The Refreshing Flavor of Rennie Peppermint

This information is intended for professional use within the healthcare field.

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Calcium Carbonate

Dosage: 680.0 mg

Heavy Magnesium Carbonate

Dosage: 80.0 mg

Active Ingredients:

- Glucose: 250mg per tablet

- Sucrose: 250mg per tablet

For a complete list of active ingredients, please refer to section 6.1.

Chewable Tablets

These tablets are square in shape with rounded corners, bevelled edges, and concave faces. They are cream white in color and engraved with the word 'Rennie' on both sides.

Indications:

These tablets are designed to relieve symptoms of indigestion, heartburn, nervous indigestion, hyperacidity, flatulence, upset stomach, dyspepsia, biliousness, overindulgence in food and drink, and indigestion during pregnancy.

Dosage Instructions:

These tablets should be taken orally, either by sucking or chewing.

For Adults and Children over 12 years:

Take two tablets as a single dose. It is recommended to take the tablets one hour after meals and before going to bed. Additionally, they can be taken in between meals if experiencing heartburn or gastric pain. The maximum daily dose should not exceed 8 g of calcium carbonate, which is equivalent to 10 tablets a day.

Not recommended for children under 12 years of age.

If symptoms persist after 14 days of continuous use, it is strongly advised to seek further medical evaluation to rule out any underlying conditions.

Do not administer Rennie to patients with:

- Hypersensitivity to any of the ingredients

- Hypercalcaemia and/or conditions resulting in hypercalcaemia

- Nephrolithiasis due to calculi containing calcium deposits

- Severe renal insufficiency

- Hypophosphataemia

It is important to avoid prolonged use of Rennie. The recommended dose should not be exceeded. If symptoms persist after 14 days of treatment or only partially disappear, patients should consult a doctor. Caution should be exercised in patients with mild to moderate impairment of renal function, and regular monitoring of plasma calcium, phosphate, and magnesium levels is advisable.

Long-term use at high doses may lead to potential adverse effects such as hypercalcaemia, hypermagnesaemia, and milk-alkali syndrome, especially in patients with renal insufficiency.

Rennie should not be used in patients with hypercalciuria as it increases the risk of renal calculi formation. Additionally, this product should not be consumed with large amounts of milk or dairy products.

Patients with rare hereditary conditions of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medication.

Please note that changes in gastric acidity caused by the use of antacids can affect the absorption of certain concurrently administered medications.

It has been observed that antacids containing calcium or magnesium may form complexes with certain substances, such as antibiotics (including tetracyclines and quinolones), cardiac glycosides (e.g. digoxin), bisphosphonates, dolutegravir, levothyroxine, and eltrombopag, leading to decreased absorption. Please consider this when considering concomitant administration.

• The absorption of fluorides and iron-containing products is reduced by calcium salts, and both calcium salts and magnesium salts can impede the absorption of phosphates.

• Calcium excretion in urine is decreased by thiazide diuretics. To monitor for hypercalcemia, it is recommended to regularly check serum calcium levels when using thiazide diuretics concurrently.

To ensure optimal efficacy, it is advisable to take antacids separately from other medications. Allow at least 4 hours before or after taking eltrombopag and a 1-2 hour interval for all other drugs.

Pregnancy

Studies on animals indicate no direct or indirect harmful effects in terms of reproductive toxicity.

There is no increased risk of congenital defects when using this product during pregnancy.

If taken as instructed, this medication can be used during pregnancy.

The maximum daily dose recommended should not be exceeded and should not be taken for more than 2 weeks. If symptoms persist or only partially improve after 2 weeks, it is advised to seek medical advice.

To prevent excessive calcium intake, pregnant women should avoid consuming milk and dairy products in excess (1 liter of milk contains up to 1.2 g of elemental calcium).

Breastfeeding

Calcium and magnesium are present in breast milk, but therapeutic doses of this product are not expected to have any effects on breastfed newborns/infants.

This medication can be used during breastfeeding.

Fertility

There is no known evidence suggesting that this medication has adverse effects on human fertility when taken at recommended doses.

There have been no observed effects on the ability to drive or operate machinery.

The reported adverse drug reactions are based on spontaneous reports, so it is not possible to categorize them according to CIOMS III frequency categories.

Disorders of the Immune System:

Hypersensitivity reactions have been very rarely reported. Clinical symptoms may include rash, urticaria, itching, swelling, difficulty breathing, and anaphylaxis.

Disorders of Metabolism and Nutrition:

Prolonged use of high doses, especially in patients with impaired renal function, can lead to hypermagnesemia, hypercalcemia, alkalosis, and the consequent occurrence of gastrointestinal symptoms and muscular weakness (see below).

Gastrointestinal Disorders:

Nausea, vomiting, stomach discomfort, constipation, and diarrhea may be experienced.

Disorders of the Musculoskeletal System and Connective Tissue:

Muscular weakness may occur.

Undesirable effects associated with milk-alkali syndrome (see section 4.9):

Gastrointestinal Disorders:

Ageusia may occur in the context of milk-alkali syndrome.

General Disorders and Conditions at the Site of Administration:

Calcifications and asthenia may occur in the context of milk-alkali syndrome.

Disorders of the Nervous System:

Headaches may occur in the context of milk-alkali syndrome.

Disorders of the Renal and Urinary Systems:

Azotemia may occur in the context of milk-alkali syndrome.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after the authorization of the medicinal product is important. It enables continued monitoring of the balance between benefits and risks of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

Prolonged use of high doses of calcium carbonate and magnesium carbonate in patients with impaired renal function can lead to renal insufficiency, hypermagnesemia, hypercalcemia, and alkalosis, resulting in gastrointestinal symptoms (nausea, vomiting, constipation) and muscular weakness. In such cases, the intake of the product should be discontinued and sufficient fluid intake should be encouraged. In severe cases of overdosage (e.g. milk-alkali syndrome), consultation with a healthcare professional is necessary as additional rehydration measures (e.g. infusions) may be required.

Pharmacotherapeutic Classification: Antacids

ATC codes:

Calcium carbonate: A02AC01

Magnesium carbonate: A02AA01

The gastric medium reacts with calcium carbonate and magnesium carbonate to produce soluble chlorides, thereby neutralizing excess acid.

CaCO3 2HCl => CaCl2 H2O CO2

MgCO3 2HCl => MgCl2 H2O CO2

Calcium carbonate is known for its rapid and potent neutralizing effect. When combined with magnesium carbonate, the neutralizing action becomes even stronger.

In vitro studies using an artificial stomach model demonstrated that Rennie increases the pH of the stomach from pH 1.5-2 to pH 3 in just 40 seconds. It is also capable of reaching pH 4 in 1 minute and 13 seconds. The maximum pH achieved in the model was pH 5.24.

In healthy volunteers, there was a significant increase in the pH of stomach contents compared to baseline pH between 1 and 6 minutes after administration.

A small amount of calcium and magnesium may be absorbed, but in healthy individuals, it is typically excreted quickly by the kidneys.

The soluble chlorides formed by the reaction of calcium and magnesium with gastric acid then interact with intestinal, biliary, and pancreatic secretions to form insoluble salts that are eliminated in the feces.

No preclinical studies are available for this medication. However, previous research on calcium carbonate and magnesium carbonate, including studies on repeated dose toxicity, genotoxicity, carcinogenic potential, and reproductive toxicity, did not indicate any specific hazards at therapeutic doses for humans.

The tablets contain the following ingredients:

- Sucrose

- Glucose

- Talc

- Polyvidone (Povidone)

- Peppermint Flavour 870652 (mint essential oil, maltodextrin, silicon dioxide, arabic gum)

- Magnesium Stearate

- Saccharin Sodium

Store the medication below 25°C and in its original package.

The tablets are packed in a hard-tempered aluminum foil (20µm) / clear thermoformable PVC (150µm) bubble pack, with six or twelve tablets per strip. The strips are then packed in a cardboard carton, with options of 1, 2, 3, 4, 8, 10, or 12 strips.

For the 12 tablet Pocket Pack, the tablets are packed in a hard-tempered aluminum foil (20µm) / clear thermoformable PVC (250µm) bubble pack, with six tablets per strip. Two strips are packed in a cardboard pocket pack.

For the 12 tablet pack, the tablets are roll wrapped in laminated foil, consisting of an external layer of aluminum foil (7µm), followed by layers of polythene (12gsm), bleached kraft paper (37gsm), and polythene (12gsm).

Alternatively, 3 roll wraps of 12 tablets can be packed into a blister card, resulting in a total of 36 tablets.

The medication is available in pack sizes of 6, 12, 24, 36, 48, 72, 96, 120, or 144 tablets.

Manufactured by Bayer plc.

400 South Oak Way

Reading

RG2 6AD

Transformation:

400 Oak Street South

Reading, RG2 6AD

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