Rennie Sugar Free 680mg/80mg Chewable Tablets

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Summary of Product Characteristics last updated on medicines.ie: 24/3/2015
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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 24 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 24 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 IMB HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imbhpra.ie; eE-mail: imbpharmacovigilance@imb.iemedsafety@hpra.ie.

 

 

10.  DATE OF REVISION OF THE TEXT

 

April 2014March 2015

           

Updated on 23 March 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 March 2015 PIL

Reasons for updating

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

Updated on 12 June 2014 PIL

Reasons for updating

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

Updated on 15 April 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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

Update to section 4.8:
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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.

 

                        6.3       Shelf life

Blisters: 3 years
Roll-wrap: 2 years

6.5 Nature and contents of container
The tablets may also be "roll wrapped" in a laminate to give pack sizes of 12 tablets.

 

Not all pack sizes may be marketed.

10.       Date of revision of the text

           

            April 2012 April 2014

 

 

Updated on 12 October 2012 PIL

Reasons for updating

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

Updated on 8 June 2012 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

Updated on 27 April 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 2:
Decimal point removed from all weights quoted in this section. e.g. "680.0mg" changed to "680mg"

Section 4.3:
"Nephrocalcinosis" replaced by "Nephrolithiasis due to calculi containing calcium deposits"

"Severe renal failure (creatinine clearance below 30ml/min)" replaced by "Severe renal insufficiency"

Section 4.4 updated to:
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 Sugar Free is to be used in these patients, plasma calcium, phosphate and magnesium levels should be regularly monitored.

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

Long term uses at high doses can result in undersiderable 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 should not take Rennie Sugar Free.

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

Section 4.5:
"Thiazide diuretics reduce the urinary excretion of calcium and increase the serum calcium." replaced by "Thiazide diuretics reduce the urinary excretion of calcium."

". . .cardiac glycosides, e.g digoxin, resulting in decreased absorption." was updated to "cardiac glycosides, e.g digoxin, levothyroxine and eltrombopag, resulting in decreased absorption."

Section 4.6:
"Up to now, no. . ." changed to "No..." in first line of first paragraph.

"For this reason, pregnant women should strictly limit their use of Rennie Sugar Free chewable tablets to the maximum recommended daily dose . . . ." updated to include a refernce to section 4.2.
"For this reason, pregnant women should strictly limit their use of Rennie Sugar Free chewable tablets to the maximum recommended daily dose (see section 4.2). . . ."

Section 5.1 has been updated to:
Pharmacotherapeutic group: Antacids, other combinations; ATC code: A02AX
ATC-Code: Calcium carbonate A02ACA1, magnesium carbonate: A02AA01
Rennie Sugar Free 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 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 vitro, the total neutralising capacity of the product is 16mEq H+ (titration to endpoint pH 2.5).

Section 5.2 has been updated to:
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 dependent 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 text updated to March 2012

 

 

Updated on 21 June 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 8 April 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 4.2 (posology and method of administration), the maximum adult daily dose has been changed from 'sixteen' to 'eleven' tablets. In addition, the following information has also been included: 
    'Children and adolescents: Not recommended for use in children and adolescents below age 18 due to a lack of sufficient data on safety and efficacy.'

In section 4.3 (contraindications), the following changes have been made:

BEFORE: Rennie Sugar Free should not be administered to patients with:

·        Severe renal function impairment.

·        Hypercalcaemia

AFTER: Rennie Sugar Free 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

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

·         Hypophosphatemia

In section 4.4 (special warnings and precautions for use), the following changes have been made:
BEFORE:        Prolonged use should be avoided.

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

Caution should generally be exercised in the case of patients with impaired renal function. If Rennie Sugar Free is used in such patients, plasma calcium and magnesium levels should be regularly monitored.

                         

      Long term use at high doses can result in undersiderable effects such as hypercalcaemia, hypermagnesaemia and milk-alkali syndrome, especially in patients with renal insufficency.  Prolonged use possibly enhances the risk for the development of renal calculi.

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

AFTER:          Rennie Sugar Free should be used with caution in the following case:

 

·        Caution should generally be exercised in the case of patients with impaired renal function. If Rennie Sugar Free 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 Sugar Free tablets may mask a malignancy in the stomach.

 

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

Long term uses at high doses can result in undersiderable 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 should not take this medicine.

 

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

In section 4.5 (interaction with other medicinal products and other forms of interaction), the following changes have been made:
BEFORE:         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.

This product may form complexes with certain drugs, e.g. antibiotics (tetracyclines and quinolones), digoxin, and vitamins, resulting in decreased absorption.  This should be borne in mind when concomitant administration is considered.

 

                        Calcium and magnesium salts can also impede the absorption of phosphates.

Because of possible changes in the rates of absorption of concurrently administered medicines, it is recommended that antacids should not be taken concurrently with these medicines, but 1 to 2 hours later.

AFTER:           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 drugs, e.g. antibiotics (tetracyclines, quinolones), and cardiac glycosides, e.g digoxin, 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 the antacid separately from other drugs, allowing a 1-2 hours interval.

In section 4.6 (pregnancy and lactation), the following changes have been made:
BEFOREEpidemiological studies show no increase in teratogenic and other hazards to the foetus if used at the recommended dosage during pregnancy. As with all medicines it should only be taken during pregnancy or lactation when considered necessary. 

AFTER:  

Up to now, 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 hypermagnaesia can not be completely excluded.

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

During pregnancy and lactation, it has to be taken into account that Rennie Sugar Free 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 Sugar Free 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

        
In section 4.8.(Undesirable effects), the following changes have been made:
BEFORE: Very rarely hypersensitivity reactions have been reported.

AFTER         

The listed adverse drug reactions are based on spontaneous reports, thus an organization according to CIOMS III categories of frequency is not pertinent.

           

            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 hypermagnesemia or hypercalcemia and alkalosis which may give rise to gastric symptoms and muscular weakness (see below).

     

            Gastrointestinal Disorders

                        Nausea, vomiting, stomach discomfort 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.

In section 4.9 (Overdose), the following changes have been made:
BEFORE: Prolonged use at high doses may cause renal dysfunction and especially in patients already with impaired renal function, milk alkali syndrome, hypermagnesaemia, hypercalcaemia, alkalosis, nausea, vomiting, constipation or abnormal muscle weakness.
AFTER: 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), a health care professional must be consulted because other measures of rehydration (e.g. infusions) might be necessary.

Updated on 31 March 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 November 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 1 the name of the medicinal product has changed to Rennie Sugar Free 680mg / 80mg Chewable Tablets to add the tablet strength

In section 10 the date of revision has been updated to October 2009

Updated on 21 May 2009 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.3 / Section 5.1: Product Name corrected in both sections to read Rennie Sugar Free

Updated on 1 November 2006 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of 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

Section 2: Sorbitol is now stated
Section 4.3: Now states Severe renal function impairments, Hypercalcaemia, Hypersensitivity to any of the ingredients
Section 4.4: Now states caution with impaired renal funtion, long term use and avoidance with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insuffiency
Section 4.5: Now provides more info about interations.
Section 4.8: Now mentions hypersensitivity reactions have been reported
Section 4.9: More information about symptoms during overdose
Section 6.4 Protect from moisture has changed to Store in the original package
Section 9: Changed from July 2005 to February 2006
Section 10: Changed from July 2005 to August 2006

Updated on 8 August 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of 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

Section 7  MA Holder changed from Roche Products Ltd to Bayer plc
Section 8 MA Number changed to 21/77/3
Section 9 Date of Authorisation changed to 1st July 2005
Section 10 Date of revision changed to 1st July 2005

Updated on 28 July 2004 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale