Acidex Advance Oral Suspension (Aniseed Flavour)

Acidex Advance Oral Suspension (Aniseed Flavour)

Each 10 ml contains:

Excipients include:

For a full list of excipients, see section 6.1

Oral Suspension,

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.

This medicinal product contains 106 mg (5.1mmol) sodium per 10 ml dose, equivalent to 5.3% of the WHO recommended maximum daily intake for sodium.

The maximum daily dose of this product is equivalent to 21% 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 cardiac failure and renal impairment).

Potassium: This medicine contains 78 mg (2.0 mmol) potassium per 10 ml dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Each 10 ml 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.

Contains parahydroxybenzoates (E214, E216) may cause allergic reactions (possibly delayed)

A time-interval of 2 hours should be considered between Acidex Advance intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.

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 foeto/neonatal toxicity of the active substances. Acidex Advance can be used during pregnancy, if clinically needed.

Breast feeding:

No known effect on breast fed infants. Acidex Advance can be used during breast feeding.

Fertility

No known effect on human fertility.

None.

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).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms

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

Management

In the event of overdose, symptomatic treatment should be given.

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.

Calcium Carbonate

Carbomer

Sodium Hydroxide

Saccharin Sodium

Ethyl Parahydroxybenzoate (E214)

Propyl Parahydroxybenzoate (E216)

Butyl Parahydroxybenzoate

Isopropyl Alcohol

Star Anise Oil

Purified Water

None known.

24 months

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.

Not applicable.

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK.

PL 29831/0697

28/09/2016

22/01/2020