Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Hypersensitivity to the active substance or any of the excipients listed in section 6.1, including ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and butyl parahydroxybenzoate (see section 4.4).
As with all medicines, it is recommended to limit the treatment duration as much as possible. 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).
Calcium: Each 20 ml dose contains 320 mg of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Contains parahydroxybenzoates (E214 and E216) which may cause allergic reactions (possibly delayed).
As with other antacid products, taking Acidex can mask the symptoms of other more serious, underlying medical conditions.
Consult your doctor if you are over 40 years and have never suffered with heartburn and acid indigestion before.
Due to the presence of calcium and carbonates, a time-interval of 2 hours should be considered between Acidex intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, biphosphonates, and estramustine. See also 4.4.
Clinical studies in more than 500 pregnant women as well as a large number of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances. Acidex can be used during pregnancy, if clinically needed.
Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction. No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Acidex can be used during breast-feeding.
Clinical data do not suggest that Acidex has an effect on human fertility.
Acidex has no or negligible influence on the ability to drive and 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).
| System organ class | Frequency | Adverse Event |
|---|---|---|
| Immune System Disorders | Very rare | Anaphylactic and anaphylactoid reactions Hypersensitivity reactions such as urticaria. |
| Respiratory, Thoracic and Mediastinal Disorders | Very rare | Respiratory effects such as bronchospasm. |
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 HPRA Pharmacovigilance Website: www.hpra.ie.
Not applicable.
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