Lansoprazol 15 mg, maagsapresistente capsule

Страна: Нидерландия

Език: нидерландски

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

Активна съставка:

LANSOPRAZOL

Предлага се от:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

АТС код:

A02BC03

INN (Международно Name):

LANSOPRAZOLE

Лекарствена форма:

Maagsapresistente capsule, hard

Композиция:

CARRAGEENAN (E 407) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; HYPROMELLOSE (E 464) ; KALIUMCHLORIDE ; MACROGOL 400 ; MAGNESIUMCARBONAAT, LICHT (E 504 (II)) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Начин на приложение:

Oraal gebruik

Терапевтична област:

Lansoprazole

Каталог на резюме:

Hulpstoffen: CARRAGEENAN (E 407); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); HYPROMELLOSE (E 464); KALIUMCHLORIDE; MACROGOL 400; MAGNESIUMCARBONAAT, LICHT (E 504 (II)); MAÏSZETMEEL; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); SACCHAROSE; SILICIUMDIOXIDE (E 551); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171);

Дата Оторизация:

2005-08-15

Листовка

Sandoz B.V.
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Lansoprazol 15, 30 mg,
maagsapresistente capsules
RVG 32983-4
v18
1.3.1.3 Package Leaflet
Juli 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LANSOPRAZOL 15 MG, MAAGSAPRESISTENTE CAPSULES LANSOPRAZOL 30 MG, MAAGSAPRESISTENTE CAPSULES
lansoprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT
CONTAINSIMPORTANT 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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name]
is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
The active substance in [Nationally completed name] is lansoprazole,
which is a proton pump
inhibitor. Proton pump inhibitors reduce the amount of acid that your
stomach makes.
Your doctor may prescribe [Nationally completed name] for the
following indications:
-
Treatment of duodenal and stomach ulcer
-
Treatment of inflammation in your oesophagus (reflux oesophagitis)
-
Prevention of reflux oesophagitis
-
Treatment of heartburn and acid regurgitation
-
Treatment of infections caused by the bacteria
_Helicobacter pylori_
when given in combination
with antibiotic therapy
-
Treatment or prevention of duodenal or stomach ulcer in patients
requiring continued NSAID
treatment (NSAID treatment is used against pain or inflammation)
-
Treatment of Zollinger-Ellison syndrome.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY

Данни за продукта

Sandoz B.V.
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12
Lansoprazol 15. 30 mg,
maagsapresistente capsules
RVG 32983 en 32984
v19
1.3.1.1 Summary of Product Characteristics
Juli 2020
1
NAAM VAN HET GENEESMIDDEL
Lansoprazol 15 mg, maagsapresistente capsule
Lansoprazol 30 mg, maagsapresistente capsule
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
[Nationally completed name] 15 mg:
Each hard gastro-resistant capsule contains 15 mg of lansoprazole
Excipient(s) with known effect
Each 15 mg capsule contains 65.6 mg sucrose
[Nationally completed name] 30 mg:
Each hard gastro-resistant capsule contains 30 mg of lansoprazole
Excipient(s) with known effect
Each 30 mg capsule contains 131.2 mg sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
[Nationally completed name] 15 mg: White / white opaque capsules
containing white to off-white
pellets.
[Nationally completed name] 30 mg: White / white opaque capsules
containing white to off-white
pellets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] 15 mg/30 mg gastro-resistant capsules are
indicated for:
-
Treatment of duodenal and gastric ulcer
-
Treatment of reflux oesophagitis
-
Prophylaxis of reflux oesophagitis
-
Eradication of
_Helicobacter pylori _
(
_H. pylori_
) concurrently given with appropriate antibiotic
therapy for treatment of
_H. pylori_
-associated ulcers
-
Treatment of NSAID-associated benign gastric and duodenal ulcers in
patients requiring continued
NSAID treatment
-
Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in
patients at risk (see section
4.2) requiring continued therapy
-
Symptomatic gastro-esophageal reflux disease
-
Zollinger-Ellison syndrome.
Sandoz B.V.
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12
Lansoprazol 15. 30 mg,
maagsapresistente capsules
RVG 32983 en 32984
v19
1.3.1.1 Summary of Product Characteristics
Juli 2020
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
TREATMENT OF DUODENAL ULCER
The recommended dose is 30 mg once daily for 2 weeks. In patients not
fully healed within this time,
the