Donepezil Almus
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Donepezil Almus 5 mg film-coated tablets, 10 mg film-coated tablets
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
Contents of this leaflet:
- What Donepezil Almus is and what it is used for
- What you need to know before taking Donepezil Almus
- How to take Donepezil Almus
- Possible side effects
- How to store Donepezil Almus
- Contents of the pack and other information
1. What Donepezil Almus is and what it is used for
Donepezil Almus belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat the symptoms of dementia in people who have been diagnosed with mild to moderately severe Alzheimer's disease. This medicine is intended for use in adults only.
2. What you need to know before taking Donepezil Almus
Do not take Donepezil Almus
- if you are allergic to the active substance, to piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant.
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil Almus.
Treatment with Donepezil Almus must be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Inform your doctor if:
- you have ever had gastric or duodenal ulcers, or if you are taking non-steroidal anti-inflammatory drugs (NSAIDs)
- you have ever had seizures. Donepezil may potentially cause seizures or fits. Your doctor will monitor your symptoms
- you have heart disease (especially if you have an irregular heartbeat, sick sinus syndrome, or other conditions affecting heart rhythm), as donepezil may reduce heart rate
- you suffer from asthma or other chronic lung diseases
- you have ever had liver disease
- you have difficulty urinating
- you are about to undergo surgery requiring general anaesthesia, as the dose of anaesthetic medication may need to be adjusted.
Other medicines and Donepezil Almus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:
- medicines used to treat pain and inflammation (NSAIDs)
- antibiotics such as erythromycin or rifampicin
- antifungal medicines, such as ketoconazole or itraconazole
- muscle relaxants
- antidepressants such as fluoxetine
- anticonvulsants, such as phenytoin or carbamazepine
- medicines for heart conditions or high blood pressure, such as beta-blockers
- other medicines that work similarly to donepezil (such as galantamine or rivastigmine), and certain medicines for diarrhoea, Parkinson's disease, or asthma.
Donepezil Almus with food, drinks and alcohol
You should avoid drinking alcohol while being treated with donepezil, as alcohol may reduce the effectiveness of donepezil.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Donepezil Almus and the disease itself may impair your ability to drive or operate machinery. The medicine may cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment. If you experience any of these symptoms, you must not drive or use machinery. Discuss this with your doctor before engaging in such activities.
Donepezil Almus contains lactose.
If you have been told by your doctor that you have an intolerance to certain sugars, inform your doctor before taking this medicine.
3. How to take Donepezil Almus
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The dose of the tablet you take may change over time depending on how long you have been taking the medicine and on your doctor's recommendations.
Donepezil Almus 5 mg film-coated tablets only
You will usually start by taking one film-coated tablet (5 mg donepezil hydrochloride) each evening. After one month, your doctor may instruct you to take two film-coated tablets (10 mg of donepezil hydrochloride) each evening. The maximum recommended dose is 10 mg each evening.
Donepezil Almus 10 mg film-coated tablets only
You will usually start by taking 5 mg of donepezil hydrochloride each evening. After one month, your doctor may instruct you to take one tablet each evening (10 mg donepezil hydrochloride).
The maximum recommended dose is 10 mg each evening.
For doses not achievable/practical with these strengths, other dosage forms of this medicine are available.
Take Donepezil Almus orally with a glass of water, in the evening before going to bed.
Dose adjustment is not required if you have kidney problems.
For adults with mild to moderate liver disease, your doctor may need to adjust your dose.
If you have severe liver problems, you must take extra care when taking Donepezil Almus (see section 2 “Before taking Donepezil Almus”). In cases of unexplained liver dysfunction during treatment with donepezil, discontinuation of Donepezil Almus should be considered.
Use in children and adolescents
Donepezil is not recommended for children and adolescents.
Always follow your doctor’s instructions on how and when to take the medicine. Do not change the dose on your own without consulting your doctor. Do not stop taking the tablets unless your doctor tells you to do so.
How long should you take Donepezil Almus
Your doctor will tell you how long you should continue taking the tablets. You will need to see your doctor regularly to review your treatment and assess your symptoms.
If you take more Donepezil Almus than you should
Do not take more tablets than your doctor has prescribed. Contact your doctor or go to the nearest hospital immediately if you take more than you should. Always bring the tablets and the pack with you to the hospital so that the doctor knows what you have taken.
Symptoms of overdose may include nausea, vomiting, salivation, sweating, slow heart rate, breathing difficulties, muscle weakness, fainting, and seizures.
If you forget to take Donepezil Almus
Do not take a double dose to make up for a forgotten dose.
If you forget to take a tablet, take a single tablet the next day at your usual time. If you forget to take the medicine for more than one week, inform your doctor before taking any further medicine.
If you stop taking Donepezil Almus
When treatment is stopped, the beneficial effects of donepezil will gradually decrease. Do not stop taking the tablets, even if you feel better, unless your doctor tells you to do so.
If you have any questions about the use of Donepezil Almus, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects:
If the patient develops fever with muscle stiffness, sweating, or reduced level of consciousness (a disorder known as "neuroleptic malignant syndrome"), they must consult a doctor immediately, as urgent medical treatment may be required.
If any of these serious side effects occur, inform a doctor immediately. Urgent medical treatment may be necessary.
- Weakness, muscle weakness, or muscle pain, particularly if accompanied by feeling unwell, high fever, or dark urine. These symptoms could be caused by abnormal muscle breakdown, which may be life-threatening and can lead to kidney problems (a condition called rhabdomyolysis).
Very common side effects (may affect more than 1 in 10 users):
- Diarrhoea
- Nausea
- Headache
Common side effects (may affect more than 1 in 100 but less than 1 in 10 users):
- Common cold
- Loss of appetite
- Hallucinations, aggressive behaviour, agitation, resolving with dose reduction or discontinuation of treatment
- Dizziness, insomnia, fainting
- Vomiting, abdominal discomfort
- Itching, skin rash
- Muscle cramps
- Urinary incontinence
- Fatigue, pain
- Accidents
Uncommon side effects (may affect more than 1 in 1,000 but less than 1 in 100 patients):
- Seizures
- Slowed heart rate
- Gastrointestinal bleeding, gastric and duodenal ulcers
- Slight increase in the muscle enzyme creatine kinase in blood tests
Rare side effects (may affect less than 1 in 1,000 users):
- Numbness or involuntary movements, particularly of the face and tongue, but also of the limbs
- Heart disorders
- Liver disorders including hepatitis
If any side effect occurs, including those not listed in this leaflet, consult your doctor or pharmacist.
5. How to store Donepezil AlmusHOW TO STORE DONEPEZIL ALMUS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack/container and outer carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Donepezil Almus contains
- The active substance is donepezil hydrochloride. Each film-coated tablet contains 5 mg or 10 mg of donepezil hydrochloride.
- The other ingredients are: tablet core: lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate; tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide E171 and iron oxide yellow E172 (only in the 10 mg tablets).
Description of the appearance of Donepezil Almus and contents of the pack
5 mg film-coated tablets are white, round and biconvex, marked with “DZ 5” on one side.
10 mg film-coated tablets are light yellow, round and biconvex, marked with “DZ 10” on one side.
Packs:
Blister packs: 14, 20, 28, 50, 56, 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea, 11/10 - 16121 Genoa - Italy
Manufacturer responsible for batch release
Actavis Ltd.
BLB16 Bulebel Industrial Estate, Zejtun ZTN 3000 - Malta