GERBION LAKSANA

Active material: dry standardized extract of leaves of Senna
When ATH: A06ab06
CCF: Laxatives, stimulating peristalsis
ICD-10 codes (testimony): K59.0
When CSF: 11.08.04
Manufacturer: KRKA d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Pills, Film-coated dark brown, round, chamfered.

1 tab.
dry standardized extract of leaves of Senna33.5 mg,
in terms of sennozid in15 mg

Excipients: lactose monohydrate, microcrystalline cellulose, povidone, Croscarmellose sodium, glycerol, Colloidal anhydrous silica, magnesium stearate.

The composition of the shell: gipromelloza, propylene glycol, talc, Titanium dioxide (E171), red iron oxide Brown (E172).

The extractant: methanol 60% (the ratio of raw materials 25-45:1).

10 PC. – blisters (2) – packs cardboard.

 

Pharmacological action

Laxative preparation plant, contains gidroksiantracenovye glycosides and sennosides, stimulating intestinal peristalsis.

Laxative effect have 1.8-gidroksiantracenovye derivatives, resulting from the metabolism in the colon. Sennosides and glycosides are not absorbed in the small intestine; unaltered fall into the large intestine, where they are metabolized by the bacteria of intestinal flora to active metabolites – reinantronov.

Reinantrony affect the irritative large bowel, increasing propulsion reduction. Reduced contact time water and electrolyte with mucous membranes of the intestine, reduced their intake and, as a result of, accelerated walkthrough kishechniku its contents. Under the influence of reinantronov also amplified the secretion of water and electrolytes in the lumen of the bowel due to stimulation of active secretion of chloride. Due to the delay of water in proswete bowel, the contents of the bowel is softened and facilitates its excretion.

 

Pharmacokinetics

After intake of sennosides practically is not absorbed in the DIGESTIVE TRACT. Glikozidnye ties are broken down in the large intestine and form sennidiny, that under the action of bacterial reduktaz converted to reinantrony – active metabolites.

Of reinantronov (more 90%) bowel problems are displayed in the form of a pharmacologically inactive polymers. The remainder of reinantronov rats, but its bioavailability is very low (about 5%).

Vsosavshiesja reinantrony metabolised in the liver. Partly inferred intestine in the form of glukuronidov and partially – kidney, What causes staining of urine from yellow-brown to red.

 

Testimony

- Constipation, caused by the change in diet and the nature of the food;

- Constipation, due to hypotonia and colon atony, incl. in old age, after surgery and childbirth.

 

Dosage regimen

The drug is taken orally, before bedtime, after meal. The tablets should be swallowed whole, without chewing, drinking a small amount of liquid.

Adults and children over 12 years appoint 1-2 tab. the evening before bedtime. Dose and duration of therapy is determined individually. The maximum daily dose – 1.2 g. It is not recommended to take the drug more 1-2 weeks without consulting a doctor.

 

Side effect

Classification of the incidence of side effects: Often (>1/10), often (> 1/100-< 1/10), infrequently (> 1/1000<1/100), rarely (>1/10000-< 1/1000), rarely (< 1/10000 or with unknown frequency (frequency cannot be determined according to the available data)).

From the digestive system: rarely – abdominal cramping, vomiting and diarrhea, flatulence.

Allergic reactions: rarely – itching, Erythema and skin rash.

From the urinary system: yellow or red-brown staining of urine, proteinuria, hematuria (prolonged use, especially in high doses).

Metabolism: gipovolemiя, kaliopenia (Propafenone, especially in high doses, against the backdrop of the admission dioretikov, corticosteroids and cardiac glycosides), hyperaldosteronism.

CNS: fatiguability, confusion, muscle cramps (prolonged use).

 

Contraindications

-spastic constipation, ileus, strangulated hernia, perforated ulcer, gastrointestinal bleeding;

-acute and chronic inflammatory diseases of the abdominal cavity organs (appendicitis, Crohn's disease, yazvennыy colitis, proctitis and hemorrhoids (acute phase));

- Abdominal pain of unknown origin;

- Metrorragija;

— violations vodno-elektrolitnogo Exchange;

- Cystitis;

- Galactosemia, lapp lactase deficiency (lactase deficiency, some people of the North) or glucose-Galactose malabsorption syndrome;

- Children up to age 12 years;

- Pregnancy;

- Lactation;

-hypersensitivity to Senna extract or other components of the drug.

FROM caution should be prescribed the drug for liver and / or kidney failure, cases after abdominal operations, diabetes.

 

Pregnancy and lactation

The drug is not recommended during pregnancy and lactation, tk. inadequate study of the efficacy and safety of its use in these periods.

Active metabolites gidroksiantracenovyh glycosides stand out with breast milk.

 

Cautions

Effective dose is determined individually. Treatment starts with a minimum dose (1 tab). Development of diarrhea is a sign of drug overdose, in this case, the dose should be reduced.

With frequent or daily need for laxatives means should consult a doctor to determine the cause of constipation. In developing constipation recommended eating foods, rich in vegetable fibers, a large amount of fluid intake and exercise.

Excess intake of laxatives can lead to addiction with the need for increased doses of the drug and the violation of water and electrolyte balance (in particular, hypokalemia), as well as bowel atony. In this connection,, We recommend alternating with other laxatives.

Colorectal pigmentation (psevdomelanoznyj colitis) may be a consequence of chronic intake of laxatives, gidroksiantracenovye-containing glycosides. This condition is reversible and passes after the cancellation of such drugs.

When taking the drug, you may receive the staining of urine – yellow or red-brown due to metabolites, Kidney output. It is not a pathological symptom and goes after drug discontinuation alone.

Patients with diabetes should take into account, each tablet contains 320 Lactose mg.

Gerbion® Laksana contains lactose, Therefore, it should not be prescribed to patients with galaktozemiej, lapp lactase deficiency deficiency (lactase deficiency, some people of the North) or malabsorbtion syndrome of glucose- galactose.

Effects on ability to drive vehicles and management mechanisms

The drug does not affect the ability to drive a car or other technical means.

 

Overdose

Symptoms: abdominal pain, diarrhea, vomiting and subsequent dehydration and electrolyte loss.

Treatment: the restoration vodno-elektrolitnogo balance by shortages of fluids and electrolytes(It is particularly important for children and the elderly), symptomatic therapy.

 

Drug Interactions

The risk gipokaliemii increases while receiving a thiazide diuretic, GCS, and preparations, contain licorice root.

Kaliopenia (appearing on the background of long administered Gerbion® Laksana) increases the sensitivity of myocardial action cardiac glycosides and may potentiate the effects of antiarrhythmic drugs.

Amid simultaneous application with Gerbionom® Laksana disturbed absorption of tetracycline antibiotics.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored in a dry, out of the reach of children at a temperature of no higher than 25° c. Shelf life – 2 year.

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