AlginoMAX

–

Chewable tablets

Oval biconvex tablets. Color: from pure white to white with a yellowish or brownish tinge, with inclusions of a darker color.

Each tablet contains:
Active substances: sodium alginate 250 mg, potassium bicarbonate 75 mg, calcium carbonate 125 mg, magnesium hydroxide 45 mg;
Excipients: hydroxyapatite (E341), polyethylene glycol (macrogol) 6000, copovidone, sodium saccharin (E954), sorbitol (E420), magnesium stearate (E572), levomenthol.

Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD).

A02BX

Pharmacokinetics
After oral administration, AlginoMAX reacts with the acidic gastric contents and forms floating alginate gel on the surface of the gastric contents. The gel has an almost neutral acidity value (about pH 7). Alginate gel prevents the reflux of stomach contents into the esophagus. In case of regurgitation or reflux, the gel enters the esophagus, where it has a neutralizing effect on hydrochloric acid and pepsin that enter during reflux and additionally protects the esophageal mucosa.
In severe cases of reflux, the gel is thrown into the esophagus, ahead of the rest of the gastric contents and reduces irritation of the gastric mucosa.

Pharmacodynamics
The mechanism of the antireflux action of AlginoMAX is associated with the formation of a physical barrier that prevents reflux, and does not have a systemic effect.

Symptomatic treatment of gastro-oesophageal reflux such as acid regurgitation, heartburn, dyspepsia (associated with regurgitation) occurring after eating (for example) or in patients with symptoms due to reflux esophagitis.

Tablets are taken orally after chewing thoroughly with a glass of drinking water. Adults and children over 12 years old take 2-4 tablets 4 times a day, 30-40 minutes after breakfast, lunch, dinner, and at bedtime.

If you miss the prescribed dose, you should continue taking the drug as usual, according to the recommended schedule. Do not take a double dose to make up for the missed one.

Duration of treatment: if the symptoms persist after 7 days of taking AlginoMAX, consult your healthcare provider to reconsider the treatment.

Use in children
AlginoMAX is not intended for use in children under 12 years of age due to limited safety and efficacy data.

Use in elderly patients
Usually no dose change is required. Caution should be exercised due to the higher incidence of kidney and cardiovascular disease in this age group of patients (see Section Warnings and precautions).

Use in patients with impaired liver function
Dose changes are not required.

Use in patients with impaired renal function and/or chronic heart failure
Use with caution when on a very salt-restricted diet. Do not exceed recommended doses! Long-term use of high doses of magnesium may cause hypermagnesemia in patients with impaired renal function and/or in those who are on chronic dialysis (see Section Warnings and precautions).

The incidence of adverse reactions was assessed based on the following criteria:
Very common (≥1/10);
Common (≥1/100, <1/10);
Uncommon (≥1/1000, <1/100);
Rare (≥1 /10000, <1/1000);
Very rare (<1/10000);
Not known (frequency cannot be estimated from the available data).

Immune system disorders: very rare. Anaphylactic and anaphylactoid reactions, and hypersensitivity reactions (such as urticaria).

Respiratory, thoracic and mediastinal disorders: very rare. Respiratory effects (such as bronchospasm).

Gastrointestinal disorders: not known. Diarrhea and/or flatulence.

Other side effects: with prolonged use of high doses, formation of kidney stones, occurrence of alkalosis, hypermagnesemia, or hypercalcemia are possible. Therefore, the recommended doses and duration of administration should not be exceeded.

If you experience any of these or any other adverse reactions not listed in this leaflet, consult your healthcare provider.

Increased individual sensitivity to any of the ingredients of AlginoMAX.
Severe renal failure (due to the presence of magnesium), rare congenital fructose intolerance, children under 12 years of age (not enough data on safety and efficacy of use).

Symptoms: possible bloating.
An overdose of magnesium and calcium does not usually cause symptoms in patients with normal kidney function. Patients with impaired renal function may experience symptoms due to the occurrence of hypermagnesemia, hypercalcemia, and hyperkalemia.

Treatment: symptomatic. In case of renal insufficiency, hemodialysis or peritoneal dialysis may be necessary.

Not known.
It is recommended to observe a time interval of 2 hours between taking AlginoMAX and other medicinal products, especially when taken simultaneously with antimicrobial agents from the group of tetracyclines and fluoroquinolones, ketoconazole, digoxin, iron salts, neuroleptics, thyroid hormones, beta-blockers (atenolol, metoprolol , propranolol), glucocorticoids, penicillamine, chloroquine, estramustine, and bisphosphonates.

If the symptoms persist after 7 days of taking AlginoMAX, consult your healthcare provider to reconsider the treatment.

Patients are also advised to see a doctor if they have symptoms such as:

• weight loss;
• difficulty swallowing or constant discomfort in the abdomen;
• indigestion that appeares for the first time or in case of changes in existing digestive disorders;
• kidney failure.

The content of sorbitol is 284 mg in 1 tablet, 568 mg in 2 tablets, 2272 mg in 8 tablets, and 4544 mg in 16 tablets. If you have intolerance to some sugars, consult your healthcare provider before taking AlginoMAX.

The content of sodium is 29 mg (1.26 mmol) in 1 tablet, 58 mg (2.52 mmol) in 2 tablets, 232 mg (10.08 mmol) in 8 tablets, and 464 mg (20.16 mmol) in 16 tablets. This data should be taken into account when treating patients on a low sodium diet.

The content of potassium is 29.25 mg (0.75 mmol) in 1 tablet, 58.5 mg (1.5 mmol) in 2 tablets, 234 mg (6 mmol) in 8 tablets, and 468 mg (12 mmol) in 16 tablets. This data should be taken into account when treating patients on a low potassium diet.

The content of calcium (in the form of calcium carbonate and hydroxyapatite) is 60 mg (1.5 mmol) in 1 tablet, 120 mg (3 mmol) in 2 tablets, 480 mg (12 mmol) in 8 tablets, and 960 mg (24 mmol) in 16 tablets. It should be taken into account when treating patients with hypercalcemia, nephrocalcinosis, and/or presence of recurrent calcium-containing kidney stones.

The content of magnesium (in the form of magnesium hydroxide and magnesium stearate) is 19.1 mg (0.8 mmol) in 1 tablet, 38.2 mg (1.6 mmol) in 2 tablets, 152.8 mg ( 6.4 mmol) in 8 tablets, and 305.6 mg (12.8 mmol) in 16 tablets.

An increase in the content of magnesium in the blood plasma and appearance of associated symptoms may occur in patients with renal insufficiency and in those on chronic dialysis. With a decrease in kidney function, long-term administration of AlginoMAX should be avoided. Administration of AlginoMAX is contraindicated in patients with severe renal insufficiency.

Safety of AlginoMAX during pregnancy has not been proved. Due to the limited data on the efficacy and safety of AlginoMAX, administration during pregnancy is possible only after consulting your healthcare providerr and assessing the ratio of benefit to the mother and risk to the fetus.

Administration during breastfeeding is possible with appropriate monitoring of the patient’s condition, not exceeding the recommended duration (see Section Dosage and administration).

There are no data on the effect of AlginoMAX on the ability to drive and work with mechanisms.

14 tablets in a blister pack. 2 blister packs and a patient information leaflet in a carton pack.

Protect from light and moisture. Store at a temperature not exceeding 25°C.
Keep out of the reach of children.

3 years. Do not use after the expiration date stated on the package.

Institute of Bioorganic Chemistry
(National Academy of Sciences of Belarus)
220141, 5/2 Kuprevicha Street, Minsk, Belarus
http://iboch.bas-net.by

State enterprise ACADEMPHARM
220141, 5/3 Kuprevicha Street, Minsk, Belarus
Phone / Fax +375 17 268 63 64
production@academpharm.by
To report adverse reactions use the electronic application form on the manufacturer’s website: https://academpharm.by/en