5 mg and 10 mg film-coated tablets
Donepezil hydrochloride
1. What Donepezil STADA is and what it is used for
Donepezil Stada belongs to a group of medicines called acetylcholinesterase inhibitors.
Donepezil Stada is used to treat the symptoms of dementia in mild to moderate Alzheimer’s disease.
Donepezil contained in Donepezil Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Donepezil STADA
Do not use Donepezil STADA
- if you are allergic to donepezil hydrochloride, or similar medicines (piperidine derivatives), or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Donepezil Stada. Especially:
- If you are going to undergo surgery that requires anesthesia. Donepezil may enhance muscle relaxation during anesthesia.
- If you have or have ever had any heart disease (especially arrhythmias, or similar conditions). Donepezil can lower your heart rate.
- If you have ever had a stomach ulcer or if you are using certain painkillers (non-steroidal anti-inflammatory drugs – NSAIDs, such as diclofenac ). Concomitant use may lead to an increased risk of stomach ulcers. Your doctor may need to check your symptoms (such as stomach pain).
- If you have difficulty urinating or mild kidney disease. Your doctor may need to check your symptoms.
- If you have ever had a seizure. Donepezil can cause new seizures. Your doctor may need to check your symptoms.
- If you have ever had extrapyramidal symptoms (uncontrolled body or face movements). Donepezil may cause or worsen extrapyramidal symptoms.
- If you have asthma or another so-called chronic lung disease. Your symptoms may get worse.
- If you have ever had liver disease (because your dose may need to be adjusted).
Donepezil Stada can be used by people with renal impairment or with mild to moderate hepatic impairment. Tell your doctor if you have any kidney or liver disease. Patients with severe hepatic impairment should not use Donepezil Stada.
Other medicines and Donepezil STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines can be affected by donepezil. They in turn can affect how well donepezil works.
Donepezil may interact with:
- drugs for cardiovascular disease, quinidine, drugs for fungal infections, ketoconazole and itraconazole, certain antibiotics, erythromycin, and antidepressants, (selective serotonin reuptake inhibitors, SSRIs eg fluoxetine ). These may enhance the effect of donepezil.
- drugs used for tuberculosis ( rifampicin ), drugs for epilepsy ( phenytoin and carbamazepine ). These medicines may reduce the effect of donepezil.
- muscle relaxants used in anesthesia and intensive care ( succinylcholine ) and certain antihypertensive drugs ( beta-blockers ). The effect of both drugs can be enhanced.
- other drugs that act in the same way as donepezil (such as galantamine or rivastigmine) and certain drugs for diarrhea, Parkinson’s disease, or asthma(anticholinergic drugs – drugs that affect and reduce the amount of the neurotransmitter acetylcholine in the brain).
- anesthetics
- painkillers or anti-inflammatory drugs such as acetylsalicylic acid and non-steroidal anti-inflammatory drugs ( NSAIDs ) such as ibuprofen or diclofenac.
Donepezil STADA with food, drink, and alcohol
You should avoid alcohol during treatment as it may inhibit the effect of donepezil.
Pregnancy, breastfeeding, 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.
There is no experience with the use of donepezil in pregnant women. Do not take donepezil if you are pregnant or planning to become pregnant, unless your doctor considers it necessary after a careful analysis of the clinical risk/benefit.
There are only limited data available to assess the safety of donepezil use during breast-feeding. You should not breast-feed while taking donepezil.
Driving and using machines
Donepezil has a small to moderate effect on the ability to drive and use machines. Alzheimer’s disease can impair your ability to drive or use machines, and you should refrain from doing so unless your doctor considers it safe for you to drive or use machines.
It may be that the medicine makes you feel tired and dizzy and that you may have muscle cramps, especially at the beginning of treatment, or after a dose increase. If you experience any of these symptoms, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Donepezil STADA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Donepezil STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Tell your doctor or pharmacist if you have a guardian. Your guardian can help you take your medicine according to the instructions.
The recommended dose is:
It is common to start treatment by taking 1 white tablet of 5 mg donepezil hydrochloride in the evening. After one month, your doctor may ask you to take 2 white tablets of 5 mg, or instead take 1 yellow tablet of 10 mg in the evening. The highest recommended dose is two white tablets of 5 mg, or 1 yellow tablet of 10 mg every night.
Do not change the dose without the advice of a doctor.
No dose adjustment is required for kidney disease.
If you have mild to moderate liver disease, your dose may need to be adjusted by your doctor. If you have a severe hepatic impairment, you should not take Donepezil Stada (see section 2. Warnings and precautions). If you have unexplained liver disease, your doctor may decide to completely stop your treatment with Donepezil Stada.
Donepezil Stada tablets should be swallowed whole with a glass of water in the evening before going to bed.
Your doctor will tell you how long to use the tablets. You need to see your doctor regularly to evaluate your treatment and assess your symptoms. Do not stop taking the tablets unless your doctor tells you to.
Use for children and adolescents
It is not recommended for use by children or adolescents (younger than 18 years)
If you use more Donepezil STADA then you should
Do not take more tablets than your doctor has told you to. Symptoms of donepezil overdose include severe nausea and vomiting, involuntary drooling, sweating, slow heart rate ( bradycardia ), low blood pressure ( hypotension ), difficulty breathing, loss of consciousness, seizures, and increased muscle weakness.
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Always take tablets and cartons to the hospital so that the doctor knows what you have taken.
If you forget to use Donepezil STADA
If you forget to take a tablet, simply take one tablet the next day at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you forget to take your medicine for more than a week, call your doctor before taking any more medicines.
If you stop using Donepezil STADA
Do not stop taking the tablets unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In most cases, they go away without the need to stop treatment.
Serious side effects:
You must talk to a doctor immediately if you experience any of the following serious side effects. In such cases, you may need immediate medical attention.
- Fever with muscle stiffness, sweating or decreased consciousness (this is a condition called ‘malignant neuroleptic syndrome’ or ‘neuroleptic malignant syndrome’) (affects less than 1 in 10,000 users).
- Muscle weakness, soreness, or pain, especially if you also feel sick, have a high fever, or dark urine. The symptoms can be caused by an abnormal breakdown of the muscles which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis ) (can occur in up to 1 in 10,000 users).
Very common (may affect more than 1 user in 10):
Diarrhea, nausea, and headache.
Common (may affect up to 1 in 10 people):
Cold symptoms, vomiting, stomach discomfort, muscle cramps, tiredness, fainting, dizziness, insomnia (insomnia), pain, loss of appetite, itching, eczema, hallucinations, unusual dreams and nightmares elation, aggressive behavior, urinary incontinence, urinary incontinence, urinary incontinence
Cases of hallucinations, abnormal dreams and nightmares, mood, and aggressive behavior have ceased the dose reduction or discontinuation of donepezil.
Uncommon (may affect up to 1 in 100 people):
Seizures, slow heartbeat, stomach ulcers, stomach upset incl. gastrointestinal bleeding (may be manifested by carbon black stools or by clearly visible bleeding from the rectum), increase in blood levels of a muscle enzyme (creatine kinase).
Rare (may affect up to 1 in 1,000 people):
Hepatic effects (incl. Hepatitis), tremors or uncontrolled movements especially of the face and tongue but also in the hands and legs (extrapyramidal symptoms). Impact on heart rhythm (conduction system).
5. How to store Donepezil STADA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is donepezil hydrochloride.
Each 5 mg tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg donepezil.
Each 10 mg tablet contains 10 mg donepezil hydrochloride, equivalent to 9.12 mg donepezil.
Other ingredients are
Tablet core:
Anhydrous lactose
Pregelatinized corn starch
Calcium hydrogen phosphate dihydrate
Talc
Magnesium stearate
Colloidal anhydrous silica
The film features:
Hypromellose
Hydroxypropylcellulose
Talc
Titanium dioxide (E171)
The 10 mg tablet also contains yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Film-coated tablet.
Donepezil Stada 5 mg film-coated tablets are white, round, and biconvex.
Diameter: 7.1 mm.
Donepezil Stada 10 mg film-coated tablets are yellow, round, and biconvex.
Diameter: 9.1 mm.
Pack sizes: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112, 120, 126, 154, 182, and 196 film-coated tablets packaged in PVC / aluminum blister packs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark