Bayer Limited

Rennie Dual Action Chewable Tablets

Calcium carbonate 625mg

Magnesium carbonate 73.5mg

Alginic acid 150mg

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 dextrates, sucrose (230 mg) and glucose (555.22 mg).

For a full list of excipients, see section 6.1.

Chewable tablet

Off white, speckled circular tablet, flat on both sides with a bevelled edge.

Symptomatic treatment of complaints resulting from gastro-oesophageal reflux and hyperacidity, such as regurgitation and heartburn.

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 of 2 tablets can also be taken in between in the case of heartburn. Do not take more than 12 tablets in any 24-hour period. Only for use by adults and children over 12 years of age.

As with all antacids, if symptoms persist in spite of therapy, diagnostic measures are strongly recommended in order to rule out a more serious disease.

For Special warning and precautions for use please also see section 4.4.

• 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.

Prolonged use should be avoided.

If the symptoms persist or only partly disappear, further medical advice should be sought.

As with other antacids, Rennie Dual Action tablets may mask a malignancy in the stomach.

Rennie Dual Action tablets should not be used in the following cases:

• Hypercalciuria

• In general, caution should be exercised in patients with impaired renal function.

• If Rennie Dual Action tablets are used in such patients, plasma concentrations of calcium, phosphate and magnesium should be monitored regularly.

In general calcium containing antacids should be carefully administered in patients with constipation, haemorrhoids and sarcoidosis.

Prolonged use of high doses may result in undesirable side-effects such as hypercalcaemia, magnesaemia and the milk alkali syndrome, particularly in patients suffering from renal insufficiency. The product should not be taken with large amounts of milk or dairy products.

Prolonged use increases the risk of formation of renal calculi.

In the literature a possible relationship between calcium carbonate and appendicitis, gastrointestinal haemorrhage, intestinal blockage, or oedema has been reported in single cases.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

If symptoms persist after seven days, the clinical situation should be reviewed by a healthcare professional.

Changes in the level of acidity of gastric juice such as those caused by taking antacids may affect the degree and speed of absorption of medicines administered concomitantly. It has been shown that antacids containing calcium and magnesium can hinder the absorption of some antibiotics (such as the tetracyclines and quinolones) and cardiac glycosides (e.g. digoxin, digitoxin).

Calcium salts reduce the absorption of fluoride.

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Calcium salts and magnesium salts can hinder the absorption of phosphates.

In view of possible changes in the rate of absorption of medicines taken concomitantly, it is recommended that antacids are not administered at the same time as other medicines but taken 1 to 2 hours later.

Effects on laboratory parameters:

The administration of antacids may interfere with physiologic values/analytics: urinary system pH may increase while serum concentration of phosphates and potassium may decrease with excessive and prolonged use.

Up to now, no increased risk of congenital defects has been observed after the use of calcium carbonate, magnesium carbonate and alginic acid during pregnancy. In case of high or prolonged doses or renal insufficiency, the risk for hypercalcaemia and/or hypermagnaesia can not be completely excluded.

Rennie Dual Action tablets can be used during pregnancy if taken as instructed but prolonged intake of high dosages should be avoided. Rennie Dual Action tablets can be used during lactation if taken as instructed.

During pregnancy and lactation, it has to be taken into account that Rennie Dual Action tablets provide a substantial amount of calcium in addition to dietary calcium intake. For this reason, pregnant women should strictly limit their use of Rennie Dual Action chewable 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.

Rennie Dual Action tablets are not expected to affect these functions.

Skin and subcutaneous tissue disorders:

Rarely, hypersensitivity reactions, including Quincke oedema and anaphylactic shock, have been reported.

Metabolism and nutrition disorders:

Prolonged use of high doses may possibly result in hypermagnesaemia or hypercalcaemia and alkalosis (GI symptoms such as nausea and vomiting, fatigue, confusion, polyuria, polydypsia, dehydration), particularly in patients with impaired renal function. Prolonged use of high doses of calcium carbonate with milk may lead to Burnett syndrome (milk-alkali syndrome).

Gastrointestinal disorders:

Although magnesium compounds may have a laxative effect, the low magnesium content in Rennie Dual Action tablets is not expected to result in undesirable effects in view of the recommended dose.

Especially in patients with impaired renal function, prolonged use of high doses of calcium carbonate and magnesium carbonate can result in renal insufficiency, hypermagnesemia, hypercalcemia 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) other measures of rehydration (e.g. infusions) might be necessary.

Pharmacotherapeutic group: Antacids, other combinations, ATC code: AO2 AX

Rennie Dual Action tablets are a combination of two antacids (calcium carbonate and magnesium carbonate) and an alginic acid.

The mode of action of Rennie Dual Action tablets is local and is not dependent on systemic absorption.

Calcium carbonate has a rapid, long-lasting 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 was achieved within 2 minutes. The total neutralising capacity of two tablets of the product is 29 mEq/H+(titration to end-point pH 2.5). Apart from the neutralising action of the antacids, the alginic acid present in Rennie Dual Action tablets cause a viscous gel to be formed which floats on the stomach contents and acts as a physical barrier against reflux.

Calcium and magnesium

In the stomach: calcium carbonate and magnesium carbonate react with the acid in the gastric juice, forming soluble salts.

Calcium and magnesium can be absorbed from these (soluble) salts.

However, the degree of absorption is dependent on the patient and the dose. Approx. 10% calcium and 15-20% magnesium is absorbed.

The small quantities of calcium and magnesium absorbed are usually excreted rapidly via the kidneys in healthy individuals. In the case of impaired renal function, serum concentrations of calcium and magnesium may be increased.

Due to the effect of various digestive juices outside the stomach, the soluble salts are converted to insoluble salts in the intestinal canal and then excreted with the faeces.

Alginic acid

After oral ingestion, alginic acid is not converted in the gastro-intestinal tract; 80-100% of the quantity ingested is excreted. Absorption of alginic salts is negligible.

Not applicable.

Sodium hydrogen carbonate

Sucrose

Glucose monohydrate

Povidone

Talc

Magnesium stearate

Dextrates

Lemon cream flavour (primarily composed of lemon oil, lime oil, orange oil, l-menthole, vanilline, maltodextrin, gum arabic, ascorbic acid, butylhydroxyanisol)

Peppermint flavour (primarily composed of peppermint oil, maltodextrin, gum arabic, silicon dioxide)

Saccharin sodium.

Not applicable.

3 years

Do not store above 30^oC. Store in the original package in order to protect from moisture.

Strips consisting of LDPE/Aluminium foil.

Pack-sizes 12, 18, 24, 30 & 36 tablets.

Not all pack sizes may be marketed.

No special requirements.

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

PA 1410/52/3

6^th February 2009

March 2010