctor or pharmacist.

Adults and the elderly:

• The usual starting dose is 5 mg once a day.
• After one month, your doctor may increase your dose to 10 mg once a day.
• The maximum recommended dose is 10 mg once a day.
• The dose is similar for patients with kidney disease or mild to moderate liver disease.

If you take more ZEPANALZ TABLETS than you should: Symptoms of overdose may include nausea and vomiting, drooling, sweating, slow heart rate, low blood pressure, breathing problems, losing consciousness and seizures (fits). In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take ZEPANALZ TABLETS: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take a double dose to make up for forgotten individual doses.

ZEPANALZ TABLETS can have side - effects. Get emergency medical help if you have any of these signs of an allergic reaction:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side - effects:

• seizures (fits) or convulsions
• slow heartbeat
• fainting
• black, bloody, or tarry stools
• coughing up blood or vomit that looks like blood or coffee grounds
• chest pain
• hepatitis (inflammation of the liver). The symptoms of hepatitis are nausea or vomiting, loss of appetite; feeling generally unwell; fever; itching; yellowing of the skin and eyes; and dark coloured urine.

Other side - effects include: the common cold; flu; excessive loss of body water; inability to sleep; abnormal dreams; being agitated; depression; abnormal crying; aggressive behaviour; increased sexual desire; nervousness; restlessness; hallucinations (seeing or hearing things that are not really there); dizziness; headache; sleepiness; language disorder; loss of muscle coordination; numbness, tingling, pins and needles; tremor (shake); decrease in vision due to clouding of the lens of the eye; eye irritation; blurred vision; hot flushes; high blood pressure; low blood pressure; shortness of breath; sore throat; diarrhoea (frequent or loose watery stools); lack of appetite; stomach pain; abnormal swelling due to a collection of gas or fluid in your abdomen, toothache; stomach ulcer; duodenal ulcer (ulcer in the duodenum); increased sweating; itching; muscle cramps; passing urine frequently; inability to control urination; infection of the urinary tract; extreme tiredness; pain; loss of weight; accidents; bone fractures.

Tell your doctor if any of the above side - effects are severe, bothersome, do not go away or about any other concerns you have while taking ZEPANALZ TABLETS.

Store at or below 25 ºC. Protect from light. Do not remove blisters from carton until required for use. Keep securitainer well - closed after use. Keep all medicines out of the reach and sight of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).