| |
Cefakliman® mono
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:
for improvement of psychical and neurovegetative disorders caused by the menopause.
Composition:
Active ingredient:
Hard capsules: 1 hard capsule contains:
Cimicifuga rootstock dry extract (6.6-8.7:1) 2.675 mg
Extraction solvent: ethanol 60% (v/v).
Drops: 100 g (= 100 ml) contain:
tincture from Cimicifuga rootstock (1:10) 20 g
Extraction solvent: ethanol 69.7% (v/v).
1 g resp. 1 ml corresponds to 33 drops.
Excipients:
Hard capsules: cellulose powder, lactose monohydrate, colloidal anhydrous silica,
microcrystalline cellulose, povidone 25, gelatin, purified water, titanium dioxide (E171),
erythrosine (E127), indigotine (E132), ferric (III) oxide (E172), ferric oxides and -hydroxides (E172).
Drops: liqueur wine.
Contra-indications:
hypersensitivity to the active ingredient or to one of the excipients. If patients, suffering
from estrogen-dependent tumours, are/were in medical care, Cefakliman® mono must
not be used as it is not sufficiently researched if Cimicifuga rootstock extracts support
estrogen-dependent tumours or if they do not have any influence. There has not been
sufficient research for the application of this medicine during pregnancy and lactation.
Therefore and due to the alcohol content of the drops it should not be used during this
period.
Additionally for drops: do not apply in case of alcohol disease.
Interactions:
Hard capsules: the simultaneous intake of estrogens can reinforce their effect. Consult
your physician.
Precautions for use and warnings:
in case of disorders resp. recurrence of menstruation as well as persistent, unclear or
newly occurring other complaints, a physician should be consulted since there may be
underlying diseases for which a medical examination may be essential. The simultaneous
intake of estrogens must be supervised by a physician since Cefakliman® mono can reinforce
their efficacy.
Additionally for hard capsules: contain lactose. In case you are adjusted to certain hormone
supplies, please consult your physician.
Additionally for drops: Cefakliman® mono drops contain 26 vol.-% alcohol. Due to the
alcohol content, Cefakliman® mono drops should only be applied to liver patients, epileptics
and brain-damaged patients after consultation of a physician.
Dosage:
Hard capsules: unless otherwise prescribed, adults take 1 hard capsule twice daily.
Drops: unless otherwise prescribed, 30 - 40 drops are taken twice daily.
Kind and duration of application:
Hard capsules: Cefakliman® mono hard capsules are taken with some liquid (e.g. water).
Drops: Cefakliman® mono drops can be taken undiluted or diluted with some liquid (e.g. water).
The duration of the treatment is generally not limited, but Cefakliman® mono should not
be taken for more than 3 months without medical advice.
Undesirable effects:
Hard capsules: rarely (less than 1 of 1,000, but more than 1 of 10,000 patients treated)
gastro-intestinal complaints (dyspeptic complaints, diarrhea), allergic reactions of the
skin (urticaria, pruritus, skin rash), facial edema and peripheral edema. Rarely there can
be an increase in weight.
Drops: very rarely (less than 1 of 1,000, but more than 1 of 10,000 patients treated)
gastro-intestinal complaints (dyspeptic complaints, diarrhea), allergic reactions of the
skin (urticaria, pruritus, skin rash), facial edema and peripheral edema. Very rarely there
can be an increase in weight.
There have been cases of liver damages with the use of Cimicifuga-containing pharmaceuticals.
Data about the frequency of these possible undesirable effects are not available.
Commercial forms:
Hard capsules: 50 pcs., 100 pcs.
Drops: 100 ml
For any questions about risks and side effects please read the leaflet or ask your doctor or pharmacist.
|
|
