Lacinet 10 mg, orodispergeerbare tabletten

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

EBASTINE

Tersedia dari:

Substipharm développement

Kode ATC:

R06AX22

INN (Nama Internasional):

EBASTINE

Bentuk farmasi:

Orodispergeerbare tablet

Komposisi:

ARABISCHE GOM (E 414) ; BUTYLHYDROXYANISOL (E 320) ; CARMELLOSE CALCIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATRIUMBENZOAAT (E 211) ; NEOTAAM ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; TRUSIL PEPERMUNT SPECIAL SMAAKSTOF,

Rute administrasi :

Oraal gebruik

Area terapi:

Ebastine

Ringkasan produk:

Hulpstoffen: ARABISCHE GOM (E 414); BUTYLHYDROXYANISOL (E 320); CARMELLOSE CALCIUM (E 466); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); GELATINE (E 441); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421); NATRIUMBENZOAAT (E 211); NEOTAAM; POLOXAMEER 188; POVIDON K 30 (E 1201); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); TRUSIL PEPERMUNT SPECIAL SMAAKSTOF;

Tanggal Otorisasi:

2015-10-09

Selebaran informasi

C O N F I D E N T I A L
MODULE 1.3.1.4
PACKAGE LEAFLET – ENGLISH VERSION
June 2015 – D210
Mod 1.3.1.4 page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lacinet 10 mg, orodispergeerbare tabletten
Lacinet 20 mg, orodispergeerbare tabletten
Ebastine
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 or
nurse.
-
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 or
nurse. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1. What LACINET is and what it is used for
2. What you need to know before you take LACINET
3. How to take LACINET
4. Possible side effects
5. How to store LACINET
6. Content of the pack and other information
1.
WHAT LACINET IS AND WHAT IT IS USED FOR
LACINET
10
mg
20
mg
is
a
medicine
that
is
used
for
the
treatment
of
allergies
(antihistaminicum). It helps you to control the symptoms of an
allergic reaction .
It is indicated in adults and children aged 12 years and older for the
treatment of seasonal and
persistent allergic rhinitis (runny nose), with or without allergic
conjunctivitis (inflammation
of the eye), and for the treatment of urticaria (hives) in adults over
the age of 18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACINET
DO NOT TAKE LACINET
-
if you are allergic to ebastine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking LACINET:
-
if you have a certain abnormal pattern to your heart beat (known
prolongation of the QTc
interval on the ECG) which can occur in some forms of heart disease
-
if you have low potassium levels in your blood.
-if you are already taking certain antibiotics or m

Karakteristik produk

C O N F I D E N T I A L
MODULE 1.3.1.1
SUMMARY OF PRODUCT CHARACTERISTICS – ENGLISH VERSION
June 2015 – D210
Mod 1.3.1.1 page 1
1. NAME OF THE MEDICINAL PRODUCT
Lacinet 10 mg, orodispergeerbare tabletten
Lacinet 20 mg, orodispergeerbare tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg ebastine.
Each orodispersible tablet contains 20 mg ebastine.
For a full list of excipients, see Section 6.1
3. PHARMACEUTICAL FORM
Orodispersible tablets.
[PRODUCT NAME] 10 mg are white to off white, round shaped, flat faced
bevel edged
orodispersible tablets approximately 8.50 mm in diameter and 2.20 mm
thickness debossed
with ’10’ on one side and plain on the other side.
[PRODUCT NAME] 20 mg are white to off white, round shaped, flat faced
bevel edged
orodispersible tablets approximately 11 mm in diameter and 2.70 mm
thickness debossed with
’20’ on one side and plain on the other side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
[PRODUCT NAME] 10 mg
Symptomatic treatment of seasonal and perennial allergic rhinitis, in
conjunction with or
without allergic conjunctivitis in adults and adolescents aged 12
years and older.
Treatment of urticaria in adults aged 18 years and older.
[PRODUCT NAME] 20 mg
Symptomatic treatment of seasonal and perennial allergic rhinitis, in
conjunction with or
without allergic conjunctivitis in adults and adolescents aged 12
years and older.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
POSOLOGY
Allergic rhinitis with or without allergic conjunctivitis
For adolescents aged 12 years and older and adults the following
dosage recommendations
apply:
C O N F I D E N T I A L
MODULE 1.3.1.1
SUMMARY OF PRODUCT CHARACTERISTICS – ENGLISH VERSION
June 2015 – D210
Mod 1.3.1.1 page 2
-
10 mg ebastine (1 [PRODUCT NAME] 10 mg orodispersible tablet) once
daily. In cases of
severe symptoms the dose may be increased to 20 mg ebastine (2
[PRODUCT NAME] 10
mg orodispersible tablets) once daily.
-
10 mg ebastine (1 [PRODUCT NAME] 10 mg orodispe