Rennie Deflatine

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE; DIMETICONE; MAGNESIUM CARBONATE, HEAVY

Available from:

Bayer PLC

ATC code:

A02AX

INN (International Name):

CALCIUM CARBONATE; DIMETICONE; MAGNESIUM CARBONATE, HEAVY

Pharmaceutical form:

CHEWABLE TABLET

Composition:

CALCIUM CARBONATE 680 mg; DIMETICONE 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

05/05/17
TL016840
102723 / 0117GB
85546864-85546856
C
TR1223051
NEIL THEOBALD
G=1; O=0; R=0; - NT - 05/05/17 07:19:00
Code 128
53%
N/A
N/A
N/A
Delpharm Gaillard
Imprimerie Lefrancq (Cande, France)
White Paper
1
LTH
PROCESS BLACK
COLOURS
102723 / 0117GB
HEARTBURN, INDIGESTION
& WIND RELIEF
Read all of this leaflet carefully because it
contains important information for you.
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION.
HOWEVER, YOU STILL NEED TO TAKE RENNIE HEARTBURN,
INDIGESTION & WIND RELIEF TABLETS CAREFULLY TO GET
THE BEST RESULTS FROM THEM. KEEP THIS LEAFLET, YOU
MAY NEED TO READ IT AGAIN. ASK YOUR PHARMACIST IF
YOU NEED MORE INFORMATION OR ADVICE. YOU MUST
CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO
NOT IMPROVE. IF YOU HAVE ANY UNUSUAL EFFECTS AFTER
TAKING RENNIE HEARTBURN, INDIGESTION & WIND
RELIEF, TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET
1. WHAT IS RENNIE HEARTBURN, INDIGESTION & WIND
RELIEF AND WHAT IS IT USED FOR?
2. BEFORE YOU TAKE RENNIE HEARTBURN,
INDIGESTION & WIND RELIEF
3. HOW TO TAKE RENNIE HEARTBURN, INDIGESTION &
WIND RELIEF
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE RENNIE HEARTBURN, INDIGESTION &
WIND RELIEF
6. FURTHER INFORMATION
1. WHAT IS RENNIE® HEARTBURN,
INDIGESTION & WIND RELIEF AND WHAT
IS IT USED FOR?
Rennie Heartburn, Indigestion & Wind Relief
IS AN ANTACID TABLET WHICH NEUTRALISES EXCESS ACID
TO RELIEVE ACID INDIGESTION, NERVOUS INDIGESTION,
HEARTBURN, FLATULENCE, UPSET STOMACH, BILIOUSNESS;
AND INDIGESTION AND HEARTBURN DURING PREGNANCY.
IT IS ALSO FORMULATED WITH SIMETICONE, A HIGHLY
EFFECTIVE INGREDIENT WHICH RELIEVES PAINFUL
TRAPPED WIND AND ITS ASSOCIATED SYMPTOMS OF
UNCOMFORTABLE BLOATING, PRESSURE AND FULLNESS
AFTER FOOD. IT ACTS GENTLY TO DISPERSE THE TRAPPED
AIR BUBBLES THUS HELPING TO ELIMINATE THE
SYMPTOMS DISCREETLY AND WITHOUT
EMBARRASSMENT.
2. BEFORE YOU TAKE RENNIE® HEARTBURN,
INDIGESTION & WIND RELIEF
Do not take Rennie Heartburn, Indigestion &
Wind Relief:
• IF YOU HAVE SEVERE KIDNEY DISEASE.
• IF YOU HAVE HIGH CALCIUM IN THE URINE OR KIDNEY
STONES

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rennie Deflatine Chewable Tablets
Rennie Heartburn, Indigestion and Wind Relief 680mg/80mg/25mg Chewable
Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Carbonate
680.0 mg
Magnesium Carbonate, heavy
80.0 mg
Simethicone
25.0 mg
Also contains Sorbitol (E420)
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Chewable Tablet
Cream white flat round tablet, scored on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the effective relief of acid indigestion, nervous indigestion,
heartburn, upset
stomach, uncomfortable bloating, biliousness, flatulence, painful
trapped wind,
and indigestion and heartburn during pregnancy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Tablets to be taken orally, sucked or chewed.
Adults and children over 12 years:
One or two tablets to be sucked or chewed as required. A maximum daily
dose of
8g calcium carbonate, corresponding to 11 tablets a day, must not be
exceeded.
Children:
Not recommended for children under 12 years.
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.
4.3
CONTRAINDICATIONS
Rennie should not be administered to patients with:

Hypersensitivity to any of the ingredients of the product

Hypercalcaemia and/or conditions resulting in hypercalcaemia

Nephrolithiasis due to calculi containing calcium deposits

Severe renal insufficiency

Hypophosphataemia
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Prolonged use should be avoided.

The stated dose should not be exceeded. If, after 14 days of
treatment,
symptoms persist or only partly disappear the patient should consult a
doctor.

Caution
should
be
exercised
in
patients
with
mild
to
moderate
impairment of renal function (see section 4.3 – contraindication in
severe renal insufficiency). If Rennie is used in such patients,
plasma
calcium and magnesium l