Gaviscon double action heartburn & indigestion mint flavour sachets 24x10ml
Gaviscon Double Action Mint sachets bring fast, soothing and long lasting relief for up to 4 hours from heartburn and indigestion. They get to work in two different ways: Neutralising excess stomach acid to help relieve discomfort . Forming a protective barrier over the stomach contents to help soothe burning sensation in your chest so, for symptoms of heartburn or indigestion Gaviscon double action can help provide fast, soothing relief.
Gaviscon double action heartburn & indigestion mint flavour sachets 12x10ml
More information
Gaviscon Double Action Mint sachets bring fast, soothing and long lasting relief for up to 4 hours from heartburn and indigestion. They get to work in two different ways: Neutralising excess stomach acid to help relieve discomfort . Forming a protective barrier over the stomach contents to help soothe burning sensation in your chest so, for symptoms of heartburn or indigestion Gaviscon double action can help provide fast, soothing relief.
Gaviscon double action heartburn & indigestion mint flavour sachets 6x10ml
How to Use
Dosage
For oral administration.
Adults, elderly and children 12 years and over: One to two sachets (10-20 ml) after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
- Name of the medicinal product
- Qualitative and quantitative composition
- Pharmaceutical form
- Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose - Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data - Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling - Marketing authorisation holder
- Marketing authorisation number(s)
- Date of first authorisation/renewal of the authorisation
- Date of revision of the text
- Name of the medicinal product
Gaviscon Double Action Liquid Sachets. - Qualitative and quantitative composition
Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.
Gaviscon double action heartburn & indigestion mint flavour sachets 4x10ml
Excipient(s) with known effect:
Methyl parahydroxybenzoate (E218) 40 mg/ 10ml
Propyl parahydroxybenzoate (E216) 6 mg/10ml
Sodium 127.88 mg / 10ml
For full list of excipients, see Section 6.1.
- Pharmaceutical form
Oral suspension in sachets. - Clinical particulars
4.1 Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2 Posology and method of administration
For oral administration.
Adults and children 12 years and over: One to two sachets (10-20 ml) after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for 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
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
This medicinal product contains 127.88 mg sodium per 1 sachet (10ml) dose, equivalent to 6.4% of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 51.15% 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 renal impairment).
Gaviscon Double Action Heartburn Relief Liquid Sachets Mint
Each 2 sachets (20 ml) dose contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions.
Contains methyl parahydroxybenzoate (E218) 40 mg/ 10ml and propyl parahydroxybenzoate (E216) 6 mg/10ml 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 and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.
4.6 Fertility, pregnancy and lactation
Pregnancy
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 the medicinal product may be used during pregnancy, if clinically.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding.
Fertility:
Clinical data do not suggest that this product has an effect on human fertility.
4.7 Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (=1/10); Common (=1/100 and <1/10); Uncommon (=1/1000 and <1/100); Rare (=1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
Gaviscon Bundle: 5 x 12 Gaviscon Double Action Liquid Oral Suspension 10ml Sachets
PATIENT INFORMATION LEAFLET
GAVISCON DOUBLE ACTION LIQUID SACHETS
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 are Gaviscon Double Action Liquid Sachets?
Gaviscon Double Action Liquid Sachets are a combination of two antacids (calcium
carbonate and sodium bicarbonate) and an alginate and work in two ways.
1) Neutralising excess stomach acid to relieve the pain and discomfort.
2) Forming a protective barrier over the stomach contents to soothe the burning pain
in your chest.
What are Gaviscon Double Action Liquid Sachets used for?
Gaviscon Double Action Liquid Sachets are 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, and for symptoms of
excess stomach acid (hyperacidity).
Before taking Gaviscon Double Action Liquid Sachets
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 occurred (see further information for a full list of
ingredients).
Take special care before treatment with Gaviscon Double Action Liquid Sachets:
This medicine contains calcium (3.25mmol per 10ml/sachet dose). This medicine
contains 127.88 mg sodium (main component of cooking/table salt) in each 10 ml.
This is equivalent to 6.4 % of the recommended maximum daily dietary intake of
sodium for an adult.
- If you have been advised to follow a diet restricted in either of these, please
consult your doctor. - Please also talk to your doctor regarding these salt contents if you suffer or have
suffered from significant kidney or heart disease, as certain salts could interfere
with these diseases.
The maximum recommended daily dose of this medicinal product contains
1023.04 mg sodium (found in table salt). This is equivalent to 51.15 % 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 of time,
especially if you have been advised to follow a low salt (sodium) diet.
Please consult your doctor if you know you have reduced amounts of gastric acid in
your stomach, as this product may be less effective.
This product contains methyl (E218) and propyl (E216) parahydroxybenzoates which
may cause allergic reactions (possibly delayed). This product can mask symptoms of
other more serious, underlying medical conditions. If symptoms persist, or treatment
is required for more than seven days continuously, please speak to your doctor or
pharmacist.
Pregnancy and breast-feeding
You can take this product if you are pregnant or breast-feeding. As with all medicines,
the treatment duration should be limited as much as possible.
Taking other medicines
Do not take this product within two hours of taking other medicines by mouth, as it can
interfere with the action of some other medicines.
This is especially important if you are taking antihistamines, antibiotics (tetracyclines
and quinolones such as norfloxacin), iron preparation, thyroid hormones, antifungals
such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for
mental illness), thyroxine, chloroquine (for malaria), bisphosphonates (for osteoporosis)
and estramustine (for prostate cancer).
How to take Gaviscon Double Action Liquid Sachets
For oral administration.
Adults including the elderly and children 12 years and over: one to two 10ml
sachets after meals and before bedtime, up to four times a day.
Children under 12 years old: Should only be taken on medical advice.
If you take too much of this product it is unlikely to cause you any harm. However,
you may feel bloated. Consult your doctor if this doesn’t go away.
If you forget a dose it is not necessary to double the dose next time, just carry on
taking as before.
Taking large doses of calcium carbonate every day for prolonged periods can lead to
high levels of calcium in the blood.
After taking Gaviscon Double Action Liquid Sachets:
If symptoms persist, or treatment is required for more than seven days continuously,
seek medical advice.
Possible side effects
Very rarely (less than 1 in 10,000 patients treated) there is a chance of an allergic
reaction to the ingredients. Symptoms of this may include skin rash, itching, difficulty
breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience
these or any other side effects, stop taking the product and consult your doctor
immediately. Other side effects of unknown frequency may include constipation,
irritability, muscle twitching or muscle cramps, indigestion that comes back when you
stop taking the tablets and high levels of calcium in the blood.
Also you can help to make sure that medicines remain as safe as possible by reporting
any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects
you can help provide more information on the safety of this medicine.
How to store
Do not use this product after the expiry date (EXP: month/year) shown. Keep out of
the sight and reach of children. Do not store above 25°C. Store in the original
package. Do not refrigerate or freeze.
Further information
This product is an off-white to cream suspension with the odour and flavour of
peppermint. Each 10ml contains 500 mg sodium alginate, 213 mg sodium bicarbonate and
325 mg calcium carbonate. The other ingredients are sodium, carbomer, methyl (E218)
and propyl (E216) parahydroxybenzoates, sodium saccharin, peppermint flavour, sodium
hydroxide, and water. This product does not contain sugar or gluten. Gaviscon Double
Action Liquid Sachets available in packs of 2,4,12 and 24 sachets. Not all pack sizes may
be marketed.
Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd.,
Hull, HU8 7DS.
PL 00063/0524
Gaviscon is a trade mark of the RB group of companies
Text Revised: October 2020
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interfere with the action of some other medicines.
This is especially important if you are taking antihistamines, antibiotics (tetracyclines
and quinolones such as norfloxacin), iron preparation, thyroid hormones, antifungals
such as ketoconazole, digoxin and beta-blockers (for heart conditions), neuroleptics (for
mental illness), thyroxine, chloroquine (for malaria), bisphosphonates (for osteoporosis)
and estramustine (for prostate cancer).
How to take Gaviscon Double Action Liquid Sachets
For oral administration.
Adults including the elderly and children 12 years and over: one to two 10ml
sachets after meals and before bedtime, up to four times a day.
Children under 12 years old: Should only be taken on medical advice.
If you take too much of this product it is unlikely to cause you any harm. However,
you may feel bloated. Consult your doctor if this doesn’t go away.
If you forget a dose it is not necessary to double the dose next time, just carry on
taking as before.
Taking large doses of calcium carbonate every day for prolonged periods can lead to
high levels of calcium in the blood.
After taking Gaviscon Double Action Liquid Sachets:
If symptoms persist, or treatment is required for more than seven days continuously,
seek medical advice.
Possible side effects
System Organ Class
Frequency
Adverse Events
Immune System Disorders
Very Rarely
Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.
Metabolism and Nutritional Disorders
Not Known
Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1
Respiratory, Thoracic and Mediastinal Disorders
Very Rarely
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Not Known
Constipation1
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension may be noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.
- Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic classification: A02BX, other drugs for peptic ulcer and gastro-oesophageal reflux disease.
The medicinal product is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate.
On ingestion, the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing oesophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-oesophageal reflux, for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the oesophagus from these gastric components
Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn. This effect is increased by the addition of sodium bicarbonate which also has a neutralising action. The total neutralising capacity of the product at the lowest dose of two tablets is approximately 10mEqH+.
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.
- Pharmaceutical particulars
6.1 List of excipients
Sodium, Carbomer 974P, methyl (E218) and propyl (E216) parahydroxybenzoate, saccharin sodium, peppermint flavour no. 2, sodium hydroxide and purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Two years.
6.4 Special precautions for storage
Do not store above 25°C and store in the original package. Do not refrigerate or freeze.
6.5 Nature and contents of container
A cardboard outer carton containing unit dose stick pack style sachets.
Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.
Not all pack sizes may be marketed.
The sachets are composed of polyester, aluminium and polyethylene.
Each sachet contains 10ml of Gaviscon Double Action Liquid.
6.6 Special precautions for disposal and other handling
None required.
- Marketing authorisation holder
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom. - Marketing authorisation number(s)
PL 00063/0524. - Date of first authorisation/renewal of the authorisation
28/07/2008 / 07/08/2019 - Date of revision of the text
22/01/2021
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Very rarely (less than 1 in 10,000 patients treated) there is a chance of an allergic
reaction to the ingredients. Symptoms of this may include skin rash, itching, difficulty
breathing, dizziness, or swelling of the face, lips, tongue or throat. If you experience
these or any other side effects, stop taking the product and consult your doctor
immediately. Other side effects of unknown frequency may include constipation,
irritability, muscle twitching or muscle cramps, indigestion that comes back when you
stop taking the tablets and high levels of calcium in the blood.
Also you can help to make sure that medicines remain as safe as possible by reporting
any unwanted side effects via the internet at www.booksg.com or search for
MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects
you can help provide more information on the safety of this medicine.
How to store
Do not use this product after the expiry date (EXP: month/year) shown. Keep out of
the sight and reach of children. Do not store above 25°C. Store in the original
package. Do not refrigerate or freeze.
Further information
This product is an off-white to cream suspension with the odour and flavour of
peppermint. Each 10ml contains 500 mg sodium alginate, 213 mg sodium bicarbonate and
325 mg calcium carbonate. The other ingredients are sodium, carbomer, methyl (E218)
and propyl (E216) parahydroxybenzoates, sodium saccharin, peppermint flavour, sodium
hydroxide, and water. This product does not contain sugar or gluten. Gaviscon Double
Action Liquid Sachets available in packs of 2,4,12 and 24 sachets. Not all pack sizes may
be marketed.
Manufacturer and PL Holder in UK: Reckitt Benckiser Healthcare (UK) Ltd.,
Hull, HU8 7DS.
PL 00063/0524
Gaviscon is a trade mark of the RB group of companies
Text Revised: October 2020
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