Rennie Direct 680 mg/80 mg oral powder

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Magnesium carbonate heavy; Calcium carbonate

Verfügbar ab:

Bayer Limited

ATC-Code:

A02AX

INN (Internationale Bezeichnung):

Magnesium carbonate heavy; Calcium carbonate

Dosierung:

680 mg/80 milligram(s)

Darreichungsform:

Oral powder

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

Antacids, other combinations

Berechtigungsdatum:

2018-08-17

Fachinformation

Health Products Regulatory Authority
31 October 2018
CRN008MPP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rennie Direct 680 mg/80 mg oral powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 680 mg of calcium carbonate (equivalent to 272 mg
elemental
calcium) and 80 mg of heavy magnesium carbonate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral powder.
Cream white to cream, mint flavoured powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For relief of stomach upsets due to hyperacidity and heartburn.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The powder is to be taken orally without water. It can be put directly
onto the
tongue. Patients who are sensitive to the inhalation of fine powders
should be
advised to put the powder under the tongue in order to prevent
inhalation.
Adults: One or two sachets to be taken as required, to a maximum of
eleven sachets
a day.
Children: Not recommended for use in children and adolescents below
age 18 due to
a lack of sufficient data on safety or efficacy.
Elderly persons:
No special dosage regimen is required, but care should be taken to
observe the
contraindications and warnings.
Health Products Regulatory Authority
31 October 2018
CRN008MPP
Page 2 of 7
4.3 CONTRAINDICATIONS
Rennie Direct should not be administered in the following cases:
•Hypersensitivity to the active substances or to any of the
excipients listed in section
6.1
•Hypercalcaemia, hypercalciuria and/or conditions resulting in
hypercalcaemia, e.g.
sarcoidosis
•Nephrolithiasis due to calculi containing calcium deposits
•Severe renal insufficiency
•Hypophosphataemia
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use should be avoided. Do not exceed the stated dose and if
symptoms
persist after 7 days, further medical advice should be sought.
Caution should generally be exercised in the case of patients with
impaired renal
function. If Rennie Direct is to be used in these patients, plasma
calcium, phosphate
and