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MEXIDOL® (Emoxipine) 125 mg, 50 coated tablets
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Description
The instruction for use
of medicine for experts
of KULZ
the Trade name
Kulz
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
the Structure Each Chewable Tablet Chewable tablets contains:
Active agents:
Dry hydroxide of aluminum of B.F. of 300 mg
of Magnesium B.F. trisilicate 50 mg
of Magnesium hydroxide F. The USA 25 mg
F. Simetikon of the USA 10 mg
Excipients for tablets with taste of mint:
Corn starch B. F., dye leyk diamond blue, sucrose B. F., povidone B. F., Natrium benzoicum of B.F., sodium chloride B. F., menthol B. F., magnesium stearate B. F., dry fragrance of a peppermint.
Excipients for tablets with taste of mango:
Corn starch B. F., dye leyk quinolinic yellow, sucrose B. F., povidone B. F., Natrium benzoicum of B.F., sodium chloride B. F., menthol B. F., magnesium stearate B. F., dry mango fragrance.
Excipients for tablets with taste of strawberry:
Corn starch B. F., dye leyk crimson 4R, sucrose B. F., povidone B. F., Natrium benzoicum of B.F., sodium chloride B. F., menthol B. F., magnesium stearate B. F., dry strawberry fragrance.
Excipients for tablets with taste of orange:
Corn starch B. F., dye leyk sucrose B. F., povidone B. F., Natrium benzoicum of B.F., sodium sanst yellow, chloride B. F., menthol B. F., magnesium stearate B. F., orange fragrance.
The pharmacotherapeutic
The Combined Antiacid Means group
the Code ATC A02AX Aluminium Pharmacodynamics hydroxide and compounds of magnesium are the main substances almost insoluble in alcohol and water, are used as antiacid means. The combination of these substances causes neutralization of gastric acid quicker. Aluminum hydroxide also works as pepsin adsorbent at rn equal 4. Delays gastric emptying and weakens its walls that promotes appearance of a constipation which is eliminated with effect of magnesium of hydroxide and magnesium of trisilicate, causing ease as a result of their osmotic action in an intestines gleam within 3-4 hours after reception. As these components are rather insoluble, antiacid effect of drug is usually extended at several o’clock and system absorption insignificant.
Simetikon represents the dense and viscous substance insoluble in water and low alcohols. Eliminates a meteorism, it is chemically inert, has no systemic action.
Aluminium pharmacokinetics hydroxide: After intake only very small amount of aluminum is soaked up. After absorption, aluminum collects in bones, lungs and tissues of nervous system.
Magnesium hydroxide and magnesium trisilicate under the influence of gastric juice turn in magnesium chloride and become soaking up. Bioavailability of magnesium of chloride and magnesium of hydroxide identical also makes more than 10%.
The main way of removal – through kidneys. In a renal failure the accumulation of magnesium in an organism is possible.
Simetikon: Absorption of a simetikon, presumably, minimum has also no clinical value, there are no data on pharmacokinetics.
Indications
– Elimination of symptoms of an acid reflux and a peptic ulcer
– the Reflux esophagitis
– Prevention of development of stressful ulcers
– the Meteorism, an abdominal distension, colic
– Not ulcer dyspepsia, gastritis
the Route of administration and doses
the Adult:
On 1-2 tablets chew or keep in an oral cavity before full dissolution, up to 4 times a day, preferably in breaks between meals, or on doctor’s orders.
Maximum single dose: 2 tablets.
Maximum daily dose: 8 tablets.
Side effects
of Aluminium hydroxide:
The main side effect is zaporoshok In isolated cases it was reported about irreversible side effects, such as proximal myopathy. At patients with a renal failure the encephalopathy and dementia can develop.
Magnesium of trisilicate / Magnesium hydroxide:
At patients with a renal failure the main side effect is the gipermagniyemiya. If not to apply in a combination with compounds of aluminum, drugs of magnesium can cause diarrhea or dysfunction of intestines.
Contraindications
– the Heavy constipation caused by the mechanical or physiological reasons.
– Exhaustion of reserves of phosphate in an organism, decrease in plasma level of phosphates.
– Osteomalacy
Medicinal interactions
Pharmacokinetic interaction:
Aluminum hydroxide can delay absorption of barbiturates and benzodiazepines therefore for ensuring adequate absorption of these drugs Kulz after two hours after their reception is recommended to accept.
Aluminum hydroxide reduces bioavailability of non-steroidal anti-inflammatory drugs (NPVS), such as diflunizat, indometacin and Naproxenum.
Compounds of magnesium can reduce bioavailability of such drugs as propranolol, an isoniazid, Prednisolonum, and NPVS, such as diflunizat, indometacin and Naproxenum.
Pharmaceutical and pharmakodinamichesky interaction: It was not reported.
The special
instructions Pregnancy and the period of a lactation
As are not present data on use of drug during pregnancy, it is necessary to appoint drug during pregnancy only in urgent cases.
Antiacid means Kulz can cause diarrhea in babies as a small amount of magnesium is distinguished with breast milk therefore drug is not appointed to nursing mothers.
Use in the nursery
the practician Preparat is not appointed the newborn.
Use at advanced age
elderly patients Should be careful when prescribing drug with a renal failure and in the presence of diseases of kidneys.
A renal failure
Prolonged use of drug at patients with a renal failure is contraindicated.
Influence on ability to run motor transport or potentially dangerous mechanisms: about influence it was not reported.
Overdose
About overdose of antiacid means Kulz it was not reported so far. However at acute overdose the development of a gipermagniyemiya with development of the progressing neuromuscular blockade and loss of deep tendon jerks as a result of action of compounds of magnesium is possible.
In case of overdose carry out symptomatic therapy (gastric lavage, prescribing of activated carbon) and the general maintenance therapy.
A form of release and packing
1) Chewable tablets with taste of mint No. 5 x 4.
2) Chewable tablets with taste of mango No. 5 x 4.
3) Chewable tablets with taste of strawberry No. 5 x 4.
4) Chewable tablets with taste of orange No. 5 x 4.
Primary packing: 4 tablets in a strip.
Secondary packing: 5 strips in cardboard packing.
To Store storage conditions in the dry place at the room temperature not over 250C
to Protect from direct sunshine
to Store out of children’s reach
the Expiration date
3 years of date of production
not to apply after an expiration date
a release Form from drugstores
Without prescription of the doctor
Plethico Pharmaceuticals Ltd/Pletkhiko Pharmasyyutikalz Ltd Adres producer of location:
A.B. the Road, Mangliya – 453,771, Indore (L. S.), India
the Legal address:
37/37A, Indastrial Isteyt, Polograund, Indore (L. S.), 452,015, India
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