Package leaflet: Information for the patient

Raphacholin Forte
Acidum dehydrocholicum
250 mg, coated tablets
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

Contents of the leaflet:

What Raphacholin Forte is and what it is used for
Important information before taking Raphacholin Forte
How to take Raphacholin Forte
Possible side effects
How to store Raphacholin Forte
Contents of the pack and other information

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

Raphacholin Forte is a medicinal product containing a combination of dehydrocholic acid with an extract of black radish, which acts to increase the volume of bile secreted (choleretic effect) and accelerates its transport into the duodenum. The increased bile volume stimulates the activity of the large intestine, giving the medicine a mild laxative effect.
Indications
The medicine is used in cases of insufficient bile secretion by the liver and indigestion characterized by bloating, abdominal pain, belching, nausea, constipation, and also 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 to any of the other ingredients of this medicine (listed in section 6).
If the patient has acute or chronic liver diseases, acute inflammatory conditions of the gastrointestinal tract, biliary tract obstruction, or gastrointestinal obstruction.

Warnings and precautions
Before starting treatment with Raphacholin Forte, consult a doctor or pharmacist.
In cases of gallstones or biliary tract disorders, use the medicine only after consulting a doctor.
In constipation, do not use the medicine without medical advice for longer than one week.
Do not exceed the dose of 6 tablets (corresponding to 1.5 g of dehydrocholic acid) per day.
The medicine contains peppermint essential oil as an excipient, which may cause allergic reactions.
Warnings regarding excipients with known effects
One coated tablet contains 37.5 mg of glucose (component of maltodextrin) and 1.5 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Children and adolescents
Raphacholin Forte should not be used in children and adolescents.
Raphacholin Forte and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
No interactions with other medicines have been reported to date.
Pregnancy, breastfeeding and fertility
There are no data available on the use of dehydrocholic acid in pregnant or breastfeeding women, or on its effect on fertility.
The medicine should not be used during pregnancy and breastfeeding.
Driving and operating machinery
Raphacholin Forte has no influence on the ability to drive or operate machinery.

3. How to use Raphacholin Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
Take the medicine orally.
In case of indigestion: 1 tablet after a meal; the dose may be increased if necessary up to 3 tablets per day.
In case of constipation: 2 tablets at once.
A laxative effect can be expected within 6 hours.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.
This medicine should not be used in children and adolescents.
Use of a higher than recommended dose of Raphacholin Forte
In case of significant overdose, when doses are many times higher than recommended, nausea, vomiting and diarrhoea may occur.
Missed dose of Raphacholin Forte
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions of the medicine are presented according to organ system classification as per MedDRA and frequency of occurrence: 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), including single cases; frequency not known (cannot be estimated from available data).
When using the medicinal product Raphacholin Forte, the following may occur:
Gastrointestinal disorders (diarrhea, nausea, vomiting, and other gastrointestinal disturbances) – frequency not known
Immune system disorders (allergic reactions) – frequency not known
If any of the symptoms listed above occur, use of the medicine should be discontinued.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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.
Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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%, extraction solvent - water]
and peppermint essential oil, microcrystalline cellulose, sodium carboxymethyl starch, potato starch,
povidone, colloidal anhydrous silica, talc, sodium lauryl sulfate, activated charcoal, coating Aqua Polish black 081.06 with composition: hypromellose, monohydrate lactose, talc, macrogol, black iron oxide (E 172), indigotine (E 132).

What Raphacholin Forte looks like and contents of the pack
Raphacholin Forte is a biconvex, smooth, graphite-black tablet, matte in appearance, with a grey-white cross-section and a black outline.
Unit packaging: 1 or 3 PVC/Al blisters containing 10 tablets or 1 PVC/Al blister containing 30 tablets, in a cardboard box with an informational leaflet for the patient.

Marketing Authorisation 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 about this medicinal product, please contact the Marketing Authorisation Holder at tel. 71 321 86 04 ext. 123