RENNIE PEPPERMINT Chewable tablet (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Rennie Peppermint 680mg/80mg Chewable Tablets.
2. Qualitative and quantitative composition
<u>Each tablet contains:</u> Calcium carbonate 680 mg (272 mg elemental calcium) Heavy Magnesium Carbonate 80 mg (20 mg elemental magnesium) <u>Excipients with known effect:</u> Each chewable tablet also ...
3. Pharmaceutical form
Chewable Tablet (Tablet). Creamy white square tablets with occasional slight speckling with concave surfaces engraved RENNIE on both faces with odour of peppermint.
4.1. Therapeutic indications
For the relief of stomach upset due to hyperacidity and heartburn.
4.2. Posology and method of administration
Posology Tablets to be taken orally, sucked or chewed according to the following dosage schedules. Adults One or two tablets to be sucked or chewed as required, to a maximum of eleven tablets a day and ...
4.3. Contraindications
Rennie should not be administered in the following cases: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Hypercalcaemia, hypercalciuria and/or conditions resulting ...
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 exercised in the case of patients ...
4.5. Interaction with other medicinal products and other forms of interaction
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 ...
4.6. Pregnancy and lactation
Pregnancy Animal studies do not indicate reproductive toxicity (see section 5.3). No increased risk of congenital defects has been observed after the use of calcium carbonate and magnesium carbonate during ...
4.7. Effects on ability to drive and use machines
Rennie Peppermint has no influence on the ability to drive and use machines.
4.8. Undesirable effects
The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories of frequency is not possible. <u>Immune System Disorders:</u> Hypersensitivity ...
4.9. Overdose
Especially in patients with impaired renal function, prolonged use of high doses of calcium carbonate and magnesium carbonate can result in renal insufficiency, hypermagnesaemia, hypercalcaemia and alkalosis ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antacids, other combinations <b>ATC code:</b> A02AX <b>ATC-Code:</b> Calcium carbonate A02AC01, magnesium carbonate: A02AA01 Rennie Peppermint is a combination of two ...
5.2. Pharmacokinetic properties
In the stomach, calcium carbonate and magnesium carbonate react with the acid in the gastric juice, forming water and soluble mineral salts. CaCO<sub>3</sub> + 2HCl => CaCl<sub>2</sub> + H<sub>2</sub> ...
5.3. Preclinical safety data
Preclinical studies on Rennie are not available. The available preclinical data on calcium carbonate and magnesium carbonate based on conventional studies of repeated dose toxicity, genotoxicity and or ...
6.1. List of excipients
Sucrose Glucose Talc Povidone Peppermint flavour* Magnesium stearate Saccharin sodium * (mint essential oil, maltodextrin, silicon dioxide (E551), arabic gum)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
The tablets are packed into PVC/aluminium blisters which are then placed in cardboard cartons to contain 12, 24, 36, 48, 72 or 96 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bayer Limited, 1st Floor, The Grange Offices, The Grange, Brewery Road, Stillorgan, Co. Dublin, A94 H2K7, Ireland
8. Marketing authorization number(s)
PA1410/053/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1983 Date of last renewal: 01 April 2008
10. Date of revision of the text
November 2022
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