FREESTOM 20 Milligram Tablets Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

INN (International Name):

PANTOPRAZOLE SODIUM SESQUIHYDRATE

Dosage:

20 Milligram

Pharmaceutical form:

Tablets Gastro-Resistant

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

Pantoprazol NL/H//1849 -

Update according to CSP  
Reference: 9330 1.3.1.3 - Leaflet Text - PIL - 20mg - 2014-09-02 - 00 - CSP RTQ national txt 1.6 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

FREESTOM 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 Freestom is and what it is used for 
2. 
What you need to know before you take Freestom 
3. 
How to take Freestom 
4. 
Possible side effects 
5. 
How to store Freestom 
6. 
Contents of the pack and other information 

1. 
WHAT FREESTOM IS AND WHAT IT IS USED FOR 

Freestom contains the active substance pantoprazole, which blocks
the “pump” that produces 
stomach acid. Hence it reduces the amount of acid in your
stomach. 
Freestom 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 Freestom, b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Freestom 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
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_
Freestom 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
Freestom 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, substituted benzimidazoles, lecithin (derived from soya oil) or to any of the
other excipients listed in section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
_____________________________________________________________________