Rennie ICE 680/80mg chewable tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/07/17

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Summary of Product Characteristics last updated on medicines.ie: 18/8/2017
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Bayer Limited

Bayer Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 18 August 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

  • In section 2 (qualitative and quantitative composition), the phrase 'Excipient' has been updated to 'Excipient(s) with known effect'
  • In section 4.3 (contraindications), the sentence 'Hypersensitivity to any of the ingredients of the product, refer to section 6.1.' has been updated to 'Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.'
  • In section 5.1 (pharmacodynamics properties), the ATC code for Calcium carbonate has been corrected from 'A01ACA1' to 'A01AC01'.
  • Date of renewal has been added to section 9

Updated on 31 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Improved presentation of PIL

Updated on 23 March 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

4.8 Undesirable effects

 

 

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, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

 

10. DATE OF (PARTIAL) REVISION OF THE TEXT

 

May 2013March 2015

Updated on 20 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 27 June 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 25 June 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Red text = deleted text

Blue text = inserted text

 

Section 2: Qualitative and Quantitative Composition

Each chewable tablet contains:

 

Calcium carbonate                              680.0  mg (272 mg elemental calcium)

Heavy Magnesium Carbonate             80.0  mg

 

Excipient:

Sucrose                                                475.0  mg

 

For full list of excipients, see section 6.1

 

Section 4.3: Contra-indications

Rennie ICE should not be administered in the following cases:

 

·         Hypersensitivity to any of the ingredients of the product, refer to section 6.1.

 

·         Hypercalcaemia, hypercalciuria and/or conditions resulting in hypercalcaemia e.g sarcoidosis

 

·         Nephrocalcinosis Nephrolithiasis due to calculi containing calcium deposits

·         Severe renal failure (creatinine clearance below 30 ml/min) insufficiency

·         Hypophosphatemia

 

 

Section 4.4: Special warnings and special precautions for use

Prolonged use should be avoided. Do not exceed the stated dose and if symptoms persist, after 7 days, further medical advice should be sought.

 

Rennie ICE should be used with caution in the following cases:

 

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

 

Prolonged use should be avoided.

 

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

 

Do not exceed the stated dose and if symptoms persist after 7 days consult your doctor.

 

Long term uses at high doses can result in undesirable effects such as hypercalcaemia, hypermagnesaemia and milk-alkali syndrome, especially in patients with renal insufficency.  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 this medicine Rennie ICE.

 

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

Section 4.5: Interactions with other medicinal products and other forms of interactions

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, quinoloines), and cardiac glycosides, e.g. digoxin, 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 and increase the serum 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 Rennie ICE separately from other drugs, allowing a 1-2 hours interval.

 

Section 4.6: Fertility, pregnancy and lactation

Up to now, Nno 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 hypermagnaesaemia can not be completely excluded. Rennie ICE tablets can be used during pregnancy if taken as instructed but prolonged intake of high dosages should be avoided. Rennie ICE tablets can be used during lactation if taken as instructed.

 

During pregnancy and lactation, it has to be taken into account that Rennie ICE 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 ICE chewable tablets to the maximum recommended daily dose (see section 4.2) and avoid concomitant, excessive intake of milk and dairy products. This warning is to prevent calcium overload which might result in milk alkali syndrome.

 

Section 4.8: Undesirable effects

The following sentence was displayed in bold formal:

Undesirable effects only occurring in the context of milk-alkali syndrome (see Section 4.9):”

5.1 Pharmacodynamic properties

 

ATC code:

 

Magnesium carbonate: A02AA01

Calcium carbonate:  A02AC01

 

Calcium carbonate and magnesium carbonate:

Calcium and magnesium carbonates function as antacids reacting with excess hydrochloric acid in the gastric medium to produce soluble chlorides.

CaCO3 + 2HCl => CaCl2 + H2O + CO2

MgCO3 + 2HCl => MgCl2 + H2O + CO2

 

Each Rennie ICE tablet neutralises 15.5 mEq H+

 

Pharmacotherapeutic group: Antacids, other combinations; ATC Code: A02AX

 

ATC Code: Calcium carbonate A01ACA1, magnesium carbonate: A02AA01

 

Rennie ICE is a combination of two antacids, calcium carbonate and magnesium carbonate. The mode of action of calcium carbonate & magnesium carbonate is local, based on the neutralisation of gastric acid, and is not dependant on systemic absorption. Calcium carbonate has a rapid, long lasting and powerful neutralising action. This effect is increased by the addition magnesium carbonate which also has a strong neutralising action. In vitro, the total neutralising capacity of the product is 15.5 mEq H+ (titration to endpoint pH 2.5)

 

5.2 Pharmacokinetic properties

 

Calcium carbonate and magnesium carbonate:

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.

 

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

 

CaCO3 + 2HCl => CaCl2 + H2O + CO2

MgCO3 + 2HCl => MgCl2 + H2O + CO2

 

Calcium and magnesium can be absorbed from these soluble salts. However, the degree of absorption is dependant on the subject and the dose. Less than 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, plasma concentrations of calcium and magnesium may be increased.

 

Due to the effects 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.

 

 

Section 10: Date of revision of the text:

December 2012 May 2013

Updated on 10 January 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 6.3

Has been updated from 2 years to 3 years

Updated on 15 October 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 7 July 2011 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 July 2011 PIL

Reasons for updating

  • New PIL for new product