Remegel 800 mg Chewable Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium carbonate

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

A02AC; A02AC01

INN (International Name):

Calcium carbonate

Dosage:

800 milligram(s)

Pharmaceutical form:

Chewable tablet

Therapeutic area:

Calcium compounds; calcium carbonate

Authorization status:

Not marketed

Authorization date:

1992-10-13

Patient Information leaflet

REMEGEL 800 mg Chewable Tablets
Calcium Carbonate
Soft Chew
24 Tablets in 3 packs
Original Mint
Fast Effective Relief:
Acid indigestion
Heartburn
Excess Acid
1. What Remegel is and what it is used for:
Remegel is a soft, mint flavour chew, that provides fast, effective
relief from acid indigestion and
heartburn. It can also reduce excess acid in stomach. Each chewable
tablet contains Calcium
Carbonate 800 mg.
2. Before you use Remegel:
Do not take if you are allergic to Remegel or to any of its
ingredients, if you have severe kidney
disease, have had kidney stones, diabetes, or high levels of calcium
or low levels of phosphate in
your blood. Contact a doctor or pharmacist before taking Remegel if
you are pregnant, under a
doctor’s care, taking other medicines particularly tetracycline and
quinolone antibiotics, digoxin,
estramustrine, on a special diet, or have severe dietary problem (e.g.
malnutrition or phosphate
deficiency). Remegel contains glucose, sucrose and sorbitol. If you
have been told by your doctor
that you have an intolerance to some sugars, contact your doctor
before taking. Glucose and sucrose
may be harmful to teeth.
3. How to take Remegel:
Adults & Children 12 years and over: Chew 1 or 2 tablets as symptoms
occur. Repeat as necessary,
up to a maximum of 12 tablets in 24 hours. Not recommended for
children under 12. Do not exceed
the stated dose except on medical advice. Consult your doctor or
pharmacist if your symptoms do
not improve after 7 days. If you take more tablets than you should,
seek medical advice.
4. Possible Side Effects:
If you experience any serious allergic reactions (rash, skin
blistering, itchiness, breathing difficulties,
swelling), stop takin the medicine and seek medical advice.
Constipation, belching, nausea, vomiting,
stomach discomfort, diarrhoea, muscle twitching, spasms, muscular
weakness or kidney stones due
to high levels of calcium may occur.
Reporting side effects: If you get any side effects, talk to your
doctor, pharmacist, or nurse. This
includes any side effe

Summary of Product characteristics

Health Products Regulatory Authority
07 March 2019
CRN008RM9
Page 1 of 5
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
Severe renal function impairment (creatinine clearance below 30ml/min)
Hypophosphataemia
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
07 March 2019
CRN008RM9
Page 2 of 5
Use with caution in patients with renal dysfunction (see Posology and
Method of Administration).
Long term uses at high do