LECTURE 11 – Preparations used to
treat some gynaecological disorders
Dr. Ivana Daňková
Dept. of Natural Drugs, Faculty of Pharmacy, VFU Brno
PHYTOPHARMACEUTICALS
academic year 2018/19
PHYTOPHARMACEUTICALS
vs. Genitourinary system
2
Genitourinary or urogenital system:
 the organ systems concerned with
reproduction and urinary excretion.
 These systems are usually grouped
together because of their proximity to
each other. Although their functions are
unrelated, the structures involved in
excretion and reproduction are
morphologically associated and often
use common ducts.
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 Gynaecological disorders = any disorder
that affects the female reproductive organs
 The most common disorders are:
 vulvodynia – is the term used to describe
chronic discomfort or pain of the vulva
(external genital organs), especially burning,
stinging, irritation, or rawness of the area
 vaginitis – any disorder that causes swelling
or infection of both the vulva and the vagina
 pelvic pain – is a general term that describes the pain in the
lower abdomen area. It signals a problem with one of the organs
in the pelvic area: uterus, ovaries, fallopian tubes, cervix,
vagina. Or, it might be a symptom of an infection.
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 The most common types of vaginitis:
 „yeast“ infections – caused by the fungus
Candida
 bacterial vaginitis – caused by an overgrowth of bacteria that are
of bacteria that are normally present
in the vagina (e.g. Gardnerella vaginalis)
or by other pathogenic bacteria (e.g.
enterococci, streptococci, E. coli…)
 other infectious vaginitis – caused by
Chlamydia sp., Trichomonas sp.,
HSV (Herpes simplex virus),
HPV (Human papilloma virus)
 non-infectious vaginitis – is typically the result of an allergic
reaction or an irritation to soaps, detergents, vaginal preparations,...
Once you stop using the product, the symptoms should go away
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 „yeast“ vaginitis
 bacterial or other infectious vaginitis
Gardnerella
vaginalis
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 Treatment of vaginitis and vulvodynia
 preventive administration of probiotics, prebiotics, eubiotics vaginally
or orally, especially in the treatment of other infectious
diseases with antibiotics
 two-stage procedure:
 provision of the normal physiological condition of the vaginal medium
and mucosa
 provision of the normal microbiocenosis – the use of vaginal eubiotics
was shown to be highly efficient
 local and general treatment – total antibiotics, antimycotics,
antiinflammatory drugs;
 topical medicines with disinfectant, antibacterial, anti-inflammatory
effect,…
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 Vaginal eubiotics
 lactobacterin (Lactobacillus sp.)
bifidumbacterin (Bifidobacterium sp.)
– fermenting sugars into lactic acid
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 TEA TREE OIL
Melaleuca alternifolia, Myrtaceae
 most Melaleuca species are native to Australia
 essential oil (isolated from the leaves) is an
efficacious natural antiseptic (antibacterial,
fungicide) agent
 composition: mainly monoterpenes
terpinen-4-ol (30-48 %), γ-terpinene (10-28 %),
α-terpinene (5-13 %) and others (1,8-cineole,
α-pinene, p-cymen,…)
terpinen-4-ol
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 FEMIGEL
(Australian Body Care)
 hormone free vaginal moisturiser with
3 % of Melaleuca alternifolia oil
 The tea tree oil acts as a natural antibacterial
and antifungal agent and so helps to prevent
recurrent thrush and candidal infection.
Femigel coats the mucous membranes, to provide long lasting
moisturisation and maintains healthy vaginal flora.
 TEA TREE OIL Vaginal gel
(Dr. Müller Pharma)
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 FEMIBION® Intima
(Merck)
 a food supplement, with probiotic strains
Lactobacillus rhamnosus GR1,
Lactobacillus reuteri RC-14
which helps to maintain the natural balance
of the vaginal flora by:
- protecting against bacteria and fungal growth that can cause
vaginal yeast infections.
- sustaining the protective bacteria
in the vagina that can be destroyed by
factors (such as antibiotics, etc.)
 available in topical and oral formats
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 CANDIVAC® cps
(Bioveta, Czech Rep.)
 Czech patented preparation – purified lysate from 4 most common
vaginal inflammation agents
 1 capsule contains 5 mg of active substance prepared by
lyophilisation of inactivated microorganisms (lysatum
cryodessicatum):
Candida albicans 0,83 mg
Candida krusei 0,83 mg
Candida glabrata 0,83 mg
Propionibacterium acnes 2,50 mg
 dosage: 1 capsule once a day, for 10 days,
then pause for 20 days. Next 2 months
to repeat the same procedure.
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 PM-CHLAMYDIL® (Purus-Meda, Czech Rep.)
 cleansing cure (especially when chlamydia occurs)
 contains:
extr. from Filipendula ulmaria - 5: 1,104.3 mg
extr. from Salix alba - 10: 1, 11.6 mg
extr. from Alnus glutinosa - 4: 1, 11.6 mg
Propolis Moravia PM ® - 12.5 mg
 Dosage: 2-4 tablets a day for 3-7 months. The treatment should last at
least 4 months, ideally 7-9 months.
During the first 4 months of dechlamydosis, the organism is purified from
active forms of Chlamydia trachomatis, between 4-7 months of chlamydia
are unable to reproduce and disappear from the organism, between 7-9
months there is probably residual detoxification of the organism from
chlamydial endotoxins.
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 MENSTRUAL DISORDERS
 painful cramps during menstruation (dysmenorrhea) – caused by
menstruation itself (contraction of the smooth muscle), or by other
condition – e.g. endometriosis, or uterine fibroids
 heavy bleeding (menorrhagia) includes prolonged menstrual
periods or excessive bleeding
 absence of menstruation (amenorrhea)
 light or infrequent menstruation (oligomenorrhea)
 premenstrual syndrome (PMS)
 Treatment:
 hormone preparations, ergot alkaloids, NSAIDs, spasmolytics
 herbal preparations – can be used as support therapy
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 Active principles of drugs:
 mostly flavonoids (spasmolytic effect), tannins (astringent),
essential oils (spasmolytic), coumarins (spasmolytic)
 Plant drugs used to treat menstrual disorders
 Alchemillae herba – Alchemilla vulgaris, Rosaceae,
lady´s mantle
 contains mainly tannins, flavonoids
 Anserinae herba – Potentilla anserina, Rosaceae, silverweed
 contains mainly tannins
 Lamii albi flos/herba – Lamium album, Lamiaceae, white deadnettle
 contains mainly tannins, flavonoids
 Agni casti fructus – Vitex agnus-castus, Lamiaceae, chaste tree
 contains flavonoids, diterpenes, essential oils
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Alchemilla vulgaris
herb
Lamium album
flower/herb
Vitex agnus-castus
fruits
Potentilla anserina
herb
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 Plant drugs used to treat menstrual disorders
 Matricariae flos – Matricaria recutita, Asteraceae, German
chamomile
 Chamomillae romanae flos – Anthemis nobilis (Chamaemelum
nobile), Asteraceae, Roman chamomille
 Millefolii herba – Achillea millefolium, Asteraceae, yarrow
 Petasitidis folium – Petasites hybridus, Asteraceae, butterbur
 contains sesquiterpene derivatives (petasin, isopetasin,…), flavonoids,…
 spasmolytic activity
 Bursae pastoris herba – Capsella bursa-pastoris, Brassicaceae,
shepherd´s-purse
 contains biogenetic amines, saponins, flavonoids, glucosinolates
 haemostyptic action (due to a peptide with oxytocin-like activity)
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Achillea millefolium
herb
Matricaria recutita
flower Anthemis nobilis
flower
Petasites hybridus
leaf
Capsela bursa-pastoris
herb
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 LADY´S MANTLE
 Alchemillae herba
Alchemilla vulgaris, Rosaceae
 loose tea or tea bags
 Leros, Megafyt Pharma,
Apotheke, Fytopharma,...
 TEA FOR WOMEN (Leros)
 10(20) x 1.5 g
 Alchemillae herba (30 %)
Origani herba (15 %)
Menthae pip. herba (15 %)
Callunae herba (15 %)
Lamii albi herba (10 %)
Melissae herba (10 %)
Millefolii herba (5 %)
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 GYNASTAN
Feminine Herbal tea
(Fytopharma)
 20 x 1.0 g
 Lamii albi herba
Alchemillae herba
Menthae pip. herba
Millefolii herba
 GYNOTON
(Dr. Müller Pharma)
 20 x 1.5 g
 content in one tea bag (1.5 g):
Lamii albi herba 450 mg
Alchemillae herba 450 mg
Millefolii herba 450 mg
Menthae pip. herba 150 mg
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 AGNUCASTON POR TBL FLM 30
(Bionorica)
 content in 1 tbl:
4 mg of Agni casti fructus extractum siccum
(7-11:1), extracted with ethanol 70%
 SUKL code: 0010045
Prescription-only medicinal products
 ATC: V11, G02CX03
 used for the harmonization of menstrual disorders and complaints
occurring ahead of the onset of menstruation (premenstrual
syndrome), as well as in case of tension and swelling of the breasts
(mastodynia)
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 SARAPIS Mensis
(Sanamed, Austria)
 content in 1 cps:
90 mg flower pollen
50 mg fermented flower pollen
22.5 mg Magnesium
21.25 mg cranberries (Vaccinium macrocarpon) extr.
18.75 mg soy beans (Glycine soya seeds) extract
12.5 mg red clover (Trifolium pratense) extract
+ vitamins B, vit. E, folic acid, zinc, phosphatidylserin
 used for the harmonization of menstrual disorders (dysmenorrhea,
irregular menstruation), premenstrual syndrome (tension and
sensitivity of the breasts, loss of appetite, nervousness,…)
 dosage: 1 capsule 2 times a day
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 MASTODYNON
POR GTT SOL 1X50ML (Bionorica)
 !! homeopathic remedy (in decimal
dilution)
 content in 100 mL:
Agnus castus D1 20 g
Caulophyllum thalictroides D4 10 g
Cyclamen europaeum D4 10 g
Strychnos ignatii D6 10 g
Iris versicolor D2 20 g
Lilium tigrinum D3 10 g
53 % of ethanol by volume
 SUKL code: 0045546
OTC medicinal products
 ATC: V11
 available also as tablets
 preparation is included into
Phytopharmaceuticals (ATC group
V11), but in fact it is homeopatic
preparation
 used in case of complaints prior to
menstruation such as, e.g. feeling
of tension and swelling of the
breasts (mastodynia), complaints
during menstruation and menstrual
cycle
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 MENOPAUSE, CLIMACTERIUM
 is defined as the state of an absence of menstrual periods for
12 months when the function of the ovaries and secretion of
estrogen/progesterone is coming to stop
 symptoms of menopause can include abnormal vaginal bleeding,
hot flashes, sweating, vaginal and urinary symptoms,
and mood changes
 complications that women may develop after
menopause include osteoporosis, metabolic
syndrome and cardiovascular diseases
 Treatment is directed toward relieving
uncomfortable or distressing symptoms
 hormone replacement therapy (HRT)
 herbal remedies with content of phytoestrogens
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 PHYTOESTROGENS
 Isoflavones are non-steroidal, polyphenolic
compounds related to flavonoids that are
capable of exerting estrogen-like effects
 the chemical structure of isoflavones is quite
similar to that of our own estrogens that is why
they can interfere with the estrogen receptors (ER)
on the cells – reduce or activate the estrogen activity
 the consumption of isoflavones may
have a positive effect in prevention of
 adverse menopausal manifestations
 hormone-dependent cancer
 cardiovascular disease
 osteoporosis – improve bone health
 cognitive decline
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 ISOFLAVONES, e.g.:
 genistein, (genistin)
 daidzein, (daidzin)
 biochanin A
 formononetin
 Plant drugs containing isoflavones, especially from the family
Fabaceae:
 Glycine max, soy beans
 Trifolium pratense, red clover
 Medicago sativa, alfalfa
 Ononis spinosa, spiny restharrow
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Glycine max, soy
seeds
Medicago sativa
herb/germs
Trifolium pratense
herb
Ononis spinosa
root
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 Other natural compounds with
estrogen-like activity:
 stilbenes
 resveratrol – Vitis vinifera var. rubra,
Vitaceae, red wine
 coumestans
 coumestrol – e.g. in alfalfa, soy
beans, red clover
 lignans
 matairesinol, secoisolariciresinol
– major food sources: oil seeds and nuts,
whole grains, vegetables, fruits,
e.g. Linum usitatissimum seed, flax seed
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 Other plant drugs used in herbal teas for reduction of
menopausal complaints:
 to calm down, eliminate psychological disorders, e.g.:
 Hyperici herba, Melissae herba/folium,...
 against excessive sweating, hot flashes, e.g.:
 Salviae herba/folium
 drugs with diuretic activity, e.g.:
 Betulae folium, Urticae folium/herba,...
 drugs that improve the functioning of the cardiovascular system
 Crataegi folium cum flore/fructus
 drugs with astringent effect, e.g.:
 Alchemillae herba
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 FYTOKLIMAN Planta
(Leros)
 POR SPC 20X1.5 GM
 composition, in 100 g:
Hyperici herba 20 g
Alchemillae herba 20 g
Crataegi folium cum flore 20 g
Betulae folium 15 g
Melissae herba 10 g
Origani herba 10 g
Lupuli flos 5 g
 SUKL code: 0089824
 ATC: V11
 be careful about the content of
Hyperici herba !
 An herbal preparation
combining different herbs with
different properties – to calm
and relax (Hyperici herba,
Melissae herba, Lupuli flos),
as an astringent to control
bleeding (Alchemillae herba),
to help reduce blood pressure
(Crataegi folium cum flore) and
as a diuretic (Betulae folium).
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 KLIMAKTERIN
(Dr. Müller Pharma)
 20 x 1.5 g
 content in one tea bag (1.5 g):
Trifolium rubri flos 1050 mg
Melissae herba 450 mg
 GYNASTAN Meno
(Fytopharma)
 20 x 1.5 g
 Trifolium rubri flos
Melissae herba
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 MENOFLAVON Classic cps.
MENOFLAVON Forte cps.
(Melbrosin International, Austria)
 content in 1 capsule:
standardized extract of Trifolium pratense,
RCE 40, corresponding to 40 (80) mg of isoflavones
(genistein, daidzein, biochanin A, formononetin)
 according to the research of Vienna University, the activity of 1 g
of Trifolium pratense extract corresponds to the activity of 85 μg
17--estradiol (20 times more than in soy)
 dosage: 1 tablet daily
 no side effects
 not recommended in pregnancy and lactating
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 MENOFLAVON OSTEO cps.
(Melbrosin International, Austria)
 content in 1 capsule:
- standardized extract of Trifolium pratense,
corresponding to 50 mg of isoflavones
+ OSTEO complex:
calcium 350 mg
magnesium 30 mg
zinc 2,5 mg
vitamin D3 2,5 µg
 dosage: 1-2 tablet daily
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 FEMIFLAVON Forte tbl.
(Favea)
 content in 1 tbl:
50 mg Silybum marianum extract (standardized to 20 % content
of silybin)
50 mg Vitis vinifera leaves and fruit extract
40 mg isoflavones from Trifolium pratense
4 mg natural carotenoids from algae Dunaliella salina
(halophile green micro-algae)
400 μg folic acid
4 mg vitamin B6
2.5 μg vitamin B12
250 mg non-soluble fibre
 dosage: 1 tablet daily
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 IVE® inkontin stop cps.
(SWISS Pharmaceutical Investments)
 content in 1 capsule:
175 mg of microsomal flavolignane complex
(extract from the Silybum marianum fruits,
lecithin, squalen,…)
90 mg dry extract from Trifolium pratense herba
75 mg dry extract from Glycine max semen
40 mg dry extract from Linum usitatissimum semen
inulin
 dosage: 1 capsule daily
 IVE® 50 InkontinStop cps.
 contains also extract from Cucurbita pepo semen
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 SARAPIS Soja
(Sanamed, Austria)
 content in 1 cps:
24 mg lyophilized royal jelly
(= 72 mg of crude r. j.)
180 mg flower pollen
100 mg fermented flower pollen
37.5 mg soy beans extract
25 mg red clover extract
20 mg vitamin C
3 mg iron (Fe)
 dosage: 1 capsule 2 times a day
 CI: hypersensitivity to any component, especially to bee products
 royal jelly (bee secret that is used in the nutrition of larvae) health
benefits: reducing the symptoms of PMS and menopausal syndrome,
lowering cholesterol levels, serving as a general tonic for rejuvenation,
improving immune system function
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 Cimicifugae rhizome/radix
Cimicifuga racemosa (Actea racemosa),
Ranunculaceae
black cohosh
 active principles are triterpenoid glycosides
– actein, cimicifugosid
and also isoflavones – formononetin
 the possible mode of action – lowering of LH
(luteinizing hormone) due to the influencing
of hypothalamic-hypophyseal system
 in 2006, European Medicines Agency (EMA,
previously EMEA) called attention to
possible hepatotoxicity in high doses of
Cimicifuga racemosa extract
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Preparations with Cimicifuga racemosa:
 MENOFEM POR TBL FLM 60X20MG
(Bionorica/Schwabe)
 content in 1 coated tablet:
2.80 mg Cimicifugae extractum
siccum 5-10:1, extracted with ethanol 58 %
 SUKL code: 0125119; OTC medicinal product
 ATC: G02CX04
 Indication: symptoms of pre- or postmenopausal neurovegetative
disorders – hot flashes, sweating, headaches, sleep disorders,
mood changes,…
 Dosage: 1 tablet 2 times a day
recommended duration of therapy: 8 weeks
 CI: hypersensitivity to any component, pregnancy, lactation
Be careful in case of any liver disease!
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Preparations with Cimicifuga racemosa:
 KLIMADYNON/KLIMADYNON Uno
(Bionorica)
 dry extract of the black cohosh rhizome
(Cimicifuga racemosa)
 GS MERILIN Harmony
(Green-Swan Pharmaceuticals)
 content in 1 tbl:
standardized dry extract of Cimicifuga racemosa
(equal to 20 mg of dry rhizome)
250 mg Calcium
10 μg vitamin D3
extr. Hyperici herba (equal to 150 mg of dry
herba)