Acidex, Compound Alginate Oral Suspension, Heartburn and Indigestion Liquid (PL 04917/0021)

This medicine alleviates the painful conditions resulting from the reflux of gastric acid and bile into the oesophagus by suppressing the reflux itself. It is indicated in heartburn, including heartburn of pregnancy, dyspepsia associated with gastric reflux, hiatus hernia, reflux oesophagitis, regurgitation and all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

For oral administration

Adults and children over 12 years: Two to four 5 ml spoonfuls.

Doses should be taken after meals and at bedtime.

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

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 (see section 4.4).

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, including ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and butyl parahydroxybenzoate (see section 4.4).

This medicine should not be taken within 1 to 2 hours of taking other medicines by mouth. If symptoms do not improve after seven days, the clinical situation should be reviewed.

This medicinal product contains 286.5 mg (12.45 mmol) sodium per 20 ml dose, equivalent to 14.3 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 57.2 % 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 of congestive heart 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.

This medicine should not be used by patients allergic to any of its constituents.

Ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoates (E216) and butyl parahydroxybenzoate: may cause allergic reactions (possibly delayed).

A time-interval of 2 hours should be considered between this medicine 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 biphosphonates (diphosphonates) and estramustine. See also 4.4.

Antacids may interact with other drugs as they alter the gastric pH which may affect dissolution, solubility or ionization of the other drug. Antacids reduce the absorption of certain drugs from the following groups: ACE Inhibitors, Analgesics, Antibacterials, Antiepileptics, Antifungals, Antimalarials, Antipsychotics, Bisphosphonates, Lithium and Penicillamine.

Antacids may increase the pH of the urine and affect the rate of drug elimination. Excretion of basic drugs is decreased whereas acidic drugs are eliminated more rapidly.

Due to effects at the renal level sodium bicarbonate may reduce plasma lithium levels and increase plasma quinidine levels.

Pregnancy:

Clinical studies in more than 500 pregnant women as well as a large amount of data from postmarketing experience indicate no malformative nor feto / neonatal toxicity of the active substances. This medicine 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 medicine 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 medicine has an effect on human fertility.

There are no effects on ability to drive or use machines.

Adverse reactions have been ranked under headings of frequency using the following convention: 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) and not known (cannot be estimated from the available data).

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 the Yellow Card Scheme Website :www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Symptoms

As this medicine`s mode of action is physical, overdosage in terms of the alginate content is virtually no hazard. The only consequence is abdominal discomfort which is best treated conservatively. The relatively low concentrations of sodium and calcium carbonate in this medicine would also make serious consequences from overdosage very unlikely.

Management

In the event of overdose symptomatic treatment should be given.

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.

Alginic acid is not absorbed into the systemic circulation.

There is no Preclinical Safety Data.

Carbomer (Carbopol 974P)

Sodium Hydroxide

Saccharin Sodium

Ethyl parahydroxybenzoate (E214)

Propyl parahydroxybenzoate (E216)

Butyl parahydroxybenzoate

Isopropyl Alcohol

Erythrosine Colour (E127)

Star Anise Oil

Purified Water

None known.

24 months - amber glass bottles

18 months - HDPE bottles

15 months – PET bottles

Do not store above 25° C. Do not refrigerate.

Pharmaceutical Grade III amber glass bottles with pilfer proof caps and tamper evident screw caps.

High density polyethylene bottles with tamper evident screw caps.

PET bottle with tamper evident screw caps.

Pack sizes: 50ml, 100ml, 150ml, 200ml, 250ml, 300ml and 500ml.

50ml (PET)

Not applicable.