Active ingredients: Sodium alginate, Sodium bicarbonate, Calcium carbonate
Gaviscon Burning and Indigestion - 500mg / 213mg / 325mg - mint flavor oral suspension
Why is Gaviscon burning and indigestion used? What is it for?
Gaviscon Burning and Indigestion mint flavor oral suspension in sachets is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate and acts in two ways.
- Neutralizing excess stomach acid to relieve pain and discomfort.
- Forming a protective barrier over the contents of the stomach to calm the burning in his chest.
This medicine is indicated for the treatment of acid-related symptoms of gastroesophageal reflux, such as acid regurgitation, heartburn and indigestion, for example after meals or during pregnancy.
Contraindications When Gaviscon should not be used burning and indigestion
Do not take Gaviscon Burns and Indigestion
- if you are allergic to the active substances or any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Gaviscon heartburn and indigestion
Talk to your doctor or pharmacist before using Gaviscon Burns and Indigestion if:
- have severe kidney problems
- have electrolyte disturbances which cause low levels of phosphate in the blood (hypophosphataemia)
- have or have suffered from significant kidney or heart disease, as some salts can interfere with these diseases (ask your doctor about salt content)
- if you know you have a low amount of gastric acid in your stomach, as this medicine may be less effective.
- As with other anti-acid products, taking Gaviscon Burn and Indigestion oral suspension mint flavor in sachets can mask the symptoms of other more serious pre-existing diseases.
- If symptoms persist after 7 days, consult your doctor.
Children
Do not give this medicine to children under 12 years of age without your doctor's advice. There is a risk of increased sodium levels in the blood (hypernatremia) in children who have kidney problems or who have inflammation of the stomach or intestines (gastroenteritis).
Interactions What medications or foods can modify the effect of Gaviscon burning and indigestion
Do not take this medicine within two hours of taking other medicines by mouth as it may interfere with the action of some other medicines. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
You can take this medicine if you are pregnant or breast-feeding or planning to become pregnant. As with all medicines, the duration of treatment should be limited as much as possible.
Important information about some of the ingredients of Gaviscon Burning and Indigestion
This medicinal product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (including delayed). It also contains 127.35 mg (5.53 mmol) of sodium per serving. This should be taken into consideration in patients on a reduced sodium diet. In addition, this medicine contains 130 mg (3.25 mmol) of calcium per dose. Talk to your doctor before using this medicine if you have kidney stones or high blood calcium levels.
Dose, Method and Time of Administration How to use Gaviscon burning and indigestion: Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults, including the elderly and children 12 years and older: 10-20 ml (1 to 2 sachets) after meals and in the evening before going to bed, up to four times a day.
Children under 12 years: should only be given on medical advice.
If you forget to take Gaviscon Burns and Indigestion
If you miss a dose there is no need to double the dose next time, just keep taking it as before.
Overdose What to do if you have taken an overdose of Gaviscon burning and indigestion
If you take more Gaviscon Heartburn and Indigestion than you should, this is unlikely to harm you. However it may feel swollen. Consult your doctor if this symptom does not go away.
Side Effects What are the side effects of Gaviscon burning and indigestion
Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur, stop taking this medicine and consult a doctor immediately.
Very rarely (less than 1 in 10,000 patients) there is a possibility of an allergic reaction to the components of the medicine. Symptoms may include abdominal pain, diarrhea, nausea, vomiting, itchy skin, rash, itching, dizziness, swelling of face, lips, tongue or throat, and difficulty breathing.
Ingestion of large amounts of calcium carbonate, a component of this medicine, can cause an increase in the pH of the blood (alkalosis), too much calcium in the blood (hypercalcaemia), an increased secretion of acid in the stomach, and constipation. These symptoms normally occur following the intake of doses higher than the recommended dose.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (Website: www.agenziafarmaco.it/it/responsabili).
Expiry and Retention
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP (month / year). The expiry date refers to the last day of that month.
Do not store above 30 ° C. Do not refrigerate or freeze.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Gaviscon contains Burning and Indigestion
The active substances in a 10 ml dose of oral suspension are sodium alginate (500 mg), sodium bicarbonate (213 mg) and calcium carbonate (325 mg).
The other ingredients are carbomer 974P, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium saccharin, mint flavor, sodium hydroxide, purified water.
What Gaviscon looks like Burning and Indigestion and contents of the pack
Gaviscon Burn and Indigestion contains a whitish suspension with a mint odor and aroma.
Gaviscon Burn and Indigestion is available in packs containing 4, 12 and 24 sachets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
GAVISCON BURNING AND INDIGESTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose (1 sachet) contains 500 mg sodium alginate, 213 mg sodium bicarbonate and 325 mg calcium carbonate.
Excipients: Methyl parahydroxybenzoate (E218) 40 mg
Propyl parahydroxybenzoate (E216) 6 mg
Sodium 127.25 mg
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral suspension in sachets.
Off-white suspension with mint odor and aroma.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of acid-related symptoms of gastroesophageal reflux, such as acid regurgitation, heartburn and indigestion, for example after meals or during pregnancy.
04.2 Posology and method of administration
For oral administration.
Adults and children 12 years and older: 10-20 ml (1 to 2 sachets) after meals and in the evening before going to bed, up to four times a day.
Children under 12 years: should only be given on medical advice.
Elderly: it is not necessary to change the doses for this age group.
04.3 Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Each 10ml dose (1 sachet) has a sodium content of 127.25mg (5.53mmol). This should be taken into consideration in cases where a particularly low-salt diet is recommended, for example in some cases of congestive heart failure and renal impairment.
Each 10 ml (1 sachet) dose contains 130 mg (3.25 mmol) of calcium. Care should be taken when treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium-containing kidney stones.
If symptoms do not improve after seven days, the clinical picture should be reassessed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which can cause allergic reactions (including delayed).
Prolonged use should be avoided.
As with other anti-acid medicinal products, taking Gaviscon Burn and Indigestion oral suspension mint flavored in sachets can mask the symptoms of other more serious pre-existing diseases.
Gaviscon Burning and Indigestion mint flavor oral suspension in sachets should not be used in the following cases:
- patients with severe renal impairment / renal insufficiency
- patients with hypophosphataemia
There is potential for reduced efficacy in patients with very low gastric acid levels.
There is an increased risk of hypernatremia in children with gastroenteritis or suspected renal insufficiency.
Treatment of children under the age of 12 is generally not recommended, unless prescribed.
04.5 Interactions with other medicinal products and other forms of interaction
Due to the presence of calcium carbonate which acts as an antacid, it is necessary to consider a time interval of two hours from the intake of Gaviscon and the administration of other medicinal products, especially antihistamines-antiH2, tetracyclines, digoxin, fluoroquinolones, iron salts , ketoconazole, neuroleptics, tyrosine, penicillamine, beta-blockers (atenonol, metoprolol, propanolol), glucocorticoids, chloroquine and bisphosphonates).
04.6 Pregnancy and breastfeeding
Open-label controlled studies in 281 pregnant women have not shown any significant undesirable effects of Gaviscon on the course of pregnancy or on the health of the fetus / newborn. Based on this and previous experience, the medicine can be used during pregnancy and breastfeeding. However, in view of the presence of calcium carbonate, it is recommended to limit the duration of treatment as much as possible.
Pre-clinical investigations in animals have found that alginate has no adverse effect on the fertility of parental and offspring or on reproduction. Clinical data do not suggest that Gaviscon may have an effect on fertility in humans.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
Very rarely (allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions, abdominal pain, itchy rash, diarrhea, nausea and vomiting.
Ingestion of large quantities of calcium carbonate can cause alkalosis, hypercalcaemia, acid return, milk-alkali syndrome or constipation. These symptoms usually occur following the intake of doses higher than the recommended dose.
04.9 Overdose
In the event of an overdose, symptomatic treatment should be resorted to. The patient may notice abdominal distension.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs for the treatment of peptic ulcer and gastroesophageal reflux disease.
A02BX.
This medicinal product is the combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate.
When ingested, the medicine reacts rapidly with stomach acid to form an alginic acid gel layer with near neutral pH characteristics that floats on the stomach contents effectively preventing gastroesophageal reflux. In severe cases, the layer itself. of gel can flow back into the esophagus instead of the stomach contents and exert an emollient effect.
Calcium carbonate neutralizes gastric acid providing rapid relief from indigestion and heartburn. This effect is enhanced by the addition of sodium bicarbonate which also has a neutralizing action. The total neutralizing capacity of the product at the lowest dose of 10 ml is approximately 10 mEqH +.
05.2 Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
05.3 Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Carbomer 974P
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Sodium saccharin
Mint aroma
Sodium hydroxide
Purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Do not store above 30 ° C. Do not refrigerate or freeze.
06.5 Nature of the immediate packaging and contents of the package
Outer carton box containing single-dose sachets of elongated shape.
The packs are 4, 12 and 24 sachets.
Not all pack sizes may be marketed.
The sachets are made of heat-sealable laminate composed of polyester / aluminum / polyethylene / polyester / polyethylene.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
Representative for Italy: Reckitt Benckiser Healthcare (Italia) S.p.A. - via G. Spadolini 7 - 20141 Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 041545017 - 500 mg / 213 mg / 325 mg mint flavor oral suspension, 4 10 ml Pet / Al / Pe sachets
AIC n. 041545029 - 500 mg / 213 mg / 325 mg oral suspension mint flavor, 12 sachets Pet / Al / Pe of 10 ml
AIC n. 041545031 - 500 mg / 213 mg / 325 mg mint flavor oral suspension, 24 10 ml Pet / Al / Pe sachets
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 2013
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of 14 October 2013.
