Gaviscon Peppermint Chewable Tablets Sodium alginate 250mg Sodium hydrogen Carbonate 133.5mgCalcium Carbonate 80mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium alginate; Sodium hydrogen carbonate; Calcium carbonate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02BX; A02BX13

INN (International Name):

Sodium alginate; Sodium hydrogen carbonate; Calcium carbonate

Dosage:

250 mg/133.5 mg/80 milligram(s)

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); alginic acid

Authorization status:

Marketed

Authorization date:

2004-12-22

Patient Information leaflet

Package leaflet: Information for the user
Gaviscon Peppermint Chewable Tablets
Sodium alginate 250mg, Sodium hydrogen carbonate 133.5mg, Calcium
carbonate 80mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse 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, pharmacist or nurse.
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 7 days.
WHAT IS IN THE LEAFLET
1.
What Gaviscon Peppermint Tablets are and what they are used for?
2.
What you need to know before you take Gaviscon Peppermint Tablets
3.
How to take Gaviscon Peppermint Tablets
4.
Possible side-effects
5.
How to store Gaviscon Peppermint Tablets
6.
Contents of the pack and other information
1.
WHAT GAVISCON PEPPERMINT TABLETS ARE AND WHAT THEY ARE USED FOR?
Gaviscon Peppermint Tablets form a protective layer which floats above
the contents of the
stomach. This layer prevents stomach acid escaping from the stomach
into the food pipe,
thus relieving the burning feeling of heartburn and the feeling of
discomfort in the throat and
mouth.
Heartburn may occur following meals (e.g. when eating fatty or spicy
food) or during
pregnancy, or in patients with symptoms related to an inflammation in
the wall of the food
pipe (e.g. difficult and/or painful swallowing, mouth sores,
vomiting).
Gaviscon Peppermint Tablets are used for the treatment of symptoms of
gastro-oesophageal
reflux such as acid regurgitation, heartburn and indigestion (related
to reflux), for example,
following meals or during pregnancy, and in patients with symptoms
related to eosophagitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GAVISCON PEPPERMINT TABLETS
DO NOT TAKE GAVISCON P

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2020
CRN008V4D
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Peppermint Chewable Tablets Sodium alginate 250mg Sodium
hydrogen Carbonate 133.5mgCalcium Carbonate
80mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate
133.5 mg and calcium carbonate 80 mg.
Excipients: Aspartame (E951) 3.75 mg per tablet.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
An off-white to cream, slightly mottled tablet.
Emboss obverse - sword and circle
Emboss reverse - G250
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion (related to reflux),
for example, following meals or during pregnancy, or in patients with
symptoms related to oesophagitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children 12 years and over: Two to four tablets after meals
and at bedtime (up to four times per day).
Children under 12 years: Should be given only on medical advice.
Duration of treatment:
If symptoms do not improve after seven days, the clinical situation
should be reviewed.
SPECIAL PATIENT GROUPS
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No modifications necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary (See section 4.4)
METHOD OF ADMINISTRATION
For oral use, after being thoroughly chewed.
Health Products Regulatory Authority
01 December 2020
CRN008V4D
Page 2 of 5
4.3 CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or
suspected hypersensitivity to sodium alginate, sodium
bicarbonate, and calcium carbonate or to any of the excipients listed
in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms do not improve after seven days, the clinical situation
should be reviewed.
Sodium: This medicinal product contains 253