Rennie Deflatine Chewable tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE, SIMETICONE, MAGNESIUM CARBONATE, HEAVY

Available from:

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

ATC code:

A02AX

INN (International Name):

CALCIUM CARBONATE 680 mg SIMETICONE 25 mg MAGNESIUM CARBONATE, HEAVY 80 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

CALCIUM CARBONATE 680 mg SIMETICONE 25 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
®
Deflatine
680mg/ 80mg/ 25mg CHEWABLE TABLETS
Calcium carbonate, magnesium Carbonate and simeticone
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.
IN THIS LEAFLET
1.
What Rennie
®
Deflatine is and what it is used for
2.
What you need to know before you take Rennie
®
Deflatine
3.
How to take Rennie
®
Deflatine
4.
Possible side effects
5.
How to store Rennie
®
Deflatine
6.
Contents of the pack and other information
1. WHAT RENNIE
®
DEFLATINE IS AND WHAT IT IS USED FOR
Rennie
®
Deflatine relieves the pain and discomfort of bloating, flatulence,
and trapped wind.
Each tablet is formulated with simeticone, a highly effective
anti-foaming agent that causes
the trapped air bubbles to combine and disperse, helping to eliminate
the symptoms
discreetly and without embarrassment. Rennie Deflatine also contains
antacids which
provide effective relief from heartburn, indigestion and acid reflux.
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
®
DEFLATINE
Do not take Rennie
®
Deflatine:

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 any of the ingredients (listed
in Section 6).
Warnings and Precautions:
As with other antacid products, taking these tablets can

Summary of Product characteristics

BCH22024
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rennie Deflatine Chewable Tablets
Calcium Carbonate 680mg
Magnesium Carbonate 80mg
Simeticone 25mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Calcium carbonate
680 mg (272 mg elemental calcium)
Magnesium Carbonate, heavy
80 mg (20 mg elemental magnesium)
Simeticone
25 mg
Excipients with known effect: Each chewable tablet also contains
Sorbitol (E420) 430mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablet
A white, circular, flat tablet, with bevelled edges and a single score
line on one surface.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the effective relief of acid indigestion, heartburn, uncomfortable
bloating, flatulence and painful
trapped wind.
4.2 Posology and method of administration
Posology:
To be taken orally sucked or chewed.
Adults: One or two tablets to be sucked or chewed as required, to a
maximum of
eleven tablets a day.
The maximum daily dose of 8 g calcium carbonate (corresponding to 11
Rennie Deflatine tablets)
should not be exceeded and should not be taken continuously for longer
than 2 weeks.
Prolonged use should be avoided. If symptoms persist after 7 days,
further medical advice should be
sought.
As with all antacids, if symptoms persist in spite of therapy,
diagnostic measures are strongly
recommended in order to rule out a more serious disease.
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
Method of administration
For oral use.
4.3 Contraindications
Rennie Deflatine 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 Spe