Rennie Orange

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE

Available from:

Bayer PLC

ATC code:

A02AC01

INN (International Name):

CALCIUM CARBONATE

Pharmaceutical form:

TABLET

Composition:

CALCIUM CARBONATE 500 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2006-12-04

Patient Information leaflet

ACTION:
CAD REF NO:
PIL 135 x 197 (SB712)
MAIN TEXT (BODY COPY):
HEIGHT (BASED ON LOWER CASE X):
10 pt
1.7 mm
FONT SIZE PANEL
B
TR1292701
1
LTH
PROCESS BLACK
COLOURS
102957 / 0817GB
AUGUST 2017
MARKETING AUTHORISATION HOLDER:
BAYER PLC, 400 SOUTH OAK WAY, READING,
RG2 6AD, UK.
[e-mail]
REPORTING OF SIDE EFFECTS:
IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR,
PHARMACIST OR NURSE. THIS INCLUDES ANY POSSIBLE
SIDE EFFECTS NOT LISTED IN THIS LEAFLET. YOU CAN ALSO
REPORT SIDE EFFECTS DIRECTLY VIA THE YELLOW CARD
SCHEME AT: WWW.MHRA.GOV.UK/YELLOWCARD.
BY REPORTING SIDE EFFECTS YOU CAN HELP PROVIDE
MORE INFORMATION ON THE SAFETY OF THIS MEDICINE.
71 mm
135 mm
197 mm
71 mm
71 mm
71 mm

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rennie Orange Flavour
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Carbonate 500mg
Also contains sucrose and Ponceau 4R (E124)
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Chewable Tablet
A square orange tablet with rounded corners, bevelled edges and
concave
faces.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of indigestion, heartburn, hyperacidity,
flatulence,
upset stomach, dyspepsia, biliousness, over indulgence in food and
drink,
indigestion during pregnancy, acid indigestion, nervous indigestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tablets to be taken orally, sucked or chewed.
As with all antacids, if symptoms persist despite 14 days of
continuous
therapy, diagnostic measures are strongly recommended in order to rule
out a
more serious disease.
Adults
and
children over 12
years:
Two tablets to be sucked or chewed as
a single dose, preferably to
be taken one hour after meals and before going to bed but also in
between in case of heartburn or gastric pain. A maximum daily dose
of 8 g calcium carbonate, corresponding to
16 tablets a day, must
not be exceeded.
Children:
Not recommended for children under 12 years.
Page 2 of 6
4.3
CONTRAINDICATIONS
Rennie should not be administered to patients with:

Hypersensitivity to any of the ingredients of the product

Hypercalcaemia and/or conditions resulting in hypercalcaemia

Nephrolithiasis due to calculi containing calcium deposits

Severe renal insufficiency

Hypophosphataemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Prolonged use should be avoided.

The stated dose should not be exceeded. If, after 14 days of
treatment,
symptoms persist or only partly disappear the patient should consult a
doctor.

Caution
should
be
exercised
in
patients
with
mild
to
moderate
impairment of renal function (see section 4.3 – contraindication in
severe renal insufficiency). If Rennie is used in such patients,