Choludexan 300 mg. 100 capsules

What Holudexan is and what it is used for

Ursodeoxycholic acid, the active substance in Holudexan, is a naturally occurring bile acid that is found in small amounts in human bile.

Holudexan is used for:

dissolution of radiolucent cholesterol gallstones with a diameter of no more than 15 mm in patients with preserved gallbladder function, regardless of the presence of gallstones;

treatment of inflammation of the stomach lining (gastritis) caused by bile acid reflux;

treatment of primary biliary cirrhosis (from chronic inflammation of the bile ducts to liver cirrhosis) in patients without decompensated liver cirrhosis (diffuse, chronic liver disease, at a stage when the disease-related reduced liver function cannot be compensated).

2. What you need to know before you take Holudexan

Do not take Holudexan

if you are allergic (hypersensitive) to ursodeoxycholic acid or to any of the other ingredients of this medicine (listed in section 6); if you suffer from acute inflammation of the gallbladder or bile ducts; if you have a biliary obstruction (blockage of the common bile duct or the duct leading to the gallbladder);

if you suffer from frequent colic pains in the upper abdomen (biliary colic) your doctor has told you that you have calcified gallstones; if you suffer from impaired contractility of the gallbladder; Please ask your doctor if any of the conditions listed above apply or have applied to you in the past.

Warnings and precautions

Talk to your doctor or pharmacist before taking Holudexan. Holudexan should be taken under medical supervision.

Regular medical follow-up of your liver function tests is required every 4 weeks during the first 3 months of treatment and once every 3 months thereafter.

When used to dissolve gallstones, it is necessary for your doctor to order a scan of your gallbladder after the first 6-10 months of treatment.

If you are a woman and taking Holudexan to dissolve gallstones, you must use an effective non-hormonal method of contraception, as hormonal contraceptives may stimulate the formation of gallstones.

When used to treat primary biliary cirrhosis, worsening of symptoms (eg, pruritus) has rarely been observed at the start of treatment. In this case, talk to your doctor about reducing the initial dose.

Tell your doctor immediately if you have diarrhoea, as this may require a dose reduction or discontinuation of Holudexan.

Other medicines and Holudexan

You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effects of these medicines may be changed (drug interactions).

When taking Holudexan, it is possible to weaken the effects of the following drugs:

colestyramine, colestipol (to lower blood lipids) or antacids (medicines that bind to stomach acids) containing aluminum hydroxide and/or aluminum oxide, eg smectite. If you are taking a medicine containing any of these active substances, it should be taken at least 2 hours before or after Holudexan;

ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines that are metabolised in a similar way. Your doctor may need to adjust the dose of these medications.

When taking Holudexan, a change in the effects of the following drugs is possible:

cyclosporine (a medicine that suppresses the immune system). If you are being treated with cyclosporine, it is necessary for your doctor to check its amount in your blood and, if necessary, adjust its dose;

rosuvastatin (a medicine to lower high blood cholesterol).

If you are taking Holudexan to dissolve gallstones, please tell your doctor if you are also taking medicines containing estrogen (eg birth control pills) or certain cholesterol-lowering medicines containing eg clofibrate.

These drugs can stimulate the formation of gallstones and counteract the effects of Holudexan in dissolving gallstones.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Treatment with Holudexan may still be indicated. Your doctor will make the right decision for your condition.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Holudexan can be used during pregnancy only after a careful assessment by the attending physician of the benefit/risk ratio.

Pregnancy

There are no or limited data from the use of ursodeoxycholic acid in pregnant women. Animal studies show that growth and development of the baby may be impaired. Holudexan should not be used during pregnancy unless your doctor considers it absolutely necessary.

Women with childbearing potential

Even if you are not pregnant, you should discuss this treatment option with your doctor, as women of childbearing age should only be treated with Holudexan if they are using a reliable method of contraception. Non-hormonal contraception or low-estrogen oral contraceptives are recommended. If you are taking Holudexan to dissolve gallstones, however, you should only use effective non-hormonal contraceptive measures, as hormonal contraceptives can stimulate the formation of gallstones.

Before starting treatment, your doctor will rule out an existing pregnancy.

Breastfeeding

There are only a small number of documented cases of ursodeoxycholic acid use in nursing women. The levels of ursodeoxycholic acid in breast milk are very low and probably no adverse reactions can be expected in the infant.

Fertility

Animal studies have shown no effect of this drug on fertility. There are no data on the effect of this drug on human fertility.

Driving and using machines

Holudexan does not affect or negligibly affects the ability to drive and operate machinery.

3. How to take Holudexan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

To dissolve cholesterol gallstones

The recommended dose is approximately 10 mg per kg body weight (BW) daily as follows:

up to 60 kg - 2 capsules daily;

61-80 kg - 3 capsules daily;

81-100 kg - 4 capsules daily;

more than 100 kg - 5 capsules daily.

Application method

The hard capsules should be swallowed whole, with a little liquid, in the evening before going to bed. Holudexan should be taken regularly.

Duration of treatment

Gallstones usually take 6-24 months to dissolve. If no reduction in gallstone size is observed after 12 months, treatment should be discontinued.

The effectiveness of the treatment should be checked by your doctor every 6 months. At each of these follow-up examinations, it should be checked whether gallstone calcification has occurred compared to the previous visit. If this is the case, your doctor will stop the treatment.

For the treatment of gastritis. caused by bile acid reflux

Application method

One capsule daily is swallowed whole, with a little liquid, in the evening before going to bed.

Duration of treatment

For the treatment of gastritis caused by bile acid reflux, Holudexan is usually taken for 10-14 days. Your doctor will estimate the duration of treatment, depending on the course of the disease.

For the treatment of primary biliary cirrhosis (PBC

During the first 3 months of treatment, you should take Holudexan in the morning, at noon and in the evening. As liver function tests improve, the total daily dose can be taken once daily in the evening.

Body weight (kg) Daily dose (mg/kg/TT) Holudexan

In the first three months After that

morning noon evening evening (once a day)

47-62 12-16 1 1 1 3

63-78 13-16 1 1 2 4

79-93 13-16 1 2 2 5

94-109 14-16 2 2 2 6

Over 110 ?? 2 2 3 7

Application method

Swallow the capsules whole, unchewed, with a little liquid. Take Holudexan regularly.

Duration of treatment

Reception of Holudexan in primary biliary cirrhosis can continue indefinitely.

Note

In patients with primary biliary cirrhosis, clinical symptoms may worsen at the beginning of treatment, for example, pruritus may increase. In such a case, the treatment should continue with a lower daily dose of Holudexan, and every subsequent week, your doctor will increase the daily dose gradually until the required dosage is reached.

Use in children and adolescents

There are no age restrictions for the application of Holudexan. The administration of Holudexan depends on the body weight and the disease.

If you have taken more than the required dose of Holudexan

In case of overdose, diarrhea may occur. Tell your doctor right away if the diarrhea persists. If you suffer from diarrhea, you should drink enough fluids to restore the balance of body fluids and electrolytes.

If you forget to take Holudexan

Do not take a double dose to make up for a missed dose. Take the usual dose as soon as you remember and then continue with your normal intake.

If you have stopped taking Holudexan

Do not interrupt or stop treatment with Holudexan without discussing it with your doctor.

If you have any further questions related to 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.

The evaluation of adverse reactions is based on the frequency information listed below.

Very common (1/10)

Common (>1/100 to <1/10)

Uncommon (>1/1,000 to <1/100)

Rare (>1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (frequency cannot be estimated from the available data)

Gastrointestinal disorders

Loose stools or diarrhea.

Very rarely, during treatment of PBC, severe pain in the right half of the abdomen may occur.

Hepatobiliary disorders

During treatment with Holudexan, in very rare cases, gallstone calcification may occur. During treatment of an advanced stage of PBC, in very rare cases a serious worsening (decompensation) of liver cirrhosis is observed, which partially undergoes reverse development after stopping treatment.

Disorders of the skin and subcutaneous tissue

Very rarely, urticaria (hives) may occur.

Your doctor will assess what measures are possible, if any are needed.

5. How to store Holudexan

Keep out of the reach of children. To be stored below 25 °C. To be stored in the original packaging.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Holudexan contains

The active substance is ursodeoxycholic acid. Each capsule contains 300 mg of ursodeoxycholic acid.

The other ingredients are: corn starch, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide (E171), red iron oxide (E172).

What Holudexan looks like and contents of the pack

Holudexan are bright red-pink, opaque, hard gelatin capsules containing a white or off-white powder.

Holudexan is available in packs of 20 capsules and 100 capsules.

Not all packages may be marketed.