RENNIE PEPPERMINT Chewable tablet Ref.[50561] Active ingredients: Calcium carbonate Magnesium carbonate

Prolonged use should be avoided. Do not exceed the stated dose and if symptoms persist after seven days further medical advice should be sought.

Caution should generally be exercised in the case of patients with impaired renal function. If Rennie Peppermint is to be used in these patients, plasma calcium, phosphate and magnesium levels should be regularly monitored.

As with other antacids, Rennie Peppermint tablets may mask a malignancy in the stomach. Long term use at high doses can result in undesirable effects such as hypercalcaemia, hypermagnesaemia and milk-alkali syndrome, especially in patients with renal insufficiency.The product should not be taken with large amounts of milk or dairy products.

Prolonged use possibly enhances the risk for the development of kidney stones.

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

Magnesium salts may cause central nervous system depression in the presence of renal insufficiency.

Changes in gastric acidity, e.g. during treatment with antacids, may impair the rate and degree of absorption of other drugs, if taken concomitantly.

• It has been shown that antacids containing calcium and magnesium may form complexes with certain substances, e.g. antibiotics (tetracyclines, quinolones), cardiac glycosides, e.g. digoxin, bisphosphonates, dolutegravir, levothyroxine and eltrombopag, resulting in decreased absorption. This should be borne in mind when concomitant administration is considered.
• 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.
• Calcium and magnesium salts can also impede the absorption of phosphates, fluorides, and iron containing products. Therefore it is preferable to administer the antacid separately from other drugs, allowing a 1-2 hours interval.

Pregnancy

Animal studies do not indicate reproductive toxicity (see section 5.3).

No increased risk of congenital defects has been observed after the use of calcium carbonate and magnesium carbonate during pregnancy. In case of high or prolonged doses or renal insufficiency, the risk for hypercalcaemia and/or hypermagnesaemia can not be completely excluded. Rennie Peppermint tablets can be used during pregnancy if taken as instructed The maximum recommended daily dose should not be exceeded and should not be taken for more than 2 weeks (see section 4.2).

In order to prevent calcium overload, pregnant women should avoid concomitant excessive intake of milk and dairy products.

Breastfeeding

Calcium and magnesium are excreted in human milk, but at therapeutic doses of Rennie no effects on the breastfed newborns/infants are anticipated.

Rennie Peppermint tablets can be used during breastfeeding if taken as instructed.

Fertility

There is no known evidence suggestive that at recommended dose Rennie has adverse effects on human fertility.

Rennie Peppermint has no influence on the ability to drive and use machines.

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, pruritus, angioedema, dyspnea 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

Gastrointestinal Disorders: Nausea, vomiting, stomach discomfort, constipation and diarrhea may occur.

Musculoskeletal and Connective Tissue Disorders: Muscular weakness may occur.

Undesirable effects only occurring in the context of milk-alkali syndrome (see section 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 HPRA Pharmacovigilance, Website: www.hpra.ie.

Not applicable.