For the use of a Registered Medical Practitioner or a Hospital or Laboratory only

Sodium Alginate, Sodium Bicarbonate and
Calcium Carbonate Oral Suspension

Digeraft^® Plus

QUALITATIVE & QUANTITATIVE COMPOSITION:
Each 10 ml contains:

• Sodium Alginate I.P.
  500 mg
• Sodium Bicarbonate I.P
  213 mg
• Calcium Carbonate I.P.
  325 mg
• In a flavored base
  q.s.
• Colour:Erythrosine

DOSAGE FORM& STRENGTH:
Oral Suspension

CLINICAL PARTICULARS:
THERAPEUTIC INDICATION
Heartburn and Indigestion

POSOLOGY AND METHOD OF ADMINISTRATION
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.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary.

CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipi- ents.
This product should not be used in patients with moderate or severe renal insufficiency

SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This medicinal product contains 127.88 mg sodium per 10ml dose, equivalent to 6.4% of the WHO recommended maximum daily
intake for sodium.
The maximum daily dose of this product is equivalent to 51.15% of the WHO recommended maximum daily intake for sodium.
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 congestive cardiac failure, hypertension edema, and renal impairment).
Each 20 ml contains 260 mg (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 7 days continuously, medical advice should be sought. As with otherantacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions

DRUG INTERACTIONS
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2 antihistaminics ,tetracyclines,digo- xine,fluoroquinolones, iron salts, thyroid hormo- nes, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol,
metoprolol, propranolol), glucocorticoid, chloroquine, diphosphonates, andestramustine

USE IN SPECIAL POPULATIONS (SUCH AS PREGNANT WOMEN, LACTATING WOMEN, PAEDIATRIC PATIENTS, GERIATRIC PATIENTS ETC.)
Pregnancy
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects on the course of pregnancy or
on the health of the fetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy, if clinically needed.

Breastfeeding
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding if clinically needed.

Fertility
Clinical data do not suggest that this product has an effect on human fertility

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
This product has no or negligible influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS
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.

Description of Selected Adverse Reactions
¹Usually occurs following larger than recommended dosages

OVERDOSE
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.

PHARMACOLOGIC PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic classification: A02BX, other drugs for peptic ulcer and gastro-esophageal 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 neutralpH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing esophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-esophageal reflux, for up to 4 hours,and protecting the esophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into theesophagus, in preference to the stomach contents,and exert a demulcent effect. In addition, in vitro evidence hasshown that the raft has a secondary action and is able to entrap bile and pepsin within its structure, further protecting theesophagus from these gastric components Calcium carbonate neutralizes gastric acid to provide fast relief from indigestion and heartburn. This effect is increasedby the addition of sodium bicarbonate which also has a neutralizing action. The total neutralizing capacity of the productat the lowest dose of two tablets is approximately 10mEqH+.

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

NONCLINICAL PROPERTIES
ANIMAL TOXICOLOGY OR PHARMACOLOGY
No pre-clinical findings of any relevance to the prescriber have been reported.

DESCRIPTION:
Light pink to pink colour suspension with mint flavor.

PHARMACEUTICAL PARTICULARS
INCOMPATIBILITIES
Not applicable

SHELF-LIFE
18 months

PACKAGING INFORMATION
Round amber glass bottle with PP Plastic Cap containing 150ml

STORAGE/ HANDLING INFORMATION:
Store at a temperature not exceeding 30°C.Do not Refrigerate or Freeze. Shake well before use.

PATIENT COUNSELLING INFORMATION:
Inform patients of the potential for drug intera- ctions. A time-interval of 2 hours should be considered between its administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones,penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine and bisphosphonates
(diphosphonates) and estramustine. Inform the patients about the necessary precautions when on a sodium restricted diet

DETAILS OF MANUFACTURER:
Manufactured in India by:
Naxpar Pharma Pvt. Ltd.182, Village Gurumajra, Kishanpura, Baddi,
Dist – Solan, Himachal Pradesh – 174 101.

Marketed by:
Abbott India Limited
Angel Space, Lifestyle Bldg. No. D-4, Gala No. 7 to 10 & 17 to 20 Ground Floor,
107 to 110 & 117 to 120 First Floor, Pimplas Village, Dist. Thane, Bhiwandi – 421 302, India.

® – Regd. Trademark of Abbott GMBH

DETAILS OF PERMISSION OR LICENCE NUMBER WITH DATE
MNB/07/617 dated 21st Sep. 2021

DATE OF REVISION
Version 01 dated 10th February 2022

For product complaints and queries please write to webmasterindia@abbott.com

Approval code: IND2258843 (v1.1) 16 DEC 2022

For Product Complaints/Queries please write to webmasterindia@abbott.com