Fungal infections of the skin caused by Trichophyton (eg. T. Rubrum, T.Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (eg. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).

Terbinafine Hydrochloride can be applied once or twice daily. Duration and frequency of treatment The likely duration of each treatment is as follows:
Tinea corporis, cruris:
1 to 2 weeks
Tinea pedis:
1 week
Cutaneous candidiasis:
2 weeks
Pityriasis versicolor:
2 weeks Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified. Dosing in special populations: Paediatric population The experience with topical Terbinafine Hydrochloride in children is still limited and its use cannot therefore be recommended.

Elderly patients There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients. Method of administration For cutaneous use. Cleanse and dry the affected areas thoroughly before application of Terbinafine Hydrochloride. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

 Terbinafine Hydrochloride Cream is for external use only. Contact with the eyes should be avoided. May be irritating to the eyes. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.  Terbinafine Hydrochloride Cream contains Cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).  This cream is NOT recommended for use on children under 16 years of age.  Do not use the cream if you are pregnant or breast-feeding, unless advised to by your doctor.

There are no known drug interactions with Terbinafine Hydrochloride Cream.

Pregnancy Category C Pregnancy There is no clinical experience with Terbinafine Hydrochloride Cream in pregnant women; therefore, unless the potential benefits outweigh any potential risks, Terbinafine Hydrochloride Cream should not be administered during pregnancy. Foetal toxicity studies in animals suggest no adverse effects (see section 5.3). Breastfeeding Terbinafine is excreted in breast milk. Therefore mothers should not receive Terbinafine whilst breast-feeding. Infants must not be allowed to come into contact with any treated skin, including the breast.

Fertility No effect of Terbinafine on fertility has been seen in animal studies.

Terbinafine Hydrochloride Cream has no influence on the ability to drive and use machines.

Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema and scab may occur at the site of application. These minor symptoms must be distinguished from hypersensitivity reactions such as widespread pruritis, rash, bullous eruptions and hives which are reported in sporadic cases but require discontinuation. In case of accidental contact with the eyes Terbinafine hydrochloride may be irritating to the eyes. In rare cases, the underlying fungal infection may be aggravated. Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: 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), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Immune system disorders Not known: Hypersensitivity Eye disorders Rare: Eye irritation Skin and subcutaneous tissue disorders Common: Skin exfoliation, pruritus Uncommon: Skin lesion, scab, skin disorder, pigmentation disorder, erythema, skin burning sensation Rare: Dry skin, dermatitis contact, eczema Not known: Rash General disorders and administration site conditions Uncommon: Pain,application site pain,irritation Rare: condition aggravated 

To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222,
• Ext: 2317-2356-2353-2354-2334-2340.
• Toll free phone: 8002490000
• E-mail: npc.drug@sfda.gov.sa • Website: www.sfda.gov.sa/npc • Other GCC States: − Please contact the relevant competent authority.

The low systemic absorption of topical Terbinafine cream renders overdosage extremely unlikely. Accidental ingestion of the contents of one 15g tube of Terbinafine Hydrochloride Cream, which contains 150mg Terbinafine Hydrochloride, is comparable to one Terbinafine Hydrochloride 250mg tablet (adult oral unit dose). Should a larger amount of Terbinafine Hydrochloride Cream be inadvertently ingested, adverse effects similar to those observed with an overdosage of Terbinafine Hydrochloride Tablets are to be expected. These include headache, nausea, epigastric pain and dizziness. If accidentally ingested, the recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed.

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01A E15) Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending of the species. Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoidase is not linked to the cytochrome P450 system.

Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is therefore very slight.

In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100 mg/kg a day. At high oral doses, the liver and possibly also the kidneys were identified as potential target organs. In a two-year oral carcinogenicity study in mice, no neoplastic or other abnormal findings attributable to treatment were made up to doses of 130 (males) and 156 (females) mg/kg a day. In a two-year oral carcinogenicity study in rats at the highest dose level, 69 mg/kg a day, an increased incidence of liver tumours was observed in males. The changes, which may be associated with peroxisome proliferation, have been shown to be species-specific since they were not seen in the carcinogenicity study in mice or in other studies in mice, dogs or monkeys. During the studies of high dose oral terbinafine in monkeys, refractile irregularities were observed in the retina at the higher doses (non-toxic effect level was 50 mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in ocular tissue and disappeared after drug discontinuation. They were not associated with histological changes. A standard battery of in vitro and in vivo genotoxicity tests revealed no evidence of a mutagenic or clastogenic potential for the drug. No adverse effects on fertility or other reproduction parameters were observed in studies in rats or rabbits.

 Cetomacrogal 1000
 Cetostearyl Alcohol
 Benzyl Alcohol
 White Soft Paraffin (White Petroleum Jelly)
 Liquid Paraffin
 Propylene Glycol
 Sodium Dihydrogen Phosphate Anhydrous Or Sodium Dihydrogen Phosphate Monohydrate
 Sodium Hydroxide 1N
 Purified Water (q.s)

Excipient with Known Effect:
Cetostearyl alcohol (72.00 mg/g) which may cause local skin reactions (e.g. contact dermatitis).

None known.

 Do not store above 30°C.
 For external use only.  Keep out of the reach of children.  Caution: Avoid contact with eye and mouth.

15g of Lamifen 1% w/w Cream filled in Aluminum Collapsible tubes and packed in carton with PIL.

Not applicable.