ACIDEX Oral suspension (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Acidex.
2. Qualitative and quantitative composition
Each 10 ml dose contains: Sodium Alginate 500 mg Sodium Bicarbonate 267 mg Calcium Carbonate 160 mg <u>Excipients with known effect:</u> Each 10 ml dose contains 143 mg sodium, 15.0 mg ethyl parahydroxybenzoate ...
3. Pharmaceutical form
Oral Suspension. Aniseed flavoured pink suspension.
4.1. Therapeutic indications
For the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress.
4.2. Posology and method of administration
Posology <b>Adults and children over 12 years:</b> 10-20 ml (Two to four 5 ml spoonfuls) after meals and at bedtime. The maximum daily dose is 80 ml. <b>Children under 12 years:</b> Should only be given ...
4.3. Contraindications
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 ...
4.4. Special warnings and precautions for use
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 ...
4.5. Interaction with other medicinal products and other forms of interaction
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, ...
4.6. Fertility, pregnancy and lactation
Pregnancy 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. ...
4.7. Effects on ability to drive and use machines
Acidex has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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 ...
4.9. Overdose
Symptoms The patient may experience abdominal discomfort and may notice abdominal distension. Management In the event of overdose symptomatic treatment should be given.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD); <b>ATC Code:</b> A02BX On ingestion Acidex Oral Suspension reacts with gastric acid to form ...
5.2. Pharmacokinetic properties
The mode of action of Acidex Oral Suspension is physical and does not depend on absorption into the systemic circulation.
5.3. Preclinical safety data
No preclinical findings relevant to the prescriber have been reported.
6.1. List of excipients
Carbomer Sodium Hydroxide (E524) (For pH adjustment) Saccharin Sodium (E954) Ethyl parahydroxybenzoate (E214) Propyl parahydroxybenzoate (E216) Butyl parahydroxybenzoate Isopropyl Alcohol Erythrosine Colour ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate.
6.5. Nature and contents of container
Type III amber glass bottles with pilfer proof caps and tamper evident screw caps, in pack sizes of 100ml, 150ml, 200ml, 250ml, 300ml and 500ml. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Shake well before use.
7. Marketing authorization holder
Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
8. Marketing authorization number(s)
PA0281/075/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 26 June 1998 Date of last renewal: 26 June 2008
10. Date of revision of the text
November 2021
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