Rennie Orange 500mg Chewable Tablets

change of word text version to print proof pdf

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

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

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'

Rennie Fruit Flavoured 500mg Chewable Tablets