Pantoprazol Sandoz OTC 20 mg, maagsapresistente tabletten

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

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

Commercializzato da:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Codice ATC:

A02BC02

INN (Nome Internazionale):

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

Forma farmaceutica:

Maagsapresistente tablet

Composizione:

CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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 ; POLYSORBAAT 80 (E 433) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), 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),

Via di somministrazione:

Oraal gebruik

Area terapeutica:

Pantoprazole

Dettagli prodotto:

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); 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);

Data dell'autorizzazione:

1900-01-01

Foglio illustrativo

Sandoz B.V.
Page 1/8
Pantoprazol Sandoz OTC 20 mg, maagsapresistente tabletten
1313-V19
RVG 105876
1.3.1.3 Package Leaflet
Februari 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PANTOPRAZOL SANDOZ
® OTC 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 further more 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 ex

Scheda tecnica

Sandoz B.V.
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Pantoprazol Sandoz OTC 20 mg, maagsapresistente tabletten
1311-V16
RVG 105876
1.3.1.1 Summary of Product Characteristics
November 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pantoprazol Sandoz OTC 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 _
Sandoz B.V.
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Pantoprazol Sandoz OTC 20 mg, maagsapresistente tabletten
1311-V16
RVG 105876
1.3.1.1 Summary of Product Characteristics
November 2023
[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.
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