Gastrolief 20 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pantoprazole

Available from:

Clonmel Healthcare Ltd

ATC code:

A02BC; A02BC02

INN (International Name):

Pantoprazole

Dosage:

20 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Proton pump inhibitors; pantoprazole

Authorization status:

Not marketed

Authorization date:

2011-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_PANTOPRAZOLE_ 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
have 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.
-
You should not take _PANTOPRAZOLE_ for more than 4 weeks without
consulting a doctor.
WHAT IS IN THIS LEAFLET
1. What _PANTOPRAZOLE_ is and what it is used for
2. What you need to know before you take _PANTOPRAZOLE_
3. How to take _PANTOPRAZOLE_
4. Possible side effects
5. How to store _PANTOPRAZOLE_
6. Contents of the pack and other information
1. WHAT _PANTOPRAZOLE_ IS AND WHAT IT IS USED FOR
_PANTOPRAZOLE_ contains the active substance pantoprazole, which
blocks the ‘pump’ that
produces stomach acid. Hence it reduces the amount of acid in your
stomach.
_PANTOPRAZOLE_ 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 _PANTOPRAZOLE_, 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

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2019
CRN0098XR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gastrolief 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium
sesquihydrate).
Excipients with known effect: 38.425 mg Maltitol and 0.345 mg Lecithin
(derived from soya oil) (see section 4.4)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Yellow, oval tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gastrolief 20 mg gastro-resistant tablets 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_
Pantoprazole 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
Gastrolief 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, lecithin (derived from soya
oil) or to any of the excipients listed in section 6.1.
Co-administration with atazanavir (see section 4.5).
Health Products Regulatory Authority
20 December 2019
CRN0098XR
Page 2 of 8
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients should be instructed to consult a do