Local treatment of bacterial vaginosis

For vaginal application

Albothyl® pessaries
Posology

1 Albothyl® pessary (90 mg policresulen) per day.

Method of administration
The pessary is inserted high into the vagina, preferably in the supine position. To prevent
premature expulsion of the pessary it should be inserted in the evening before going to
sleep. To make insertion easier the pessary can be briefly immersed in water prior to use.
The use of a sanitary pad prevents soiling of clothing and bedding.
The pessaries should be used until the symptoms have disappeared, but not for more than 9
days. If the symptoms have not resolved after this period, treatment should be discontinued
and a doctor consulted.
No data are available on the relapse rate after stopping treatment with Albothyl® pessaries.

Children and Adolescents
Albothyl concentrate /pessaries are not indicated for use in children and adolescents under
the age of 18 years, as to date there is no experience in these age groups.
Elderly people
Albothyl concentrate /pessaries are not indicated for use in postmenopausal women, as
there is no experience in these age groups.
Sexual intercourse must be avoided during treatment with Albothyl concentrate/ pessaries
and in the following 10 days.
Washing with soaps that trigger irritation must be avoided during the treatment period.
Albothyl concentrate/ pessaries are not effective against HIV infections or other sexually
transmitted diseases such as gonorrhoea or syphilis.
Albothyl concentrate/ pessaries should not be used during menstruation.
As a sign of the therapeutic effect necrotic tissue may be expelled from the vagina,
sometimes in large amounts. For this reason sanitary pads should be worn and changed
regularly when soiled to prevent tissue residues causing any irritation of the vulva.
If Albothyl concentrate/ pessaries have been swallowed by mistake, the person must
immediately drink plenty of water and be medically examined and treated as quickly as
possible for any erosive effect on the mouth, throat and oesophagus.
After contact with the eyes, Albothyl concentrate/ pessaries must be thoroughly rinsed out
at once with water. It may be necessary to consult an ophthalmologist.

Albothyl concentrate/ pessaries are for local use only.
During treatment with Albothyl concentrate/ pessaries other medicinal products for vaginal
use should be avoided as interactions cannot be excluded.

During pregnancy and breastfeeding Albothyl concentrate/ pessaries may be used only
where strictly indicated, after due consideration of the risks to the mother and child.
There have not been any studies of the risks associated with use during pregnancy in
humans. Studies in animals have not yielded any evidence of foetal malformation. It is not
known whether the active substance is excreted in breast milk.
In addition for Albothyl concentrate:
Swabbing of the cervix should be avoided in pregnant women, especially in the advanced
stage of pregnancy, as this could trigger labour.
Swabbing of the portio and the portio adjacent parts of the vagina should be performed
with appropriate care and only in certain strictly defined indications.

Effects on the ability to drive, use machines or work without proper safeguards are not
known.

The assessment of undesirable effects is based on the following frequencies:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1.000 to < 1/100)
Rare (≥ 1/10.000 to < 1/1.000)
Very rare (<1/10.000)
Not known (cannot be estimated from the available data)
Immune system disorders
Not known: systemic allergic reactions (e.g. angioedema, generalised urticaria) up to
anaphylaxis.
Reproductive system and breast disorders
Very common: dryness in the vagina.
Common: burning sensation in the vagina, discharge of shreds of mucous membrane.
Not known: vaginal candidiasis, pruritus vulvae, discomfort, foreign body sensation in the
vagina.
Skin and subcutaneous tissue disorders
Not known: urticaria.
If severe local irritation occurs Albothyl concentrate/ pessaries should be discontinued and
an alternative antibacterial therapy being considered.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions to the
Bundesinstitut für Arzneimittel und Medizinprodukte
Abt. Pharmakovigilanz
Kurt-Georg-Kiesinger Allee 3
D-53175 Bonn
Website: www.bfarm.de

No cases of overdose have been reported.
If Albothyl pessaries have been swallowed by mistake, a doctor should be consulted so that
he can decide what further measures are necessary.

Pharmacotherapeutic group: gynaecological antiseptic
ATC code: G01AX03
Mechanism of action
The therapeutic activity of policresulen is based on two mechanisms of action that are interconnected:
- antimicrobial effect on bacteria
- denaturation of necrotic tissue.
Coagulation and subsequent elimination of necrotic and pathologically changed tissue
stimulate wound healing processes and promote reepithelialisation. Squamous epithelium is
less attacked by policresulen than columnar epithelium. However, exfoliation of the vaginal
and cervical squamous epithelium has been observed.

Absorption
Only a negligible portion of policresulen is absorbed after vaginal use, resulting in a high
concentration of active ingredient at the administration site. Results of clinical studies with
Albothyl pessaries in healthy women have shown that low-molecular constituents of the
active ingredient policresulen, such as m-cresol-4-sulfonic acid, m-cresol-6-sulfonic acid,
m-cresol-4,6-disulfonic acid and dicresulene, are absorbed in small quantities. Serum
concentrations measured in these studies were in the lower nanogram range per ml.
Elimination
Hence, due to rapid renal elimination, the overall systemic availability of these substances
is low.
Absorption and systemic availability of policresulen and its low-molecular constituents
after repeated administration on irritated vaginal skin, which is typical for bacterial
vaginosis, have not been investigated.

Policresulen is non-toxic when used locally, as has been demonstrated over about 50 years
of clinical experience.
Acute toxicity
The acute toxicity was determined in mice at 340 to 380 mg/kg (i.v. administration) and
2,300 to 2,500 mg/kg (oral) and in rats at 390 to 420 mg/kg (i.v. administration) and 3,200
to 3,900 mg/kg (oral).

The LD50 in the mouse is more than 200 times and in the rat more than 300 times the
human dose.
Chronic toxicity
After 3 months, rats given 40 times the human dose and dogs 9 times the human dose
exhibited no substance-specific signs of toxicity. Dermal tolerability of policresulen was
investigated on depilated dorsal skin in mice and rabbits. Policresulen applied topically at
various concentrations (4%, 12% and 36%) on 10 out of 14 days caused only transient
redness that vanished after the 3rd application.

Reproduction toxicity
Studies in pregnant rats and rabbits showed that this substance has no embryotoxic or
teratogenic effects.
Mutagenicity/ carcinogenicity
In-vitro tests were not indicative of a mutagenic effect.
No carcinogenicity studies are available.
Therapeutic use of policresulen for many decades has not revealed any mutagenic or
carcinogenic properties.

Albothyl pessaries: Macrogol 1500 and 4000, edetic acid, water

None known

Albothyl® pessaries:
Two-layer multiplast cells of PVC/PE white, opaque.
Pack of 6 pessaries.

Textiles and leather should be cleaned with water immediately after coming into contact
with Albothyl concentrate/pessaries before the substance begins to dry. Instruments etc.
must be placed in a bowl of water (if appropriate adding 1-2% sodium hydrogen carbonate)
immediately after use until sterilisation.

The spotted characteristics of the pessaries are caused by the natural appearance of the
pessary base and do not affect the usability, efficacy or tolerability.

NA