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FEBICHOL

FEBICHOL
 

Soft gelatin capsules

Febichol is a choleretic agent which means a drug increasing the production of bile.
Each capsule of Febichol contains 100 mg of active ingredient fenipentol (fenipentolum).

Febichol capsules are to be used by adult patients to treat digestive problems in chronic (long-term) liver disease and bile duct disease (disorders of gall bladder activity, chronic cholecystitis, chronic development of gall bladder stones, chronic liver disease associated with digestive symptoms caused by impairment or disorder of biliary tree) and conditions after surgical removal of gall bladder or after hepatitis.
The product may be used by adults and youths older than 15 years of age.

  • Dosage: Standard dosage for adults and youths over 15 years of age is 2 capsules of Febichol three times a day (always immediately before meals), some patients with less severe symptoms may use Febichol only occasionally as needed (2 capsules immediately before meal).
Capsules are to be swallowed unchewed and unmacerated (the contents have hot, bitter taste!) and are to be swallowed with sufficient amount of water (e.g. one glass of water).
Febichol capsules may be used in the long-term. However if you intend to use them continually longer than 14 days, consult your physician who will advise you whether it is appropriate for your particular case.

  • Adverse effects: Febichol capsules are in general well tolerated.
Some patients may report heartburn [or having “hot feeling in the throat (in the pharynx and the esophagus) or burning retrosternal pain] or feeling burning in the stomach”.
Some patients using Febichol capsules report symptoms hard to discern from their own treated symptoms (feeling pressure and fullness in the upper abdomen, nausea, flatulence).
Rarely, allergic reactions (hypersensitivity reactions) such as urticaria (efflorescence of itching, red extensive, confluent elevated spots on the skin), skin rash or face swellings cannot be excluded.
If you develop any of the mentioned symptoms of hypersensitivity reactions, stop using Febichol and seek medical help immediately!

  • Package: One package contains 50 soft gelatin capsules.
  • Storage: Store at temperature 25°C in the original container to protect against light and moisture.
Keep out of reach and sight of children.

Medicinal product for internal use. Read carefully the package information that can be found in part VPOIS.
The following web pages are designed for health care specialists only, i.e. for people authorized to prescribe and hand out medications. Here, you can find a link to specialist information services for health care professionals, summaries of product characteristics and various useful supplementary services, such as provision of special information, interesting links, etc.

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Abbreviated Summary of Product Characteristics on FEBICHOL soft gelatin capsules.

  • Composition and pharmaceutical form: One capsule contains 100 mg of fenipentol (fenipentolum). For complete list of excipients see SPC*.
  • Pharmacotherapeutic group: Choleretic. ATC code: A05AX
  • Therapeutic indications: Febichol capsules are indicated in adult patients to treat dyspeptic symptoms in chronic disorders of hepatobiliary tract (functional cholecystopathy, chronic cholecystitis, chronic cholelithiasis, chronic liver disease with biliary dyspepsia) and conditions after cholecystectomy or after hepatitis.
  • Posology and method of administration: Standard dosage is 2 capsules of Febichol three times a day (always immediately before meals), some patients with less severe symptoms may use Febichol only occasionally as needed (2 capsules immediately before meal).
Capsules are to be swallowed unchewed and unmacerated (the contents have a hot, bitter taste!) and are to be swallowed with sufficient amount of water (e.g. one glass of water).
Instruction on dose adjustment in case of kidney or liver dysfunction are not available (in acute hepatitis and other severe liver dysfunction, Febichol capsules are contraindicated).
  • Contraindications: biliary colic, obstruction of the biliary tract, acute disease of the biliary tract, empyema of gall bladder, acute pancreatitis, ileus and other acute conditions in the abdominal cavity; ulcers and tumors of the gastrointestinal tract; acute hepatitis and other severe liver diseases, hypersensitivity to fenipentol or any other of excipients contained in Febichol capsules.
Febichol capsules should not be used by pregnant or breast-feeding women for safety reasons.
Due to lack of experience Febichol capsules should not be used by children under 15 years of age.
  • Special warnings and precautions for use: Contents of the capsules have a very hot and bitter taste; therefore, capsules must be swallowed unchewed and unmacerated.
  • Interactions: There are no known interactions of fenipentol.
  • Pregnancy and lactation: For safety reasons, Febichol capsules are contraindicated in pregnant women. Women using Febichol capsules should not breastfeed. No data are available concerning excretion of fenipentol to breast milk.
  • Effects on ability to drive and use machines: Febichol capsules are not known to have adverse effects on the capability to drive vehicles, to operate machinery or to work at heights.
  • Undesirable effects: Febichol capsules are in general well tolerated. Some patients may report heartburn or having a “hot feeling in the stomach”. Some patients using Febichol capsules report symptoms hard to discern from their own treated symptoms (feeling pressure and fullness in the upper abdomen, nausea, flatulence). Rarely, allergic reactions such as urticaria, maculopapular or other exanthema or face swellings cannot be excluded.
  • Overdose: Symptoms of fenipentol overdose are not known. Fenipentol does not have any specific antidote. Therapy of any overdose must be symptomatic.
  • Pharmacokinetic properties: Pharmacokinetic studies of fenipentol in people have not been performed.

Type of package and size of package:
  • a) Brown glass vial with screw-on PE cap with sealing ring confirming originality, paper carton
  • 
b) PVC/Al blister, paper carton

  • Size of package: 50 soft capsules
  • Storage: Store at temperature 25°C in the original container to protect against light and moisture.

Name and address of the Marketing Authorization Holder: Noventis, s. r. o., Filmová 174, 761 79 Zlín, Czech Republic
  • Marketing Authorization Number: 43/326/69-S/C
  • Date of the authorization and the latest renewal of the authorization: 1969 / 4. 6. 2008
  • Date of text revision: 12. 11. 2008

This medicinal product is available without a prescription. The product is not reimbursed by public health insurance. Before prescribing the medication, please study the information about the medicinal product with due care. More detailed information can be found in the valid Summary of Product Characteristics. Further information is available at Noventis s. r. o., Filmová 174, 761 79 Zlín, the Czech Republic.

* SPC – Summary of Product Characteristics