GAVISCON COOL MINT LIQUID

Active substance: SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Cool Mint Liquid

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose contains sodium alginate 500 mg, sodium hydrogen carbonate
267 mg and calcium carbonate 160 mg.
Excipients: methyl parahydroxybenzoate (E218) 40 mg/10 ml and
propylparahydroxybenzoate (E216) 6 mg/10 ml.
For full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Oral suspension.
An off-white suspension with the odour and flavour of peppermint

4
4.1

CLINICAL PARTICULARS
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.
Adults and children 12 years and over: 10-20 ml after meals and at bedtime
(up to four times a day).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.

4.3

Contraindications
Hypersensitivity to any of the ingredients, including the esters of hydroxybenzoates
(parabens)

4.4

Special warnings and precautions for use
Each 10 ml dose has a sodium content of 141 mg (6.2 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 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be
taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent
calcium containing renal calculi.
There is a possibility of reduced efficacy in patients with very low levels of gastric
acid.
If symptoms do not improve after seven days, the clinical situation should be
reviewed.
Treatment of children younger than 12 years of age is not generally recommended,
except on medical advice.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate
(E216) which may cause allergic reactions (possibly delayed).

4.5

Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium carbonate which acts as an antacid, a time-interval of
2 hours should be considered between Gaviscon intake and the administration of
other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine,
fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, betablockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine and
diphosphonates.

4.6

Pregnancy and lactation
Open controlled studies in 281 pregnant women did not demonstrate any significant
adverse effects of Gaviscon on the course of pregnancy or on the health of the
foetus/new-born child. Based on this and previous experience, this product may be
used during pregnancy and lactation.

4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
Very rarely ( 1/10,000) patients may develop allergic manifestations such as urticaria
or bronchospasm, anaphylactic or anaphylactoid reactions.



4.9

Overdose
In the event of overdosage symptomatic treatment should be given. The patient may
notice abdominal distension.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic classification: A02BX13. Other drugs for peptic ulcer
and gastro-oesophageal reflux disease.
On ingestion the medicinal product reacts rapidly with gastric acid to form a
raft of alginic acid gel having a near neutral pH and which floats on the
stomach contents effectively impeding gastro-oesophageal reflux. In severe
cases the raft itself may be refluxed into the oesophagus, in preference to the
stomach contents, and exert a demulcent effect.

5.2

Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on
absorption into the systemic circulation.

5.3

Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Carbomer 974P
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Mint flavour no. 4
Mint flavour no. 5
Sodium hydroxide
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.

6.5

Nature and contents of container
Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident
band lined with expanded polyethylene wad with either a measuring device (natural
polypropylene) containing 5 ml, 10 ml, 15 ml, and 20 ml graduations, or a measuring
spoon (crystal poltstyrene) containing 2.5 ml and 5 ml measure, and containing 100,
150, 200, 300, 500 or 600 ml.
Not all pack sizes may be marketed. The carton and measuring device or spoon may
not be made available in all markets/pack sizes.

.
6.6

Special precautions for disposal
None required.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United
Kingdom.

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0158.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/11/2008

10

DATE OF REVISION OF THE TEXT
29/06/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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