TERBINAFINE MYLAN Cream Ref.[7467] Active ingredients: Terbinafine

Terbinafine 1% Cream cream is for external use only.

Terbinafine 1% Cream cream may be irritating to the eyes. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse eyes thoroughly with running water.

Terbinafine cream should be kept out of the reach of children.

In the event of allergic reaction, the cream should be removed and the treatment interrupted.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Candidiasis: It is not recommended to use acid pH soap. This provides favourable growth conditions for Candida spp.

Excipients

This medicine contains 10 mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation. This medicine also contains cetyl alcohol and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

No drug interactions are known with the topical forms of terbinafine.

Pregnancy

There is no clinical experience with terbinafine in pregnant women. Foetal toxicity studies conducted in animals suggest no adverse effects (see section 5.3). Terbinafine 1% Cream should not be used during pregnancy unless clearly necessary.

Breast-feeding

Terbinafine is excreted into breast-milk. After topical use, only a low systemic exposure is expected (see section 5.2). Terbinafine 1% Cream cream should not be used during breast-feeding. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.

Fertility

No effects of terbinafine on fertility have been seen in animal studies (see section 5.3).

Terbinafine 1% Cream 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, scab, etc. may occur at the site of application.

These harmless symptoms must be distinguished from hypersensitivity reactions including rash, which are reported in sporadic cases and require discontinuation of therapy.

In case of accidental contact with the eyes terbinafine 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 the 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), not known (cannot be estimated from the 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, application site irritation

Rare: Condition aggravated

* Based on post-marketing experience.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.