Rennie Peppermint 680/80mg Chewable Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/03/15

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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 27 March 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 27 March 2015 PIL

Reasons for updating

  • New PIL for new product

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 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 23 August 2013 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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

6.1 List of excipients

Sucrose

Glucose

Talc

Povidone

Peppermint Flavour*

Magnesium Stearate

Saccharin Sodium

 

*(oil of Mentha arvensis, levomenthol, maltodextrin, silica colloidal anhydrous (E551))

*(mint essential oil, maltodextrin, silicon dioxide E551, arabic gum)


10. DATE OF REVISION OF THE TEXT

 

April 2012August 2013

 

Updated on 12 October 2012 PIL

Reasons for updating

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

Updated on 6 July 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

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 1 May 2012 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 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

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

"272mg elemental calcium" added after " Calcium carbonate 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 excerised in the case of patients with impaired renal function. If Rennie Peppermint is to be used in these patients, plasma calcium and magnesium levels should be regularly monitored.

 

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

 

Long term uses at high doses can result in undersirable 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 insuffiency should not take Rennie Peppermint.

 

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 . . . " replaced by "No. . ."

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

Section 5.1 updated to:

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

 

ATC-Code: Calcium carbonate A02ACA1, magnesium carbonate: A02AA01

 

Rennie Peppermint 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 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:
April 2012

Updated on 27 August 2010 PIL

Reasons for updating

  • Deletion of a pack size

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 6.5:

The following sentences have been deleted:

The tablets may also be "roll-wrapped" in a laminate to give pack sizes of 12 tablets.

Three roll wraps of 12 tablets may also be packed into a blister card to contain 36 tablets.

12 pack has now been added to the following section:

 

The tablets are packed into PVC/aluminium blisters which are then placed in cardboard cartons to contain 12, 24, 48 or 96 tablets.

Updated on 14 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 statement has been revised to read:
'Children and adolescents: Not recommended for use in children and adolescents below age 18 due to a lack of sufficient data on safety or efficacy.'

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

 

Rennie Peppermint 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), this section has been updated to read as follows:


'Rennie Peppermint should not be used in the following case:

 

·       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.

 

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

 

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

 

Long term use at high doses can result in undesirable effects such as hypercalcemia, hypermagnesemia 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 and tetracyclines if taken concomitantly. If the user is taking other prescribed medicine, 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 and magnesium 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.

·       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.

·       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:

BEFORE:

Epidemiological studies show no increase in teratogenic and other hazards to the foetus if used at the recommended dosage during pregnancy. May be taken in pregnancy or during lactation, but 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 Peppermint tablets can be used during pregnancy if taken as instructed but prolonged intake of high dosages should be avoided. Rennie Peppermint tablets can be used during lactation if taken as instructed.

During pregnancy and lactation, it has to be taken into account that Rennie Peppermint 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 Peppermint 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 effects have been added:

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 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 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 1 April 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 July 2009 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 is now Bayer Ltd

Section 8: PA number is now 1410/53/1

Updated on 22 June 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 1 - Name of medicinal product

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 1: Name updated to Rennie Peppermint 680mg/80mg chewable tablets

Section 2: The following text has been added to this section:

Excipients: Each chewable tablet also contains 250mg Sucrose and 250mg Glucose.

 For a full list of excipients, see section 6.1


Section 3: (Tablet) added after 'chewable tablet'

Section 4.2: The following statement has been added:

 

 

'Children:Not recommended for use in children below age 18 due to a lack of insufficient data on safety or efficacy.'
 

 

 

 

Section 6.1: The components of the peppermint flavour are now listed here

Section 6.5: 'Not all pack sizes may be marketed' has been added here.

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 PA 21/77/1
Section 9 Date of Authorisation changed to 1st July 2005
Section 10 Date changed to 1st July 2005

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale