Remegel 800mg chewable tablets mint

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Calcium carbonate

MAH:

SSL International Plc

ATC_code:

A02AC01

INN:

Calcium carbonate

dosage:

800mg

pharmaceutical_form:

Chewable tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 01010201; GTIN: 5038483000267 5038483000229 5038483000243

SPC

OBJECT 1
REMEGEL
Summary of Product Characteristics Updated 15-May-2013 | SSL
International plc
1. Name of the medicinal product
Remegel
2. Qualitative and quantitative composition
Each Remegel tablet contains 800 mg calcium carbonate
Also contains glucose syrup, sucrose, glycerol and sorbitol (E420).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Soft, light-green, mint flavoured, chewable square tablet
4. Clinical particulars
4.1 Therapeutic indications
Remegel tablets are indicated for the relief of acid indigestion and
heartburn, and associated stomach
upsets (dyspepsia)
4.2 Posology and method 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. Current use of
calcium carbonate as a phosphate binder should be taken into account
to prevent hypercalcaemia.
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 a history of renal calculi
Severe renal function impairment (creatinine clearance below 30ml/min)
Hypophosphatemia
4.4 Special warnings and precautions for use
This product should be used with caution in renal dysfunction (see
Posology and Method of
Administration).
Long term uses at high doses can result in undesirable effects such as
hypercalcaemia and milk-alkali
syndrome, especially in patients with renal insufficiency. Prolonged
use possibly enhances the risk for the
development of renal calculi.
Calcium carbonate should be used with cau