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UrsofalK
Indications/Uses
URSOFALK is indicated in the treatment of chronic cholestatic liver diseases. For CF, the general recommended dose is up to 20 mg/kg/day. This dose has been shown to improve histology in PSC patients.
Overdosage
Film-coated tablet: Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the feces.
No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
Contraindications
Capsule: Ursodeoxycholic acid (Ursofalk) must not be used if: the patient has an acute inflammation of the gallbladder or bile ducts; the patient has an obstruction of the biliary tract (common bile duct or cystic duct); the patient suffers from frequent cramp-like pains in the upper abdomen (biliary colic); the doctor has told that the patient has calcified gallstones; the patient’s gall bladder is not able to contract properly; the patient is hypersensitive (allergic) to bile acids (such as ursodeoxycholic acid) or to any of the other ingredients of this medicine.
Use in Children: Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia.
Film-coated tablet: Ursofalk 500 mg film-coated tablets should not be used in patients with: acute inflammation of the gall bladder or biliary tract; occlusion of the biliary tract (occlusion of the common bile duct or cystic duct); frequent episodes of biliary colic; radio-opaque calcified gallstones; impaired contractility of the gall bladder; hypersensitivity to bile acids or any excipient of the medicinal product.
Use in Children: Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia.
Film-coated tablet: Ursofalk 500 mg film-coated tablets should not be used in patients with: acute inflammation of the gall bladder or biliary tract; occlusion of the biliary tract (occlusion of the common bile duct or cystic duct); frequent episodes of biliary colic; radio-opaque calcified gallstones; impaired contractility of the gall bladder; hypersensitivity to bile acids or any excipient of the medicinal product.
Warnings
Capsule: Ursodeoxycholic acid (Ursofalk) 250 mg capsules must be used under medical supervision. Doctor should test liver function regularly every 4 weeks for the first 3 months of treatment. After this time, it should be monitored at 3-month intervals.
When used to dissolve gallstones, the doctor should arrange for a scan of the patient’s gall bladder after the first 6-10 months of treatment.
If the patient is a woman and take this medicine for dissolution of gallstones the patient should use an effective non-hormonal method of contraception, since hormonal contraceptives may encourage the formation of gallstones.
When used in the treatment of PBC, in rare cases the symptoms (e.g. itching) may worsen at the beginning of treatment. If this happens, please speak to the doctor about reducing the initial dose.
Tell the doctor immediately if the patient is suffering from diarrhoea, as the patient may need the dose to be reduced or to stop taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules.
When used to dissolve gallstones, the doctor should arrange for a scan of the patient’s gall bladder after the first 6-10 months of treatment.
If the patient is a woman and take this medicine for dissolution of gallstones the patient should use an effective non-hormonal method of contraception, since hormonal contraceptives may encourage the formation of gallstones.
When used in the treatment of PBC, in rare cases the symptoms (e.g. itching) may worsen at the beginning of treatment. If this happens, please speak to the doctor about reducing the initial dose.
Tell the doctor immediately if the patient is suffering from diarrhoea, as the patient may need the dose to be reduced or to stop taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules.
Side Effects
Side effects of Ursofalk are Abdominal pain, Diarrhea, Hair loss, Itching, Nausea, Rash, Headache, Back pain, Abdominal discomfort, Allergy, Chest pain, Fatigue, Dyspepsia, Flatulence, Vomiting, Joint pain, Joint inflammation, Muscle pain, Insomnia (difficulty in sleeping), Bronchitis (inflammation of the airways).
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