Nolpacid 20 mg gastro-resistant tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Pantoprazole

Tilgjengelig fra:

KRKA, d.d., Novo mesto

ATC-kode:

A02BC; A02BC02

INN (International Name):

Pantoprazole

Dosering :

20 milligram(s)

Legemiddelform:

Gastro-resistant tablet

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Proton pump inhibitors; pantoprazole

Autorisasjon status:

Not marketed

Autorisasjon dato:

2013-11-25

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOLPACID 20 MG GASTRO-RESISTANT TABLETS
pantoprazole
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 2 weeks.
WHAT IS IN THIS LEAFLET
1.
What Nolpacid is and what it is used for
2.
What you need to know before you take Nolpacid
3.
How to take Nolpacid
4.
Possible side effects
5.
How to store Nolpacid
6.
Contents of the pack and other information
1.
WHAT NOLPACID IS AND WHAT IT IS USED FOR
Nolpacid contains the active substance pantoprazole, which blocks the
‘pump’ that produces stomach
acid. Hence it reduces the amount of acid in your stomach.
Nolpacid is used for the short-term treatment of reflux symptoms (for
example heartburn, acid
regurgitation) in adults.
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).
You may experience relief from your acid reflux and heartburn symptoms
after just one day of
treatment with Nolpacid, but this medicine is not meant to bring
immediate relief. It may be necessary
to take the tablets for 2–3 consecutive days to relieve the
symptoms.
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOLPACID
DO NOT TAKE NOLPACID:
-
if you are allergic to pantoprazole or any of the other ingredients of
this medicine (l

Preparatomtale

Health Products Regulatory Authority
25 March 2024
CRN00DTHL
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nolpacid 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablets contains 20 mg pantoprazole as
pantoprazole sodium sesquihydrate.
Excipient with known effect:

sorbitol (E420): 18 mg/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Gastro-resistant tablets are light yellowish brown, oval (3 mm x 9
mm), slightly biconvex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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_
Nolpacid 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
Nolpacid 20 mg gastro-resistant tablets 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 section 6.1.
Co-administration of pantoprazole is not recommended with HIV protease
inhibitors for which absorption is dependent on
acidic intragastric pH such as atazanavir, nelfinavir; due to
significant reduction in their bioavailability (see section 4.5).
Health Products Regulat