Asacol Mesalazine tablets 800mg №60

Asacol Mesalazine tablets 800mg №60

Product Code: 7987
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active substance:1 capsule contains mebeverine hydrochloride 200 mg

Excipients:microcrystalline cellulose, manit (E 421), spherical sugar, povidone, sodium lauryl sulfate, ethyl cellulose, hypromellose (hydroxypropyl methylcellulose) phthalate, cetyl alcohol;

the composition of the shell capsules: gelatin, titanium dioxide (E 171).


Dosage form

modified release solid capsules.

basic physical and chemical properties:capsules, solid, gelatin, with white lid and body. The contents of capsules - pellets white, or almost white.


drug description

agents used in functional gastrointestinal disorders. Synthetic anticholinergics, esterification tertiary amines.

Code ATKH А0ЗА A04, collect statistical agencies.


Pharmacological properties


Mebeverine is a myotropic spasmolytic agent with a selective action on the smooth muscle of the digestive tract. Eliminates spasms mebeverine without oppression normal intestinal motility. Since this action is not mediated by the Autonomous nervous system, there are no typical anticholinergic side effects.



Mebeverine is rapidly and completely absorbed after oral administration. Due to prolonged release of the drug from the capsule, it can be taken 2 times a day.


with repeated use mebeverina significant cumulation does not occur.


Severina hydrochloride is mainly metabolized by serum esterases, which at the first stage of the metabolic break down of the ester bond with the formation of veratrole acid and mebeverine alcohol. In plasma dimethylquinoxaline acid (DMCC) is the main metabolite. Half - life of DMCC in equilibrium-5,77 hours. With repeated use of capsules (200 mg 2 times a day) CmaxDMKK was 804 ng/ml, and tmax- about 3:00. The relative bioavailability of prolonged action capsules was optimal with an average ratio of 97%.


Mebeverine is not excreted in unchanged form, it is completely metabolised and the metabolites are excreted almost completely. Veratric acid is excreted in the urine. Mebeverine alcohol is also excreted by the kidneys in the form of carboxyl (UK) or dimethylquinoxaline acid (DMCC).


Pharmacokinetic studies in children were not carried out.


Adults and children over 10 years of age:


    symptomatic treatment of abdominal pain and spasms, intestinal disorders and discomfort in the intestines with irritable bowel syndrome; The

  • the treatment of gastrointestinal spasm secondary origin, caused by organic disease.


Hypersensitivity to the active substance or to any of the components of the drug.


Interaction with other medicinal products and other forms of interaction

the interaction of the drug with alcohol was studied. Studies ofin vitroandin vivoon animals have shown that there is no interaction between mebeverine and ethanol.

application Features


use during pregnancy or lactation.

Aspadmin not recommended for use during pregnancy in light of limited data on the use mebeverine pregnant.

it is Unknown, displayed mebeverine or its metabolites in breast milk, so Aspadmin should not be used during breast-feeding.

there are no Clinical data on the effect of the drug on male or female fertility.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms.

Studies on the effect of the drug on the ability to drive and operate machinery were not carried out. Pharmacodynamic and pharmacokinetic profile does not indicate a harmful effect on the ability to drive or operate machinery.

Method of application and doses

the Drug is designed for oral use.

drink Capsules with sufficient amount of water (not less than 100 ml). It is not recommended to chew the capsule as the capsule coating provides prolonged release of the active substance.

Adults and children over 10 years old take 1 capsule 2 times daily (morning and evening).

the Duration of use is not limited. If the patient missed taking one or more doses, the following dose should be taken as expected. Missed doses should not be taken additionally.

Special patient groups

dosing Studies were not conducted for elderly patients, patients with impaired renal or liver function. There was no specific risk for elderly patients, patients with impaired renal or liver function. Dose adjustment for the above-mentioned groups of patients is not necessary. should Not use the drug to children under 3 years due to the lack of clinical data regarding this age group of patients. Children aged 3 to 10 years also should not use the drug for its high content of active substance.


Symptoms.overdose may theoretically cause Central nervous system excitation. In cases of overdose mebeverina symptoms were absent or were mild and quickly disappeared. Symptoms of overdose observed were of neurological or cardiovascular origin.

Treatment.Specific antidote is unknown. Symptomatic treatment is recommended. Gastric lavage is recommended only in case of intoxication with several drugs within 1:00 from the moment of taking medicines. Measures to reduce absorption are not necessary.

Side effects

on the part of the skin and subcutaneous tissue:urticaria, angioneurotic edema, facial edema, and rash.

from the immune system:hypersensitivity (anaphylactic reactions).


shelf Life

2 years old.

storage Conditions

Store in its original packaging at a temperature not exceeding 25 ° C.

keep out of reach of children.



: 10 capsules per blister, 3 blisters per bundle.


Category vacation

According to the recipe.



PJSC "Kyiv vitamin factory".

location of the manufacturer and address of the place of business

04073, Ukraine, G.. Kyiv, Kopylivska, 38.



Asacol tablets 800 mg № 60 – medicinal anti-inflammatory agent that is used in diseases of the intestine. Mesalazine-the main active ingredient of the drug, rapidly absorbed into the bloodstream and inhibits the activity of lipoxygenases. As a result, the synthesis of leukotrienes (anti-inflammatory) in the intestinal walls is inhibited.


the product is:

  • in the treatment of ulcerative colitis patients mild as well as moderate severity.
  • The
  • as the main support means in the period of remission.
  • while treatment of the disease Krona.

the Product, accumulating in the body, has a positive effect on the submucosal tissue and intestinal mucosa. On the second day of taking the tablets, the bowel function normalizes and acute pain, which is typical for ulcerative colitis, goes away.

Method of application and doses

Pills you need to eat inside 1 hour before a meal. For patients with ulcerative colitis, 800 mg of the drug is prescribed per day (1 tablet). In the treatment

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