Rennie 750 mg Medicated Chewing Gum

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Calcium carbonate

Tilgjengelig fra:

Bayer Limited

ATC-kode:

A02AC01

INN (International Name):

Calcium carbonate

Legemiddelform:

Medicated chewing-gum

Terapeutisk område:

calcium carbonate

Autorisasjon status:

Not marketed

Autorisasjon dato:

2022-07-22

Informasjon til brukeren

BCH22023
PACKAGE LEAFLET: INFORMATION FOR THE USER
RENNIE 750 MG MEDICATED CHEWING-GUM
Calcium 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 continuous days of
treatment.
WHAT IS IN THIS LEAFLET
1.
What Rennie Gum is and what is it used for
2.
What you need to know before you take Rennie Gum
3.
How to take Rennie Gum
4.
Possible side effects
5.
How to store Rennie Gum
6.
Contents of the pack and other information
1.
WHAT RENNIE GUM IS AND WHAT IS IT USED FOR
Rennie Gum is a sugar-free, mint-flavoured medicated chewing-gum. It
provides a fast and effective
relief from:
•
heartburn,
•
stomach pain
•
other symptoms associated with too much stomach acid leading to acid
reflux and indigestion.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 continuous days of
treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE GUM
DO NOT TAKE RENNIE GUM IF YOU ARE/HAVE
•
allergic to calcium carbonate or any of the other ingredients of this
medicine (listed in section 6)
•
high calcium levels in the blood
•
high calcium levels in urine, or kidney stones, which consist of
calcium
•
severely reduced kidney function
•
low phosphate levels in the blood
WARNINGS AND PRECAUTIONS
Do not exceed the stated dose or use Rennie Gum for more than 7 days
unless recommended by a doctor.
Talk to your doctor or pharmacist before taking Rennie Gum if you have
mild or moderate kidney
problems as regular blood tests are recommended.
BCH22023
CHILDREN UNDER 12

Preparatomtale

Health Products Regulatory Authority
10 November 2022
CRN00D61K
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rennie 750 mg Medicated Chewing Gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated chewing-gum contains 750 mg calcium carbonate (300 mg
elemental calcium).
Excipients with known effect:
Isomalt (E 953)
Sorbitol (E 420)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Medicated chewing-gum
Round shape 16 mm chewing-gum, composed of two layers, a blue layer
with speckling and a white layer embossed with
"750".
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic relief of heartburn and acid related symptoms in adults
and children from 12 years old.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and children from 12 years old:_
One or two pieces to be taken as a single dose, as required. The
product should be taken in case of heartburn or gastric pain
which occur usually after meal or at bed time.
The maximum of 8 pieces per day should not be exceeded and should not
be taken continuously for longer than 7 days, unless
recommended by a healthcare professional.
_Elderly:_
No special dosage regimen is required, but care should be taken to
observe the contraindications and warnings.
_Children: _
The safety and efficacy of the product in children aged below 12 years
old have not been established. No data are available.
_Pregnant women:_
One or two pieces to be taken as a single dose, as required. The
product should be taken in case of heartburn or gastric pain
which occur usually after meal or at bed time.
The maximum of 5 pieces per day should not be exceeded and should not
be taken continuously for longer than 1 week. In
order to prevent calcium overload, pregnant women should avoid
concomitant intake of calcium supplements and excessive
intake milk and dairy products (section 4.6).
_Method of administration:_
The recommended time for chewing is 15 minutes and the remaining gum
should not be swallowed.
If symptoms persist in spite o