Cefanorm^®

Hard capsules, drops

basic information

This product information corresponds to the patient leaflet, prescribed by law in Germany, in all essential parts.
 
Fields of application:
irregularities of the menstrual cycle, sensations of tension and swelling in the breasts (mastodynia), monthly recurring complaints before the onset of the menstruation (premenstrual symptoms). In the leaflet the following is pointed out to the patient: in case of feelings of tension and swelling in the breasts as well as disorders in menstruation, a physician should be consulted since there may be underlying diseases for which a medical examination may be essential.
 
Composition:
Active ingredient:
Hard capsules:
1 hard capsule contains: dry extract from chaste tree fruits (7-13:1) 4 mg
Extraction solvent: ethanol 60% (m/m).
Drops:
100 g (= 109 ml) contain: tincture from chaste tree fruits (1:5) 20 g
Extraction solvent: ethanol 70% v/v.
1 ml corresponds to 40 drops.
 
Excipients:
Hard capsules: glucose syrup, lactose monohydrate, talc, maize starch, magnesium stearate, colloidal anhydrous silica, gelatin, sodium laurilsulfate (dodecyl sulfate), purified water, dyestuff E171.
Drops: ethanol 96%, purified water.
 
Contra-indications:
Cefanorm® must not be used in case of
- hypersensitivity to chaste tree fruits (monk’s pepper) or to one of the excipients of the pharmaceutical
- hypophyseal tumour
- mammary carcinoma.
Due to not sufficient investigations and because of the alcohol content of the drops, Cefanorm® must not be taken in during pregnancy and lactation. After administration of chaste tree fruits (monk’s pepper) an impairment of milk production was observed in animal experiments.
Additionally for drops: do not apply in case of alcohol disease. Due to the alcohol content, Cefanorm® drops should only be taken in by liver patients, epileptics, brain patients or brain-damaged patients after consultation of a physician.
 
Interactions:
interactions are not known. There are references - based on experiments in animals - to a dopaminergic effect of the drug; thus an alternating weakening of the effect could be possible in case of administration of dopamine-receptor-antagonists.
 
Warning:
Hard capsules: contain glucose and lactose.
Drops: Cefanorm® drops contain 55 vol.-% alcohol.
 
Dosage:
Hard capsules: intake of 1 hard capsule daily (corresponding to 40 mg drug).
Drops: unless otherwise prescribed, adults take in 35 - 45 drops in the morning before eating and drinking.
 
Kind and duration of application:
Hard capsules: Cefanorm® hard capsules can be swallowed with some liquid (e.g. water). They should preferably always be taken in at the same time of day.
Drops: Cefanorm® drops are taken in diluted with some liquid (e.g. water).
The preparation should be taken in over 3 menstrual cycles at least.
 
Undesirable effects:
Hard capsules: occasionally headache, itching, abdominal complaints such as nausea, stomach ache or pains in the lower abdomen as well as systemic hypersensitivity reactions with exanthema, urticaria, facial swelling, dyspnea and swallowing complaints. In the leaflet, the following is pointed out to the patient: in case of occurrence of above mentioned undesirable effects, stop the intake of the preparation and consult a physician. If you notice undesirable effects, not mentioned in this leaflet, inform your physician or pharmacist.
Drops: after intake of pharmaceuticals containing chaste tree fruits, headache, itching, abdominal complaints such as nausea, stomach ache or pains in the lower abdomen are described. Cases of systemic hypersensitivity reactions with exanthema, urticaria, Quincke’s edema, dyspnea and swallowing complaints are described as well. In the leaflet, the patient is instructed to stop the intake and immediately consult a physician in case of signs of hypersensitivity reactions.
 
Commercial forms:
Hard capsules: 30 pcs., 60 pcs., 100 pcs.
Drops: 100 ml
 
For any questions about risks and side effects please read the leaflet or ask your doctor or pharmacist.