ESSENTIALE FORTE 300MG (CAPSULE)

Administration Should be taken with food: Swallow whole w/ a glass of water, do not chew. Interactions Anticoagulants. Contraindications Known hypersensitivity to soya-bean preparations or to any of the excipients. Special Precautions The leaflet draw the attention of the patient to the following: This drug therapy is not a substitute for the avoidance of the noxious agent causing liver damage (e.g. alcohol). In chronic hepatitis the adjuvant therapy with soya-bean phospholipids is justified only when improved subjective well-being becomes manifest during therapy. Consult the doctor when complaints aggravate or when other unclear complaints occur. Effects on ability to drive or use machines: Essentiale Forte P capsule 300 mg has no effect on the ability to drive and to use machines. Use in children: As information about the administration in children is insufficient, Essentiale Forte P capsule 300 mg should not be given to children under 12 years of age. Due to the content in soya-bean oil the medicinal product may provoke severe allergic reactions. Use In Pregnancy & Lactation Preparations from soya-beans are largely used in human food and so far no clue has appeared that would suggest any risk during pregnancy. Results from investigation are insufficient. For this reason, the use of Essentiale Forte P capsule 300 mg is not recommended during pregnancy and lactation. Caution for Usage Incompatibilities: Not applicable. Adverse Reactions For the evaluation of any adverse effects the following incidences are considered: Very frequent (≥1/10); frequent (≥1/100 to ≥1/10); occasional (≥1/1,000 to ≥1/100); rare (≥ 1/10,000 to ≥1/1,000); very rare (<1/10,000). Occasionally the administration of Essentiale Forte P capsule 300 mg may provoke gastrointestinal disorders, such as stomach complaints, soft stool and diarrhoea. On very rare occasions allergic reactions may occur, such as exanthema and urticaria. The doctor or pharmacist should be informed about any undesirable effect not listed in the leaflet. The administration of Essentiale Forte P capsule 300 mg should be discontinued in the event of one of the above mentioned side effects, especially in hypersensitivity reactions. The patient should consult the doctor who may decide about the severity and any measures that might be necessary.