Gelraft Suspension

Sodium Alginate, Sodium Bicarbonate & Calcium Carbonate Oral Suspension

Each 5 ml oral suspension contains:

Sodium Alginate IP 250 mg

Sodium Bicarbonate IP 133.5 mg

Calcium Carbonate IP 80 mg

Oral suspension.

4.1 Therapeutic Indication

Indicated for the treatment of heartburn and indigestion.

4.2 Posology and method of administration

Adults and children over 12 years: 10-20ml after meals and at bedtime.

Children under 12 years: Should be given only on medical advice.

A time interval of 2 hours should be considered between Gelraft & administration of other medicinal products.

Elderly: No dosage modification is required in this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary

4.3 Contraindications

Patients with known or suspected hypersensitivity to the active substances

4.4 Special warnings and precautions for use

• If symptoms do not improve after 7 days, the clinical situation should be reviewed.
• 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). Each 10 ml dose contains 160 mg of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
• Care should be taken if on a highly restricted Sodium diet e.g. in some cases of congestive cardiac failure, renal impairment, hypertension & oedemic states.
• Care to be taken in treating patients with hypercalcaemia, nephrocalcinosis & recurrent calcium containing renal calculi.

4.5 Drugs interactions

A time-interval of 2 hours should be considered between Gelraft intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine and bisphosphonates (diphosphonates) and estramustine.

4.6 Use in special populations

Pregnancy

Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances. Gelraft can be used during pregnancy, if clinically needed.

Breast feeding

No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gelraft can be used during breast-feeding.

Fertility

Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.

Clinical data do not suggest that Gelraft has an effect on human fertility.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

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 email to: medico@zuventus.com Website : https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Symptoms

Symptoms are likely to be minor; some abdominal discomfort may be experienced.

Management

In the event of overdose symptomatic treatment should be given.

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.

5.2 Pharmacokinetic properties

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

6.1 Animal Toxicology or Pharmacology

No preclinical findings relevant to the prescriber have been reported.

Gelraft Peppermint Liquid Relief 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. Gelraft Peppermint Liquid Relief 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.

8.1 Incompatibilities

Not applicable.

8.2 Shelf-life

Refer on pack.

8.3 Packaging information

150 ml bottle

8.4 Storage and handing instructions

Store at a temperature not exceeding 30°C.

Do not refrigerate or freeze. Protect from light.

Keep out of reach of children.

Shake Well Before Use.

This product is sugar-free and gluten-free.

Avoid taking Gelraft Oral Suspension 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:

a) Make sure you eat regular meals and drink plenty of water.

b) Avoid spicy and fatty fried food.

c) Lose weight if you are obese.

d) If you are a smoker, consider giving up.

e) Don't drink too much alcohol.

f) 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.