Rennie Ice

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CARBONATE, MAGNESIUM CARBONATE, HEAVY

Available from:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

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:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2015-07-07

Patient Information leaflet

REFERENCE NO:
PACK SIZE:
ACTION:
PIL 125x157.5
24 Pack
MAIN TEXT (BODY COPY):
HEIGHT (BASED ON LOWER CASE X):
8 pt
1.4 mm
FONT SIZE PANEL
A
TR1310594
1
LTH
PROCESS BLACK
COLOURS
103113 / 1017GB
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 ICE 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 ICE, TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET
1. WHAT IS RENNIE ICE AND WHAT IS IT USED FOR?
2. BEFORE YOU TAKE RENNIE ICE
3. HOW TO TAKE RENNIE ICE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE RENNIE ICE
6. FURTHER INFORMATION
1. WHAT IS RENNIE® ICE AND WHAT IS IT USED FOR?
RENNIE ICE IS AN ANTACID TABLET WHICH QUICKLY RELIEVES
INDIGESTION, HEARTBURN, ACID INDIGESTION, DYSPEPSIA,
HYPERACIDITY, NERVOUS INDIGESTION, FLATULENCE, UPSET
STOMACH, INDIGESTION DURING PREGNANCY AND
BILIOUSNESS.
2. BEFORE YOU TAKE RENNIE® ICE
DO NOT TAKE RENNIE ICE:
• IF YOU HAVE SEVERE KIDNEY DISEASE.
• IF YOU HAVE HIGH CALCIUM IN THE URINE OR KIDNEY STONES.
• IF YOU HAVE HIGH CALCIUM OR LOW PHOSPHATE LEVELS IN
THE BLOOD.
• IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO ANY OF THE
INGREDIENTS (_LISTED IN SECTION 6. FURTHER_
_ INFORMATION_).
_ICE_
SPECIAL PRECAUTIONS:
DO NOT EXCEED THE STATED DOSE.
RENNIE ICE SHOULD NOT BE USED FOR MORE THAN 14 DAYS
WITHOUT CONSULTING A DOCTOR.
PLEASE CONSULT YOUR DOCTOR OR PHARMACIST IF YOU HAVE
MILD OR MODERATE KIDNEY PROBLEMS AS REGULAR BLOOD
TESTS SHOULD BE CARRIED OUT.
THIS PRODUCT CONTAINS SUCROSE. IF YOU HAVE BEEN TOLD BY
YOUR DOCTOR THAT YOU HAVE AN INTOLERANCE TO SOME
SUGARS, CONTACT YOUR DOCTOR BEFORE TAKING THIS MEDICINAL
PRODUCT.
TAKING RENNIE ICE WITH FOOD AND DRINK
AVOID TAKING RENNIE ICE WITH LARGE AMOUNTS OF MILK OR
DAIRY PRODUCTS.
TAKING O

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rennie Ice
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Carbonate
680.0 mg
Heavy Magnesium Carbonate
80.0 mg
Also contains sucrose
For full list of excipients, see section 1
3.
PHARMACEUTICAL FORM
Chewable Tablets
A square cream white tablet with occasional slight speckles, rounded
corners, bevelled edges and
concave faces, engraved ‘Rennie’ on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of indigestion, heartburn, nervous indigestion,
hyperacidity, flatulence, upset
stomach, dyspepsia, biliousness, overindulgence in food and drink,
indigestion during
pregnancy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Tablets to be taken orally, sucked or chewed.
Adults and Children over 12 years:
Two tablets to be sucked or chewed as a single dose, preferably to be
taken one hour after
meals and before going to bed but also in between in case of heartburn
or gastric pain. A
maximum daily dose of 8 g calcium carbonate, corresponding to 10
tablets, a day must not be
exceeded.
Children
Not recommended for children under 12 years.
2
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
insufficie