Instructions for Rennie with orange flavor chewable tablets No. 24
Composition
active ingredients: calcium carbonate, heavy magnesium carbonate;
1 tablet contains 680 mg of calcium carbonate (272 mg of elemental calcium) and 80 mg of heavy magnesium carbonate;
excipients: sucrose, pregelatinized corn starch, potato starch, talc, magnesium stearate, light mineral oil, sodium saccharin, orange flavoring.
Dosage form
Chewable tablets.
Main physicochemical properties: creamy white, square tablets with concave surfaces, engraved with “RENNIE” on both sides, with an orange odor.
Pharmacotherapeutic group
Antacids, other combinations. ATX code A02A X.
Pharmacological properties
Pharmacodynamics
Rennie® is a combination of two antacids: calcium carbonate and magnesium carbonate, which have a local effect by neutralizing gastric acid, which is independent of systemic absorption. Calcium carbonate has a long-lasting and strong neutralizing activity. This effect is enhanced by magnesium carbonate, which also has a strong neutralizing activity. The total neutralizing capacity of the drug in vitro is 16 mEq H+ (titration to an end point of pH 2.5).
In healthy volunteers, the onset of neutralization is rapid. Administration of 2 Rennie® tablets on an empty stomach resulted in an increase of more than 1 pH unit within 5 minutes and a significant increase in gastric pH above baseline pH, which was achieved within 2 minutes.
Pharmacokinetics
In the stomach, calcium carbonate and magnesium carbonate react with gastric juice to form water and soluble mineral salts.
CaCO3 + 2HCl → CaCl2 + H2O + CO2
MgCO3 + 2HCl → MgCl2 + H2O + CO2
Calcium and magnesium can be absorbed in the form of their soluble salts. The level of absorption of calcium and magnesium from these compounds depends on the dose of the drug. The maximum level of absorption is 10% of calcium and 15–20% of magnesium. In healthy volunteers, a small amount of absorbed calcium and magnesium is excreted by the kidneys. If their function is impaired, the concentration of calcium and magnesium in the blood plasma may increase. In the intestine, insoluble compounds are formed from soluble salts, which are excreted in the feces.
Indication
Adults and children aged 15 years and over to relieve symptoms associated with increased gastric acidity (e.g. heartburn, gastroesophageal reflux) leading to indigestion and dyspepsia.
Contraindication
- Increased individual sensitivity to the components of the drug;
- hypercalcemia and/or conditions leading to hypercalcemia;
- nephrolithiasis, caused by the deposition of stones containing calcium;
- severe renal failure (creatinine clearance below 30 ml/min);
- hypophosphatemia.
Interaction with other medicinal products and other types of interactions
It is recommended to take other medications 1–2 hours before or after taking Rennie®.
Antacids containing calcium and magnesium can form complexes with some substances. Therefore, in the case of simultaneous use of Rennie® and antibiotics (tetracyclines, quinolones), cardiac glycosides (digoxin), phosphates, fluorine compounds and iron-containing products, levothyroxine and eltrombopag, the absorption of the latter is reduced.
Thiazide diuretics reduce urinary calcium excretion and increase serum calcium levels. Due to the increased risk of hypercalcemia, serum calcium levels should be monitored regularly during concomitant use of thiazide diuretics.
Calcium salts reduce the absorption of fluoride and iron-containing agents, and calcium salts and magnesium salts can interfere with the absorption of phosphates.
A 2-hour interval should be allowed between the use of Rennie® and the following medications: H2-blocking antihistamines, atenolol, metoprolol or propanolol, chloroquine, diflunisal, digoxin, diphosphonates, fexofenadine, glucocorticoids (prednisolone and dexamethasone, except hydrocortisone in replacement therapy), indomethacin, ketoconazole, phenothiazid neuroleptics, penicillamine, thyroxine, ethambutol, isoniazid, lansoprazole, lincosamide.
It should be taken into account that with simultaneous use, increased excretion of salicylates by the kidneys is observed through alkalization of urine.
Sodium sulfonate – cationic ion exchange resin: the ability of the resin to bind potassium is reduced, which leads to the risk of developing metabolic alkalosis in renal failure.
Application features
If symptoms persist, partially persist or worsen after 10 days of treatment, an examination should be performed to clarify their nature and review the treatment regimen. The course of treatment with Rennie® should not exceed 10 days. Adverse reactions have been observed with simultaneous use with thiazide diuretics (see section "Interaction with other medicinal products and other types of interactions"). Long-term use of the drug in high doses may lead to the appearance of such adverse reactions as hypercalcemia, hypermagnesemia and milk-alkali syndrome, especially in patients with renal failure. The drug should not be taken simultaneously with large amounts of milk or dairy products. Long-term use of Rennie® may increase the risk of kidney stones. When using 4 to 5 tablets per day, the course of treatment should be short, treatment should be stopped immediately after the disappearance of symptoms.
It is recommended to consult a doctor in case of: weight loss, problems with swallowing or a constant feeling of discomfort in the abdomen, signs of digestive disorders, if they appear for the first time or have changed their nature, kidney failure (it is necessary to monitor calcium and magnesium levels).
Calcium carbonate and magnesium carbonate should not be used in hypercalciuria. This drug should be used with caution in patients with impaired renal function. If calcium carbonate and magnesium carbonate must be used in such patients, regular monitoring of plasma calcium, phosphorus and magnesium levels is necessary.
Patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not use this medicine as it contains 475 mg of sucrose. This should also be taken into account by patients with diabetes mellitus.
Use during pregnancy or breastfeeding
There are no reliable data on teratogenicity in animals. At high doses and with prolonged use of calcium carbonate, disturbances in bone formation have been reported.
To date, no increased risk of fetal malformations has been observed after the administration of calcium carbonate and magnesium carbonate during pregnancy. However, monitoring of pregnancies in which this combination was used is insufficient to exclude any risk. Rennie® can be administered during pregnancy and lactation if the drug is used according to the instructions, but prolonged use of high doses should be avoided. It should also be taken into account that the presence of magnesium salts can cause diarrhea, and the presence of calcium in high doses used for a long time increases the risk of hypercalcemia with calcification of various organs, in particular the kidneys.
It should be noted that during pregnancy and breastfeeding, calcium carbonate and magnesium carbonate provide a significant amount of calcium in addition to the amount supplied by food. Therefore, pregnant women should limit the use of Rennie® to 1 week and, while using the drug, avoid constant consumption of milk (1 liter contains up to 1.2 g of elemental calcium) and dairy products to prevent excess calcium, which can lead to the so-called milk-alkali syndrome (Burnett syndrome), which is a rare but serious disease that requires medical attention.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
Oral preparation for adults and children over 15 years of age. The usual daily dose is 1–2 chewable tablets during periods of pain or heartburn; in case of pain, the dose can be increased for a short period to 5 tablets per day. The duration of treatment should not exceed 10 days.
Children.
Do not use in children under 15 years of age.
Overdose
Prolonged use of high doses of calcium carbonate and magnesium carbonate, especially in patients with impaired renal function, can lead to renal failure, hypermagnesemia, hypercalcemia and alkalosis, manifested by gastrointestinal symptoms (nausea, vomiting, constipation) and muscle weakness. In these cases, the drug should be discontinued and adequate fluid intake should be ensured. In severe cases of overdose (e.g., Burnett syndrome), a doctor should be consulted, as additional rehydration (e.g., by infusion) may be required. In case of overdose, diarrhea may also develop.
Adverse reactions
From the immune system.
Hypersensitivity reactions, manifested as rash, urticaria, angioedema and anaphylaxis, have been reported very rarely.
Metabolic and nutritional disorders.
In patients, especially with impaired renal function, prolonged use of high doses may lead to hypermagnesemia (when using antacids containing magnesium) or hypercalcemia and alkalosis, which manifests itself in the form of gastric symptoms and muscle weakness, there is also a risk of kidney stones and the development of renal failure.
From the gastrointestinal tract.
Nausea, vomiting, stomach discomfort, and diarrhea may occur.
Muscle weakness is possible.
Side effects observed only in milk-alkali syndrome (Burnett syndrome):
- gastrointestinal disorders (ageusia);
- general disorders (calcinosis and asthenia);
- nervous system disorders (headache);
- kidney and urinary tract disorders (azotemia).
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
6 tablets in PVC and aluminum blisters, 2 or 4 blisters in a cardboard box or 12 tablets in PVC and aluminum perforated blisters, 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Delfarm Gaillard /
Delpharm Gaillard
Address
33 Rue Industrie, 74240, Gaillard, France /
33 rue de l'Industrie, 74240, Gaillard, France
