REMEGEL

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

CALCIUM CARBONATE

Dostopno od:

SSL International plc

Koda artikla:

A02AC01

INN (mednarodno ime):

CALCIUM CARBONATE

Odmerek:

800 Milligram

Farmacevtska oblika:

Tablets Chewable

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

calcium carbonate

Status dovoljenje:

Not Marketed

Datum dovoljenje:

1992-10-13

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Remegel 800 mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800mg Calcium Carbonate.
Excipients with known effect: each tablet contains 99.71mg sorbitol
(E420), 1.47g sucrose and 992.5mg glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Light green, soft, chewable squares with bevelled edges and rounded
corners.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Remegel tablets are indicated for the relief of stomach upsets due to
hyperacidity and heartburn.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral. Tablets to be chewed and swallowed.
ADULTS AND CHILDREN 12 YEARS AND OVER:
One or two tablets of Remegel to be chewed as a single dose, when
symptoms occur. Repeat as necessary. Maximum
dose: 12 tablets in 24 hours.
CHILDREN UNDER 12 YEARS OF AGE:
Not recommended.
THE ELDERLY:
As for adults, see above.
HEPATIC DYSFUNCTION:
There is no specific information relating to the use of Remegel in
hepatic impairment. Normal adult dosage is
appropriate.
RENAL DYSFUNCTION:
Remegel should be used with caution in subjects with mild to moderate
renal impairment (see section 4.4). Current use
of calcium carbonate as a phosphate binder should be taken into
account to prevent hypercalcaemia. Use in severe renal
impairment is contraindicated (see sections 4.3).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient or any of the excipients,
refer to section 6.1
Hypercalcaemia
Nephrocalcinosis
Patients with renal calculi, or with history of renal calculi
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