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Donepezil Mylan

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Document: Donepezil Mylan orodispersible tablet ENG PL change

Package leaflet: Information for the patient


Donepezil Mylan 5 mg Orodispersible Tablets

Donepezil Mylan 10 mg Orodispersible Tablets

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. See section 4.


What is in this leaflet

1. What Donepezil Mylan is and what it is used for

2. What you need to know before you take Donepezil Mylan

3. How to take Donepezil Mylan

4. Possible side effects

5. How to store Donepezil Mylan

6. Contents of the pack and other information


1. What Donepezil Mylan is and what it is used for


Donepezil Mylan contains the active substance donepezil hydrochloride.

Donepezil hydrochloride belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil hydrochloride increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of that substance.


It is used to treat the symptoms of dementia in people diagnosed as having mild to moderately severe Alzheimer’s disease. Symptoms of the illness include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer’s disease find it more difficult to carry out their normal daily activities.


It is for use in adult patients only.


2. What you need to know before you take Donepezil Mylan


Do not take Donepezil Mylan:

- if you are allergic to donepezil, to piperidine derivative medicines (your doctor or pharmacist can advise on this) or any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions

Talk to your doctor or pharmacist before taking Donepezil Mylan if you suffer, or have ever suffered, from any of the following conditions:



Children and adolescents

Children and adolescents under the age of 18 years of age should not take this medicine.


Other medicines and Donepezil Mylan


Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following:



If you are going to have an operation, including dental surgery, that requires you to have an anaesthetic, tell your doctor, dentist, hospital staff or the anaesthetist that you are taking this medicine.


Donepezil Mylan with alcohol


Take special care if drinking alcohol whilst taking this medicine, as alcohol can reduce the effect of donepezil hydrochloride.


Pregnancy and breast-feeding


If you are pregnant, think you may be pregnant or are planning to have a baby, do not take this medicine before speaking to your doctor for advice. Donepezil hydrochloride should not be used in pregnancy unless clearly necessary.


Women taking this medicine should not breast-feed.


Driving and using machines


Do not drive or operate machinery if you feel dizzy, sleepy/tired or get muscle cramps while taking this medicine.


Alzheimer’s disease may also impair your ability to drive or operate machinery and you must not perform these activities unless your doctor tells you that it is safe to do so.


3. How to take Donepezil Mylan


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Tell the doctor the name of your caregiver. Your caregiver will help you take your medicine as it is prescribed.


Adults

The recommended usual starting dose is 5 mg taken once a day, normally in the evening before you go to bed, for at least one month.


After one month, your doctor may increase this to 10 mg taken once a day, normally in the evening before you go to bed.


The maximum daily dose is 10 mg.


Use in patients with liver and kidney disease

For adults with mild to moderate liver problems, your doctor may need to adjust your dose.


No dosage adjustment is normally required if you have kidney problems.


Use in children or adolescents

Children and adolescents under the age of 18 years of age should not take this medicine.


Method of administration

The tablet should be placed on your tongue and allowed to disintegrate before swallowing, with or without water, according to your preference. You can take this medicine with or without food.


Your doctor will advise you on how long you should continue to take your tablets. You will need to see your doctor regularly to review your treatment and assess your symptoms.


If you take more Donepezil Mylan than you should


Do not take more than one tablet each day.Contact your doctor or nearest hospital casualty department immediately if you take more tablets than you should. Take the container and any remaining tablets with you to the hospital so that the doctor knows what has been taken.


Symptoms of taking more than you should include feeling and being sick, salivation, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing),breathing problems, losing consciousness, seizures (fits) or convulsions and muscle weakness.


If you forget to take Donepezil Mylan


If you forgot to take a tablet, just take one tablet the following 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 one week, contact your doctor before taking any more medicine.


If you stop taking Donepezil Mylan


When treatment is stopped the beneficial effects of Donepezil Mylan will decrease gradually.


Do not stop taking your tablets without first discussing with your doctor.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Tellyour doctor or go to your nearest hospital casualty department straight awayif you have any of the followingserious side effects:

Uncommon (may affect up to 1 in 100 people):

bleeding in the stomach, guts or bowel, or ulcers of the stomach or duodenum (gut). If you are sick you may notice fresh blood or coffee like grounds in the sick, or you may pass black tarry stools (poo) or fresh blood from the rectum (back passage)

seizures (fits).


Rare (may affect up to 1 in 1,000 people):

liver problems including hepatitis (inflammation of the liver). You may notice dark urine, pale stools, yellowing of the skin and whites of the eyes (jaundice), feel sick and have a fever

changes in heart rhythm or a very slow heart rate.


Very rare (may affect up to 1 in 10,000 people):


Other side effects include:


Very common (may affect more than 1 in 10 people):


Common (may affect up to 1 in10 people):


Uncommon (may affect up to 1 in100 people):

Rare (may affect up to 1 in 1,000 people):

stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [To be completed nationally].By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Donepezil Mylan



6. Contents of the pack and other information


What Donepezil Mylan contains


The active substance is donepezil hydrochloride.

- Donepezil Mylan 5 mg orodispersible tablets: Each tablet contains 5 mg donepezil hydrochloride (equivalent to 4.56 mg donepezil).

- Donepezil Mylan 10 mg orodispersible tablets: Each tablet contains 10 mg donepezil hydrochloride (equivalent to 9.12 mg donepezil).


The other ingredients are mannitol (E421), silica colloidal anhydrous, hydroxypropylcellulose, acesulfame potassium, glycine, sodium starch glycolate crospovidone, microcrystalline cellulose, magnesium stearate.


Donepezil Mylan 10 mg orodispersible tablets also contain yellow iron oxide (E172).


What Donepezil Mylan looks like and contents of the pack


Your medicine is in the form of an orodispersible tablet.


5 mg donepezil tablets are white coloured round flat bevelled edged tablets, marked with “DL 5” on one side and “M” on the other side.


10 mg donepezil tablets are yellow coloured round flat bevelled edged tablets, marked with “DL 10” on one side and “M” on the other side


Donepezil Mylan are supplied in blister packs of 7, 10, 14, 28, 30, 50, 56, 60, 84, 98, 100, 120 and 180 orodispersible tablets.


Not all pack sizes may be marketed.




Marketing Authorisation Holder



[To be completed nationally]



Manufacturer


McDermott Laboratories Ltd. T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., H-2900, Komárom, Mylan utca.1, Hungary.

[To be completed nationally]


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria

Donepezil Arcana 5 mg & 10 mg – Schmelztabletten

Belgium

Donepezil ODIS Mylan 5 mg &10 mg

Cyprus

Donepezil/Generics

Czech Republic

Donepezil Mylan 5 mg & 10 mg tablety dispergovatelné v ústech

France

Donepezil Mylan 5 mg & 10 mg, comprimé orodispersible

Greece

Donepezil/Mylan

Ireland

Aripil Orotab 5 mg & 10 mg oro-dispersible tablets

Poland

Donegen ODT

Portugal

Donepezilo Mylan

Romania

Donepezil Mylan 5mg & 10 mg comprimate orodispersabile

Slovenia

Donepezil Mylan 5 mg & 10 mg orodisperzibilne tablete

Slovakia

Donepezil Mylan 5mg & 10 mg orodispergovateľné tablety

Spain

Donepezilo FLAS MYLAN Pharmaceuticals

5 mg & 10 mg Comprimidos bucodispersables EFG

Sweden

Donepezil Mylan

United Kingdom

Donepezil Hydrochloride 5 mg & 10 mg Orodispersible tablets


This leaflet was last revised in 2 June 2016