Rennie Spearmint 680mg / 80mg Chewable Tablets

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

 

 

4.4 Special warnings and precautions for use

 

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 Spearmint is to be used in these patients, plasma calcium, phosphate and magnesium levels should be regularly monitored.

10. DATE OF REVISION OF THE TEXT

 

April 2012August 2013

 

 

Section 2:
Decimal point removed from all weights quoted in this section. e.g. "680.0 mg" was 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 excerised in the case of patients with impaired renal function. If Rennie Spearmint 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 Spearmint.

 

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 Spearmint 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 Spearmint 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 Spearmint 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:
Date of revision of text updated to March 2012

Section 6.5

The folliowing 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.

And 12 pack has been added to the following:

 

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



In section 4.2 (posology and method of administration), the maximum allowable daily dose has been reduced from ‘sixteen’ to ‘eleven’ tablets daily.

 

In addition, the following has been included in this section:

 

‘Children and adolescents: Not recommended for use in children and adolescents below age 18 due to lack of sufficient data on safety and efficacy’

 

The following changes have been made to section 4.3 (contraindications):

 

BEFORE:

‘Rennie Spearmint should not be administered to patients with:

 

·        Severe renal function impairment

·        Hypercalcaemia

·        Hypersensitivity to the active ingredients or any of the excipients, refer to section 6.1.’

 

AFTER:

Rennie Spearmint 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 30 ml/min)

·         Hypophosphatemia

 

 

Section 4.4 (special warnings and precautions for use) has been updated to read as follows:

 

BEFORE:

‘Prolonged use should be avoided.

 

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

 

Caution should generally be excerised in the case of patients with impaired renal function. If Rennie Spearmint is used in such patients, plasma calcium and magnesium levels should be regularly monitered.

 

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 sucrase-isomaltase insuffiency should not take this medicine.’

 

AFTER:

‘Rennie Spearmint should be used with caution in the following case:

 

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

 

Prolonged use should be avoided.

 

As with other antacids, Rennie Spearmint 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 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 this medicine.

 

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

 

 

In section 4.5 (interactions with other medicinal products and other forms of interactions), 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 substances, e.g. antibiotics (tetracyclines, quinolines), 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 Rennie Spearmint separately from other drugs, allowing a 1-2 hours interval.’

 

Section 4.6 (pregnancy and lactation) has been updated to read as follows:

BEFORE:

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

During pregnancy and lactation, it has to be taken into account that Rennie Spearmint 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 Spearmint 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 hypercalcaemia and alkalosis which may give rise to gastric symptoms and muscular weakness (see below).

 

Gastrointestinal Disorders

Nausea, vomiting, stomach discomfort and diarrhoea 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.’

 

 

Section 4.9 (overdose) has been updated to read as follows:

 

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.’

In section 1 the name of the medicinal product has been changed to Rennie Spearmint 680mg / 80mg Chewable Tablets to include the strength of the medicinal product.

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