MEMANTINE HYDROCHLORIDE 10 Mg/Ml Oral Solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

MEMANTINE HYDROCHLORIDE

Διαθέσιμο από:

Rosemont Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

N06DX01

INN (Διεθνής Όνομα):

MEMANTINE HYDROCHLORIDE

Δοσολογία:

10 Mg/Ml

Φαρμακοτεχνική μορφή:

Oral Solution

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Other anti-dementia drugs

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-08-22

Φύλλο οδηγιών χρήσης

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE 
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

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Keep this leaflet. You may need to read it again. 
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If you have any further questions, ask your doctor or pharmacist. 
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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. 
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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 Memantine Oral Solution is and what it is used for 
2. What you need to know before you take Memantine Oral Solution 
3. How to take Memantine Oral Solution 
4. Possible side effects 
5. How to store Memantine Oral Solution 
6. Contents of the pack and other information
1. WHAT MEMANTINE ORAL SOLUTION IS AND WHAT IT IS USED FOR
HOW DOES MEMANTINE ORAL SOLUTION WORK 
Memantine Oral Solution belongs to a group of medicines known as
anti-dementia 
medicines.
Memory loss in Alzheimer’s disease is due to a disturbance of
message signals in the brain.  
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The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors
that are involved in  
  transmitting nerve signals important in learning and memory.  
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Memantine belongs to a group of medicines called NMDA-receptor
antagonists.    
  Memantine acts on these NMDA-receptors improving the transmission
of nerve signals  
  and the memory.
WHAT IS MEMANTINE ORAL SOLUTION USED FOR 
Memantine Oral Solution is used for the treatment of patients with
moderate to severe 
Alzheimer’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE ORAL SOLUTION 
DO NOT TAKE MEMANTINE ORAL SOLUTION

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if you are allergic (hypersensitive) to the memantine hydrochloride or
any of the other  
  ingredients of Memantine Oral Solution (see section 6).
WARNINGS AND PRECAUTIONS  
Talk to your doctor before taking

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Memantine Hydrochloride 10mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre (ml) of solution contains 10mg Memantine Hydrochloride
which is equivalent to 8.32 mg memantine
Excipients:
Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg
potassium, see section 4.4
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of patients with moderate to severe Alzheimer’s disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and treatment of Alzheimer’s
dementia. Therapy should only be started if a caregiver is available
who will regularly monitor the intake of the
medicinal product by the patient. Diagnosis should be made according
to current guidelines. The tolerance and dosing
of memantine should be reassessed on a regular basis, preferably
within three months after start of treatment.
Thereafter, the clinical benefit of memantine and the patient’s
tolerance of treatment should be reassessed on a regular
basis according to current clinical guidelines. Maintenance treatment
can be continued for as long as a therapeutic
benefit is favourable and the patient tolerates treatment with
memantine. Discontinuation of memantine should be
considered when evidence of a therapeutic effect is no longer present
or if the patient does not tolerate treatment.
Memantine Oral Solution should be taken once daily at the same time
each day. The solution can be taken with or
without food.
The solution is withdrawn from the bottle with the oral syringe and
can be swallowed directly from the oral syringe.
Alternatively, it can be dosed onto a spoon or into a glass of water
using the syringe.
_Adults:_
Dose titration
The maximum daily dose is 20 mg once daily. In order to reduce the
risk of undesirable effects, the maintena