Previfect 20 mg, maagsapresistente tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PANTOPRAZOL NATRIUM 1,5-WATER 22,6 mg/stuk SAMENSTELLING overeenkomend met ; PANTOPRAZOL 20 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A02BC02

INN (Algemene Internationale Benaming):

PANTOPRAZOL NATRIUM 1,5-WATER 22,6 mg/stuk SAMENSTELLING overeenkomend met ; PANTOPRAZOL 20 mg/stuk

farmaceutische vorm:

Maagsapresistente tablet

Samenstelling:

CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Pantoprazole

Product samenvatting:

Hulpstoffen: CALCIUMSTEARAAT (E 470A); CELLULOSE, MICROKRISTALLIJN (E 460); CHINOLINEGEEL ALUMINIUMLAK (E 104); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 400; MACROGOL 600; NATRIUMCARBONAAT 0-WATER (E 500 (I)); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); PONCEAU 4R ALUMINIUMLAK (E 124); POVIDON (E 1201); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);

Autorisatie datum:

2011-02-01

Bijsluiter

Sandoz B.V.
Page 1/7
Previfect 20 mg, maagsapresistente tabletten
RVG 105877
1313-V17
1.3.1.3 Package Leaflet
November 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREVIFECT
® 20 MG, MAAGSAPRESISTENTE TABLETTEN
pantoprazole
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.
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 .
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] contains the active substance
pantoprazole, which blocks the ‘pump’ that
produces stomach acid. Hence it reduces the amount of acid in your
stomach.
[Nationally completed name] is used for the short-term treatment of
reflux symptoms (for example
heartburn, acid regurg

Productkenmerken

Sandoz B.V.
Page 1/11
Previfect 20 mg, maagsapresistente tabletten
RVG 105877
1311-V13
1.3.1.1 Summary of Product Characteristics
November 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Previfect 20 mg, maagsapresistente tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium
sesquihydrate).
Excipient with known effect
Each gastro-resistant tablet contains 1 microgram of azo colouring
agent Ponceau 4R aluminium lake
(E 124).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
Yellow, oval coated tablet, approx.. 8.9 x 4.6 mm.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for short-term treatment of
reflux symptoms (e. g. heartburn,
acid regurgitation) in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 20 mg pantoprazole (one tablet) per day.
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of
symptoms. Once complete relief of symptoms has occurred, treatment
should be discontinued.
The treatment should not exceed 4 weeks without consulting a doctor.
If no symptom relief is obtained within 2 weeks of continuous
treatment, the patient should be
instructed to consult a doctor.
Special populations
_ _
No dose adjustment is necessary in elderly patients or in those with
impaired renal or liver function.
_Paediatric population _
[Nationally completed name] is not recommended for use in children and
adolescents below 18 years
of age due to insufficient data on safety and efficacy.
Sandoz B.V.
Page 2/11
Previfect 20 mg, maagsapresistente tabletten
RVG 105877
1311-V13
1.3.1.1 Summary of Product Characteristics
November 2023
Method of administration
[Nationally completed name] should not be chewed or crushed, and
should be swallowed whole with
liquid before a meal.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in sec