Rennie Peppermint

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE; MAGNESIUM CARBONATE, HEAVY

Available from:

Bayer PLC

ATC code:

A02AC01

INN (International Name):

CALCIUM CARBONATE; MAGNESIUM CARBONATE, HEAVY

Pharmaceutical form:

CHEWABLE TABLET

Composition:

CALCIUM CARBONATE 680 mg; MAGNESIUM CARBONATE, HEAVY 80 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2006-08-16

Patient Information leaflet

REFERENCE NO:
PACK TYPE:
PACK SIZE:
ACTION: REF NO:
PIL 125x157.5 (
Leaflet
12 / 24 Pack
MAIN TEXT (BODY COPY):
HEIGHT (BASED ON LOWER CASE X):
8 pt
1.4 mm
FONT SIZE PANEL
B
TR1309417
1
LTH
PROCESS BLACK
COLOURS
103111 / 1017GB
THIS LEAFLET WAS LAST REVISED IN: 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.
125 mm
157.5 mm REFERENCE NO:
PACK TYPE:
PACK SIZE:
ACTION: REF NO:
PIL 170X210 [
Leaflet
36/48/72/96 Pack
MAIN TEXT (BODY COPY):
HEIGHT (BASED ON LOWER CASE X):
11 pt
1.9 mm
FONT SIZE PANEL
B
TR1309421
1
LTH
PROCESS BLACK
COLOURS
103112 / 1017GB
THIS LEAFLET WAS LAST REVISED IN: AUGUST 2017.
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.
MARKETING AUTHORISATION HOLDER: BAYER PLC,
400 SOUTH OAK WAY, READING, RG2 6AD, UK.
[e-mail]
SB768 B - Notice Bobine
Dimensions : 210 x 170 mm
210 mm
170 mm

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
Page 1 of 8
1.
NAME OF THE MEDICINAL PRODUCT
Rennie Peppermint
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Carbonate
680.0 mg
Heavy Magnesium Carbonate
80.0 mg
Also contains glucose and sucrose
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Chewable Tablets
A square cream white tablet with rounded corners, bevelled edges and
concave
faces, engraved ‘Rennie’ on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of indigestion, heartburn, nervous indigestion,
hyperacidity,
flatulence, upset stomach, dyspepsia, biliousness, overindulgence in
food and
drink, indigestion during pregnancy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Tablets to be taken orally, sucked or chewed.
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 10 tablets a day, must not be exceeded.
Children
Not recommended for children under 12 years.
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 8
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.
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 SPECIAL 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