Rennie Ice Sugar Free
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rennie Ice Sugar Free
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium carbonate 680 mg
Magnesium carbonate, heavy 80 mg
Also contains Sorbitol (E420)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Chewable tablet
A square white tablet with rounded corners, bevelled edges and concave faces, embossed ‘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, gastritis, 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 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.
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 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, phosphate and magnesium levels should be regularly monitored.
• Long term uses at high doses can result in undesirable effects such as hypercalcaemia, hypermagnesaemia and milk-alkali syndrome, especially in patients with renal insufficiency.
• Rennie should not be used in patients with hypercalciuria (see also section 4.3). Prolonged use increases the risk of formation of renal calculi.
• This product should not be taken with large amounts of milk or dairy products.
• Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Changes in gastric acidity, such as that caused by the ingestion of antacids, can affect the rate and degree to which some concurrently administered medicines are absorbed.
• It has been shown that antacids which contain calcium or magnesium may form complexes with certain substances e.g., antibiotics (such as tetracyclines and quinolones), and cardiac glycosides (e.g. digoxin), levothyroxine, and eltrombopag, resulting in decreased absorption. This should be borne in mind when concomitant administration is considered.
• Calcium salts reduce the absorption of fluorides and iron-containing products, and calcium salts and magnesium salts can hinder the absorption of phosphates.
• Thiazide diuretics reduce the urinary excretion of calcium. Due to an increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Therefore it is preferable to take the antacid separately from other drugs, allowing at least 4 hours before or after taking eltrombopag and a 1-2 hour interval for all other drugs.
4.6. Fertility, pregnancy and lactation
No increased risk of congenital defects has been observed after the use of this product during pregnancy and it can be used during pregnancy and lactation if taken as instructed but prolonged intake of high dosages should be avoided. Pregnant women should limit the use of these products to the maximum recommended daily doses (see Section 4.2).
During pregnancy and lactation, it has to be taken into account that the tablets provide a substantial amount of calcium in addition to dietary calcium intake. For this reason, pregnant women should strictly limit their use of tablets to the maximum recommended daily dose and avoid concomitant, excessive intake of milk and dairy products. This warning is to prevent calcium overload which might result in milk-alkali syndrome.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories of frequency is not possible.
Immune System Disorders:
Hypersensitivity reactions have very rarely been reported. Clinical symptoms may include rash, urticaria, angioedema and anaphylaxis.
Metabolism and Nutrition Disorders:
Especially in patients with impaired renal function, prolonged use of high doses can result in hypermagnesaemia or hypercalcaemia and alkalosis which may give rise to gastric symptoms and muscular weakness (see below).
Gastrointestinal Disorders:
Nausea, vomiting, stomach discomfort and diarrhoea may occur.
Musculoskeletal and Connective Tissue Disorders:
Muscular weakness may occur.
Undesirable effects occurring in the context of milk-alkali syndrome (see 4.9):
Gastrointestinal Disorders:
Ageusia may occur in the context of milk-alkali syndrome.
General Disorders and Administration Site Conditions:
Calcinosis and asthenia may occur in the context of milk-alkali syndrome.
Nervous System Disorders:
Headache may occur in the context of milk-alkali syndrome.
Renal and Urinary Disorders:
Azotemia may occur in the context of milk-alkali syndrome.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Especially in patients with impaired renal function, prolonged use of high doses of calcium carbonate and magnesium carbonate can result in renal insufficiency, hypermagnesaemia, hypercalcaemia and alkalosis which may
give rise to gastrointestinal symptoms (nausea, vomiting, constipation) and muscular weakness. In these cases, the intake of the product should be stopped and adequate fluid intake encouraged. In severe cases of overdosage (e.g. milk-alkali syndrome), a health care professional must be consulted because other measures of rehydration (e.g. infusions) might be necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Classification: Antacids ATC codes: Calcium carbonate: A02AC01
Magnesium carbonate: A02AA01
Calcium and magnesium carbonate react with excess acid in the gastric juice to
produce soluble chlorides
CaCO3 + 2HCl => CaCl2 + H2O + CO2
MgCO3 + 2HCl => MgCl2 + H2O + CO2
Calcium carbonate has a rapid and powerful neutralising action. This effect is increased by the addition of magnesium carbonate which also has a strong neutralising action.
In healthy volunteers, a significant increase in the pH of stomach contents above baseline pH was achieved between 1 and 6 minutes after dosing.
5.2 Pharmacokinetic properties
A small amount of calcium and magnesium may be absorbed, but in healthy subjects it is usually rapidly excreted by the kidney. The soluble chlorides produced by the reaction of calcium and magnesium with gastric acid react, in turn, with intestinal, biliary and pancreatic secretions to form insoluble salts, which are excreted in the faeces.
5.3. Preclinical safety data
There is no information of relevance to the safety assessment in addition to what is stated in other parts of the Summary of Product Characteristics.
6.1 List of excipients
Sorbitol (E420)
Potato starch
Maize starch pregelatinised Magnesium stearate Talc
Light liquid paraffin Saccharin sodium
Cooling flavour - consists of: diethyl malonate, maltodextrin (maize), menthol, menthyl lactate, modified starch E1450 (waxy maize), iso-pulegol Mint flavour - consists of: maltodextrin (maize), menthol, modified starch E 1450 (waxy maize)
6.2 Incompatibilities
None
6.3 Shelf life
Blister packs: 36 months Roll wraps: 24 months
6.4 Special precautions for storage
Blister packs: Do not store above 25oC. Protect from moisture. Roll wraps: Protect from moisture.
6.5 Nature and contents of container
Tablets are packed in aluminium foil/pvc bubble packs with six or twelve tablets per strip.
3, 4, 6 or 8 strips are packed in a cardboard carton. The foil is printed with the name “Rennie Ice Sugar free”.
12 tablet Pocket Pack - Tablets are packed in a hard tempered aluminium foil (20pm)/clear thermoformable PVC (250pm) bubble pack, with six tablets per strip. Two strips are packed in a cardboard pocket pack.
12 tablet pack tablets are roll wrapped in laminated foil.
Pack sizes: 12, 24, 36, 48, 72, 96.
6.6 Special precautions for disposal
No special precautions necessary.
7 MARKETING AUTHORISATION HOLDER
Bayer plc, Consumer Care Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00010/0624
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/05/2009
10 DATE OF REVISION OF THE TEXT
06/07/2015