Lonrela 20 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE

Beschikbaar vanaf:

Laboratorio STADA, S.L. Frederic Mompou, 5 08960 SANT JUST DESVERN-BARCELONA (SPANJE)

INN (Algemene Internationale Benaming):

MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-02-19

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lonrela 20 mg filmomhulde tabletten
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
HOW DOES WORK
contains the active substance memantine hydrochloride.
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. belongs to a
group of medicines called NMDA-receptor antagonists.
acts on these
NMDA-receptors improving the transmission of nerve signals and the
memory.
WHAT IS USED FOR
is used for the treatment of patients with moderate to
severe Alzheimer’s
disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE

if you are allergic to memantine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking

if you have a history of epileptic seizures

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lonrela 20 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of memantine hydrochloride
equivalent to 16.62 mg
memantine.
Excipient with known effect
One film-coated tablets contains 1.09 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval, biconvex, 13.5 mm – 7.3 mm, film-coated tablet.
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.
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 per day. 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. For up-titration other tablet strengths are
available.
Week 1 (day 1-7)
2
The patient should take 5 mg per day for 7 days.
Week 2 (day 8-14)
The patient should take 10 mg per day for 7 days.
Week 3 (day 15-21)
The patient should take 15 mg p