Cefanorm

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Active ingredient Extract from Chaste tree
fruits
Indication Menstrual disorders
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Botany
Vitex agnus castus L.
Family Verbenaceae (vervain plants) Synonyms
Monks pepper Mönchspfeffer Abrahamsstrauch Ch
aste tree Origin Mediterranean area, Central
Asia, Isle Krim. Preferably also on brooksides
and riversides.
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Botany
Medicinal drug Chaste tree fruits (Agni casti
fructus), consisting of the ripe, dried
fruits.
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Brief profile

• Chaste tree is a shrub up to 4 m high.
• The leaves are crossed-opposite, long-stemmed.
• Separated finger-shaped with up to 7 lanceolate
  feathered small leaves.
• The mauve, ear-like inflorescences build
  reddish-black, peppercorn-sized drupes.
• Time of prosperity June to September.

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Ingredients

• bicyclic diterpenes (aucubin, agnoside)
• lipophile flavonoids (casticin)
• essential oil
• fatty oil

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Effects

• inhibition of the prolactin secretion and thus,
  reduction of increased prolactin levels
• point of action at the hypophyseal portal system
• dopaminergic effect
• inhibition of lactation (experiments in animals)

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Release and inhibition of hormones in hormonal
circuit of regulation
Quelle PZ Nr. 10, 144 Jahrg. 1999
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Fields of application
Traditional - in the antique for womens
diseases, especially fertility disorders Gynaecol
ogy - for all symptoms of corpus luteum
insufficiency and estrogen-progesterone-imbalanc
e
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Fields of application
1. Premenstrual syndrome (PMS)
symptoms psychic nervousness, irritability,
mood swings, depressive states, lack of
concentration, insomnia. somatic migraine-like
headache, feeling of tension in the breasts,
swellings, edema, lower abdominal cramps,
nausea, feeling of fullness, bloating,
constipation, tiredness.
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Fields of application
2. Menstrual irregularities
irregularities of the menstrual rhythm
polymenorrhea/oligomenorrhea too frequently /
too rarely irregularities of the menstrual
intensityhypomenorrhea/hypermenorrhea too weak
/ too strong irregularities of the duration of
the menstruationmenorrhagia/brachymenorrhea too
long / shortened secondary amenorrhea (absence of
menstruation over a period of 6 months, after
prior normal course)
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Fields of application
3. Mastodynia
premenstrual, mostly painful breast tension,
complaints are mostly limited to the second half
of the cycle
4. Fertility disorders
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Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Menstrual irregularities
Increased prolactin levels, existing before start
of the therapy, could be reduced during the
treatment with Vitex agnus castus. Roeder D,
(1994) Therapy of menstrual cycle
disturbancesVitex agnus-castus. Zeitschrift für
Phytotherapie 15, 155-159

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Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Premenstrual syndrome
The most frequent and most important symptoms
such as headache, breast tension, nervousness,
lack of concentration, emotional changes and
depressions showed a clear improvement. Berger
D, Schaffner W, Schrader E, Meier B, Brattstrom
A, (2000) Efficacy of Vitex agnus castus L.
extract Ze 440 in patients with premenstrual
syndrome (PMS). Arch Gynecol Obstet. Nov 264
(3) 150-153 Loch EG, Selle H, Boblitz N, (2000)
Treatment of premenstrual syndrome with a
phytopharmaceutical formulation containing Vitex
agnus castus. J Womens Health Gend Based Med. 9
(3) 315-320

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Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Premenstrual syndrome
Placebo-controlled, randomised double-blind study

• The treatment of PMS with monks pepper is
  effective

• Significant reduction of irritability, mood
  swings, aggressiveness, headache and breast
  tensions.
• Schellenberg R, et al., (2001) Treatment for the
  premenstrual syndrome with agnus castus fruit
  extract prospective, randomized, placebo
  controlled study. BMJ 322 134-137

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Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Mastodynia
Placebo-controlled, randomised double-blind study

• Reduction of the inconvenient feeling of
  tension and swelling in the breast before
  menstruation

Halaska M, Beles P, Gorkow C, Sieder C, (1999)
Treatment of cyclical mastalgia with a solution
containing a Vitex agnus castus extract results
of a placebo-controlled double-blind study.
Breast. 8 (4) 175-181
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Clinical efficacy
Rational phytotherapy with Vitex agnus castus
Fertility disorders
Placebo-controlled, randomised double-blind study

• Duration of the luteal phases increased clearly
• Release of prolactin decreased significantly

Milewicz A, Gejdel E, Sworen H, Sienkiewicz K,
Jedrzejak J, Teucher T, Schmitz H, (1993) Vitex
agnus castus extract in the treatment of luteal
phase defects due to latent hyperprolactinemia.
Results of a randomized placebo-controlled
double-blind study Arzneimittelforschung 43 (7)
752-756
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Cefanorm - Advantages at a glance

• normalises cycle disorders in a natural and
  gentle way
• stimulates corpus luteum
• reduces prolactin level
• does not contain any hormones

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Basic information
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).
Composition Active ingredient 1 capsule
contains Dry extract from Chaste tree fruits (7
- 13 1) 4 mg. Extraction solvent Ethanol 60
(m/m). Excipients Glucose syrup, lactose
monohydrate, talc, maize starch, magnesium
stearate, colloidal anhydrous silica, gelatin,
sodium laurilsulfate (dodecylsulfate), purified
water, titanium dioxide E 171.
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Basic information
Contra-indications Cefanorm must not be taken in
when suffering from hypersensitivity to Chaste
tree fruits (Monks pepper) or to one of the
excipients of the medicament, hypophyseal
tumours, mammary carcinoma. Use during pregnancy
and lactation Due to not sufficient
investigations Cefanorm must not be taken in
during pregnancy and lactation. Interactions
with other substances 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 None
known. Dosage Intake of 1 capsule daily
(corresponding to 40 mg drug).
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Basic information
Kind and duration of application Cefanorm
capsules should preferably always be taken in at
the same time of day. The preparation should be
taken in over 3 menstrual cycles. Side
effects After intake of Cefanorm there are
rarely itching rashes (urticarial exanthema). In
the leaflet, the patient is instructed to stop
the intake and immediately consult a physician in
case of signs of hypersensitivity
reactions. Commercial form Capsules 30 pcs.
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Monograph
Chaste Tree fruit, Agni casti fructus Official
Monograph of the Bundesinstitut für Arzneimittel
und Medizinprodukte (BfArM) (German Federal
Institute for Drugs and Medical
Devices) Commission E (Phytotherapy), BAnz.-No.
226 dated December 02, 1992 Name of Drug Agni
castus fructus chaste tree fruit, vitex
fruit. Composition of Drug Chaste tree fruit
composed of the ripe, dried fruits of Vitex agnus
castus L. Fam. Verbenaceae, as well as their
preparations in effective dosage. Pharmacological
Properties, Pharmacokinetics, Toxicology There
is evidence that aqueous-alcoholic extracts of
chaste tree fruit inhibit secretion of prolactin
in vitro. In human pharmacology there are no data
about the lowering of prolactin levels. There is
no knowledge regarding pharmacokinetics.
Systematic studies about toxicology are unknown.
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Monograph
Clinical data 1. Uses Irregularities of the
menstrual cycle. Premenstrual complaints.
Mastodynia. Note In case of feeling of tension
and swelling of the breasts and at disturbances
of menstruation, a physician should be consulted
for diagnosis. 2. Contraindications None
known. 3. Side Effects Occasional occurrence of
itching, urticarial exanthemas. 4. Special
Cautions for Use None known. 5. Use During
Pregnancy and Lactation No application during
pregnancy. In animal experiments an influence on
the nursing performance was observed.
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Monograph
6. Interactions with Other Drugs Interactions are
unknown. In animal experiments there is evidence
of a dopaminergic effect of the drug therefore,
a reciprocal weakening of the effect can occur
in case of ingestion of dopamine-receptor
antagonists. 7. Dosage Unless otherwise
prescribed Daily dosage aqueous-alcoholic
extracts corresponding to 30 - 40 mg of the
drug. 8. Mode of Administration Aqueous-alcoholic
extracts (50 70 percent v/v) from the crushed
fruits taken as liquid or dry extract. 9.
Overdosage None known. 10. Special warnings None
known. 11. Effects on Operators of Vehicles and
Machines None known.
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Differentiation in the area of dysmenorrhoea
PMS (Cefadian / Cefanorm)
general accompanying symptoms such as nausea,
backache, headache, mental depressive moods