Gaviscon Original Aniseed Releif

Components:
Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate
Method of action:
Antacid
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Name of the medicinal product

Gaviscon Original Aniseed Releif

Qualitative and quantitative composition

Calcium Carbonate; Sodium Alignate; Sodium Bicarbonate

Therapeutic indications

The information provided in Therapeutic indications of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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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.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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For oral administration.

Adults and children 12 years and over: 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.

Contraindications

The information provided in Contraindications of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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This product should not be used in patients with moderate or severe renal insufficiency

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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Each 20 ml dose has a sodium content of 254.5 mg (11.06 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 20 ml contains 260mg (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 seven 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) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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This product has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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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.

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

Overdose

The information provided in Overdose of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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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.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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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+.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.

Preclinical safety data

The information provided in Preclinical safety data of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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No pre-clinical findings of any relevance to the prescriber have been reported.

Incompatibilities

The information provided in Incompatibilities of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Gaviscon Original Aniseed Releif is based on data of another medicine with exactly the same composition as the Gaviscon Original Aniseed Releif of the medicine (Calcium Carbonate, Sodium Alignate, Sodium Bicarbonate). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Gaviscon Original Aniseed Releif directly from the package or from the pharmacist at the pharmacy.
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No special requirements.