Almagel Neo - instructions for use, dose, side effects, contraindications

Active substanceAlgealdrate + Magnesium hydroxide + SimethiconeAlgealdrate + Magnesium hydroxide + Simethicone

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Almagel® Neo

suspension inwards

Balkanfarm - Troyan AD Bulgaria

Сималгел -ВМ

suspension inwards

World Medical Co., Ltd. Egypt

Dosage form: & nbsporal suspension

Composition:

5 ml (one measuring spoon) of the suspension contains:

Active substances:

Algeldrate (Aluminum hydroxide gel - in terms of aluminum hydroxide) 340 mg

Magnesium hydroxide (Magnesium hydroxide paste - in terms of magnesium hydroxide) 395 mg

Simethicone (simethicone emulsion - in terms of dimethicone) 36 mg

The content of excipients in 5 ml of suspension: hydrogen peroxide solution 30% 0.495 mg, sorbitol 474.60 mg, sodium saccharinate 1.13 mg, guiethella 5.65 mg, citric acid monohydrate 5.65 mg, ethyl parahydroxybenzoate 7.90 mg, propyl parahydroxybenzoate 3.40 mg, propylene glycol 113, 00 mg, macrogol 4000 452,00 mg, flavoring orange 2,26 mg, ethanol 96% 113,00 mg, water purified to 5 ml.

10 ml (1 sachet) of the suspension contains:

Active substances:

Algeldrate (Aluminum hydroxide gel - in terms of aluminum hydroxide) 680 mg

Magnesium hydroxide (Magnesium hydroxide paste - in terms of magnesium hydroxide) 790 mg

Simethicone (emetic simethicone - in terms of dimethicone) 72 mg

The content of excipients in 10 ml of the suspension: of hydrogen peroxide solution 30% 0.990 mg, sorbitol 949.20 mg, sodium saccharinate 2.26 mg, hyethellose 11.30 mg, citric acid monohydrate 11.30 mg, ethyl parahydroxybenzoate - 15,80 mg, propyl parahydroxybenzoate - 6,80 mg, propylene glycol 226.00 mg, macrogol 4000 904.00 mg, orange flavoring 4.52 mg, ethanol 96% 226.00 mg, water purified to 10 ml.

Description:

White or almost white suspension, with the smell of orange.

Pharmacotherapeutic group:Antacid agent + carminative agent

ATX: & nbsp

A.02.A.F Antacids in combination with drugs that reduce gassing in the intestine

Pharmacodynamics:

Combined drug, the effect of which is due to its constituent components. Has antacid, adsorbing, enveloping, carminative effect. Algeldrat (aluminum hydroxide) and magnesium hydroxide neutralize free hydrochloric acid in the stomach, reduce the acidity of the gastric juice, bind bile acids. The relaxing effect of magnesium hydroxide balances the ability of the algebra to slow intestinal motility. Simethicone complicates the formation of gas bubbles and contributes to their destruction. The gases released in this way are absorbed by the walls of the intestine and are excreted from the body by peristalsis.

Pharmacokinetics:

Simethicone due to physiological and chemical inertness is not absorbed into organs and tissues and after passage through the gastrointestinal tract (GIT) is withdrawn in an unchanged form.Absorption of aluminum and magnesium ions in the intestine is low. With normal kidney function, the concentration of aluminum and magnesium in the blood does not change. In patients with chronic renal insufficiency, the level of aluminum and magnesium in the blood can rise to toxic values as a result of disruption of their excretion.

Indications:

Acute gastritis; chronic gastritis with increased and normal secretory function of the stomach (in the phase of exacerbation); acute duodenitis, duodenogastric reflux; peptic ulcer of the stomach and duodenum (in the phase of exacerbation); symptomatic gastrointestinal ulcers of different genesis; erosion of the mucous membrane of the upper gastrointestinal tract; gastroesophageal reflux, reflux-esophagitis; acute pancreatitis, exacerbation of chronic pancreatitis; gastralgia, heartburn (after excess consumption of ethanol, nicotine, coffee, medication, illicit diet, negatively affecting the functioning of the digestive tract); flatulence; fermentation or putrefactive dyspepsia.

Contraindications:

Hypersensitivity, chronic renal failure, pregnancy, Alzheimer's disease, hypophosphatemia, children under 10 years of age, congenital intolerance to fructose.

Carefully:Lactation period, liver disease, alcoholism, craniocerebral trauma, brain diseases, epilepsy, children and adolescence from 10 to 18 years.

Pregnancy and lactation:Due to the lack of controlled clinical trials, breastfeeding women Almagel® Neo should only be taken after consultation with a doctor.

Dosing and Administration:

Adults

Inside, but 2 measuring spoons or 1 packet of a suspension with orange flavor 4 times a day 1 hour after eating and in the evening before bedtime. If necessary, single dose can be increased to 3 measuring spoons 4 times a day.

The maximum daily dose should not exceed 12 measuring spoons.

Children over 10 years old

Dosage is determined by the attending physician-usually 1/2 dose for adults.

The course of treatment - no more than 4 weeks. Before use, the suspension must be thoroughly homogenized, shaking the bottle or mashing and shaking the bag. It is advisable to take Almagel® Neo without diluting with water and without washing down. P is recommended to take liquid for half an hour after taking the drug.

Side effects:

Allergic reactions, nausea, vomiting, taste changes, constipation, diarrhea.With long-term admission in high doses - hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesia, hyperaluminia, encephalopathy, nephrocalcinosis, renal dysfunction. In patients with concomitant renal failure - thirst, lowering blood pressure, hyporeflexia.

Overdose:

Symptoms. Long-term use of high doses can lead to the development of hypermagnesemia, which is characterized by rapid fatigue, reddening of the face, exhaustion, muscle weakness and inadequate behavior.

There may also be signs of metabolic alkalosis: mood changes, mental disorders, numbness or pain in the muscles, nervousness and fatigue, slowing of breathing, unpleasant taste sensations.

Urgent measures. It is necessary to immediately take measures to quickly remove Ptreatment - gastric lavage, stimulation of vomiting, reception of activated charcoal.

Interaction:

Almagel® Neo reduces and slows down the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, H blockers₂histamine receptors, beta-blockers, diflunisal, ketoconazole and itraconazole, isoniazid, tetracycline antibiotics and quinolone, azithromycin, cefpodoxime, pivampitsillina, rifampicin, anticoagulants, barbiturates, fexofenadine, dipyridamole, zalcitabine, and efsodezoksiholevoy chenodeoxycholic acid, penicillamine and lansoprazole.

M-holinoblokatory, slowing the emptying of the stomach, strengthen and lengthen the action of the drug.

Special instructions:

The interval between receiving Almagel® Neo and other medications should be 1-2 hours.

With long-term admission should ensure sufficient supply of phosphorus with food.

Due to the lack of controlled clinical trials, breastfeeding women Almagel® Neo should only be taken after consultation with a doctor.

One measuring spoon (5 ml) of the preparation contains 0.113 g of ethyl alcohol. One packet (10 ml) of the preparation contains 0.226 g of ethyl alcohol.

As a result, complications may occur in patients with liver and brain diseases, alcoholism and epilepsy, in pregnant women and children under 18 years of age.

The daily dose of the preparation (8 scoops or 4 sachets) contains 0.904 g of ethyl alcohol, the maximum daily dose of the suspension (12 scoops or 6 sachets) contains 1.356 g of ethyl alcohol. One measuring spoon (5 ml) of Almagel® Neo contains 0.475 g of sorbitol. One packet (10 ml) of the suspension contains 0.950 g of sorbitol. Sorbitol is contraindicated in congenital intolerance to fructose and can cause stomach irritation and diarrhea.

Effect on the ability to drive transp. cf. and fur:Almagel® Neo does not adversely affect the ability to drive vehicles and work with mechanisms that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Suspension for oral administration.

Packaging:

For 170 ml or 200 ml of the drug in a bottle of dark glass or polyethylene terephthalate with a screwed plastic cap. Each vial with instructions for use and a measuring spoon for 5 ml in a cardboard bundle.

For 10 ml of the drug in a bag of multilayer foil. 10 or 20 bags together with instructions for use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.Do not freeze! Keep out of the reach of children!

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013310 / 01

Date of registration:18.09.2009 / 20.03.2012

Expiration Date:Unlimited

The owner of the registration certificate:Balkanfarm - Troyan ADBalkanfarm - Troyan AD Bulgaria

Manufacturer: & nbsp

BALKANPHARMA-TROYAN, AD Bulgaria

Representation: & nbspAktavis, Open Company Aktavis, Open Company

Information update date: & nbsp11.07.2017

Illustrated instructions

Instructions

Almagel® Neo (Almagel® Neo)