Rennie Spearmint 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:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-12-20

Patient Information leaflet

BCH22024
Package leaflet: Information for the user
Rennie
®
Spearmint
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 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
®
Spearmint is and what it is used for
2.
What you need to know before you take Rennie
®
Spearmint
3.
How to take Rennie
®
Spearmint
4.
Possible side effects
5.
How to store Rennie
®
Spearmint
6.
Contents of the pack and other information
1. WHAT RENNIE
® SPEARMINT IS AND WHAT IT IS USED FOR
RENNIE
® SPEARMINT
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 contact 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
®
SPEARMINT
DO NOT TAKE RENNIE
® SPEARMINT:
•
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
®
Spearmint if

Summary of Product characteristics

BCH22024
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rennie Spearmint 680mg / 80mg Chewable tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Calcium carbonate 680 mg (272mg elemental calcium)
Heavy Magnesium Carbonate 80 mg (20 mg elemental magnesium)
Excipients of know 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
Creamy white square tablets with occassional slight speckling with
concave surfaces
engraved ‘RENNIE’ on both faces with odour of spearmint.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
For relief of stomach upsets due to hyperacidity and heartburn.
4.2 Posology and method of administration
Posology
Tablets to be taken orally, sucked or chewed.
Adults Only:
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 and efficacy.
BCH22024
2
Elderly persons:
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 Spearmint should not be administered in the following cases:

Hypersensitivity to any of the ingredients of the product, refer to
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 excerised in the case of patients with
impaired renal function. If
Rennie Spearmint is to be used in these p