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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Terbital® 10 mg/g cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g of the cream contains 10 mg of terbinafine hydrochloride.
Excipient: cetostearyl alcohol.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM

Cream.
White or almost white cream with a specific odour.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications

Fungal infections of the skin caused by dermatophytia and Candida. Pityriasis versicolor.

Clinically relevant spectrum of activity. Trichophyton (T. rubrum, T. mentagrophytes,
T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum (tinea pedis,
tinea cruris and tinea corporis), Candida albicans, Pityrosporum orbiculare (also named
Malassezia furfur).
4.2 Posology and method of administration

Presumable length of treatment using – cream:
- Tinea pedis: 2 to 4 weeks. If the cream is used 2 times daily, often 1 week of treatment is
sufficient.
- Tinea cruris and tinea corporis: 1 to 2 weeks.
- Cutaneous candidiasis: 2 weeks.
- Tinea versicolor (Pityriasis versicolor): 2 weeks.
The treated skin area must be cleaned and dried carefully before using Terbital. A thin
layer of cream is smeared and lightly embrocated into the infected skin and its periphery
once or two times daily. In case of intertriginous infections (area under mammary glands,
area between fingers/toes, gluteal fold area and groin area) the site of administration may
be covered with a bandage, especially for overnight. To increase the efficiency of treatment,
it is important to eliminate the external source of fungal infection.
Clinical improvement is noticeable already within a few days. Irregular using of the
medicine or untimely discontinuation of the treatment may increase the risk of recurrence.
If the symptoms have not regressed within 2 weeks, the correctness of the diagnosis must
be verified.

Children. Clinical data about using topical treatment in children is insufficient and its use is
not recommended.

Elderly patients. There are no data that elderly patients need different doses or experience
adverse effects different from those in younger patients.
4.3 Contraindications

Hypersensitivity to terbinafine or any of the excipients of the cream.

Relative contraindications: clinical experience with topical treatment in treating children is
insufficient. Therefore, the relation between possible risk and expected benefit must be
evaluated, if therapy is necessary.
4.4 Special warnings and precautions for use

The cream is for external use only. Avoid contact of the cream with the eyes.
4.5 Interaction with other medicinal products and other forms of interaction

Not observed.
4.6 Pregnancy and lactation

There are no clinical data about using terbinafine in pregnancy. Due to lack of clinical
experience Terbital may not be used during pregnancy. Exceptional cases are if the benefit
from the treatment exceeds the potential risk to the fetus. Terbinafine is excreted in breast
milk but the effect on the neonate is unlikely due to minimal absorption of the active
substance with topical use. However, Terbital may only be used during breast-feeding
when the potential benefit outweighs the potential risks to the child.
The cream should not be applied on breasts during breast-feeding.
4.7 Effects on ability to drive and use machines

Not relevant.
4.8 Undesirable effects

Rash, pruritus and urticaria may sometimes occur at the site of administration but usually
the discontinuation of the treatment is not necessary. Those symptoms must be
distinguished from the allergic reactions to the medicine, which occur rarely but require
discontinuation of the treatment.
4.9 Overdose

There have been no reports about overdosing. Systemic adverse effects may occur
conditioned by accidental ingestion of Terbital – disturbances of gastrointestinal tract
(nausea, loss of appetite, abdominal pain, diarrhoea) and headache. Initiate symptomatic
and supporting treatment, if necessary, gastric lavage may be performed and activated
carbon may be administered to reduce absorption.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antifungal substances for topical use. ATC-code: D01AE15
The active substance of the cream, terbinafine, is an antifungal allylamine derivative with a
broad spectrum of activity. Terbinafine has a fungicidal activity against dermatophytes,
moulds and certain dimorphic fungi. Activity against yeast is fungicidal or fungistatic,
depending on the species. Terbinafine affects specifically the sterol biosynthesis in the
early stage. This leads to a deficiency in ergosterol and to an intracellular accumulation of
squalene, which results in fungal cell death. Terbinafine inhibits squalene epoxidase in the
fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome
P450 system and therefore, terbinafine does not influence the metabolism of hormones, as
well as other drugs.
5.2 Pharmacokinetic properties

Less than 5 % of the active substance is absorbed with topical administration and therefore
systemic effect is very small. After using Terbital for 7 days, the concentration of
terbinafine in the stratum corneum of the skin is higher than needed for fungicidal effect
and it persists for at least 7 days after the treatment is finished.
5.3 Preclinical safety data

Preclinical studies of pharmacological safety, chronic toxicity, genotoxicity,
carcinogenicity and reproduction toxicity have not revealed any adverse effects in humans.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Isopropyl myristate, cetostearyl alcohol, sorbitan stearate, cetyl palmitate, polysorbate 60,
benzyl alcohol, sodium hydroxide and water purified.
6.2 Incompatibilities

Not applicable.
6.3 Shelf life

2 years.
6.4 Special precautions for storage

Do not store above 25 °C.
Do not freeze.
6.5 Nature and contents of container

Terbital 10 mg/g cream: 15 g or 30 g of cream in an aluminum tube.
6.6 Special precautions for disposal and other handling

No special requirements.
7. MARKETING AUTHORISATION HOLDER

JSC GRINDEKS.
Krustpils 53, Riga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
E-mail: [email protected]
8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

08/2009

Source: http://www.mildronat.com/mce/uploads/produktu_apraksti/terbital_eng.pdf