Patient leaflet - URSONORM 400 MG FILM-COATED TABLETS
Ursonorm® 400 mg
ursodeoxycholic acid
< PRO.MED.CS \___7 Praha a. s.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
– Keep this leaflet. You may need to read it again.
-
– If you have any further questions, ask your doctor or pharmacist.
-
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
-
1. What Ursonorm® is and what it is used for
-
2. What you need to know before you take Ursonorm®
-
3. How to take Ursonorm®
-
4. Possible side effects
-
5. How to store Ursonorm®
-
6. Contents of the pack and other information
1. what ursonorm® is and what it is used for
Ursodeoxycholic acid, the active substance in Ursonorm®, is a naturally-occurring bile acid. Small amounts are found in human bile.
Ursonorm® is used:
-
– to dissolve gallstones caused by excess cholesterol in the gall bladder, where the gallstones are not visible on a plain x-ray (gallstones that are visible will not dissolve) and not more than 15 mm in diameter. The gall bladder should still be working despite the gallstone(s).
-
– to treat the symptoms of primary biliary cholangitis (PBC – a chronic biliary tract disorder, which may progress to liver cirrhosis) in patients without decompensated liver cirrhosis (a diffuse, chronic liver disease, in which poor liver function due to disease can no longer be corrected).
-
– to treat liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.
2. what you need to know before you take ursonorm®
Do not take Ursonorm® if:
-
– if you are allergic to bile acids (like ursodeoxycholic acid) or any of the other ingredients of this medicine (listed in section 6)
-
– you have acute inflammation of the gall bladder and biliary tract
-
– you have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract)
-
– you have frequent cramp-like pains in the upper abdomen (biliary colic)
-
– your doctor has said you have calcified gallstones
-
– you have a problem with gall bladder contraction – you are a child with biliary atresia and have poor bile flow, even after surgery.
Please ask your doctor about any of the conditions mentioned above. You should also ask if you have previously had any of these conditions.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ursonorm®.
Your doctor should test your liver function regularly every 4 weeks for the first 3 months of treatment. After this time, it should be monitored at 3 months intervals.
When used to dissolve gallstones, your doctor should arrange for a scan of your gall bladder after the first 6–10 months of treatment.
If you are taking Ursonorm® for the dissolution of gallstones, please inform your doctor, in case you are taking any medicines that contain oestrogenic hormones, as these medicines stimulate the formation of gallstones.
When used in the treatment of PBC, in rare cases the symptoms may worsen at the beginning of treatment. If this happens, please speak to your doctor about reducing your initial dose.
Please inform your doctor immediately if you have diarrhoea, as this may require a dose reduction or discontinuation of treatment.
Children and adolescents
Ursonorm® is not suitable for children under 6 years due to the strength of the tablet.
Other medicines and Ursonorm®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of these medicines may be altered: Efficacy of Ursonorm® may be reduced when taking it with the following medicines:
- cholestyramine, colestipol (used to lower blood lipid levels) or antacids containing aluminium hydroxide or smectite (aluminium oxide) (used to bind stomach acid): If you must take medication that contains any of these substances, it must be taken at least two hours before or after Ursonorm®.
Ursonorm® may reduce the efficacy of the following medicines:
- ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines that are metabolized in a similar way. It may be necessary for your doctor to alter the dose of these medicines.
A change in the effects of the following medicines is possible when taking Ursonorm®:
- ciclosporin (to reduce the activity of the immune system). If you are being treated with ciclosporin, your doctor should check the amount of ciclo-sporin in your blood. If necessary, your doctor will adjust its dose.
- rosuvastatin (for high cholesterol and related conditions).
If you are taking Ursonorm® for the dissolution of gallstones, please inform your doctor, in case you are taking any medicines that contain oestrogenic hormones or blood cholesterol lowering agents such as clofibrate. These medicines stimulate the formation of gallstones, which is a counter-effect to the treatment with Ursonorm®.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 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 reproductive toxicity. Ursonorm® must not be used during pregnancy unless clearly necessary.
Women of child-bearing potential
Even if you are not pregnant, you should still consult your doctor.
Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, if you are taking Ursonorm® to dissolve your gallstones, you should use effective, non-hormonal contraceptive measures, as hormonal oral contraceptives may promote the formation of gallstones.
Your doctor must exclude the possibility of a pregnancy before beginning of treatment.
Breast-feeding
According to few documented cases of breastfeeding women milk levels of ursodeoxycholic acid are very low and probably no adverse reactions are to be expected in breastfed infants.
Fertility
Animal studies did not show an influence of ursodeoxycholic acid on fertility. Human data on fertility effects following treatment with ursodeoxycholic acid are not available.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
Ursonorm® contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. how to take ursonorm®
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
To dissolve cholesterol gallstones
Dosage
The recommended dose is about 10 mg ursodeoxycholic acid per kg body weight (BW) daily, as follows:
| up to 50 kg | 1 film-coated tablet |
| 51 to 70 kg | 1 4 film-coated tablet |
| 71 to 90 kg | 2 film-coated tablets |
| 91 to 110 kg | 2 4 film-coated tablets |
| over 110 kg | 3 film-coated tablets |
If you weigh less than 47 kg or if you are unable to swallow Ursonorm® other formulations containing ursodeoxycholic acid might be available to you. Method of administration
Swallow the tablets whole with a drink of water or other liquid. Take the tablets in the evening at bedtime. Take your medicine regularly. The tablet can be divided into equal doses.
Duration of treatment
It usually 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, your doctor should check whether the treatment is working. At each of these followup examinations, it should be checked whether a build-up of calcium causing hardening of the stones has occurred since the last time. If this happens, your doctor will stop the treatment.
For the treatment of primary biliary cholangitis (chronic inflammatory disease of the biliary tract)
Dosage
The daily dose depends on the body weight and ranges from 1 4 to 4 film-coated tablets. During the first 3 months of treatment, you should take Ursonorm® in the morning, at midday and in the evening. As liver function values improve, the total daily dose can be taken once daily in the evening. Take your medicine regularly.
| Body weight (kg) | Ursonorm® 400 mg film-coated tablets | |||
| first 3 months | subsequently | |||
| morning midday | evening | evening (1× daily) | ||
| 47–50 | 4 | 4 | 4 | 1 4 |
| 51–62 | 4 | 4 | 1 | 2 |
| 63–78 | 4 | 4 | 1 4 | 2 4 |
| 79–93 | 4 | 1 | 1 4 | 3 |
| 94–109 | 1 | 1 | 1 4 | 3 4 |
| over 110 | 1 | 1 | 2 | 4 |
If you weigh less than 47 kg or if you are unable to swallow Ursonorm®, other pharmaceutical forms (suspension) containing ursodeoxycholic acid are available.
Method of administration
Swallow the tablets whole (not chewed) with a glass of water or other liquid.
Duration of treatment
Ursonorm® may be continued indefinitely in cases of primary biliary cholangitis.
Note
If you have primary biliary cholangitis, your symptoms may worsen at the start of treatment. One sign of this may be increased itching. This happens only in rare cases. In this event, treatment can be continued with a reduced daily dose of Ursonorm®. Your doctor will then increase the daily dose every week, until the required dose is once again reached.
Use in children and adolescents (6 to 18 years) for treatment of liver disease associated with cystic fibrosis
Dosage
The recommended dose is about 20 mg/kg/day in 2–3 divided doses. If necessary, your doctor may increase the dose further to 30 mg per kg body weight daily.
| Body weight [kg] | Daily dose W | Ursonorm® 400 mg film-coated tablets | ||
| mornings | midday | evenings | ||
| 20–23 | 17–20 | 4 | – | 4 |
| 24–32 | 19–25 | 4 | 4 | 4 |
| 33–39 | 21–24 | 4 | 4 | 1 |
| 40–49 | 20–25 | 4 | 4 | 1 4 |
| 50–59 | 20–24 | 4 | 1 | 1 4 |
| 60–69 | 20–23 | 1 | 1 | 1 4 |
| 70–79 | 20–23 | 1 | 1 4 | 1 4 |
| 80–89 | 20–23 | 1 4 | 1 4 | 1 4 |
| 90–99 | 20–22 | 1 4 | 1 4 | 2 |
| 100–109 | 20–22 | 1 4 | 2 | 2 |
| > 110 | < 22 | 2 | 2 | 2 |
If you feel that the effect of Ursonorm® is too strong or too weak, please talk to your doctor or pharmacist.
If you take more Ursonorm® than you should
Diarrhoea may occur in the event of an overdose.
Please inform your doctor immediately if you have persistent diarrhoea. If you do suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and electrolyte balance.
If you forget to take Ursonorm®
Do not take a double dose to make up for a forgotten dose, but just continue the treatment with the prescribed dose.
If you stop taking Ursonorm®
Always talk to your doctor before you decide to interrupt treatment with Ursonorm® or to stop your treatment early.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
-
– soft, loose stools or diarrhoea.
Very rare side effects (may affect up to 1 in 10,000 people)
-
– during the treatment of primary biliary cholangitis: severe, right-sided upper abdominal pain, severe worsening of liver scarring – this partially eases after treatment is stopped;
-
– hardening of gallstones;
-
– nettle rash (urticaria).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store ursonorm®
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information what ursonorm® contains
- The active substance is ursodeoxycholic acid. Each film-coated tablet contains 400 mg ursodeoxycholic acid.
- The other ingredients are:
-
– tablet core: maize starch, maize starch pregelatinised, sodium starch glycolate (E468), silica colloidal anhydrous (E551), magnesium stearate (E470b),
-
– tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol.
What Ursonorm® looks like and contents of the pack
Ursonorm® is almost white, round biconvex film-coated tablet with a score line on both sides, 12 mm in diameter. The tablet can be divided into equal doses.
Ursonorm® is available in packs of 10, 20, 30, 40, 50, 60, 80, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
PRO.MED.CS Praha a. s., Telcska 377/1, Michle, 140 00 Prague 4, Czech Republic
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands Ursonorm 400 mg filmomhulde tabletten
Belgium Ursosan 400 mg comprimes pellicules
Finland URSOSAN 400 mg
kalvopaallysteinen tabletti
Ireland Proursan 400 mg film-coated tablets
Luxembourg Ursosan 400 mg comprimes pellicules
United Ursonorm 400 mg film-coated
Kingdom tablets
This leaflet was last revised in 11/2021.
URSONORM_400mg_PIL_145×300mm_GB-11–21.indd 2
10.11.2021 7:31:35