Rennie Orange 500mg Chewable Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calcium carbonate

Available from:

Bayer Limited

ATC code:

A02AC01

INN (International Name):

Calcium carbonate

Dosage:

500 milligram(s)

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

calcium carbonate

Authorization status:

Marketed

Authorization date:

1990-11-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RENNIE
® ORANGE_ _
_500MG CHEWABLE TABLETS _
Calcium carbonate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you.
-
Keep this Ieaflet, you may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
-
You must contact a doctor if you do not feel better or if you feel
worse after 7
days.
WHAT IS IN THIS LEAFLET
1. What Rennie
®
Orange is and what it is used for
2. What you need to know before you take Rennie
®
Orange
3. How to take Rennie
®
Orange
4. Possible side effects
5. How to store Rennie
®
Orange
6. Contents of the pack and other information
1. WHAT RENNIE
® ORANGE IS AND WHAT IS IT USED FOR?
RENNIE
® ORANGE Chewable tablets get to work to provide fast-effective relief
from
heartburn, indigestion and acid reflux.
Each antacid tablet works to neutralise excess acid in the stomach.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE
® ORANGE
DO NOT TAKE RENNIE
® ORANGE:

If you have severe kidney disease or suffer from kidney stones.

If you have high calcium levels in the blood, kidneys or urine.

If you have low phosphate levels in the blood.

If you are allergic (hypersensitive) to calcium carbonate or any of
the
ingredients of this medicine _(listed in Section 6). _
WARNINGS AND PRECAUTIONS:
Consult your doctor before taking Rennie
®
Orange if you have any kidney problems.
This product contains sucrose. If you have been told by your doctor
that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
As with other antacid products, taking these tablets can mask the
symptoms of other,
more serious, underlying medical conditions. Do not exceed the stated

Summary of Product characteristics

Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rennie Orange 500mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Calcium Carbonate 500 mg (200mg elemental
calcium).
Excipients with known effect:
Each chewable tablet also contains ponceau 4R (E124) and 887.5 mg
sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
A square orange chewable tablet with rounded corners, bevelled edges
and concave faces.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of stomach upset due to hyperacidity and
heartburn, e.g. indigestion, hyperacidity, flatulence,
dyspepsia, biliousness, and acid indigestion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tablets to be taken orally, sucked or chewed, according to the
following dosage schedules:
Adults:
One or two tablets to be sucked or chewed as required, to a maximum of
eleven tablets a day and should not be taken
continuously for longer than 2 weeks.
Elderly
No special dosage regimen is required, but care should be taken to
observe the contraindications and warnings.
Children
Not recommended for children under 12 years of age.
4.3 CONTRAINDICATIONS
Rennie Orange should not be administered in the following cases:
o Hypersensitivity to any of the ingredients of the product
o Hypercalcaemia, hypercalciuria and/or conditions resulting in
hypercalcaemia e.g sarcoidosis
o Nephrolithiasis due to calculi containing calcium deposits
o Severe renal insufficiency
o Hypophosphatemia
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Rennie Orange
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 2 of 5
Prolonged use should be avoided. Do not exceed the stated dose and if
symptoms persist after seven days, further medical
advice should be sought.
Caution should generally be exercised in the case of patients with
impaired renal function. If Rennie Orange is to be used in
these patients, pl