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Cefasilymarin®
Film coated tablets
basic information
This product information corresponds to the patient leaflet, prescribed by law in Germany, in all essential parts.
Fields of application:
for supportive treatment of chronic inflammatory liver diseases, hepatic cirrhosis and
toxic liver damages. This remedy is not suitable for treatment of acute poisonings.
Composition:
1 film coated tablet contains:
Active ingredient:
176 - 200 mg dry extract from milk thistle fruits (35-45:1)
corresponding to 105 mg silymarin (calc. as silibinin, HPLC).
Extraction solvent: acetone.
Excipients:
microcrystalline cellulose, lactose monohydrate, copovidone, colloidal anhydrous silica,
magnesium stearate, crospovidone, povidone, macrogol, hypromellose, talc, titanium
dioxide (E171), ferric (III) oxides (E172), polyacrylate.
Contra-indications:
this medicine has not been sufficiently researched for children’s use. Please refrain from
giving the tablets to children under 12 years. There has not been sufficient research for
the use of this medicine during pregnancy and lactation. Therefore, it must not be used
during this period. Cefasilymarin® must not be used in case of known hypersensitivity
to milk thistle fruits and/or other Compositae or one of the excipients.
Interactions:
interactions of Cefasilymarin® with other pharmaceuticals - even in case of pharmaceuticals
not subject to prescription - have not been finally clarified. A mutual influence cannot
be excluded.
By improvement of the liver function with the intake of Cefasilymarin®, the metabolisation
of other pharmaceuticals, which are taken simultaneously, can be changed so that the
dosage has to be adjusted if necessary.
Precautions for use and warnings:
contains lactose. The pharmacotherapy does not replace the prevention of liver-damaging
reasons (e.g. alcohol). In case of icterus (light to dark yellow-colouring of the skin,
yellow-colouring of the sclera, mostly as a result of an insufficient liver function) a physician
should be consulted.
Dosage:
adults and adolescents from 12 years take 1 film coated tablet Cefasilymarin® (extract
from milk thistle fruits corresponding to 210 mg - 315 mg silymarin) twice to three times
daily.
Kind and duration of application:
Cefasilymarin® is taken without chewing with some liquid. In case of intake twice daily,
application in the morning and in the evening, in case of intake three times daily, application
in the morning, at noon and in the evening.
The attending physician decides about the duration of intake. In case of persistent complaints
despite the intake of Cefasilymarin®, the physician should be consulted.
Undesirable effects:
like all medicines, Cefasilymarin® can have undesirable effects. Gastro-intestinal complaints,
such as e.g. a slight laxative effect, have been observed. Furthermore, hypersensitivity
reactions such as e.g. skin rashes or dyspnea can occur. Data on the frequency
are not available. In the leaflet, the following is pointed out to the patient: in case of occurrence
of above mentioned undesirable effects, inform your physician so that he/she
can decide about the severity and possible necessary measures. In case of hypersensitivity
reactions stop the intake of Cefasilymarin®.
Commercial forms:
Film coated tablets: 20 pcs., 60 pcs., 100 pcs.
For any questions about risks and side effects please read the leaflet or ask your doctor or pharmacist.
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