Gaviscon Peppermint Liquid Relief

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Laadi alla Infovoldik (PIL)
25-03-2022
Laadi alla Toote omadused (SPC)
25-03-2022

Toimeaine:

Sodium alginate; Calcium carbonate; Sodium bicarbonate

Saadav alates:

Reckitt Benckiser Healthcare (UK) Ltd

ATC kood:

A02BX13

INN (Rahvusvaheline Nimetus):

Sodium alginate; Calcium carbonate; Sodium bicarbonate

Annus:

50mg/1ml ; 16mg/1ml ; 26.7mg/1ml

Ravimvorm:

Oral suspension

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 01010201; GTIN: 5000158065376 5000158064591 5000158065581 5000158065093

Infovoldik

                                TR1565541
H
10
mm
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CUSTOMER INFO:
Minimum Point Size =
(FRONT LABEL ONLY)
LEAFLET MEASURES AT 9PT
7.00pt
G av i s co n Pe p p e r m i nt
L i q u i d
R e l i e f
T B R 2 6 4 6 - D 8 3 4 6 1 4 2 – E n g l i s h
PATIENT INFORMATION LEAFLET
GAVISCON PEPPERMINT LIQUID RELIEF
Sodium alginate, Sodium bicarbonate, Calcium carbonate
Please read this leaflet carefully before you take this medicine. If
you are not sure about
anything ask your pharmacist or doctor.
WHAT IS GAVISCON PEPPERMINT LIQUID RELIEF AND WHAT IS IT USED FOR?
Gaviscon Peppermint Liquid Relief belongs to a group of medicines
called ‘reflux
suppressants’, which form a protective layer on top of the stomach
contents to prevent
stomach acid escaping from the stomach where it works into the food
pipe causing pain
and discomfort. Gaviscon Peppermint Liquid Relief is used for the
treatment of
symptoms of gastro-oesophageal reflux such as acid regurgitation,
heartburn and
indigestion, which may occur, for example, following meals or during
pregnancy.
BEFORE USING GAVISCON PEPPERMINT LIQUID RELIEF
DO NOT TAKE THIS PRODUCT IF:
• You know you are allergic to any of the ingredients as very rarely
difficulty in
breathing and skin rashes have occured (see further information for
full ingredients list).
TAKE SPECIAL CARE BEFORE TREATMENT WITH GAVISCON PEPPERMINT LIQUID
RELIEF :
This medicine contains 285.2 mg (12.4 mmol) of sodium per 20 ml dose.
If you have
been advised to follow a low sodium (salt) diet ask your doctor before
taking this
product. The maximum recommended daily dose of this medicinal product
contains
1140.8 mg sodium (found in table salt). This is equivalent to 57 % of
the adult
recommended maximum daily dietary intake for sodium. Talk to your
doctor or
pharmacist if you need this product on a daily basis for a prolonged
period, especially if
you have been advised to follow a low salt (sodium) diet.
This product contains methyl (E218) and propyl (E216)
parah
                                
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Toote omadused

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Peppermint Liquid Relief.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon Peppermint Liquid Relief contains 250mg sodium alginate,
133.5mg sodium
bicarbonate and 80mg calcium carbonate per 5ml.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sodium
For excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension.
An opaque, off-white to cream suspension with the odour and flavour of
peppermint.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Gastric reflux, heartburn, flatulence associated with gastric reflux,
heartburn of pregnancy, all
cases of epigastric and retrosternal distress where the underlying
cause is gastric reflux.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults and children over 12 years: 10-20ml after meals and at bedtime.
Children under 12 years: Should be given only on medical advice.
Elderly: No dosage modification is required in this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary (see section 4.4).
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,
including methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see
section 4.4).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms do not improve after 7 days, the clinical situation should
be reviewed.
This medicinal product contains 285.2 mg (12.4 mmol) sodium per 20 ml
dose, equivalent to
14.26 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 57 % of the
WHO recommended
maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly
taken into account for
those on a low salt diet (e.g. in some cases of congestive heart
failure and
                                
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