Gaviscon Cool Tablets

국가: 몰타

언어: 영어

출처: Malta Medicines Authority

유효 성분:

CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN

제공처:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC 코드:

A02BX13

INN (국제 이름):

SODIUM ALGINATE 250 mg CALCIUM CARBONATE 80 mg SODIUM HYDROGEN CARBONATE 133.5 mg

약제 형태:

CHEWABLE TABLET

구성:

SODIUM ALGINATE 250 mg CALCIUM CARBONATE 80 mg SODIUM HYDROGEN CARBONATE 133.5 mg

처방전 유형:

OTC

치료 영역:

DRUGS FOR ACID RELATED DISORDERS

승인 상태:

Invalid

승인 날짜:

2012-03-01

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

           Gaviscon Cool Tablets. 
           Gaviscon Cool Mint Tablets. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains sodium alginate 250mg, sodium
bicarbonate 133.5mg and calcium 
carbonate 80mg. 

For excipients, see Section 6.1. 

3. 
PHARMACEUTICAL FORM 

Chewable tablet. 

An off-white to cream, circular, flat with bevelled edges tablet
with the odour and flavour of 
peppermint. 

4. 
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn 
and indigestion, for example, following meals or
during pregnancy. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

 For oral administration, after being thoroughly chewed. 

 Adults and children 12 years and over:  Two to four tablets
after meals and at bedtime. 

 Children under 12 years:  Should be given only on medical
advice. 

 Elderly:  No dose modifications necessary for this age group. 

4.3 
CONTRAINDICATIONS 

This medicinal product is contraindicated in patients with known
or suspected 
hypersensitivity to the active substances 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. 

The sodium content of a four-tablet dose is 246 mg (10.6 mmol).  This should be taken into 
account when a highly restricted salt diet is recommended. e.g. in some cases of congestive 
cardiac failure and renal impairment. 

Each four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate.  Care needs to be 
taken  in  treating  patients  with  hypercalcaemia,  nephrocalcinosis  and  recurrent  calcium