Zorviscon DS Suspension

To be sold on retail on prescription of a Registered Medical Practitioner only.
Prescribing Information

Zorviscon DS Suspension

1.0 Generic Name

Alginate raft- forming Oral Suspension

2.0 Qualitative and Quantitative Composition

Each 10 ml of Zorviscon Double Action Liquid contains:
Sodium alginate …500 mg,
Sodium bicarbonate …213 mg,
Calcium carbonate …325 mg

3.0 Dosage Form and Strength

Oral suspension

4.0 Clinical Particulars

4.1 Therapeutic Indications

Indicated for the treatment of heartburn and indigestion.

4.2 Posology and Method of Administration

Adults and children 12 years and above
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 dosage modifications necessary in this group.

Duration of use
If symptoms do not improve after seven days, the clinical situation should be reviewed.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings and Precautions for use

Each 10 ml dose of Zorviscon double action liquid contains 127.25 mg (5.53 mmoI) of sodium. Sodium bicarbonate should be administered with caution in patients with congestive heart failure, renal impairment, cirrhosis of the liver, hypertension, patients receiving corticosteroids, patients with metabolic or respiratory alkalosis, hypocalcaemia, hypochlorhydia or patients on a salt restricted diet.

Each 10 ml dose of Zorviscon double action liquid contains 130 mg (3.25 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

High doses or prolonged use of calcium carbonate may lead to gastric hypersecretion and acid rebound. Hypercalcaemia/alkalosis can occur, especially in patients with renal function impairment or after high doses of calcium carbonate. There have been rare reports of the milk-alkali syndrome associated with calcium carbonate.

4.5 Drug Interactions

Large doses of Zorviscon Double Action Liquid may affect the rate and/or the extent of absorption of other oral medicines. A time interval of 2 hours should be considered between Zorviscon Double Action Liquid intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine. Thiazide diuretics and vitamin D – Hypercalcaemia has occurred when calcium salts are given with thiazide diuretics or vitamin D.

4.6 Use in Special Population

Pregnancy:
Clinical studies as well as post-marketing data indicated no malformities nor feto/neonatal toxicity of Zorviscon Double Action Liquid.

Lactation:
No effects of Zorviscon Double Action Liquid have been shown in breastfed newborns/ infants of treated mothers. Zorviscon Double Action Liquid can be used during breastfeeding.

Fertility:
Clinical Data do not suggest that Zorviscon Double Action Liquid has an effect on human fertility.

4.7 Effects on Ability to Drive and Use Machines

Not relevant.

4.8 Undesirable Effects

Adverse reactions have been ranked under headings of frequency using the following convention: Very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000; Not known: cannot be estimated from the available data.

Gastrointestinal disorders: Uncommon: Stomach cramps, flatulence, constipation. Very rare (<1/10000) Nausea, vomiting and diarrhoea

Immune System Disorders: Not known: Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity such as Urticaria

Respiratory, Thoracic and Mediastinal Disorders: Not known: Respiratory effects such as Bronchospasm

Musculo-skeletal disorders: Very rare (<1/10000) Abdominal distension and abdominal cramps

Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorization 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 email to: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Very large doses may produce a feeling of abdominal distension. Treatment of overdosage is symptomatic and supportive.

5.0 Pharmacological Properties

5.1 Mechanism of action/ Pharmacodynamic properties

On ingestion the product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.

5.3 Pharmacokinetic properties

The mode of action of the product is physical and does not depend on absorption into the systemic circulation.

6.0 Nonclinical Properties

6.1 Animal Toxicology or Pharmacology

No preclinical findings relevant to the prescriber have been reported.

7.0 Description

Zorviscon Double Action Liquid 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. Zorviscon Double Action Liquid 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.

8. Pharmaceutical particulars

8.1 Incompatibilities

Not applicable

8.2 Shelf-Life

Refer on pack

8.3 Packaging Information

60ml & 200ml Bottle

8.4 Storage and Handling Instructions

Store below 30°C. Protect from light.

9.0 Patient Counselling Information

  • Avoid taking Zorviscon Double Action Liquid at the same time as you take other medicine. This is because antacids can affect how well other medicine is absorbed.
  • Incorporate the following lifestyle changes to prevent heartburn and indigestion:
    • Make sure you eat regular meals and drink plenty of water.
    • Avoid spicy and fatty fried food.
    • Lose weight if you are obese.
    • If you are a smoker, consider giving up.
    • Don't drink too much alcohol.
    • Do not go to bed immediately after taking a meal. Sit in a relaxed position for some time for better digestion.
  • Avoid soft drinks and citrus fruits like orange and lemon, which can irritate the stomach and increase acid secretion.
  • Drink 6 to 8 full glasses of water daily to help prevent constipation while taking this medicine.

10.0 Date of Revision

17th March 2026

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