Rennie Peppermint 680mg/80mg Chewable Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE, MAGNESIUM CARBONATE, HEAVY

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

A02AC01

INN (International Name):

CALCIUM CARBONATE 680 mg MAGNESIUM CARBONATE, HEAVY 80 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

CALCIUM CARBONATE 680 mg MAGNESIUM CARBONATE, HEAVY 80 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2006-08-16

Patient Information leaflet

BCH22024
Package leaflet: Information for the user
Rennie
®
Peppermint
680mg/80mg CHEWABLE TABLETS
Calcium carbonate and Magnesium 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 leaflet. 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 talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Rennie
®
Peppermint is and what it is used for
2.
What you need to know before you take Rennie
®
Peppermint
3.
How to take Rennie
®
Peppermint
4.
Possible side effects
5.
How to store Rennie
®
Peppermint
6.
Contents of the pack and other information
1. WHAT RENNIE
® PEPPERMINT IS AND WHAT IT IS USED FOR
RENNIE
® PEPPERMINT
Chewable Tablets get to work within minutes to provide fast, effective
relief from
heartburn, indigestion and acid reflux. Each tablet contains two
antacids – calcium carbonate and
magnesium carbonate – that work quickly and effectively to
neutralise excess acid in the stomach.
Through
this neutralisation they protect the stomach and the food pipe against
damaging effects of the excess acid.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE
® PEPPERMINT
DO NOT TAKE RENNIE
® PEPPERMINT:
•
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 to calcium carbonate, magnesium carbonate or any
of the ingredients
_(listed in _
_Section 6)_
WARNINGS AND PRECAUTIONS:
Consult your doctor before taking Rennie
®

Summary of Product characteristics

BCH22024
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rennie Peppermint 680mg/80mg Chewable Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Calcium carbonate 680 mg (272 mg elemental calcium)
Heavy Magnesium Carbonate 80 mg (20 mg elemental magnesium)
Excipients with known effect:
Each chewable tablet also contains 250mg Sucrose and 250mg Glucose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Chewable Tablet (Tablet).
Creamy white square tablets with occasional slight speckling with
concave surfaces engraved
‘RENNIE’ on both faces with odour of peppermint.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the relief of stomach upset due to hyperacidity and heartburn.
4.2 Posology and method of administration
Posology
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.
Paediatric population:
Not recommended for use in children and adolescents below age 18 due
to a lack of sufficient
data on safety or efficacy.
BCH22024
Elderly:
No special dosage regimen is required, but care should be taken to
observe the contraindications and
warnings.
Method of administration
For oral use.
4.3 Contraindications
Rennie should not be administered in the following cases:

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1

Hypercalcaemia, hypercalciuria and/or conditions resulting in
hypercalcaemia e.g sarcoidosis

Nephrolithiasis due to calculi containing calcium deposits

Severe renal insufficiency

Hypophosphatemia
4.4 Special warnings and precautions for use
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