URSOFALK Ursodeoxycholic Acid 500mg Film-Coated Tablet 1's
RXDRUG-DR-XY43043-1pc
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Features
Brand
Ursofalk
Full Details
Dosage Strength
500mg
Drug Ingredients
- Ursodeoxycholic Acid
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Ursodeoxycholic Acid
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY43043
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For the dissolution of cholesterol-rich gallstones in the bladder and for the treatment of biliary reflux gastritis and cholestatic liver disease. The gallstones must not be visible on X-ray, and gallbladder function must be intact despite the gall stone(s).
Film-coated tablet: For the symptomatic treatment of primary biliary cirrhosis (PBC) in patients without decompensated hepatic cirrhosis.
Film-coated tablet: For the symptomatic treatment of primary biliary cirrhosis (PBC) in patients without decompensated hepatic cirrhosis.
Dosage/Direction for Use
Capsule: The daily dose for the following indications are: Ursodeoxycholic acid (Ursofalk) capsule: For the dissolution of cholesterol gallstones: Approx 10 mg per kg body weight equivalent to: Up to 60 kg 2 capsules; Up to 80 kg 3 capsules; Up to 100 kg 4 capsules; Over 100 kg 5 capsules.
For the treatment of biliary reflux gastritis: 1 Ursofalk 250 mg capsule daily at bedtime.
For the treatment of primary biliary cirrhosis: During the first 3 months of treatment, the patient should take Ursodeoxycholic acid (Ursofalk) 250 mg capsules in the morning, at midday, and in the evening. As liver function tests improve, the total daily dose may be taken once a day in the evening. (See Table 1).
For the treatment of biliary reflux gastritis: 1 Ursofalk 250 mg capsule daily at bedtime.
For the treatment of primary biliary cirrhosis: During the first 3 months of treatment, the patient should take Ursodeoxycholic acid (Ursofalk) 250 mg capsules in the morning, at midday, and in the evening. As liver function tests improve, the total daily dose may be taken once a day in the evening. (See Table 1).
Children with cystic fibrosis aged 6 years to less than 18 years: 20 mg/kg/body weight/day in 2-3 divided doses, with a further increase to 30 mg/kg/body weight/day if necessary (see Table 2).
Route and duration of administration: Swallow the capsules whole, do not chew, with a little fluid.
Take the capsules regularly.
Gallstones generally take from 6 to 24 months to dissolve. If the gallstones have not become smaller after 12 months, do not continue treatment.
The results of therapy should be monitored by ultrasonography or X-ray every 6 months.
For the treatment of biliary reflux gastritis, Ursodeoxycholic acid (Ursofalk) should normally be taken for 10-14 days. The attending physician will decide how long treatment should be continued.
Notes: It is important for the result of treatment to take the capsules regularly.
Liver function parameters should be monitored several times during treatment.
Film-coated tablet: There are no age restrictions on the use of Ursofalk 500 mg film-coated tablets. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk 500 mg film-coated tablets, Ursofalk capsules are available.
The following daily dose is recommended for the various indications: For dissolution of cholesterol gallstones: Approx 10 mg of ursodeoxycholic acid per kg of body weight, equivalent to: Up to 60 kg: 1 film-coated tablet.
61-80 kg: 1½ film-coated tablets.
81-100 kg: 2 film-coated tablets.
Over 100 kg: 2½ film-coated tablets.
The film-coated tablets should be swallowed whole with some liquid in the evening at bedtime. They must be taken regularly.
The time required for the dissolution of gallstones is generally 6-24 months. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued.
The success of the treatment should be checked by means of ultra-sound or X-ray examination every 6 months. At the follow-up examinations, a check should be made to see whether calcification of the stones has occurred in the meantime. Should this be the case, the treatment must be ended.
For the symptomatic treatment of primary biliary cirrhosis (PBC).
The daily dose depends on body weight and ranges from 1½ to 3½ film-coated tablets (14±2 mg of ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment, Ursofalk 500 mg film-coated tablets should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening. (See Table 3).
Take the capsules regularly.
Gallstones generally take from 6 to 24 months to dissolve. If the gallstones have not become smaller after 12 months, do not continue treatment.
The results of therapy should be monitored by ultrasonography or X-ray every 6 months.
For the treatment of biliary reflux gastritis, Ursodeoxycholic acid (Ursofalk) should normally be taken for 10-14 days. The attending physician will decide how long treatment should be continued.
Notes: It is important for the result of treatment to take the capsules regularly.
Liver function parameters should be monitored several times during treatment.
Film-coated tablet: There are no age restrictions on the use of Ursofalk 500 mg film-coated tablets. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk 500 mg film-coated tablets, Ursofalk capsules are available.
The following daily dose is recommended for the various indications: For dissolution of cholesterol gallstones: Approx 10 mg of ursodeoxycholic acid per kg of body weight, equivalent to: Up to 60 kg: 1 film-coated tablet.
61-80 kg: 1½ film-coated tablets.
81-100 kg: 2 film-coated tablets.
Over 100 kg: 2½ film-coated tablets.
The film-coated tablets should be swallowed whole with some liquid in the evening at bedtime. They must be taken regularly.
The time required for the dissolution of gallstones is generally 6-24 months. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued.
The success of the treatment should be checked by means of ultra-sound or X-ray examination every 6 months. At the follow-up examinations, a check should be made to see whether calcification of the stones has occurred in the meantime. Should this be the case, the treatment must be ended.
For the symptomatic treatment of primary biliary cirrhosis (PBC).
The daily dose depends on body weight and ranges from 1½ to 3½ film-coated tablets (14±2 mg of ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment, Ursofalk 500 mg film-coated tablets should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening. (See Table 3).
The film-coated tablets should be swallowed whole with some liquid. They must be taken regularly. The use of Ursofalk 500 mg film-coated tablets in primary biliary cirrhosis may be continued indefinitely.
In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this event, therapy should first be continued with half an Ursofalk 500 mg film-coated tablet or one Ursofalk capsule (containing 250 mg of ursodeoxycholic acid) daily, and the dose then gradually increased (weekly increase of the daily dose by half a film-coated tablet or one Ursofalk capsule) until the dose indicated in the respective dosage regimen is reached again.
In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this event, therapy should first be continued with half an Ursofalk 500 mg film-coated tablet or one Ursofalk capsule (containing 250 mg of ursodeoxycholic acid) daily, and the dose then gradually increased (weekly increase of the daily dose by half a film-coated tablet or one Ursofalk capsule) until the dose indicated in the respective dosage regimen is reached again.
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.
Administration
Should be taken with food: Swallow whole, do not chew.
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.
Long-term, high-dose Ursodeoxycholic acid therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis was associated with higher rates of serious adverse events.
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.
Long-term, high-dose Ursodeoxycholic acid therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis was associated with higher rates of serious adverse events.
Special Precautions
Film-coated tablet: Ursofalk 500 mg film-coated tablet should be taken under medical supervision.
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders or non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis.
When used for dissolution of cholesterol gallstones: In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gall bladder should be visualized (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment.
If the gall bladder cannot be visualized on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, Ursofalk 500 mg film-coated tablet should not be used.
When used for treatment of the advanced stages of primary biliary cirrhosis: In very rare cases decompensation of the hepatic cirrhosis has been observed; which partially regressed after the treatment discontinued. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
Female patients taking Ursofalk 500 mg film-coated tablets for dissolution of gallstones should use an effective non-hormonal method of contraception, since hormonal contraceptives may increase biliary lithiasis.
In patients with PBC, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this case the dose of Ursofalk should be reduced to one Ursofalk 250 mg capsule daily and then gradually increased again (see Dosage & Administration).
Long-term, high-dose UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis was associated with higher rates of serious adverse events.
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and γ-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders or non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis.
When used for dissolution of cholesterol gallstones: In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gall bladder should be visualized (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment.
If the gall bladder cannot be visualized on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, Ursofalk 500 mg film-coated tablet should not be used.
When used for treatment of the advanced stages of primary biliary cirrhosis: In very rare cases decompensation of the hepatic cirrhosis has been observed; which partially regressed after the treatment discontinued. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.
Female patients taking Ursofalk 500 mg film-coated tablets for dissolution of gallstones should use an effective non-hormonal method of contraception, since hormonal contraceptives may increase biliary lithiasis.
In patients with PBC, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this case the dose of Ursofalk should be reduced to one Ursofalk 250 mg capsule daily and then gradually increased again (see Dosage & Administration).
Long-term, high-dose UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis was associated with higher rates of serious adverse events.
Use In Pregnancy & Lactation
Capsule: If the patient is pregnant or breast-feeding, if the patient thinks she is pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: There are no or limited amounts of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown that the growth and development of the baby may be affected. The patient should not take Ursodeoxycholic acid (Ursofalk) 250 mg capsules during pregnancy unless the doctor thinks it is absolutely necessary.
Women of child-bearing potential: Even if the patient is not pregnant, the patient should 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. Non-hormonal methods of contraception or low-dose oestrogen contraceptives ("the Pill") are recommended. The patient should use an effective non-hormonal method of contraception if she is taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules to dissolve gallstones, as hormonal contraceptives may encourage the formation of gallstones.
The doctor will check that the patient is not pregnant before starting the treatment.
Breast-feeding: There are only a few documented cases of Ursodeoxycholic acid (Ursofalk) use in breast-feeding women. Levels of Ursodeoxycholic acid (Ursofalk) in milk are very low and probably no adverse reactions will occur in breastfed infants.
Film-coated tablet: There are no or limited amounts of data from the use of UDCA in pregnant women.
Studies in animals have shown reproductive toxicity during the early phase of gestation. Ursofalk 500 mg film-coated tablets must not be used during pregnancy unless clearly necessary.
Women of childbearing potential should be treated only if they are using reliable contraception. Non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking Ursofalk 500 mg film-coated tablets for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis. The possibility of a pregnancy must be excluded before beginning treatment.
According to few documented cases of breastfeeding women milk levels of UDCA are very low and probably no adverse reactions are to be expected in breastfed infants.
Pregnancy: There are no or limited amounts of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown that the growth and development of the baby may be affected. The patient should not take Ursodeoxycholic acid (Ursofalk) 250 mg capsules during pregnancy unless the doctor thinks it is absolutely necessary.
Women of child-bearing potential: Even if the patient is not pregnant, the patient should 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. Non-hormonal methods of contraception or low-dose oestrogen contraceptives ("the Pill") are recommended. The patient should use an effective non-hormonal method of contraception if she is taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules to dissolve gallstones, as hormonal contraceptives may encourage the formation of gallstones.
The doctor will check that the patient is not pregnant before starting the treatment.
Breast-feeding: There are only a few documented cases of Ursodeoxycholic acid (Ursofalk) use in breast-feeding women. Levels of Ursodeoxycholic acid (Ursofalk) in milk are very low and probably no adverse reactions will occur in breastfed infants.
Film-coated tablet: There are no or limited amounts of data from the use of UDCA in pregnant women.
Studies in animals have shown reproductive toxicity during the early phase of gestation. Ursofalk 500 mg film-coated tablets must not be used during pregnancy unless clearly necessary.
Women of childbearing potential should be treated only if they are using reliable contraception. Non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking Ursofalk 500 mg film-coated tablets for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis. The possibility of a pregnancy must be excluded before beginning treatment.
According to few documented cases of breastfeeding women milk levels of UDCA are very low and probably no adverse reactions are to be expected in breastfed infants.
Adverse Reactions
Capsule: Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
Common adverse effects (occurring in less than 1 in 10 but more than 1 in 100 people treated): soft, loose stools or diarrhoea.
Very rare adverse effects (occurring in less than 1 in 10,000 people treated): 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; nettle rash (urticaria).
Common adverse effects (occurring in less than 1 in 10 but more than 1 in 100 people treated): soft, loose stools or diarrhoea.
Very rare adverse effects (occurring in less than 1 in 10,000 people treated): 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; nettle rash (urticaria).
Drug Interactions
Capsule: Please tell the doctor if the patient is taking/using, have recently taken/used or might take/use any other medicines which contain the following active substances. The effects of these medicines may be altered (interactions): A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules: Colestyramine, colestipol (medicines 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 substances, it must be taken at least two hours before or after Ursofalk 250 mg capsules.
Ciprofloxacin, dapsone (antibiotics), nitrendipine (a medicine used to treat high blood pressure) and other medicines which are metabolised in a similar way. The doctor may possibly alter the dose of these medicinal products.
A change in the effects of the following medicines is possible when taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules: Ciclosporin (a medicine that inhibits 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.
Rosuvastatin (a medicine for high blood cholesterol).
If the patient is taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules to dissolve gallstones, please tell the doctor if the patient is also taking oestrogen-containing medicinal products or certain medicines to lower the cholesterol levels that contain clofibrate, for example. These medicines may encourage the formation of gallstones and counteract the effects of Ursodeoxycholic acid (Ursofalk) 250 mg capsules in dissolving the gallstones.
Film-coated tablet: Ursofalk 500mg film-coated tablets should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after Ursofalk 500mg film-coated tablets.
Ursofalk 500mg film-coated tablets can affect the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.
In isolated cases, Ursofalk 500mg film-coated tablets can reduce the absorption of ciprofloxacin.
In a clinical study in healthy volunteers concomitant use of UDCA (500 mg/day) and rosuvastatin (20 mg/day) resulted in slightly elevated plasma levels of rosuvastatin. The clinical relevance of this interaction also with regard to other statins is unknown.
UDCA has been shown to reduce peak plasma concentrations (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers. Close monitoring of the outcome of concurrent use of nitrendipine and UDCA is recommended. An increase of the dose of nitrendipine may be necessary.
An interaction with a reduction of the therapeutic effect of dapsone was also reported.
These observations, together with in-vitro findings could indicate a potential for UDCA to induce cytochrome P450 3A enzymes. Induction has, however, not been observed in a well-designed interaction study with budesonide, which is a known cytochrome P450 3A substrate.
Oestrogenic hormones and blood cholesterol lowering agents such as clofibrate increase hepatic cholesterol secretion and may therefore encourage biliary lithiasis, which is a counter-effect to UDCA used for dissolution of gallstones.
Ciprofloxacin, dapsone (antibiotics), nitrendipine (a medicine used to treat high blood pressure) and other medicines which are metabolised in a similar way. The doctor may possibly alter the dose of these medicinal products.
A change in the effects of the following medicines is possible when taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules: Ciclosporin (a medicine that inhibits 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.
Rosuvastatin (a medicine for high blood cholesterol).
If the patient is taking Ursodeoxycholic acid (Ursofalk) 250 mg capsules to dissolve gallstones, please tell the doctor if the patient is also taking oestrogen-containing medicinal products or certain medicines to lower the cholesterol levels that contain clofibrate, for example. These medicines may encourage the formation of gallstones and counteract the effects of Ursodeoxycholic acid (Ursofalk) 250 mg capsules in dissolving the gallstones.
Film-coated tablet: Ursofalk 500mg film-coated tablets should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after Ursofalk 500mg film-coated tablets.
Ursofalk 500mg film-coated tablets can affect the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.
In isolated cases, Ursofalk 500mg film-coated tablets can reduce the absorption of ciprofloxacin.
In a clinical study in healthy volunteers concomitant use of UDCA (500 mg/day) and rosuvastatin (20 mg/day) resulted in slightly elevated plasma levels of rosuvastatin. The clinical relevance of this interaction also with regard to other statins is unknown.
UDCA has been shown to reduce peak plasma concentrations (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine in healthy volunteers. Close monitoring of the outcome of concurrent use of nitrendipine and UDCA is recommended. An increase of the dose of nitrendipine may be necessary.
An interaction with a reduction of the therapeutic effect of dapsone was also reported.
These observations, together with in-vitro findings could indicate a potential for UDCA to induce cytochrome P450 3A enzymes. Induction has, however, not been observed in a well-designed interaction study with budesonide, which is a known cytochrome P450 3A substrate.
Oestrogenic hormones and blood cholesterol lowering agents such as clofibrate increase hepatic cholesterol secretion and may therefore encourage biliary lithiasis, which is a counter-effect to UDCA used for dissolution of gallstones.
Storage
Capsule: Store at temperatures not exceeding 30°C.
Film-coated tablet: Store at temperatures not exceeding 25°C.
Film-coated tablet: Store at temperatures not exceeding 25°C.
MedsGo Class
Cholagogues, Cholelitholytics & Hepatic Protectors
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