Summary of Product Characteristics Updated 02-Apr-2019 | Wockhardt UK Ltd
Acidex Advance Oral Suspension (Aniseed Flavour)
Each 10 ml contains:
Potassium hydrogen carbonate
Ethyl parahydroxybenzoate (E214)
Propyl parahydroxybenzoate (E216)
15.0 mg/10 ml
5.50 mg/10 ml
2.50 mg/10 ml
For a full list of excipients, see section 6.1
Aniseed flavoured white or cream coloured suspension
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
Adults and children 12 years and over: 5 -10ml after meals and at bedtime
Children under 12 years: Should be given only on medical advice.
Elderly: no dose modification is required in this age group.
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients, or any of the excipients listed in section 6.1, including the esters of hydroxybenzoates (Parabens) (see section 4.4).
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Each 10 ml dose contains about 5.1mmol of sodium and 2mmol of potassium. 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 or when taking drugs which can increase potassium levels.
Each 10ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Parahydroxybenzoates (E214, E216) may cause allergic reactions (possibly delayed)
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Acidex Advance can be used during pregnancy, if clinically needed.
No known effect on breast fed infants. Acidex Advance can be used during breast feeding.
No known effect on human fertility.
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 cases), and not known (cannot be estimated from the available data).
System Organ Class
Immune System Disorders
Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria.
Respiratory, Thoracic and Mediastinal Disorders
Respiratory effects such as bronchospasm.
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 at: www.mhra.gov.uk/yellowcard
In the event of overdosage, symptomatic treatment should be given. The patient may notice abdominal distension.
ATC Code: A02BX13
Pharmaceutical group: Other drugs for peptic ulcer and gastro-oesophageal reflux
On ingestion the suspension reacts with gastric acid to rapidly form a raft of alginic acid gel having a near-neutral pH which floats on the stomach contents effectively impeding gastro-oesophageal reflux for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the oesophagus from these gastric components.
The mode of action of the product is physical and does not depend on absorption into the systemic circulation.
There are no preclinical data of relevance to the prescriber in addition to that included in other sections of the SmPC.
Ethyl Parahydroxybenzoate (E214)
Propyl Parahydroxybenzoate (E216)
Star Anise Oil
Use within 3 months of opening
Do not store above 25◦C. Do not refrigerate or freeze.
Pharmaceutical Grade Type III amber glass bottles with white polypropylene caps that have a Low density Polyethylene (LDPE) liner
Pack sizes: 150ml, 200ml, 250ml, 300ml, and 500ml.
Not all pack sizes may be marketed.
Wockhardt UK Ltd
Ash Road North
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
+44 (0)1978 661 261
+44 (0)1978 661 702