DONEPEZIL FLAS KERN PHARMA 10 mg ORALLY DISINTEGRATING TABLETS
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How to use DONEPEZIL FLAS KERN PHARMA 10 mg ORALLY DISINTEGRATING TABLETS
Introduction
Package Leaflet: Information for the User
Donepezil Flas Kern Pharma 10 mg Orodispersible Tablets EFG
Donepezil Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Contents of the pack:
- What is Donepezil Flas Kern Pharma and what is it used for
- What you need to know before you take Donepezil Flas Kern Pharma
- How to take Donepezil Flas Kern Pharma
- Possible side effects
- Storage of Donepezil Flas Kern Pharma
- Contents of the pack and further information
1. What is Donepezil Flas Kern Pharma and what is it used for
Donepezil Flas is a specific and reversible inhibitor of acetylcholinesterase, the predominant cholinesterase in the brain.
It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.
2. What you need to know before you take Donepezil Flas Kern Pharma
Do not take Donepezil Flas Kern Pharma
- If you are allergic to donepezil hydrochloride or any of the other ingredients of Donepezil Flas Kern Pharma.
- If you are pregnant or breastfeeding.
Warnings and precautions
- Before starting treatment with Donepezil Flas Kern Pharma, you should tell your doctor if you have or have had stomach ulcers, heart disease, seizures, asthma, chronic pulmonary disease, or difficulty urinating.
- In case of surgery with general anesthesia, you should inform your doctor that you are taking Donepezil Flas.
- Donepezil Flas is not recommended for use in children.
- You should avoid taking Donepezil Flas with other acetylcholinesterase inhibitors and other agonists or antagonists of the cholinergic system.
- If you have vascular dementia (loss of brain function due to a series of small strokes).
- A heart condition (such as irregular or very slow heartbeats, heart failure, heart attack)
- A heart condition called "prolongation of the QT interval" or a history of certain abnormal heart rhythms called torsades de pointes or if someone in your family has "prolongation of the QT interval"
- Low levels of magnesium or potassium in the blood
Using Donepezil Flas Kern Pharma with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, and especially if you are taking any of the following medicines:
- Ketoconazole and itraconazole (to treat fungal infections).
- Quinidine and beta-blockers (to treat irregular heartbeats).
- Erythromycin (to treat bacterial infections).
- Fluoxetine (to treat depression).
- Rifampicin (to treat bacterial infections and tuberculosis).
- Phenytoin and carbamazepine (to treat epilepsy).
- Cholinergic agonists and medicines with anticholinergic activity (acting on the central nervous system).
- Succinylcholine and other neuromuscular blockers (to produce muscle relaxation).
- Medicines for heart rhythm problems (e.g., amiodarone, sotalol, and quinidine).
- Medicines for depression (e.g., citalopram, escitalopram, amitriptyline), medicines for psychosis (e.g., pimozide, sertindole, ziprasidone), medicines for bacterial infections (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin).
Using Donepezil Flas Kern Pharma with food, drink, and alcohol
Place the tablet on the tongue and let it dissolve. Swallow with or without water.
Taking Donepezil with alcohol may reduce the absorption of this medicine.
Pregnancy, breastfeeding, and fertility
Do not take Donepezil Flas if you are pregnant.
Do not take Donepezil Flas if you are breastfeeding.
Driving and using machines
Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you it is safe to do so. Donepezil may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.
Donepezil Flas Kern Pharma contains aspartame. It may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.
3. How to take Donepezil Flas Kern Pharma
Follow exactly the administration instructions of Donepezil Flas Kern Pharma given by your doctor. Ask your doctor or pharmacist if you have any doubts.
Donepezil Flas Kern Pharma is administered orally. The tablet should be placed on the tongue and allowed to dissolve before swallowing with or without water.
Treatment with Donepezil Flas Kern Pharma starts with a 5 mg tablet, taken once a day with a little water, at night immediately before bedtime. After one month of treatment, your doctor may indicate an increase in the dose to 10 mg, once a day and at night. The maximum recommended dose is 10 mg/day.
If you have abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take Donepezil Flas Kern Pharma in the morning.
If you have mild or moderate liver impairment (disease affecting the liver) or renal impairment (disease affecting the kidney), you may follow a similar dosage regimen as indicated above.
If you take more Donepezil Flas Kern Pharma than you should
If you have taken more Donepezil Flas Kern Pharma than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.
If you forget to take Donepezil Flas Kern Pharma
Do not take a double dose to make up for forgotten doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Donepezil Flas Kern Pharma can cause side effects, although not everybody gets them. The estimated frequency of their occurrence is as follows:
The most common side effects that may affect at least 1 in 10 patients are:
- Diarrhea
- Nausea
- Headache
Common side effects that may affect up to 1 in 100 patients but more than 1 in 10 are:
- Cold
- Loss of appetite
- Hallucinations, agitation, aggressive behavior
- Fainting, dizziness, difficulty sleeping
- Vomiting, abdominal discomfort
- Urinary incontinence
- Rash, itching
- Muscle cramps
- Fatigue, pain
- Accidents
Uncommon side effects that may affect up to 1 in 1,000 patients but more than 1 in 100 are:
- Seizures
- Decreased heart rate
- Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
- Increased levels of a type of enzyme (creatine kinase) in the blood
Rare side effects that may affect less than 1 in 1,000 patients are:
- Extrapyramidal symptoms (such as tremor or rigidity of the hands or legs)
- Conduction disorders
- Liver function disorders, including hepatitis
Side effects with unknown frequency:
- Changes in heart activity that can be seen on an electrocardiogram (ECG) called "prolongation of the QT interval"
- Fast and irregular heartbeat, fainting that can be symptoms of a potentially fatal disorder known as torsades de pointes
- Increased libido, hypersexuality
- Pisa syndrome (a condition that involves involuntary muscle contraction with abnormal flexion of the body and head to one side)
If you think you have any of the side effects that are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.
Severe side effects:
Consult your doctor immediately if you experience these severe side effects. You may need urgent medical treatment.
- Weakness, sensitivity, or muscle pain, especially if you feel unwell, have a fever, or your urine is dark. This can be due to abnormal muscle destruction that can be fatal and cause kidney problems (a disease called rhabdomyolysis).
5. Storage of Donepezil Flas Kern Pharma
Keep out of the sight and reach of children.
No special storage conditions are required.
Do not use Donepezil Flas Kern Pharma after the expiry date stated on the pack. The expiry date is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Place the pack and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.
6. Contents of the pack and further information
Composition of Donepezil Flas Kern Pharma
- The active substance is donepezil. Each tablet contains 10 mg of donepezil hydrochloride (equivalent to 9.12 mg of donepezil).
- The other ingredients are: mannitol (E-421), microcrystalline cellulose (E-460i), guar gum, crospovidone, aspartame (E-951), magnesium stearate, and yellow iron oxide (E-172).
Appearance of the product and pack contents
Round tablets, yellow in color, with a score line on one face and the anagram K on the other. The tablet can be divided into two equal halves.
The tablets are packaged in blister packs in cartons of 28 tablets.
Marketing authorization holder and manufacturer
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Date of last revision of this leaflet: November 2022
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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