Donepezil Ratio 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Donepezil ratio 10 mg film-coated tablets EFG
donepezil, hydrochloride (as monohydrate)
Read the entire 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Donepezil ratio is and what it is used for
- What you need to know before taking Donepezil ratio
- How to take Donepezil ratio
- Possible side effects
- How to store Donepezil ratio
- Contents of the pack and other information
1. What Donepezil ratio is and what it is used for
Donepezil (donepezil hydrochloride) belongs to a group of medicines called cholinesterase inhibitors.
Donepezil hydrochloride increases the levels in the brain of a substance (acetylcholine) involved in memory function by reducing the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people diagnosed with mild to moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion, and behavioural changes. As a result, patients with Alzheimer's disease find it increasingly difficult to carry out their usual daily activities. It is for use in adult patients only.
2. What you need to know before taking Donepezilo ratio
Do not take Donepezilo ratio
- if you are allergic to donepezil hydrochloride or to piperidine derivatives, or to any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant, think you may be pregnant, or are breastfeeding.
Inform your doctor if any of these situations apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezilo ratio if you have or have had:
- stomach or duodenal ulcer
- stroke or seizures
- a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction)
- a heart condition known as “QT interval prolongation” or a history of certain abnormal heart rhythms called torsade de pointes, or if anyone in your family has “QT interval prolongation”
- low levels of magnesium or potassium in the blood
- asthma or other long-term lung diseases
- liver problems or hepatitis
- difficulty urinating or mild kidney disease
Also inform your doctor if you are pregnant or think you might be pregnant.
You should avoid taking Donepezilo Teva together with other acetylcholinesterase inhibitors and other cholinergic agonists or antagonists.
Use in children and adolescents
Donepezilo ratio is not recommended for children and adolescents under 18 years of age.
Other medicines and Donepezilo ratio Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
This includes medicines not prescribed by your doctor but which you have obtained over-the-counter from a pharmacist. It also applies to medicines you may take in the future while continuing to take Donepezilo ratio. This is because these medicines may weaken or strengthen the effects of Donepezilo ratio.
In particular, inform your doctor if you are taking any of the following medicines:
- medicines for heart rhythm problems, e.g. amiodarone or sotalol
- medicines for depression, e.g. citalopram, escitalopram, amitriptyline, fluoxetine
- medicines for psychosis, e.g. pimozide, sertindole, or ziprasidone
- medicines for bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
- antifungal medicines, such as ketoconazole
- other medicines for Alzheimer's disease, e.g. galantamine
- painkillers or treatment for arthritis, e.g. Aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
- anticholinergics, e.g. tolterodine
- anticonvulsants, e.g. phenytoin, carbamazepine
- medication for heart disease, e.g. quinidine, beta-blockers (propranolol and atenolol)
- muscle relaxants, e.g. diazepam, succinylcholine
- general anaesthetics
- over-the-counter medicines, e.g. herbal remedies
If you are undergoing surgery requiring general anaesthesia, you must inform your doctor and anaesthetist that you are taking Donepezilo ratio. This is because your medicine may affect the amount of anaesthetic required.
Donepezilo ratio may be used in patients with mild to moderate renal or hepatic impairment.
Inform your doctor if you have kidney or liver disease. Patients with severe liver disease should not take Donepezilo ratio.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you take the medicine as prescribed.
Taking Donepezilo ratio with food, drinks, and alcohol
Donepezilo ratio should be taken with water. Food does not affect the absorption of donepezil hydrochloride. You should not drink alcohol while taking Donepezilo ratio, as alcohol may alter its effect.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take Donepezilo ratio if you are pregnant or think you might be pregnant.
Do not take Donepezilo ratio if you are breastfeeding.
Driving and using machines
Alzheimer's disease can impair your ability to drive or operate machinery. Do not drive or use tools or machinery unless your doctor tells you it is safe to do so.
Donepezilo ratio may also cause fatigue, dizziness, or muscle cramps, especially at the beginning of treatment or when the dose is changed. If you experience these effects while taking Donepezilo ratio tablets, you should not drive or operate machinery.
Donepezilo ratio contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Donepezilo ratio contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.
3. How to take Donepezil ratio
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Taking the Donepezil ratio dose
You will usually start by taking 5 mg (one white tablet) each night before going to bed. After one month, your doctor may instruct you to take 10 mg (one yellow tablet) each night before going to bed. If you experience abnormal dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil in the morning. The tablet dose you take may vary depending on how long you have been taking this medicine and your doctor's advice. The maximum recommended dose is 10 mg each night. Always follow your doctor's or pharmacist's advice on how and when to take your medicine. Do not change the dose yourself without consulting your doctor.
How to take your medicine
Swallow your tablet with some water at night before going to bed.
How long you should take Donepezil ratio
Your doctor or pharmacist will advise you on how long you should continue taking the tablets. You need to visit your doctor from time to time to review your treatment and assess your symptoms.
Use in children and adolescents
Donepezil ratio is not recommended for use in children and adolescents (under 18 years of age).
If you take more Donepezil ratio than you should
Contact your doctor or nearest hospital immediately if you take more medicine than you should.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or hospital immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Take the tablets and packaging with you to the hospital so the doctor knows what you have taken.
Symptoms of overdose include nausea (feeling sick), vomiting, drooling, sweating, slowed heart rate, low blood pressure (dizziness or lightheadedness upon standing), breathing difficulties, loss of consciousness, and seizures or convulsions.
If you forget to take Donepezil ratio
If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses. If you have forgotten to take your medicine for more than one week, contact your doctor before taking any more.
If you stop taking Donepezil ratio
Do not stop taking the tablets unless your doctor has told you to do so. If you stop taking Donepezil ratio, the benefits of treatment will gradually disappear.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Donepezil ratio may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported by people taking Donepezil ratio.
Tell your doctor if you experience any of these effects while taking Donepezil ratio.
Serious adverse effects:
Seek immediate medical advice if you notice any of the following adverse effects. You may require urgent medical treatment.
- Liver damage, for example, hepatitis. Symptoms of hepatitis include feeling unwell or sick, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (may affect up to 1 in 1,000 people).
- Stomach or duodenal ulcers. Symptoms of ulcers include stomach pain and discomfort (indigestion), discomfort between the navel and the breastbone (may affect up to 1 in 100 people).
- Bleeding in the stomach or intestines. This may cause your stools to become black and tarry or visible blood to appear in the rectum (may affect up to 1 in 100 people).
- Seizures or convulsions (may affect up to 1 in 100 people).
- Fever with muscle rigidity, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome") (may affect up to 1 in 10,000 people).
- Weakness, tenderness, or muscle pain, particularly if accompanied by feeling unwell, fever, or dark-colored urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people).
- Fast or irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.
Very common (may affect more than 1 in 10 people):
- Diarrhea,
- Feeling unwell,
- Headache.
Common (may affect up to 1 in 10 people):
- Common cold,
- Loss of appetite,
- Hallucinations (seeing or hearing things that are not real),
- Unusual dreams and nightmares,
- Agitation,
- Aggressive behavior,
- Fainting,
- Dizziness,
- Inability to sleep (insomnia),
- Vomiting,
- Uncomfortable stomach sensation,
- Rash,
- Itching,
- Muscle cramps,
- Urinary incontinence,
- Fatigue,
- Pain,
- Accidents (patients more prone to falls and accidents).
Uncommon (may affect up to 1 in 100 people):
- Slowed heart rate.
Rare (may affect up to 1 in 1,000 people):
- Tremors, stiffness, or uncontrollable movements, especially of the face and tongue, but also of the limbs.
Frequency not known: cannot be estimated from available data:
- Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "prolongation of the QT interval",
- Increased libido, hypersexuality,
- Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side).
Reporting of adverse effects:
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products:
https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Donepezil ratio
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Donepezilo ratio 10 mg film-coated tablets EFG
- The active substance is donepezil hydrochloride. Each tablet contains 10 mg of donepezil hydrochloride (as monohydrate).
- The other components are:
Core: maize starch, monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato), colloidal anhydrous silica, magnesium stearate.
Coating: monohydrate lactose, hypromellose 15cp, titanium dioxide (E-171), macrogol 4000.
Appearance of the product and contents of the pack
Donepezilo ratio 10 mg: yellow, round, biconvex, film-coated tablets marked with “DN 10” on one side.
Film-coated tablets are supplied in blister packs containing 7, 28, 30, 50, 56, 60, 84, 90, 98 and 120 film-coated tablets.
Film-coated tablets are also supplied in calendar blister packs containing 7, 28, 56, 84 or 98 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Pharma, S.L.U.
Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid (Spain)
Manufacturer
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, 31-456 Kraków
Poland
or
PLIVA CROATIA LIMITED (PLIVA KRVATSKA D.O.O.)
Prilaz Baruna Filipovica 25
10000 Zagreb, Croatia
or
Merckle GmbH
Ludwig-Merckle-Str. 3,
89143 Blaubeuren
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain: Donepezilo ratio 10 mg film-coated tablets EFG
This leaflet was approved in January 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/