Ebixa 5mg0.5ml pump actuation oral solution

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Memantine hydrochloride

Saatavilla:

Lundbeck Ltd

ATC-koodi:

N06DX01

INN (Kansainvälinen yleisnimi):

Memantine hydrochloride

Annos:

10mg/1ml

Lääkemuoto:

Oral solution

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04110000; GTIN: 5702157127405 5702157127504

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
EBIXA 5 MG/PUMP ACTUATION ORAL SOLUTION
Memantine 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 Ebixa is and what it is used for
2.
What you need to know before you take Ebixa
3.
How to take Ebixa
4.
Possible side effects
5.
How to store Ebixa
6.
Contents of the pack and other information
1.
WHAT EBIXA IS AND WHAT IT IS USED FOR
Ebixa contains the active substance memantine hydrochloride. It
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. The brain
contains so-called N-methyl-D-aspartate (NMDA)-receptors that are
involved in transmitting nerve
signals important in learning and memory. Ebixa belongs to a group of
medicines called NMDA-
receptor antagonists. Ebixa acts on these NMDA-receptors improving the
transmission of nerve
signals and the memory.
Ebixa is used for the treatment of patients with moderate to severe
Alzheimer’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EBIXA
DO NOT TAKE EBIXA
-
if you are allergic to memantine or any of the other ingredients of
this medicine (listed in
section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ebixa:
-
if you have a history of epileptic seizures
-
if you have recently experienced a myocardial infarction (heart
attack), or if you are suffering
from congestive heart failure or from an uncontrolled hypertension
(high blood pressure).
In these situ

Valmisteyhteenveto

OBJECT 1
EBIXA 5MG/PUMP ACTUATION ORAL SOLUTION
Summary of Product Characteristics Updated 06-Mar-2017 | Lundbeck
Limited
1. Name of the medicinal product
Ebixa 5 mg/pump actuation oral solution.
2. Qualitative and quantitative composition
Each pump actuation delivers 0.5 ml of solution which contains 5 mg of
memantine hydrochloride which
is equivalent to 4.16 mg memantine
Excipients with known effect_:_
Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg
potassium, see section 4.4.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
The solution is clear and colourless to light yellowish.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of adult 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.
Posology
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.
_Adults_
_Dose titration _
The maximum daily dose is 20 mg once daily. In order to reduce the
risk of undesirable effects, the
maintenance dose is achieved by upward titration of 5 mg per week over
the first 3 weeks as follows:
_Week 1 (day 1-7) _
The patient should take 0.5 ml solution (5 mg