Raphaholin Forte

Package Leaflet: Information for the Patient

Raphacholin Forte

Dehydrocholic Acid
250 mg, coated tablets

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Raphacholin Forte and what is it used for
• 2. Important information before using Raphacholin Forte
• 3. How to use Raphacholin Forte
• 4. Possible side effects
• 5. How to store Raphacholin Forte
• 6. Contents of the pack and other information

1. What is Raphacholin Forte and what is it used for

Raphacholin Forte is a medicine containing a composition of dehydrocholic acid with an addition of black radish extract, which has a choleretic effect (increasing the volume of bile secreted) and accelerates its transport to the duodenum. The increased amount of bile stimulates the large intestine, giving the medicine a mild laxative effect.

Indications for Use

The medicine is used in cases of insufficient bile secretion by the liver and indigestion manifested by bloating, abdominal pain, belching, nausea, constipation, and as a mild laxative.

2. Important Information Before Using Raphacholin Forte

When Not to Use Raphacholin Forte

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient has acute and chronic liver diseases, acute inflammatory conditions of the digestive tract, bile duct obstruction, and digestive tract obstruction.

Warnings and Precautions

Before starting to use Raphacholin Forte, the patient should discuss it with their doctor or pharmacist. In the case of gallstones or bile duct stones, the medicine should only be used after consulting a doctor. In constipation, the medicine should not be used without consulting a doctor for more than a week. The dose should not exceed 6 tablets (which corresponds to 1.5 g of dehydrocholic acid) per day. The medicine contains peppermint essential oil as an excipient, which may cause allergic reactions. Warnings related to excipients with known effects: One coated tablet contains 37.5 mg of glucose (maltodextrin component) and 1.5 mg of anhydrous lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, which means that the medicine is considered "sodium-free".

Children and Adolescents

The medicine should not be used in children and adolescents.

Raphacholin Forte and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. No interactions with other medicines have been reported to date.

Pregnancy, Breastfeeding, and Fertility

There are no data on the use of dehydrocholic acid in pregnant or breastfeeding women, or on its effects on fertility. The medicine should not be used during pregnancy and breastfeeding.

Driving and Using Machines

Raphacholin Forte does not affect the ability to drive and use machines.

3. How to Use Raphacholin Forte

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Adultsshould take the medicine orally. In the case of indigestion: 1 tablet after a meal, if necessary, the dose can be increased to 3 tablets per day. In the case of constipation: 2 tablets at once. The laxative effect is expected within 6 hours. If after 7 days there is no improvement or the patient feels worse, they should contact their doctor. The medicine should not be used in children and adolescents.

Using More Than the Recommended Dose of Raphacholin Forte

In the case of significant overdose, exceeding the recommended doses, nausea, vomiting, and diarrhea may occur.

Missing a Dose of Raphacholin Forte

A double dose should not be taken to make up for a missed dose.

4. Possible Side Effects

Like all medicines, Raphacholin Forte can cause side effects, although not everybody gets them. Side effects are presented according to the classification of organs and systems according to MedDRA and frequency of occurrence: very common (≥1/10); common (≥1/100 to <1>

Reporting Side Effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Raphacholin Forte

Raphacholin Forte should be stored at a temperature not exceeding 25°C. The medicine should be kept out of sight and reach of children. The medicine should not be used after the expiry date stated on the packaging after: Expiry Date (EXP). The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Raphacholin Forte Contains

One coated tablet contains: Active substance: 250 mg of dehydrocholic acid. Excipients: dry extract of black radish root (10-15:1) [native extract (20-30:1) 50%, maltodextrin 50%, extractant - water] and peppermint essential oil, microcrystalline cellulose, sodium carboxymethyl starch, potato starch, povidone, colloidal anhydrous silica, talc, sodium lauryl sulfate, activated carbon, Aqua Polish black 081.06 coating with the composition: hypromellose, anhydrous lactose, talc, macrogol, black iron oxide (E 172), indigo carmine (E 132).

What Raphacholin Forte Looks Like and Contents of the Pack

Raphacholin Forte is a double-sided, smooth, gray-black tablet with a matte finish, with a gray-white break line and a black border. Single pack: 1 or 3 blisters of PVC/Al foil containing 10 tablets or 1 blister of PVC/Al foil containing 30 tablets in a cardboard box with a patient information leaflet.

Marketing Authorization Holder and Manufacturer

Wrocławskie Zakłady Zielarskie "Herbapol" SA, 50-951 Wrocław, ul. św. Mikołaja 65/68, tel.: +48 71 33 57 225, fax: +48 71 372 47 40, e-mail: [email protected]. For more detailed information on this medicine, please contact the marketing authorization holder, tel. 71 321 86 04 w.123.

Date of Last Revision of the Leaflet: