Lonrela 5 mg +10 mg + 15 mg + 20 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE ; MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE ; MEMANTINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; MEMANTINE ; 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 ; MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE ; MEMANTINEHYDROCHLORIDE COMPOSITION in accordance with ; MEMANTINE ; 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) ; IJZEROXIDE ZWART (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 5 mg +10 mg + 15 mg + 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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lonrela 5 mg +10 mg + 15 mg + 20 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of memantine hydrochloride
equivalent to 4.15 mg
memantine.
Excipient with known effect
One film-coated tablets contains 0.27 mg sodium.
Each film-coated tablet contains 10 mg of memantine hydrochloride
equivalent to 8.31 mg
memantine.
Excipient with known effect
One film-coated tablets contains 0.55 mg sodium.
Each film-coated tablet contains 15 mg of memantine hydrochloride
equivalent to 12.46 mg
memantine.
Excipient with known effect
One film-coated tablets contains 0.92 mg sodium.
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.
The 5 mg film-coated tablets are white, oval, biconvex, 8.1 mm – 4.1
mm, film-coated tablet
embossed on one side with ‘5’.
The 10 mg film-coated tablets are white, slim through the middle,
biconvex, 10 mm –
5.6 mm, film-coated tablet with breaking lines on both sides and
engraving ‘1 0’ on one side.
The 10 mg tablet can be divided into equal doses.
The 15 mg film-coated tablets are light brown, oval, biconvex, 12.3 mm
– 6.6 mm, film-
coated tablets.
The 20 mg film-coated tablets are pink, oval, biconvex, 13.5 mm –
7.3 mm, film-coated
tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of patients with moderate to severe Alzheimer’s disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
2
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