Ursogrix 250 mg ursodeoxycholic acid hard capsules
What Ursogrix Is And What It Is Used For
This medicine contains ursodeoxycholic acid, which is a naturally occurring bile acid. It is only found in small amounts in the bile of humans.
Ursogrix is used:
- To dissolve gallstones made up of cholesterol in patients
- Who have one or more gallstones that are invisible on X-ray, preferably with a diameter not exceeding 2 cm, in a normally functioning gallbladder
- Who cannot undergo surgery
- Which supersaturation of cholesterol and chemical tests have demonstrated this on bile?
- Before and after lithotripsy (crushing of gallstones with shock wave treatment).
- For the treatment of conditions where the bile ducts in the liver have been damaged, leading to the accumulation of bile. This can cause scarring of the liver. The liver damage must not be so severe that the liver does not function normally. This condition is called primary biliary cholangitis (PBC, also called primary biliary cirrhosis ).
- For the treatment of liver disease associated with cystic fibrosis (cystic fibrosis) in children and adolescents between 6 and 18 years of age
Ursodeoxycholic acid found in Ursogrix tablets may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before You Use Ursogrix
Do Not Use Ursogrix Tablets
- If you are allergic to ursodeoxycholic acid, bile acids, or any of the other ingredients of this medicine (listed in section 6)
- If you have acute inflammation of the gallbladder or bile ducts
- If you have blocked bile ducts (blockage in the common bile duct or gallbladder duct)
- If you often have cramp-like pain in the upper part of the abdomen (biliary colic)
- If the doctor has said that you have calcified gallstones
- If your gallbladder has reduced ability to contract
- If your child has blocked bile ducts (bile duct atresia) and has poor bile flow, even after surgery.
Ask your doctor about the conditions mentioned above. Also, ask your doctor if you have previously had any of these conditions or are unsure.
Warnings And Precautions
- Talk to your doctor or pharmacist before taking Ursogrix. This medicine should only be used under medical supervision.
- During the first 3 months of treatment, the function of your liver will be tested regularly every four weeks. After that, tests will be conducted at 3-month intervals.
- In treatment to dissolve gallstones, the gallbladder will be checked after 6 to 10 months of treatment.
- Women taking this medicine to dissolve gallstones should use effective, non-hormonal contraceptives because hormonal contraceptives ( birth control pills ) can increase the formation of gallstones.
- When treating the liver disease PBC, the symptoms (e.g. itching ) may, in rare cases, increase at the beginning of the treatment. If this occurs, tell your doctor. The starting dose may need to be reduced.
- If you get diarrhea, you must tell your doctor. The dose may need to be reduced, or treatment with Ursogrix should be discontinued.
Children
There are no restrictions on using Ursogrix 250 mg hard capsules except in cystic fibrosis (aged 6–18 years).
Other Medicines And Ursogrix
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of this medicine can be affected ( interaction er):
Ursogrix may have a reduced effect if it is used at the same time as the following medicines:
- Cholestyramine, colestipol (for high blood fats), or antacids (heartburn medicines) containing aluminum hydroxide or smectite (aluminum oxide). If you are taking a medicine containing any of these active substances, the medicine should be taken 2 hours before or after Ursogrix.
The following medicines may have a reduced effect if used simultaneously as Ursogrix.
- Ciprofloxacin, dapsone ( antibiotic ), nitrendipine (for high blood pressure ), and other similarly excreted drugs from the body. The doctor may need to change the dose of these medicines.
The following medicines may have an altered effect if they are used simultaneously as Ursogrix.
- Ciclosporin (to reduce the activity of the immune system). If you are being treated with ciclosporin, your doctor will check the ciclosporin concentration in your blood. The doctor adjusts the dose if necessary.
- Rosuvastatin (against high blood fats).
If you are taking Ursogrix to dissolve gallstones, tell your doctor if you are also taking medicines containing estrogen (e.g. birth control pills ) or certain cholesterol-lowering medicines, e.g. clofibrate. These medicines can increase the formation of gallstones and thus counteract the dissolution of gallstones that Ursogrix does.
Pregnancy, Breastfeeding, And Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There is no or limited amount of data on the use of ursodeoxycholic acid in pregnant women. It would be best if you did not take Ursogrix during pregnancy unless the doctor considers it necessary. Based on animal studies, using ursodeoxycholic acid during pregnancy may affect fetal development.
Fertile women
Even if you are not pregnant, you should still discuss this with your doctor. Fertile women (women who have the potential to become pregnant) should only be treated if they use a safe method of contraception. Non-hormonal or oral contraceptives ( birth control pills ) with low-dose estrogen are recommended. If you are taking Ursogrix to dissolve gallstones, you should use effective, non-hormonal contraception, as hormonal contraceptives can increase the formation of gallstones.
Before starting the treatment, the doctor will check that you are not pregnant.
Breast-feeding
There are only a few documented cases of using ursodeoxycholic acid during breastfeeding. The levels of ursodeoxycholic acid in breast milk are very low. Therefore, it is unlikely that this medicine would cause side effects in breastfed infants.
Fertility/the ability to bear children
Animal studies have not shown any effect on fertility/ability to give birth.
So far, there is no information on the effects on human fertility
Driving Ability And Use Of Machinery
No special precautions are necessary.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How To Use Ursogrix
Ursogrix uses
- Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
For dissolution of cholesterol gallstones (without or with shock wave therapy)
- Dosage
- The recommended dose is 2–4 capsules of Ursogrix (8–10 mg ursodeoxycholic acid/kg body weight).
- Does one should be taken with a meal as follows:
- A daily dose of 2 capsules: both capsules are taken with food in the evening.
- A daily dose of 3 capsules: 1 capsule in the morning and 2 in the evening.
- A daily dose of 4 capsules: 2 in the morning and 2 in the evening.
OR
- Taken as a daily dose of 2–4 capsules in the evening before bedtime.
How To Take Ursogrix
- Swallow the capsules whole with a glass of water or other liquid. Take the capsules regularly.
- Treatment time
- Gallstones generally take 6–24 months to dissolve. The treatment time depends on the size of the existing gallstones at the start of the treatment. If the size of the gallstones has not decreased after 12 months, treatment should be discontinued.
- At 6-month intervals, the doctor must check whether the treatment has any effect. At each check-up, it must be followed up on whether calcification caused stone formation since the last time. If this is the case, the doctor will stop the treatment.
- Even if your symptoms have stopped, you should continue the treatment. Interruption of the treatment leads to a longer total treatment time. Treatment should continue for 3–4 months after the gallstones have dissolved.
- For the treatment of primary biliary cholangitis ( chronic inflammatory disease of the bile ducts)
Dosage
Grades I–III
The daily dose depends on body weight. During the first three months after starting treatment, you must take Ursogrix in the morning, afternoon, and evening. When liver function has improved, the daily dose can be taken once daily in the evening.
| Body weight (kg) | Ursogrix 250 mg hard capsules | |||
| Dosage during the first 3 months | Dosage after the first 3 months | |||
| Morning | Afternoon | Evening | Evening(once daily) | |
| 47–62 | 1 | 1 | 1 | 3 |
| 63–78 | 1 | 1 | 2 | 4 |
| 79–93 | 1 | 2 | 2 | 5 |
| 94–109 | 2 | 2 | 2 | 6 |
| over 110 | 2 | 2 | 3 | 7 |
Grade IV
- At the beginning of the treatment, 2-3 Ursogrix capsules daily with a meal:
- A daily dose of 2 capsules: 1 capsule in the morning and 1 capsule in the evening.
- A daily dose of 3 capsules: 1 capsule in the morning and 2 in the evening.
- If this dosage has a good effect (according to the blood test or the doctor’s judgment), the doctor will increase the dose one ( dosage according to the treatment of grades I–III).
- Swallow the capsules whole with a glass of water or other liquid. Take the capsules regularly.
- Treatment time
- The use of Ursogrix in treating primary biliary cholangitis can be continued indefinitely.
ATTENTION!
If you have primary biliary cholangitis, the symptoms, e.g. itching, increase at the beginning of the treatment. This happens only in rare cases. If this occurs, treatment can be continued with a reduced daily dose of Ursogrix. The doctor will increase the daily dose by one after each week until the desired dose is reached.
Use in children and adolescents (aged 6 to 18 years) for treating a liver disease associated with cystic fibrosis.
Dosage
The recommended daily dose is 20 mg/kg body weight divided into 2–3 doses. If necessary, the doctor can increase the dose to 30 mg/kg body weight daily.
| Body weight (kg) | Daily dose (mg/kg body weight) | Ursogrix 250 mg hard capsules | ||
| Morning | Afternoon | Evening | ||
| 20–29 | 17–25 | 1 | — | 1 |
| 30–39 | 19–25 | 1 | 1 | 1 |
| 40–49 | 20–25 | 1 | 1 | 2 |
| 50–59 | 21–25 | 1 | 2 | 2 |
| 60–69 | 22–25 | 2 | 2 | 2 |
| 70–79 | 22–25 | 2 | 2 | 3 |
| 80–89 | 22–25 | 2 | 3 | 3 |
| 90–99 | 23–25 | 3 | 3 | 3 |
| 100–109 | 23–25 | 3 | 3 | 4 |
| > 110 | 3 | 4 | 4 |
How to take:
Swallow the capsules whole with a glass of water or other liquid. Take the capsules regularly.
If you have trouble swallowing or weigh less than 47 kg, other pharmaceutical forms of ursodeoxycholic acid are available.
Tell your doctor or pharmacist if you think Ursogrix has too strong or too weak an effect.
If You Use Too Much Ursogrix
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Diarrhea may occur in case of overdose. Tell your doctor immediately if you have persistent diarrhea. If you have diarrhea, drink enough to restore fluid and salt balance.
If You Forget To Use Ursogrix
Do not take more capsules the next time, but continue the treatment with the prescribed dose.
If You Stop Using Ursogrix
Always talk to your doctor before stopping treatment with Ursogrix or if you intend to stop treatment early. If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible Ursogrix Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Common (may affect up to 1 in 10 patients):
- Soft, loose stools or diarrhea.
Very rare Ursogrix side effects(may affect up to 1 in 10,000 patients):
- In the treatment of primary biliary cholangitis:
- Severe pain in the upper right part of the stomach, severe scarring of the liver that partially resolves after treatment ends
- Calcification of gallstones ar
- Hives
How To Store Ursogrix
- Store at a maximum of 30 °C.
- Store in the original packaging. Moisture sensitive.
- Keep this medicine out of sight and reach of children.
- Use before the expiry date, which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substance is ursodeoxycholic acid.
- Each hard capsule contains 250 mg of ursodeoxycholic acid.
- Other ingredients are corn starch, silicon dioxide (E 551), magnesium stearate (E 470B), hard gelatin capsule (capsule shell): titanium dioxide (E 171), and gelatin (E 441).
AppearanceAand Package Sizes Of The Medicine
- White, hard gelatin capsule containing white or almost white powder. Capsule size 0, approximately 21.7mm x 7.64mm.
- The capsules are packed in PVC/aluminum blisters.
- 10 capsules per blister.
- 5, 6, or 10 blisters (50, 60, or 100 capsules) are packed in a carton.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
AS GRINDEKS. Krustpils iela 53, Rīga, LV-1057, Latvia
Local Representative
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Denmark
This medicine is approved in the European Economic Area under the names:
| Austria | Ursogrix 250 mgThe resin capsule |
| Belgium | URSOGRIX 250 mg hard capsules |
| Bulgaria | Ursogrix250 mg hard capsulesУрсогрикс 250 mg solidcapsule |
Czech Republic | URSOGRIX |
| Croatia | URSOGRIX 250 mg hard capsule |
| Denmark | Ursogrix |
| Estonia | URSOGRIX |
| France | ACIDE URSODESOXYCHOLIQUE GRINDEKS 250 mg, gelule |
| Germany | Ursogrix 250 mg hard capsule |
| Greece | Ursogrix 250 mg Σκληρά καψάκια |
| Hungary | Urzodezoxikol sap Grindeks250 mg hard capsule |
| Ireland | Ursogrix 250 mg hard capsules |
| Latvia | URSOGRIX 250 mg cietās kapsulas |
| Lithuania | URSOGRIX 250 mg kietosios kapsulės |
| Netherlands | GRINTEROL 250 mg hard capsules |
| Norway | URSOGRIX 250 mg hard capsules |
| Poland | URSOXYN |
| Portugal | GRINTEROL 250 mg capsules duras |
| Romania | Ursogrix 250 mg capsule |
| Slovakia | Ursogrix 250 mg hard capsules |
| Spain | Ácido Ursodesoxicólico Grindeks250 mg capsules duras |
| Sweden | Ursogrix 250 mg hard capsules |
| UK | Ursodeoxycholic Acid 250 mg Capsules, hard |