Almagel Neo oral suspension 10ml x 20 sachets — Made in Bulgaria — Free Delivery
(Almagel Neo)
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Description Almagel Neo oral suspension 10ml x 20 sachets — Made in Bulgaria — Free Delivery
Pharmacological properties
Almagel Neo is a balanced gel of aluminum hydroxide and magnesium hydroxide in combination with a carminative component - simethicone. has a long-term antacid effect, exhibits a mild laxative effect, successfully eliminates constipation and reduces flatulence in patients with stomach ulcers.
The double mechanism of action, combining acid-neutralizing ability and cytoprotective activity, protects the gastric mucosa and its healing in case of damage.
The alkaline active components of the preparation are finely dispersed, which increases their active surface, provides closer contact with the surface of the mucous membrane of the stomach and duodenum, slows down the evacuation of stomach contents and prolongs the neutralizing effect.
Cytoprotective activity is associated with the activation of the synthesis of prostaglandins, which stimulate the secretion of mucus and bicarbonates from the gastric mucosa.
Given the ability of the preparation to bind bile acids and lysolecithin, as well as to have a gastroprotective effect, Almagel Neo can be used to treat duodenogastric reflux.
Simethicone, which is part of the preparation Almagel Neo, helps to eliminate flatulence. Simethicone is a stable silicone compound that is not absorbed in the gastrointestinal tract, and causes the natural release of gases and their absorption by the intestinal walls. Simethicone acts in the lumen of the small intestine and is excreted unchanged from the body.
The constituents of the preparation are not absorbed in the gastrointestinal tract and, therefore, do not lead to clinically significant plasma concentrations when used in recommended doses and with the recommended duration of treatment.
Aluminum hydroxide neutralizes the increased secretion of hydrochloric acid in the stomach, forming aluminum chloride. Under the influence of the alkaline environment of the intestine, the latter turns into alkaline aluminum salts, which are little absorbed and excreted in the feces. With normal renal function, the plasma level of aluminum remains practically unchanged.
Magnesium hydroxide also neutralizes hydrochloric acid in the stomach and converts to magnesium chloride. In the intestine, it turns into magnesium carbonate, which is poorly absorbed, so the concentration of magnesium ions in the blood practically does not change.
In patients with chronic renal failure, the level of aluminum and magnesium ions may increase to toxic values due to impaired excretion.
Indications
Symptomatic treatment of diseases of the digestive tract, accompanied by increased or normal acidity of gastric juice and increased gas production.
The preparation should be used alone or in combination with other preparations for:
- gastritis and duodenitis;
- ulcers of the stomach and duodenum;
- erosions of the stomach and duodenum;
- gastroesophageal reflux disease;
- duodenogastric reflux;
- functional dyspepsia;
- flatulence, discomfort as a result of increased gas production.
Application
Adults and children over the age of 14: for gastroesophageal reflux disease, the recommended dose is 10-15 ml (2-3 scoops) or 1 sachet 4 times a day 1 hour after meals and before bedtime. after achieving the desired effect, the recommended dose is 10 ml (2 scoops) or 1 sachet 4 times a day.
For gastritis, duodenitis, erosions of the stomach and duodenum, stomach and duodenal ulcers, duodenogastric reflux, functional dyspepsia, flatulence, the recommended dose is 10 ml (2 scoops) or 1 sachet 4 times a day 1 hour after meals and before bedtime ...
The duration of treatment is determined by the doctor.
The maximum daily dose is 60 ml (12 scoops or 6 sachets), the maximum duration of treatment is 4 weeks.
If symptoms persist, you should see a doctor.
The preparation must be taken undiluted. It is not recommended to drink fluids within 30 minutes after ingestion. Before use, the suspension must be thoroughly homogenized by shaking the bottle.
Patients with impaired renal function. The medicine should be taken after consulting a doctor. With prolonged use, it is necessary to take into account the state of renal function.
Contraindications
Hypersensitivity to any of the active and / or auxiliary substances that make up the preparation. severe impairment of renal function, including in patients on hemodialysis, in whom there is a risk of an increase in the concentration of aluminum and magnesium ions in the blood plasma to toxic levels as a result of a decrease in renal excretion. hypophosphatemia, severe osteoporosis, Alzheimer's disease, habitual constipation, chronic diarrhea, intestinal obstruction, suspected appendicitis, bleeding from the gastrointestinal tract of unexplained origin, severe abdominal pain of unspecified origin, ulcerative colitis, conditions causing imbalance in water and electrolyte balance.
Side effects
Long-term use of Almagel Neo or taking it in high doses can cause phosphorus deficiency syndrome (loss of appetite, muscle weakness, weight loss).
It should be borne in mind that even with the use of the preparation in usual doses in patients whose diet is characterized by a low phosphorus content, it is possible to reduce the phosphorus content in the body, increase the resorption processes in bone tissue, hypercalciuria, osteomalacia, osteoporosis, since this preparation contains aluminum (see . SPECIAL INSTRUCTIONS).
In patients with renal failure, there are increased plasma concentrations of both aluminum and magnesium, therefore, prolonged use of aluminum and magnesium salts in high doses can lead to the development of encephalopathy, dementia, microcytic anemia, or worsen the course of osteomalacia induced by dialysis. Patients with renal impairment should take a lower dose of the preparation or increase the interval between doses of the preparation, based on the severity of the renal impairment. In patients of this group, the parameters of the plasma concentration of aluminum and magnesium should be monitored.
Aluminum hydroxide can be hazardous to patients with porphyria on hemodialysis.
Adverse reactions:
- from the digestive system: taste disturbance (feeling of a chalk taste), diarrhea, constipation, nausea, vomiting, discoloration of feces;
- from the immune system: hypersensitivity reactions, including bronchospasm, pruritus, urticaria, angioedema and anaphylactic reactions;
- from the nervous system: intoxication with aluminum and / or magnesium, most often in patients with renal failure, dementia, deterioration in Alzheimer's disease.
- If you identify any unwanted effects or unusual reactions, you should consult your doctor regarding the further use of the preparation!
Special instructions
Before starting to use the preparation, the presence of a malignant process should be excluded.
Aluminum hydroxide can lead to constipation, and magnesium hydroxide can cause intestinal hypokinesia. High dose use of this preparation may cause or complicate bowel obstruction and bowel obstruction, especially in patients at increased risk of such complications, such as those with renal insufficiency or the elderly.
Patients should consult a doctor if:
decrease in body weight;
Difficulty swallowing or persistent abdominal discomfort
digestive disorders, which appeared for the first time, or changes in the course of existing digestive disorders;
renal failure.
In patients with impaired renal function, an increase in plasma levels of aluminum and / or magnesium is possible, therefore it should be borne in mind that prolonged use of the preparation in high doses can lead to the development of dementia and microcytic anemia.
Long-term use of the preparation is not recommended in the presence of Alzheimer's disease, since it is believed that aluminum is concentrated in the neurofibrils of the brain tissue and can lead to complications.
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 in the gastrointestinal tract. In addition, 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). This preparation is not suitable for patients with hypophosphatemia as it can cause hypophosphatemia with prolonged use.
This preparation should be used with caution in patients with renal impairment. 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 plasma level of aluminum and magnesium.
Each dose (10 ml) of Almagel Neo contains:
0.226 g of ethanol, the presence of which can adversely affect the condition of patients with liver and brain diseases, persons with alcohol dependence, epilepsy, pregnant women and children under the age of 14;
0.95 g sorbitol, which is contraindicated in patients with rare hereditary diseases such as fructose intolerance and can cause stomach irritation and diarrhea.
Parabens, which are part of the preparation as excipients, can cause allergic reactions, including urticaria, bronchospasm.
Use during pregnancy and lactation. Due to the lack of clinical experience, it is advisable to avoid using the preparation during pregnancy and lactation. Due to the lack of data of adequate clinical studies for women during pregnancy, Almagel Neo can only be used as directed by a doctor if the expected benefit to the mother outweighs the possible risk to the fetus / child.
It is necessary to take into account the content of aluminum and magnesium ions that can affect the transit in the gastrointestinal tract, namely:
magnesium hydroxide salts can cause diarrhea;
aluminum salts can cause constipation and worsen the course of constipation, which is often noted during pregnancy, so prolonged use and excess doses of this preparation should be avoided.
When used in pregnant women, the preparation can cause damage due to the content of ethyl alcohol (0.226 g per dose).
During treatment with the preparation, breastfeeding should be discontinued.
Children. The preparation can be used in children over the age of 14. The safety and efficacy of using the preparation in children under the age of 14 have not been established.
The ability to influence the reaction rate when driving or working with other mechanisms. There is no evidence of a negative impact on the ability to drive vehicles or work with complex mechanisms.
Interactions
Almagel neo interacts with some other preparations used orally. note a decrease in the absorption volume of preparations taken simultaneously in the gastrointestinal tract. as a precautionary measure, a break of at least 2 hours should be taken between taking antacids and other medicines.
It is recommended to take 2 hours before or 2 hours after using the preparation Almagel Neo: antibiotics of the tetracycline group (tetracycline, doxycycline), fluoroquinolones (ciprofloxacin, norfloxacin, ofloxacin), H2-antihistamines, anti-tuberculosis preparations: ethambutol, isoniazid (oral , metoprolol, propranolol, chloroquine, cyclins, diflunisal, digoxin, diphosphonates, fexofenadine, iron (salts), sodium fluoride, corticosteroids (interaction with prednisolone and dexamethasone is described), indomethacin, sodium polystyrenesulfonate, ketoconazole, lyncotylaminazolecines , phosphorus (additives), thyroxine.
Combinations to consider: when used simultaneously with salicylates, the excretion of salicylates by the kidneys increases due to alkalization of urine.
The preparation should not be used simultaneously with quinolines.
Excretion of quinidine with manifestations of quinidine toxicity may be impaired, especially in patients with renal insufficiency.
Simultaneous use with cholinergic preparations reduces their effectiveness.
The simultaneous use of aluminum hydroxide and citrates can lead to an increase in the level of aluminum, especially in patients with renal insufficiency.
The use of the preparation simultaneously with preparations that have an enteric coating can lead to a more rapid dissolution of the membrane and irritation of the stomach and duodenum.
Simultaneous use with the preparation Almagel Neo can lead to a decrease in the absorption of the following preparations:
- tetracycline antibiotics (tetracycline, doxycycline);
- quinolones (ciprofloxacin, norfloxacin, ofloxacin);
- derivatives of bisphosphonates (clodronate, alendronate, risedronate);
- protease inhibitors (atazanavir, tipranavir, fosamprenavir);
- ketoconazole, itraconazole;
- rosuvastatin;
- allopurinol, diflunisal, gabapentin, iron, mycophenolate mofetil;
- levothyroxine;
- dasatinib;
- strontium ranelate.
The preparation can reduce the absorption of folic acid.
When combined with levothyroxine, a decrease in the severity of its hormonal action is possible. Pirenzepine enhances and prolongs the effect of the preparation Almagel Neo.
Plasma concentrations of penicillamine, sotalol, propranolol, phenytoin, cefpodoxime, fexofenadine may decrease when used simultaneously with antacids.
The effect of calcium polystyrene sulfonate can be weakened by the simultaneous use of antacids.
Preparation interactions are less likely with low-dose antacids.
Overdose
Long-term use of Almagel Neo can cause hypermagnesemia, despite the fact that the preparation is almost not absorbed into the gastrointestinal tract. overdose symptoms are manifested by rapid fatigue, facial flushing, exhaustion, muscle weakness and inappropriate behavior.
Signs of metabolic alkalosis may also be noted: changes in mood or mental activity, numbness or muscle pain, nervousness and fatigue, slow breathing, unpleasant taste sensations.
If you suspect an overdose of the preparation or the appearance of clinical signs, it is necessary to cancel the preparation and take measures to quickly remove the preparation from the gastrointestinal tract (introduce activated charcoal, perform gastric lavage and other procedures to reduce the absorption of aluminum and magnesium ions).
Treatment for magnesium overdose: rehydration, forced diuresis. Calcium gluconate IV can be given. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.
Storage conditions
In its original packaging at a temperature not exceeding 25 ° c. do not freeze! after the first opening of the primary package, the suspension can be stored for 30 days under the specified conditions.
Tags: Almagel
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