Riopan oral suspension 800mg/10ml, 10ml x 20 sachets — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. Riopan is an antacid agent with a layered lattice structure. the active ingredient of the preparation riopan is magaldrat. it contains aluminum and magnesium hydroxide in one molecule.

The preparation Riopan reduces the amount of acid in the stomach and, depending on the dose and pH level, binds pepsin, bile acids and lysolecithin. Thus, the aggressive effect of gastric juice is eliminated and a layer is formed that protects its mucous membrane.

The acid binding is explained by the binding of protons by sulfate and hydroxide ions in the middle layer of the lattice. During neutralization, the lattice structure is destroyed.

800 mg of anhydrous magaldrate neutralizes about 18-25 mEq of hydrochloric acid.

Riopan 800 mg tablet corresponds in vitro to approximately 19 mEq of acid-neutralizing activity.

10 ml of Riopan, oral suspension, 800 mg corresponds in vitro to approximately 20 mEq of acid-neutralizing activity.

10 ml of Riopan, oral suspension, 1600 mg corresponds in vitro to approximately 45.2 mEq of acid-neutralizing activity.

Since the pH level for 20–40 minutes is kept in the range from 3 to 5, which is therapeutically optimal, the use of the preparation does not cause an acid rebound.

Magaldrat does not affect gastric motility.

Pharmacokinetics. Magaldrat is not absorbed in the gastrointestinal tract. In the process of neutralization, a small amount of aluminum and magnesium ions is released, which, when passing through the intestines, are converted into sparingly soluble phosphates and then excreted in the feces. A certain amount of cations is absorbed. There was a slight increase in aluminum levels even in patients with normal renal function. Long-term use of aluminum-containing antacids can lead to a decrease in phosphate absorption.

Indications

Heartburn, sour belching, a feeling of heaviness and fullness in the stomach.

Application

Riopan chewable tablets. adults: the recommended dose is 1 tablet of Riopan.

In case of minor complaints, the preparation should be used 0.5–1 hours after a meal or immediately when significant complaints appear.

Chewable tablets must be sucked or chewed thoroughly.

Do not exceed the maximum daily dose of 8 chewable tablets (6.4 g magaldrat).

Riopan, oral suspension. Adults: The recommended dose is 1 sachet of Riopan.

In case of minor complaints, the preparation should be used 0.5–1 hours after a meal or immediately when significant complaints appear.

Shake the preparation Riopan in a sachet before use, open along the indicated line. Squeeze the contents of the sachet directly into the mouth and swallow.

Do not exceed the maximum daily dose - 8 sachets of 800 mg each or 4 sachets of 1600 mg each (6.4 g of magaldrat).

If symptoms persist after 2 weeks of treatment, you should consult a doctor for an examination.

Elderly patients do not need dose adjustment.

Contraindications

Hypersensitivity to the active substance or other components of the preparation. hypophosphatemia. habitual constipation. chronic diarrhea. severe abdominal pain of unspecified origin. Alzheimer's disease. intolerance to fructose and sorbitol (riopan, chewable tablets).

The preparation can be used in patients with impaired renal function (creatinine clearance 30 ml / min) only with regular monitoring of the levels of magnesium and aluminum in the blood plasma. Plasma aluminum levels should not exceed 40 ng / ml.

Side effects

In terms of frequency of occurrence, side effects are classified into the following categories: very often (≥10%), often (≥1% –10%), infrequently (≥0.1% –1%), rarely (≥0.01% –0, 1%), very rarely (1/10 000, including isolated cases).

On the part of the digestive tract: often - bowel movements of soft consistency (especially when using the preparation in a high dose); very rarely - diarrhea, constipation.

In patients with renal insufficiency or with long-term use of the preparation  in a high dose, it is possible to increase the level of aluminum and magnesium in the blood, which can lead to the accumulation of aluminum, mainly in the nervous and bone tissues, and to a deficiency of phosphates.

Disturbance of taste (feeling of a chalk taste), nausea, vomiting, intoxication with aluminum and / or magnesium, most often in patients with renal failure.

Dementia, worsening in Alzheimer's disease.

Osteomalacia, osteoporosis.

Hypersensitivity reactions, including pruritus, urticaria, angioedema and anaphylactic reactions, bronchospasm.

A decrease in the phosphorus content in the body is also possible with the use of the preparation in usual doses in patients whose diet is characterized by a low phosphorus content.

Strengthening the processes of resorption in bone tissue, hypercalciuria.

In patients with renal insufficiency, long-term use of aluminum and magnesium salts in high doses can lead to the development of encephalopathy, microcytic anemia, or worsen the course of dialysis-induced osteomalacia. Long-term use or taking the preparation in high doses can cause phosphorus deficiency syndrome (loss of appetite, muscle weakness, weight loss).

Aluminum hydroxide can be hazardous to porphyria patients on hemodialysis.

special instructions

Riopan should not be used for more than 2 weeks without consulting a doctor. if the complaints persist for a long time and / or are often repeated, an examination should be carried out to rule out the presence of a serious illness, such as a peptic ulcer or malignant tumor. to establish a diagnosis, you should consult a doctor.

In rare cases, after using the preparation  in high doses for several years, there was a decrease in the absorption of calcium and phosphates, followed by osteomalacia.

The preparation can be used in patients with impaired renal function (creatinine clearance 30 ml / min), especially those on dialysis, only with regular monitoring of the levels of magnesium and aluminum in the blood plasma. Plasma aluminum levels should not exceed 40 ng / ml. The preparation  is contraindicated in patients with Alzheimer's disease and should be used with caution in patients with metabolic disorders in bone tissue, in patients on a low-phosphate diet to reduce the risk of aluminum intoxication, hypermagnesemia and hypophosphatemia. When using the preparation  for a long time and in high doses, it is necessary to regularly monitor the level of magnesium and aluminum in the blood serum.

In case of impaired renal function and prolonged use of the preparation due to the content of aluminum salts, high levels of aluminum in blood plasma and / or in tissues (aluminum deposits, primarily in the nervous and bone tissues), as well as signs of overdose, can be noted. However, the results of studies indicate that the absorption of aluminum in patients with impaired renal function with the use of magaldrat is lower than with the use of aluminum salts. In addition, after short-term use of magaldrat in patients with normal renal function, no aluminum deposits are observed in the brain and bone tissue, in contrast to the use of aluminum salts without the use of antacids.

An increase in the pH of gastric juice increases the risk of reproduction of pathogenic microorganisms; during artificial respiration, it can increase the incidence of nosocomial pneumonia in patients.

Since Ryopan does not contain sugar and contains a small amount of sodium, it can be used to treat patients with diabetes mellitus and hypertension.

Aluminum hydroxide can lead to constipation, and magnesium hydroxide can lead to intestinal hypokinesia. The use of the preparation in high doses can cause or aggravate intestinal obstruction and intestinal obstruction, especially in individuals at increased risk of such complications, for example, in patients with renal insufficiency or in the elderly.

Patients should consult a doctor in case of weight loss, difficulty swallowing and a constant feeling of discomfort in the abdomen, in case of digestive disorders, the first appearance or change in the course of already existing digestive disorders; with renal failure.

With prolonged use of the preparation, it is necessary to ensure that a sufficient amount of phosphorus is supplied to the body, since aluminum hydroxide binds to phosphates and reduces their absorption from the digestive tract. The excretion of calcium in the urine increases, which can lead to disturbances in calcium-phosphate balance and create conditions for the development of osteomalacia (symptoms are complaints of weakness and pain in the bones).

During the treatment of patients with renal failure, it is necessary to monitor the dynamics of the indicators of the state of the kidneys, the size of the ulcer, the appearance of diarrhea, the level of aluminum and magnesium in the blood serum.

Use during pregnancy and lactation

Controlled studies of the effect of magaldrat in animals, as well as in humans during pregnancy, have not been carried out. Experiments on animals have shown that the use of aluminum salts has an adverse effect on the fetus. To prevent aluminum intoxication, the preparation is taken for a short time and in the lowest possible dose.

Aluminum compounds also pass into breast milk. Studies have found that the level of aluminum after taking aluminum salts increases markedly, while after taking magaldrate, due to the layered structure of the lattice, the level of aluminum in the blood plasma does not differ from the level without the use of antacids.

Consideration should be given to the content of aluminum and magnesium ions that can affect transit in the gastrointestinal tract, namely:

magnesium hydroxide salts can cause diarrhea;

aluminum salts can cause constipation and worsen the constipation often experienced during pregnancy.

Long-term use and excess doses of the preparation  during pregnancy should be avoided.

During treatment, breastfeeding should be discontinued.

Children. Currently, there are no data from systematic studies on the use and safety of the preparation in children.

The ability to influence the reaction rate when driving or operating other mechanisms. Does not affect.

Interactions

When taking the preparation riopan and other preparations, an interval of at least 2 hours should be observed, since antacids can affect the absorption of other preparations.

There was a significant decrease in the absorption of antibiotics, including tetracycline, quinolone derivatives (ciprofloxacin, ofloxacin, norfloxacin), therefore, it is not recommended to take antacids during treatment with these antibiotics. There was also a slight decrease in the absorption of digoxin, isoniazid, iron preparations, chlorpromazine, benzodiazepines, heno- and ursodeoxycholic acid, indomethacin and cimetidine when these preparations were used simultaneously with Riopan.

Potential enhancement of the action of coumarin anticoagulants was noted.

Antacids containing aluminum should not be used in combination with acidic drinks (fruit juices, wines), effervescent tablets, citric and tartaric acid, since the absorption of aluminum salts in the intestine increases.

With simultaneous use with salicylates, the excretion of salicylates by the kidneys increases due to alkalization of urine.

Overdose

No cases of an overdose of Riopan have been recorded.

Symptoms of an overdose of aluminum hydroxide and magnesium hydroxide are manifested by rapid fatigue, facial flushing, exhaustion, muscle weakness and inappropriate behavior.

Signs of metabolic alkalosis may also be observed: changes in mood or mental activity, numbness or muscle pain, nervousness and fatigue, slow breathing, unpleasant taste sensations.

Treatment for magnesium overdose: rehydration, forced diuresis. You can prescribe intravenous calcium gluconate. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.

Storage conditions

At a temperature not higher than 25 ° C. Do not freeze Riopan oral suspension.