Novelta Power – Dhaka Rx

ANTIULCERANTS: Sodium Alginate, Sodium Bicarbonate & Calcium Carbonate

Indication

Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

Contraindication

This product is contraindicated in patients with known or suspected hypersensitivity to the active ingredients or to any of the excipients.

Dosage & Administration

For Oral Administration: Adult and children over 12 years:10-20 ml after meals and at bedtime, up to four times a day. Children 6 to 12 years: 5-10 ml after meals and at bedtime, up to four times a day. Children under 6 years: Not recommended. Elderly: No dosage modification is required for this age group.

Side Effect

ln addition to the desired effect of the drug, some side effects may appear such as constipation, flatulence, stomach cramp or belching. ln these cases consult a physician. If too big dose has been taken, there might appear a sensation of swelling. ln this case, it is advisable to consult a physician.

Precaution

lf symptoms do not improve after 7 days, the clinical situation should be reviewed. Each 10 ml dose has a Sodium content of 141 mg (6.2 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 10 ml dose contains 160 mg (1.6 mmol) of Calcium Carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Drug Interaction

A time-interval of 2 hours should be considered between this drug intake and the administration of other medicinal products, especially Tetracyclines, Digoxine, Fluoroquinolone, lron salt, Ketoconazole, Neuroleptics, Thyroid Hormones, Penicillamine, beta-blockers (Atenolol, Metoprolol, Propranolol), Glucocorticoid, Chloroquine and Biphosphonates (diphospho- nates) and Estramustine.

Presentation

Each commercial box contains a PET bottle containing 200 ml suspension with a measuring cup.

Use Pregnancy Lactation

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 ingredients. This drug 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. This drug 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 this drug has an effect on human fertility.