SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME ... - Grindeks

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
BENZOTAL ® 200 mg/g ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains 200 mg of benzyl benzoate.
INN. Benzylis benzoas.
Excipients: methyl parahydroxybenzoate, bronopol, propyl parahydroxybenzoate
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Ointment.
White or almost white ointment with specific odour.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Scabies.
4.2 Posology and method of administration
During one administration 10...15 g of ointment is applied to the skin. In children, the
whole surface of the skin is covered with ointment, in adults it is not applied to the face and
scalp.
The ointment is applied to the previously washed skin and is rubbed into the skin. First of
all, the ointment is applied to the hands, arms and other parts of the body in descending
order. Finally, the ointment is applied to the legs, soles of the feet and between toes. In the
regions with delicate skin (the groin area, genitals, breasts), as well as in the case of eczema,
dermatitis and pyodermia, the ointment should be applied carefully, not rubbing it into the
skin.
The hands should not be washed within 3 hours after applying the ointment. Every time the
hands are washed, the ointment should be re-applied to the hands. The whole body can be
washed only after 3 days. It is essential to use clean bedlinen, underwear and clothes after
using the ointment.
The ointment is applied to the skin 4 times during 2 weeks, every 3...4 days. An average of
60...90 g of ointment is used for one treatment course.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
In order to avoid irritation, contact with eyes and mucous membranes should be prevented.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions studies have been performed.

4.6 Pregnancy and lactation
The ointment may be used during pregnancy. If treatment is needed, breastfeeding should
be discontinued and it can be resumed after the ointment has been washed off.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
When rubbing the ointment into the skin, prickling sensation may occur that disappears in a
couple of minutes. If the prickling sensation does not disappear, the ointment should be
washed off the skin. Allergic skin reactions may occur, such as skin irritation, burning
sensation. The sensitivity of the skin is increased particularly on scratched areas and the
genitals. Sometimes contact dermatitis may occur.
4.9 Overdose
In case of accidental ingestion of ointment or applying very excessive amounts of ointment,
excitation of the central nervous system (seizures) and urinary retention may occur.
Treatment is symptomatic. The ointment should be washed off the skin; in case of ingestion
gastric lavage with activated charcoal should be performed. If necessary, an anticonvulsant
should be administered.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: ectoparasiticides, incl. scabicides; insecticides and repellents,
ATC code: P03AX01
Benzyl benzoate is a benzyl ester of benzoic acid. Benzyl benzoate acts selectively against
scabies mite (Acarus scabiei) - it penetrates through the chitin shell of the scabies mite and
accumulates in toxic concentrations, thus leading to the death of adult scabies mite. It is not
effective against the eggs of the scabies mite. Benzyl benzoate also has a mild anesthetic
effect.
5.2 Pharmacokinetic properties
Following topical administration, benzyl benzoate absorbs into the superficial layers of the
epidermis, it does not absorb into the blood.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polysorbate 80, carbomers, sodium hydroxide, methyl parahydroxybenzoate, bronopol,
propyl parahydroxybenzoate and purified water.

6.2 Incompatibilities
Not applicable.
6.3 Shelf life
30 months
6.3 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
6.4 Nature and contents of container
30 g of ointment in aluminium tube, aluminium tube in carton box.
6.5 Instructions for use and handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
JAS «Grindeks»
Krustpils 53, Riga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
e-mail: GRINDEKS@GRINDEKS.LV
8. MARKETING AUTHORISATION NUMBER(S)
115195
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07.11.1995/09.03.2006
10. DATE OF REVISION OF THE TEXT
Approved by the State Agency of Medicines:
September 2008