Ursofalk Capsule

Ursofalk Capsule

ursodeoxycholic acid


Dr Falk


Agencia Lei Va Hong


A. Menarini
Full Prescribing Info
Ursodeoxycholic acid.
Each capsule contains 250 mg ursodeoxycholic acid.
Ursodeoxycholic acid, the active substance in Ursofalk capsules, is a naturally-occurring bile acid with small amounts found in human bile.
Excipients/Inactive Ingredients: Gelatin, colloidal silica anhydrous, magnesium stearate, maize starch, sodium dodecyl sulfate, titanium dioxide and purified water.
Ursofalk capsules are used: to dissolve cholesterol gallstones. These stones must be radiolucent (not visible on a plain X-ray) and no larger than 15 mm in diameter. The gall bladder must still be working despite the gallstone(s).
To treat inflammation of the stomach lining caused by the reflux of bile acids (bile reflux gastritis).
For the symptomatic treatment of primary biliary cirrhosis (PBC which is a disease of the bile ducts up to cirrhosis of the liver), provided there is no decompensated liver cirrhosis (diffuse chronic disease of the liver, at a stage when the reduced liver function can no longer be compensated).
Dosage/Direction for Use
To dissolve cholesterol gallstones: Approx. 10 mg per kg body weight (BW) daily, as follows: up to 60 kg 2 capsules, 61-80 kg 3 capsules, 81-100 kg 4 capsules, over 100 kg 5 capsules.
How to take Ursofalk capsules: Swallow the capsules whole with a drink of water or other liquid. Take the capsules in the evening at bedtime. Take the capsules regularly.
Duration of treatment: It generally takes 6-24 months to dissolve gallstones. If there is no reduction in the size of the gallstones after 12 months, therapy should be stopped.
Every 6 months, check with the doctor whether the treatment is working. At each of these follow-up examinations, it should be checked whether calcification of the stones has occurred since the last time. Should this be the case, stop the treatment.
To treat bile reflux gastritis: Take one Ursofalk capsule in the evening at bedtime; swallow the capsule whole with a drink of water or other liquid.
Duration of treatment: Ursofalk capsules are usually taken for 10-14 days in the treatment of bile reflux gastritis. The doctor will decide how long the patient will have to take the capsules for, depending on the course of the medical condition.
Symptomatic treatment of primary biliary cirrhosis (chronic disease of the bile ducts): During the first 3 months of treatment, take Ursofalk capsules in divided doses during the day. As liver function tests improve, the total daily dose may be taken once a day in the evening. (See table.)

Click on icon to see table/diagram/image

Ursofalk suspension is available if the weight is less than 47 kg or cannot swallow Ursofalk capsules.
How to take Ursofalk capsules: The capsules should be swallowed whole with a drink of water or other liquid. Make sure to take the medicine regularly.
Duration treatment: Ursofalk capsules can be continued indefinitely in cases of primary biliary cirrhosis.
Note: In patients with primary biliary cirrhosis, the clinical symptoms may worsen at the start of treatment, e.g. the itching may increase. This only occurs in rare cases. In this case, therapy can be continued with a lower daily dose of Ursofalk capsules. Each week, the doctor will then gradually increase the daily dose, until the required dose is reached.
If the effect of Ursofalk capsule is too strong or too weak, talk to a doctor or pharmacist.
If the patient takes too few Ursofalk capsules or forget a dose: Do not take more capsules the next time, but just continue the treatment with the prescribed dose.
Effects when the patient stops taking Ursofalk capsules: Always ask a doctor before interrupting the treatment with Ursofalk capsules or stopping the treatment early.
Diarrhoea may occur as a result of overdose. Inform a doctor immediately for persistent diarrhoea, as this may require a reduction in the dose and make sure to drink enough liquids to replace the fluid and electrolyte balance.
Hypersensitivity (allergic) to ursodeoxycholic acid or to any of the other ingredients of Ursofalk capsules (listed in Description).
If the patient has an acute inflammation of the gall bladder or biliary tract.
If the patient has an obstruction of the biliary tract (blockage of the common bile duct or cystic duct).
Special Precautions
If the gall bladder cannot be seen on X-ray; calcified gallstones; gall bladder is not able to contract properly; frequent cramp-like pains in the upper abdomen (biliary colic).
Ask the doctor about any of the conditions mentioned and if the patient previously had any of these conditions.
Ursofalk capsules must be used under medical supervision. The doctor should test the liver function regularly every 4 weeks for the first 3 months of treatment. After this time, it should be monitored at 3-monthly intervals.
Driving and using machines: No particular precaurions are necessary.
Use in children: There are no age limits to the use of Ursofalk capsules. The administration of Ursofalk capsules is based on body weight and the medical condition. For children who are not able to swallow capsules or weigh less than 47 kg, Ursofalk is available in a liquid form (Ursofalk suspension).
Use In Pregnancy & Lactation
Do not take Ursofalk capsules during pregnancy unless the doctor thinks it is absolutely necessary. Even if not pregnant, still discuss this possibility with the doctor as women of child-bearing age, should only be treated if they are using a reliable method of contraception. Check if the patient is not pregnant before starting the treatment with Ursofalk capsules.
There is insufficient experience in humans, particularly in the first three months of pregnancy. Studies in animals have shown evidence of teratogenic effects during the early phase of gestation.
Do not take this medicine if breastfeeding. It is not known whether the active substance in Ursofalk capsules passes into breast milk. If treatment with Ursofalk capsules is necessary, stop breastfeeding.
Side Effects
Like all medicines, Ursofalk capsules can cause side effects, although not everybody gets them.
Common side effects: (occurring in less than 1 in 10 but more than 1 in 100 patients): soft, loose stools or diarrhoea.
Very rare side effects: (occurring in less than 1 in 10,000 patients): during the treatment of primary biliary cirrhosis: severe right-sided upper abdominal pain, severe worsening (decompensation) of liver cirrhosis which partially regresses after treatment is discontinued; calcification of gallstones; urticaria (nettle rash).
If any of the side effects gets serious, or if there is any side effects not listed tell the doctor or pharmacist.
Drug Interactions
Tell the doctor if the patient is taking or have recently taken any other medicines which contain the following ingredients. The effects of these medicines may be altered (interactions): A reduction in the effects of the following active ingredients possible when taking Ursofalk capsules: colestyramine, colestipol (to lower blood lipids) or aluminium hydroxide, smectite (aluminium oxide)-containing antacids (agents that bind gastric acid). If the patient is taking medication that contains any of these active ingredients, it must be taken at least two hours before or after Ursofalk capsules.
Ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines which are metabolised in a similar way. It may be necessary for the doctor to alter the dose of these medicines.
An increase in the effects of the following medicines is possible when taking Ursofalk capsules: ciclosporin (to reduce the activity of the immune system). If the patient is being treated with ciclosporin, the doctor should check the amount of ciclosporin in the blood. The doctor will adjust its dose, if necessary.
Tell a doctor or pharmacist if the patient is taking or have recently taken any other medicines, even if they are medicines obtainable without a prescription. Treatment with Ursofalk capsules may still be indicated.
Caution For Usage
Do not exceed the recommended dose. In a clinical trial, the use of high dose ursodeoxycholic acid (28-30 mg/kg/day) was associated with higher rates of serious adverse events.
ATC Classification
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
Cap (white, opaque, containing white powder/granules) 250 mg x 100's.
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