Ursactive

Ursactive

• The active ingredient of the preparation is Ursodeoxycholic Acid. This is a natural bile acid that is present in small quantities in the human body. In medicinal form, it is used in a higher concentration to provide therapeutic effect.

Ursactive is available in two forms to ensure convenience of administration for patients of different ages and with different needs:

• Capsules of 250 mg and 500 mg — suitable for adults and adolescents who have no problems with swallowing.

• Oral suspension — 250 mg/5 ml — mainly used for children under 12 years or patients who find it difficult to swallow capsules. The choice of form depends on the patient's age, body weight and preferences for taking medicine.

Ursactive is used to treat diseases of the liver, gallbladder and bile ducts. It helps dissolve certain types of gallstones, protects liver cells and normalises bile secretion.

Indications for use include:

• Dissolution of cholesterol gallstones — provided that the stones are radiolucent (do not contain calcium), their size is up to 15 mm, and the gallbladder is functioning.

• Primary biliary cirrhosis (PBC) — in early stages, without signs of decompensation.

• Biliary reflux esophagitis and gastritis — to reduce the aggressive effect of bile on the mucosa.

• Hepatobiliary disorders in cystic fibrosis (in children from 6 to 18 years).

• Chronic active and acute hepatitis accompanied by cholestasis.

• Cystic fibrosis, congenital bile duct atresia, biliary dyspeptic syndrome.

• Alcoholic and non-alcoholic liver damage (including steatohepatitis).

• Prevention of cholestasis when taking hormonal contraceptives.

• Support of liver function when taking cytostatics.

• Organ transplantation — as adjunctive therapy.

Ursactive helps not only to eliminate symptoms but also affects the causes of bile formation disorders and bile acid metabolism.

The regimen for Ursactive is selected individually depending on the diagnosis, body weight and age of the patient.

Dosage for adults and adolescents (from 12 years):

• 10–15 mg/kg body weight per day, divided into 2–3 doses.

• For primary biliary cirrhosis — 13–15 mg/kg/day.

• For biliary reflux gastritis — 250 mg once a day, before bedtime.

For children:

• Usually 10–20 mg/kg/day in 2–3 doses.

• Children under 12 years are more often prescribed suspension — it allows accurate dosing.

Duration of treatment:

• For gallstones — from 6 months to 2 years.

• For chronic liver diseases — long-term maintenance therapy.

Administration rules:

• Swallow capsules whole with water.

• If swallowing is difficult, the contents of the capsule can be dissolved in water.

• The intake should be regular, without skipping. Disruption of the regimen reduces the effectiveness of treatment.

Ursactive should not be used in a number of conditions where its action may be ineffective or even dangerous.

Absolute contraindications:

• Allergy to ursodeoxycholic acid or any other component of the preparation.

• Acute inflammation of the gallbladder and bile ducts.

• Empyema of the gallbladder — accumulation of pus in its cavity.

• Biliary-intestinal fistulas — pathological connections between the biliary tract and intestine.

• Frequent attacks of biliary colic — may indicate obstruction of the ducts.

• Calcified (radiopaque) stones — Ursactive cannot dissolve them.

• Impaired motility of the gallbladder — if there are no contractions, the preparation will not be excreted.

• Liver cirrhosis in the stage of decompensation — in severe liver failure.

• Severe renal disorders — due to the risk of accumulation of the preparation.

Before starting treatment, it is important to conduct an examination, including ultrasound of the gallbladder, and make sure that Ursactive is right for you.

Treatment with Ursactive requires regular monitoring and following the doctor's recommendations, especially with long-term use.

• With long-term therapy, it is necessary to regularly monitor liver enzymes (ALT, AST, GGT) and perform ultrasound of the gallbladder every 6 months — to track the effectiveness of treatment and not miss possible complications.

• If diarrhoea occurs — the dose should be reduced or intake temporarily discontinued.

• Women taking Ursactive to dissolve stones should use reliable non-hormonal contraception. Hormonal preparations (e.g., oral contraceptives) may reduce the effectiveness of treatment and contribute to the formation of new stones.

• Use of the preparation in children should be carried out under strict medical supervision — especially in congenital diseases of the liver or bile ducts.

If you notice a change in stool colour, increased pain in the right hypochondrium or deterioration of your general condition — consult a doctor.

Ursactive may interact with a number of preparations, which affects its effectiveness or enhances side effects.

Most significant interactions:

• Aluminium-containing antacids (e.g., Almagel) — reduce the absorption of Ursactive. They should be taken no earlier than 2 hours after the preparation.

• Cholestyramine and colestipol — bind bile acids in the intestine. Ursactive should be taken 4–6 hours after them, otherwise its effect is reduced.

• Cyclosporin — possible change in its blood level. Monitoring and dose adjustment are necessary.

• Rosuvastatin — its concentration may increase, which increases the risk of side effects.

• Clofibrate, bezafibrate — may reduce the effectiveness of Ursactive by increasing cholesterol production in bile.

Before starting treatment, be sure to tell your doctor about all preparations you are taking, including dietary supplements and herbal preparations.

Ursactive is contraindicated during pregnancy — especially in the first trimester.

• Before starting treatment, pregnancy must be excluded.

• Women of childbearing age are recommended to use reliable contraception. Non-hormonal methods are preferred, as hormonal preparations may enhance stone formation.

• Data on the penetration of ursodeoxycholic acid into breast milk are insufficient. Use during lactation is possible only as prescribed by a doctor if the expected benefit outweighs the potential risk.

If you are planning a pregnancy — be sure to inform your doctor before starting treatment.

Ursactive generally does not affect the ability to drive or work with machinery. However, in rare cases, the following may occur:

• dizziness;

• decreased concentration.

If during taking the preparation you feel these symptoms — you should refrain from driving and working with potentially dangerous machinery until your condition normalises.

Like any medicine, Ursactive can cause side effects. Most often they are related to the gastrointestinal tract, less often — to the immune and hematopoietic system.

Gastrointestinal reactions:

• very common — diarrhoea;

• common — nausea, vomiting, abdominal pain;

• rare — constipation.

Allergic reactions:

• rare — skin rash, itching, urticaria;

• very rare — angioedema, anaphylactic shock.

Blood-related:

• very rare — leukopenia (decreased level of leukocytes), thrombocytopenia (decreased platelets).

Nervous system:

• rare — dizziness.

Urinary system:

• very rare — renal colic.

Other side effects:

• rare — calcification of gallstones;

• very rare — exacerbation of psoriasis, hair loss (alopecia).

If during treatment you notice any adverse reactions, especially skin rashes, deterioration of well-being or stool disorders, be sure to consult a doctor. You should not stop the preparation on your own — this may affect the course of the disease.

Ursactive is considered relatively safe, but exceeding the dose may cause side effects.

The main symptom of overdose is diarrhoea. This is because excess bile acids enhance intestinal motility.

What to do in case of overdose:

• if diarrhoea occurs — reduce the dose or temporarily stop taking it;

• in severe cases — consult a doctor for symptomatic treatment.

There is no specific antidote. Usually, discontinuation of the preparation and supportive therapy are sufficient.

Ursodeoxycholic acid (UDCA) — the active ingredient of Ursactive — belongs to natural bile acids. It has several important effects:

• hepatoprotective — protects liver cells from damage by toxic bile acids;

• cholelitholytic — reduces the level of cholesterol in bile and promotes the dissolution of cholesterol stones;

• choleretic — stimulates the formation and outflow of bile;

• immunomodulatory — reduces inflammation in autoimmune liver diseases (e.g., in primary biliary cirrhosis).

These properties make the preparation effective for cholestasis, biliary disorders and fatty liver disease.

After oral administration, ursodeoxycholic acid is rapidly absorbed in the small intestine. The further path of the preparation includes:

• metabolism in the liver — it is conjugated with glycine or taurine;

• excretion with bile — as part of bile, it enters the intestine and participates in digestion;

• enterohepatic circulation — returns to the liver, going in a circle;

• elimination — mainly with faeces, in unchanged or conjugated form.

Ursactive practically does not accumulate in the body. However, in case of impaired liver or bile duct function, the pharmacokinetics may change.

Ursactive belongs to several pharmacological groups at once. This allows it to be used for a wide variety of liver and bile duct diseases.

• Bile acids. The main active ingredient of Ursactive — ursodeoxycholic acid (UDCA) — is a natural bile acid. It is part of human bile and participates in the process of digestion, breaking down fats and regulating the composition of bile. In medicinal form, UDCA is introduced into the body in a higher concentration to correct pathological changes in bile and protect the liver.

• Hepatoprotectors. The preparation protects liver cells from damage — both from toxic bile acids and from external factors (alcohol, medicines, viral infections). UDCA stabilises cell membranes, reduces inflammation and promotes regeneration of liver tissue.

• Cholelitholytic agents. Ursactive dissolves cholesterol stones in the gallbladder. This happens due to a decrease in the concentration of cholesterol in bile and an increase in its fluidity. Such an effect is possible only under certain conditions: if the stones are non-calcified (radiolucent), small in size, and the gallbladder works normally.

• Choleretics (bile-stimulating preparations). The preparation stimulates the formation and excretion of bile, improving outflow through the bile ducts. This is especially important in diseases accompanied by bile stasis (cholestasis), including biliary disorders and fatty liver disease.

Thus, Ursactive acts comprehensively: it does not just "improve the liver", but normalises the composition of bile, protects hepatocytes and promotes the dissolution of stones. This is why it is valued by both gastroenterologists and patients with chronic liver diseases.

In addition to the main active ingredient — ursodeoxycholic acid — Ursactive contains auxiliary components. They do not have a therapeutic effect but ensure the stability of the preparation, convenience of its administration and proper absorption in the body.

The composition may differ slightly depending on the form of release:

Capsules:

• Corn starch — a filler that gives volume and improves powder flowability.

• Colloidal silicon dioxide — prevents caking, ensures uniform distribution of the active ingredient.

• Magnesium stearate — a lubricant, facilitates the production of capsules.

• Gelatin — the base of the capsule shell, dissolves in the stomach.

• Titanium dioxide (E171) — a colourant that gives the shell a white colour and protects the contents from light.

Oral suspension: Contains flavourings, preservatives and stabilisers that provide uniform consistency and long shelf life. The exact composition depends on the manufacturer and is indicated in the instructions.

If you are allergic to any of the auxiliary components — be sure to inform your doctor before starting treatment.

The shelf life of Ursactive depends on the form of release, but on average is 2–3 years from the date of manufacture.

The packaging always indicates:

• the expiry date (month and year);

• batch number — important when reporting side effects;

• storage conditions — compliance with which directly affects the stability of the preparation.

Do not use the preparation after the expiry date. This may reduce its effectiveness and increase the risk of adverse reactions. This is especially important for liquid forms, which have a much shorter shelf life after opening.

For Ursactive to maintain its effectiveness, it is important to observe storage conditions:

General recommendations:

• store at a temperature not exceeding 25°C;

• protect from light, moisture and overheating;

• do not allow freezing of the suspension — this destroys the structure of the preparation;

• keep in the original packaging — it protects from external influences;

• keep away from children — even with accidental intake, side effects may occur.

Features of storing the suspension after opening:

• store in the refrigerator at a temperature of 2–8°C;

• do not freeze;

• before each use — shake thoroughly;

• the shelf life after opening is indicated in the instructions (usually 30 days).

Following these recommendations helps maintain the therapeutic properties of the preparation until the end of its shelf life.

The form and format of packaging depend on the dosage form of the preparation:

Ursactive capsules:

• packed in blisters (foil + plastic) of 10, 25, 50 or 100 capsules;

• blisters are placed in a cardboard box with instructions;

• the packaging indicates the name, dosage, batch number, expiry date.

Oral suspension:

• produced in dark glass or plastic bottles, with a volume of 100, 250 or 500 ml;

• the bottle is equipped with a cap with first opening control;

• the kit includes a measuring spoon or dosing syringe — for accurate dosing;

• the packaging contains information about dosage, volume, manufacturer, storage conditions.

Important: before use, make sure the packaging is intact. Do not use the preparation if the expiry date has passed or there is visible damage to the bottle or blister.

Proper disposal of preparations helps avoid environmental pollution and accidental ingestion of the medicine by children or animals.

How to safely dispose of Ursactive:

• do not throw the preparation in the sink, toilet or waste bin;

• if possible, return the remains to a pharmacy — many pharmacies accept expired medicines;

• if this is not possible — mix the preparation with an inedible substance (coffee grounds, cat litter), seal in a bag and throw in household waste;

• erase or cross out personal data from the packaging and prescriptions.

Additionally:

• do not store Ursactive near food;

• do not give the preparation to other people — even if they have the same symptoms;

• in case of accidental contact with skin or eyes — rinse with water and consult a doctor if necessary.

• Ursactive is officially registered and distributed in Turkey.

• Humanis (Turkey)

Ursactive is a prescription medication and is dispensed only by doctor's prescription.

This is due to the need for:

• individual calculation of dosage;

• regular monitoring of the condition of the liver and bile ducts;

• assessment of contraindications and risk of side effects.

Self-treatment with the preparation may be ineffective or unsafe — especially if there are stones in the gallbladder.

For treatment with Ursactive to give the expected effect, it is important to follow a number of recommendations:

• Follow your doctor's prescriptions — regarding dosage, duration of the course and regimen of intake.

• Monitor your well-being: if pain in the right hypochondrium, diarrhoea, rash appear — consult a doctor.

• Women taking the preparation to dissolve stones should use reliable non-hormonal contraception.

• The preparation is not intended for a quick effect — results appear with regular and long-term use.

• Ursactive can only be used with a functioning gallbladder. Before starting treatment, ultrasound and X-ray are usually performed to exclude calcified stones.

• If the patient has previously had a liver or organ transplant — the preparation is prescribed only under the supervision of specialists.

And finally: information in open sources may differ. For accurate data, always refer to the official instructions and recommendations of your doctor.

• A05AA02 — Ursodeoxycholic acid

Ursactive can be used for the following diseases (according to ICD-10 classification):

• K74 — fibrosis and cirrhosis of the liver

• K77 — liver disorders in other diseases

• K80 — cholelithiasis

• K80.2 — gallstones without cholecystitis

The preparation may also be used for other liver and biliary system diseases — as prescribed by a doctor.