Rennie Orange 500mg Chewable tablets

  • Name:

    Rennie Orange 500mg Chewable tablets

  • Company:
    info
  • Active Ingredients:

    Calcium Carbonate

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/07/20

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Summary of Product Characteristics last updated on medicines.ie: 23/3/2015
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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 1 July 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Change to description of what the product is used for. the layout and mandatory regulatory statements have been revised patient readability. 

Updated on 23 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 23 March 2015 PIL

Reasons for updating

  • New PIL for new product

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 REVISION OF THE TEXT

 

August 2013March 2015

 

Updated on 23 March 2015 PIL

Reasons for updating

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

Updated on 4 September 2013 SmPC

Reasons for updating

  • 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

4.4 Special warnings and precautions for use

 

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

Updated on 15 October 2012 PIL

Reasons for updating

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

Updated on 1 August 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 4 May 2012 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 1:
"Rennie Fruit" changed to "Rennie Orange"

Section 2:
"500.0mg" changed to "500mg".

("200mg elemental calcium") added after "500mg"

Section 3:
Yellow, pink and purple removed from "A square yellow, pink, purple or orange chewable tablet with rounded corners, bevelled edges and concave faces."
 
Section 4.2:
"Not recommended for children under 12" changed to "Not recommended for children under 12 years of age"

Section 4.3:
"Rennie Fruit" changed to "Rennie Orange"

"Nephrolithiasis due to calculi containing calcium deposits" replaced "Nephrocalcinosis"

"Severe renal insufficiencies" replaced "Severe renal failure (creatinine clearnce below 30ml/min)"

Section 4.4:
"Rennie Fruit should be used with caution in the following case:" changed to "Rennie Orange"

"Prolonged use should be avoided. Do not exceed the stated dose and if symptoms persist, consult your doctor.  or only partly disappear, further medical advice should be sought.after seven days, further medical advice should be sought." replaced by "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 Orange is to be used in these patients, plasma calcium and phosphate levels should be regularly monitored." changed from
"Caution should generally be exercised in the case of patients with impaired renal function. If Rennie Fruit is to be used in these patients, plasma calcium and phosphate levels should be regularly monitored."
This section was also moved from above the "prolonged use should be avoided..." paragraph above, to below it on the SPC.

"As with other antacids, Rennie Fruit tablets may mask a malignancy in the stomach" replaced by "As with other antacids, Rennie Orange tablets may mask a malignancy in the stomach"

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

replaced by "Prolonged use increases 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" replaced by "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Rennie Orange."

Section 4.5:
"Thiazide diuretics reduce the urinary excretion of calcium and increase the serum calcium. Due to an increased risk of hypercalcemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics."

replaced by "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"

". . .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.

All mentions of Rennie Fruit" were changed to "Rennie Orange"

"For this reason, pregnant women should strictly limit their use of Rennie Orange chewable tablets to the maximum recommended daily dose and avoid concomitant" changed to include see section 4.2- "For this reason, pregnant women should strictly limit their use of Rennie Orange chewable tablets to the maximum recommended daily dose (see section 4.2) and avoid concomitant"

Section 4.8:
Immune System Disorders section changed from:
"Hypersensitivity reactions including anaphylaxis have been reported" to "Hypersensitivity reactions have very rarely been reported. Clinical symptoms may include rash, urticaria, angioedema and anaphylaxis."

Skin and subcutaneous disorders section:
removed from SPC

Section 5.1 has been updated to:

Pharmacotherapeutic group: Antacid; ATC code: A02A

 

ATC-Code: Calcium carbonate A02AC01

 

Rennie Orange contains calcium carbonate as an antacid. The mode of action of calcium 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.

Section 5.2 has been updated to:

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

 

CaCO3   +              2 HCl                                 CaCl2                     +              H2O        +              CO2

 

Calcium can be absorbed from these soluble salts. However, the degree of absorption depends on the subject and the dose. Less than 10% of calcium is absorbed.

 

The small quantities of calcium absorbed are usually excreted rapidly via the kidneys in healthy individuals. In the case of impaired renal function, plasma concentration of calcium 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 6.1 has been updated to:

6.1 List of excipients

Sucrose

Potato starch

Pregelatinised maize starch

Magnesium stearate

Talc

Citric acid anhydrous

Orange flavour

Quinoline yellow (E104)

Ponceau 4R (E124)

Saccharin.

Section 6.4:

"Store in the original package in order to protect from moisture." added after "Do not store above 25oC"

Section 10:
Date of revision of text updated to March 2012

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 24 February 2012 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

In Section 1, Rennie Fruit Flavoured 500mg Chewable tablets was changed to Rennie Orange 500mg Chewable Tablets.

In Section 3, the words 'yellow, pink, purple or' were deleted.

In Section 4.3, Rennie Fruit was changed to Rennie Orange.

In Section 4.4, Rennie Fruit was changed to Rennie Orange.

In Section 4.6, Rennie Fruit was changed to Rennie Orange.

In Section 6.1, Lemon flavour, raspberry flavour and blackcurrent flavour were deleted.

In Section 6.4, the sentence 'Store in the original package in order to protect from moisture.' was added.

     

Updated on 23 February 2012 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Change to product name

Updated on 16 June 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 1 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
  • Change to section 5.1 - Pharmacodynamic properties

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 allowed total daily dose for an adult has been changed from 'sixteen' to 'eleven' tablets.

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

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

AFTER: 'Rennie Fruit should not be administered in the following cases:

 

·       Hypersensitivity to any of the ingredients of the product

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

 

·       Nephrocalcinosis

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

·       Hypophosphatemia'

In section 4.4 (Special warnings and precautions for use), the following changes have been made:

BEFORE: 'Do not exceed the stated dose. If symptoms persist consult your doctor.'

AFTER:
'Rennie Fruit 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 Fruit is to be used in these patients, plasma calcium and phosphate levels should be regularly monitored.

 

Prolonged use should be avoided. Do not exceed the stated dose and if symptoms persist, consult your doctor.

 

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

Long term use at high doses can result in undesirable effects such as hypercalcemia 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 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: 'Antacids may impair the absorption of other drugs, including antibiotics digoxin and tetracyclines if taken concomitantly. If the user is taking other prescribed medicines, professional advice should be sought before taking this product.'

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 may form complexes with certain substances, 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.

·       Calcium salts can also impede the absorption of phosphates, fluorides, and iron containing products.

·       Thiazide diuretics reduce the urinary excretion of calcium and increase the serum calcium. Due to an increased risk of hypercalcemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

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:

BEFORE: 'Epidemiological studies show no increase in teratogenic and other hazards to the foetus if used at the recommended dose during pregnancy. May be taken during pregnancy or lactation, but as with all medicines it should only be taken during pregnancy or during 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 Fruit tablets can be used during pregnancy if taken as instructed but prolonged intake of high dosages should be avoided. Rennie Fruit tablets can be used during lactation if taken as instructed.

During pregnancy and lactation, it has to be taken into account that Rennie Fruit 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 Fruit 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: 'No side effects have been reported at the recommended dose.'

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

 

 

Immune System Disorders

Hypersensitivity reactions including anaphylaxis have been reported.

 

Metabolism and Nutrition Disorders

Especially in patients with impaired renal function, prolonged use of high doses can result in 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.

 

Skin and Subcutaneous Disorders

Rash, urticaria, and angioedema in context of hypersensitive reactions

 

Undesirable effects only 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.'

In section 4.9 (overdose), the following changes have been made:

BEFORE:  'Milk alkali syndrome, (which may include hypercalcaemia and alkalosis), or constipation or renal dysfunction may occur at high dosages.'

AFTER: 'Especially in patients with impaired renal function, prolonged use of high doses of calcium carbonate can result in renal insufficiency, 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.'
 
In section 5.1 (pharmacodynamic properties), the ATC-code has been changed to 'ATC A02 AC01'




 

 

 

 

 

 

 

Updated on 29 March 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 November 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 1 Name of the medicinal product changed to

Rennie Fruit Flavoured 500mg Chewable Tablets

Updated on 1 September 2009 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 7: MA holder is now Bayer Ltd
Section 8: MA number is now 1410/54/1

Updated on 30 November 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale