Rennie Dual Action Chewable Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE, MAGNESIUM CARBONATE, HEAVY, ALGINIC ACID

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 625 mg MAGNESIUM CARBONATE, HEAVY 73.5 mg ALGINIC ACID 150 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

CALCIUM CARBONATE 625 mg MAGNESIUM CARBONATE, HEAVY 73.5 mg ALGINIC ACID 150 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-05-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RENNIE DUAL ACTION TABLETS
Calcium carbonate, Magnesium carbonate, Alginic acid
Chewable tablets
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 14
days.
WHAT IS IN THIS LEAFLET
1.
What Rennie Dual Action Tablets are and what they are used for
2.
What you need to know before you take Rennie Dual Action Tablets
3.
How to take Rennie Dual Action Tablets
4.
Possible side effects
5.
How to store Rennie Dual Action Tablets
6.
Contents of the pack and other information
1.
WHAT RENNIE DUAL ACTION TABLETS ARE AND WHAT THEY ARE
USED FOR
Rennie Dual Action tablets provide relief from heartburn and acid
indigestion.
Rennie Dual Action tablets work in two different ways:
1.
Alginic acid forms a protective barrier in the stomach to stop acid
escaping
upwards, soothing that burning pain in your chest
2.
Calcium carbonate and magnesium carbonate provide rapid and long
lasting
neutralization of excess acid in the stomach
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE DUAL
ACTION TABLETS
DO NOT TAKE RENNIE DUAL ACTION TABLETS:
•
If you have severe kidney disease or suffer from kidney stones.
•
If you have high calcium or low phosphate levels in the blood.
•
If you are allergic to any of the ingredients.
WARNINGS AND PRECAUTIONS:
As with other antacid products, taking these tablets can mask the
symptoms of other,
more serious, underlying medical conditions. If symptoms persist after
fourteen days
consult your doctor.
Patients aged 55 years or older with unexplaine

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rennie Dual Action Chewable Tablets
Calcium carbonate 625mg
Magnesium carbonate 73.5mg
Alginic acid 150mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Alginic
acid
150mg,
calcium
carbonate
625mg
and
heavy
magnesium
carbonate
73.50mg.
Excipients: each chewable tablet contains 14 mg sodium as well as
sucrose (230mg) and
glucose (555.22 mg).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Off white, speckled circular tablet, flat on both sides with a
bevelled edge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic
treatment
of
complaints
resulting
from
gastro-oesophageal
reflux
and
hyperacidity, such as regurgitation and heartburn.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual dose is 2 tablets to be chewed. It should preferably be
taken one hour after
meals and before going to bed. An additional dose can also be taken in
between in the
case of heartburn. The maximum dose of 8 grams calcium carbonate
(corresponding to 12
tablets) per day should not be exceeded and should not be taken
continuously for longer
than 2 weeks. Only for use by adults and children over 12 years of
age.
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.
Pregnant women should limit the duration of treatment this medicinal
product is used as
symptoms subside, and it should not be used for more than two weeks.
For Special warnings and precautions for use please also see section
4.4.
4.3
CONTRAINDICATIONS

Severe renal insufficiency

Hypercalcaemia and/or conditions resulting in hypercalcaemia

Pre-existing hypophosphataemia

Nephrolithiasis due to calculi containing calcium deposits

Hypersensitivity to the active substances or to any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use should be avoided.
If the symptoms persist or o