Ms. Peppermint, Rennie

This information is intended for health professionals only.

Excipients with known effects include:

• Each tablet contains 250mg of glucose.

• 250mg Sucrose per tablet

Section 6 contains a complete list of excipients. 1

Tablets that can be chewed

A square cream white tablet with rounded corners, bevelled edges, and concave faces engraved on both sides with 'Rennie.'

Indigestion, heartburn, nervous indigestion, hyperacidity, flatulence, upset stomach, dyspepsia, biliousness, overindulgence in food and drink, pregnancy indigestion

Posology:

Tablets to be swallowed, sucked, or chewed

Adults and children over the age of 12:

Two tablets to be sucked or chewed as a single dose, preferably one hour after meals and before going to bed, but also in between in case of heartburn or gastric pain. A daily dose of 8 g calcium carbonate, equivalent to 10 tablets, is not to be exceeded.

Children

Children under the age of 12 are not advised to use this product.

If symptoms persist despite 14 days of continuous therapy, as with all antacids, diagnostic measures are strongly advised to rule out a more serious disease.

Rennie should not be given to patients who have:

• Hypersensitivity to the product's ingredients

• Hypercalcaemia and/or hypercalcaemia-causing conditions

• Nephrolithiasis caused by calculi containing calcium deposits

• End-stage renal failure

• Hypophosphatasia

• Excessive use should be avoided.

• The recommended dose should not be exceeded. If symptoms persist or only partially disappear after 14 days of treatment, the patient should see a doctor.

• Caution should be used in patients with mild to moderate renal impairment (see section 4). 3 - contraindication in severe renal failure) If Rennie is used in such patients, plasma calcium, phosphate, and magnesium levels should be monitored on a regular basis.

• Long-term use at high doses can cause adverse effects such as hypercalcaemia, hypermagnesaemia, and milk-alkali syndrome, particularly in patients with renal insufficiency.

• Rennie should not be used in hypercalciuric patients (see also section 4). 3) Prolonged use increases the risk of renal calculi formation.

• Avoid taking this product with large amounts of milk or dairy products.

• Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not use this medication.

Changes in gastric acidity, such as those caused by antacid use, can impact the rate and extent to which some concurrently administered medications are absorbed.

• It has been demonstrated that antacids containing calcium or magnesium can form complexes with certain substances e.g. g antibiotics (tetracyclines and quinolones, for example) and cardiac glycosides (e.g. g Digoxin), bisphosphonates, dolutegravir, levothyroxine, and eltrombopag, all of which cause decreased absorption. This should be kept in mind when considering concomitant administration.

• Calcium salts inhibit the absorption of fluorides and iron-containing products, and calcium salts and magnesium salts can inhibit the absorption of phosphates.

• Thiazide diuretics reduce calcium excretion in the urine. Because of the increased risk of hypercalcaemia with thiazide diuretics, serum calcium should be monitored on a regular basis.

As a result, it is preferable to take the antacid separately from other medications, allowing at least 4 hours before or after taking eltrombopag and 1-2 hours for all other medications.

Pregnancy

Animal studies show no evidence of either direct or indirect reproductive toxicity.

There has been no increase in the risk of congenital defects as a result of using this product during pregnancy.

If used as directed, this medication can be used during pregnancy.

The maximum daily dose should not be exceeded and should not be taken for more than two weeks. If symptoms persist or only partially disappear after two weeks, seek medical attention.

To avoid calcium overload, pregnant women should limit their intake of milk and dairy products (1 litre of milk contains up to 1 gram of calcium). 2 g calcium ion)

Breastfeeding

Although calcium and magnesium are excreted in human milk, no adverse effects on breastfed newborns/infants are expected at therapeutic doses of the product.

This medication is safe to take while breastfeeding.

Fertility

There is no evidence that this medicine has an adverse effect on human fertility when taken at the recommended dose.

There have been no reported effects on ability to drive or use machines.

Because the listed adverse drug reactions are based on spontaneous reports, an organization based on CIOMS III frequency categories is not possible.

Immune System Issues:

Hypersensitivity reactions are extremely rare. Rash, urticaria, pruritus, angioedema, difficulty breathing, and anaphylaxis are some of the clinical symptoms.

Disorders of Metabolism and Nutrition:

Prolonged use of high doses, particularly in patients with impaired renal function, can result in hypermagnesaemia, hypercalcaemia, and alkalosis, which can cause gastric symptoms and muscular weakness (see below).

Disorders of the Gastrointestinal Tract:

Nausea, vomiting, stomach discomfort, constipation, and diarrhoea are all possible side effects.

Disorders of the Musculoskeletal System and Connective Tissues:

Muscular weakness is possible.

Unwanted effects that occur in the context of milk-alkali syndrome (see section 4). 9)

Disorders of the Gastrointestinal Tract:

Ageusia can occur as a result of milk-alkali syndrome.

General Disorders and Site Conditions:

Calcinosis and asthenia are possible complications of milk-alkali syndrome.

Disorders of the Nervous System

Headache may occur as a result of milk-alkali syndrome.

Urinary and Renal Disorders:

Azotemia can occur as a result of the milk-alkali syndrome.

Adverse reaction reporting

It is critical to report suspected adverse reactions after the medicinal product has been approved. It enables continuous monitoring of the medicinal product's benefit/risk balance. Healthcare providers are encouraged to report any suspected adverse reactions to the Yellow Card Scheme at: www. mhra gov uk/yellowcard, or in the Google Play or Apple App Store, search for MHRA Yellow Card.

Prolonged use of high doses of calcium carbonate and magnesium carbonate, particularly in patients with impaired renal function, can result in renal insufficiency, hypermagnesaemia, hypercalcaemia, and alkalosis, which can cause gastrointestinal symptoms (nausea, vomiting, constipation), and muscular weakness. In these cases, the product should be discontinued and adequate fluid intake encouraged. In extreme cases of overdosage (e.g. g Because other methods of rehydration (e.g., milk-alkali syndrome) are ineffective, a health care professional should be consulted. g infusions) may be required.

Antacids Pharmacotherapeutic Classification

In the gastric medium, calcium and magnesium carbonates react with excess acid to produce soluble chlorides.

CaCO3 2HCl => CaCl2 H2O CO2

MgCO3 2HCl -> MgCl2 H2O CO2

Calcium carbonate has a quick and effective neutralizing action. The addition of magnesium carbonate, which also has a strong neutralizing effect, enhances this effect.

In vitro acid neutralisation studies (artificial stomach model) revealed that Rennie raises stomach pH from pH 1 to pH 3. 5-2 to pH 3 in 40 seconds and pH 4 in 1 minute and 13 seconds The model's maximum pH was 5. 24

A significant increase in the pH of stomach contents above baseline pH was achieved in healthy volunteers between 1 and 6 minutes after dosing.

A small amount of calcium and magnesium may be absorbed, but it is usually quickly excreted by the kidney in healthy subjects.

The soluble chlorides formed when calcium and magnesium react with gastric acid react with intestinal, biliary, and pancreatic secretions to form insoluble salts that are excreted in the feces.

There are no preclinical studies on this medicine. Based on studies of repeated dose toxicity, genotoxicity and/or carcinogenic potential, and toxicity to reproduction, the available preclinical data on calcium carbonate and magnesium carbonate revealed no specific hazard at therapeutic doses for humans.

Sucrose

Glucose

Talc

(Povidone) Polyvidone

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

Magnesium Stearate is a type of mineral.

Sodium Saccharinum

Keep below 25°C. Keep in the original packaging.

The tablets are packaged in a hard tempered aluminium foil (20m)/clear thermoformable PVC (150m) bubble pack, with six or twelve tablets per strip. A cardboard carton contains 1, 2, 3, 4, 8, 10, or 12 strips.

12 tablet Pocket Pack - tablets are packed in a hard tempered aluminium foil (20m)/clear thermoformable PVC (250m) bubble pack, six tablets per strip. A cardboard pocket pack contains two strips.

12 tablet pack - tablets are roll wrapped in laminated foil made of aluminium foil (7m) on the outside, polythene (12gsm), bleached kraft paper (37gsm), and polythene (12gsm) on the inside.

3 roll wraps of 12 tablets can also be packed into a blister card to make a total of 36 tablets.

Pack sizes are as follows: 6, 12, 24, 36, 48, 72, 96, 120, and 144 tablets.

Bayer plc

South Oak Way 400

Reading

RG2 6AD