ACTAL PASTILS 500 Milligram Tablets
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
07-06-2024
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Ingredient activ:
HYDROTALCITE
Disponibil de la:
Seven Seas Ltd
INN (nume internaţional):
HYDROTALCITE
Dozare:
500 Milligram
Forma farmaceutică:
Tablets
Statutul autorizaţiei:
Withdrawn
Data de autorizare:
2007-03-01
Caracteristicilor produsului
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actal 500mg Oral Gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One oral gum contains:
Hydrotalcite 500 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Oral gum
Cream to honey coloured triangular pastille on the surface.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of heartburn and acid-induced gastric complaints.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS & ADOLESCENTS AGED 13 YEARS AND OVER:_
1-2 pieces of oral gum to be taken several times a day up to a maximum daily dose of 8 pieces, between meals and
before going to bed, or when acid- induced gastric complaints occur (refer to section 4.4).
The pieces of oral gum should be chewed well before swallowing.
_INFANTS & CHILDREN AGED 12 YEARS AND BELOW:_
Actal Oral Gum is not recommended for use in this age group as no data are available on efficacy and safety.
4.3 CONTRAINDICATIONS
Do not use Actal Oral Gum in the presence of hypersensitivity to the active substance or to any of the other excipients,
severe renal insufficiency (creatinine clearance < 30ml / min), hypophosphataemia.
Patients with rare heredity problems of fructose intolerance should not take this medicine.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The following special warnings and precautions for use are related to the two major components of hydrotalcite,
magnesium and aluminium.
Patients with mild to moderate renal insufficiency (creatinine clearance
30 ml/min) should use this product with great
caution. Chronic use of hydrotalcite by these patients may cause encephalopathy (aluminium) or hypermagnesaemia
(magnesium) in rare cases.
IRISH MEDICINES BOARD
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