Gaviscon Liquid 10 g Suspension
Clinical Summary
Quick overview from the medicine insert
Indication
Gastric reflux and related conditions.
Dosage (summary)
10-20 ml after meals and at bedtime for adults and children over 12.
Special Populations
- Renal impairment
- Congestive heart failure
- Cirrhosis
- Hypertension
Pregnancy & Breastfeeding
Safe in pregnancy and breastfeeding.
Key Drug Interactions
- Tetracyclines
- Fluoroquinolones
- Iron salts
- Thyroid hormones
- Chloroquine
- Biphosphates
- Estramustine
Contraindications
- Hypersensitivity to ingredients
Common side effects
- Stomach cramps
- Flatulence
- Hypersensitivity reactions
Counselling Points
- Shake well before use
- Consult if symptoms persist after 7 days
- Keep out of reach of children
Serious warnings
- Caution in renal impairment and congestive heart failure
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
GAVISCON LIQUID ANISEED is indicated for the following conditions: Gastric reflux, reflux oesophagitis, heartburn, including heartburn of pregnancy, and conditions associated with gastric reflux including hiatus hernia; flatulence; epigastric and retrosternal distress where the underlying cause is gastric reflux.
4.2 Posology and method of administration
For oral use. SHAKE WELL BEFORE USE. Adults and children over 12 years: 10 - 20 ml after meals and at bedtime. Children under 12 years: Should be given only on medical advice. Renal insufficiency: Caution if highly restricted salt diet is necessary (see u201c WARNINGS u201d) Duration of treatment: If symptoms do not improve after seven days, the clinical situation should be reviewed by a medical practitioner.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Sodium bicarbonate should be administered with caution in patients with congestive heart failure, renal impairment and cirrhosis of the liver, hypertension and to patients receiving corticosteroids, patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria. Hypocalcaemia/alkalosis can occur following the regular use of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Contains methyl parahydroxybenoate and propyl parahydroxybenzoate: May cause allergic reactions (possibly delayed).
4.5 Interactions with other medicines
Large doses of GAVISCON LIQUID ANISEED may affect the rate and/or the extent of absorption of other oral medicines. A time-interval of 2 hours should be considered between GAVISCON LIQUID ANISEED intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, biphosphates and estramustine.
4.6 Fertility, pregnancy and lactation
Pregnancy: Clinical studies as well as post-marketing data indicate no malformative nor feto/neonatal toxicity of the active substances. Lactation: No effects of GAVISCON LIQUID ANISEED have been shown in breast fed newborns/infants of treated mothers. Gaviscon can be used during breastfeeding. Fertility: GAVISCON LIQUID ANISEED has no negative effect in parental or offspring fertility or reproduction. Clinical data do not suggest that GAVISCON LIQUID ANISEED has an effect on human fertility.
4.7 Effects on ability to drive and use machines
GAVISCON LIQUID ANISEED has no or negligible influence on driving or the ability to operate tools or machines.
4.8 Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention: Very common: u2265 1/10; Common: u2265 1/100 to < 1/10; uncommon: u2265 1/1,000 to <1/100; rare: u2265 1/10,000 to <1/1,000; very rare: <1/10,000; Not known: cannot be estimated from the available data. Immune system disorders: Not known: Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria. Respiratory, thoracic and mediastinal disorders: Not known: respiratory effects such as bronchospasm. Gastrointestinal disorders: Administration of sodium bicarbonate can cause stomach cramps and flatulence.
4.9 Overdose
Very large doses may produce a feeling of abdominal distension. Treatment of overdosage is symptomatic and supportive.