Omeprazol (als magnesium) Sandoz OTC 20 mg, maagsapresistente tabletten

দেশ: নেদারল্যান্ডস

ভাষা: ডাচ

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

সক্রিয় উপাদান:

OMEPRAZOL MAGNESIUM 20,6 mg/stuk SAMENSTELLING overeenkomend met ; OMEPRAZOL 20 mg/stuk

থেকে পাওয়া:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

এটিসি কোড:

A02BC01

INN (আন্তর্জাতিক নাম):

OMEPRAZOL MAGNESIUM 20,6 mg/stuk SAMENSTELLING overeenkomend met ; OMEPRAZOL 20 mg/stuk

ফার্মাসিউটিকাল ফর্ম:

Maagsapresistente tablet

রচনা:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON (E 1208) ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOVIDON ; CROSPOVIDON (E 1202) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROLMONOSTEARAAT 40-55 (E 471) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551)

প্রশাসন রুট:

Oraal gebruik

থেরাপিউটিক এলাকা:

Omeprazole

পণ্য সারাংশ:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); COPOVIDON; CROSPOVIDON (E 1202); DIMETICON (E 900); GLUCOSE, VLOEIBAAR; GLYCEROLMONOSTEARAAT 40-55 (E 471); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POLYSORBAAT 80 (E 433); POVIDON K 25 (E 1201); PROPYLEENGLYCOL (E 1520); SACCHAROSE; SILICIUMDIOXIDE (E 551); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); STEARINEZUUR (E 570); SUGAR SPHERES; TALK (E 553 B); TITAANDIOXIDE (E 171);

অনুমোদন তারিখ:

2010-09-03

তথ্য লিফলেট

Sandoz B.V.
Page 1/8
Omeprazol (als magnesium) Sandoz OTC 20 mg
RVG 105012
V13
1.3.1.3 Bijsluiter
maart 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOL (ALS MAGNESIUM) SANDOZ
® OTC 20 MG, MAAGSAPRESISTENTE TABLETTEN
Omeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
−
Keep this leaflet. You may need to read it again.
−
Ask your pharmacist if you need more information or advice.
−
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.
−
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
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
[Nationally completed name] gastro-resistant tablets contain the
active substance omeprazole.
It belongs to a group of medicines called ‘proton pump
inhibitors’. They work by reducing
the amount of acid that your stomach produces.
[Nationally completed name] is used in adults for the short-term
treatment of reflux
symptoms (for example, heartburn, acid regurgitation).
Reflux is the backflow of acid from the stomach into the gullet
“foodpipe”, which may
become inflamed and painful. This may cause you symptoms such as a
painful burning
sensation in the chest rising up to the throat (heartburn) and a sour
taste in the mouth (acid
regurgitation).
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of
symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT

পণ্য বৈশিষ্ট্য

Sandoz B.V.
Page 1/13
Omeprazol (als magnesium) Sandoz OTC 20 mg
RVG 105012
V12
1.3.1.1 Samenvatting van de Productkenmerken
maart 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Omeprazol (als magnesium) Sandoz OTC 20 mg, maagsapresistente
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg omeprazole (as omeprazole
magnesium).
Excipients with known effect
glucose, sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
Pink, oval film-coated tablet with a breaking notch on both sides. The
tablet can be divided into equal
doses(14.2x7.2 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] gastro-resistant tablets are indicated for
the treatment of reflux
symptoms (e.g. heartburn, acid regurgitation) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The recommended dose is 20 mg once daily for 14 days.
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of
symptoms.
The majority of patients achieve complete relief of heartburn within 7
days. Once complete relief of
symptoms has occurred, treatment should be discontinued.
Sandoz B.V.
Page 2/13
Omeprazol (als magnesium) Sandoz OTC 20 mg
RVG 105012
V12
1.3.1.1 Samenvatting van de Productkenmerken
maart 2023
Special populations
_Renal impairment _
Dose adjustment is not needed in patients with impaired renal function
(see section 5.2).
_Hepatic impairment _
Patients with impaired hepatic function should be advised by a doctor
before taking [Nationally
completed name] (see section 5.2).
_Elderly _
Dose adjustment is not needed in the elderly (see section 5.2).
Method of administration
It is recommended to take [Nationally completed name] tablets in the
morning, swallowed whole with
half a glass of water. The tablets must not be chewed or crushed.
_For patients with swallowing difficulties _
Break the tablet and disperse it in a spoonful of non-carbonated w