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SPC, UK: LAMISIL Tablets (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Lamisil Tablets 250mg.

Qualitative and quantitative composition

Each tablet contains 281.25mg terbinafine hydrochloride, equivalent to 250mg terbinafine.

Pharmaceutical form

Tablets for oral administration. LAMISIL Tablets 250mg: Whitish to yellow tinged white, circular, biconvex tablets, scored on one side and coded LAMISIL 250 on the other.

Therapeutic indications

Fungal infections of the skin and nails caused by Trichophyton (eg. T. rubrum, T.mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Oral Lamisil is indicated ...

Posology and method of administration

Adults 250mg once daily. The duration of treatment varies according to the indication and the severity of the infection. Skin infections Likely durations of treatment are as follows: Tinea pedis (interdigital, ...

Contraindications

Known hypersensitivity to terbinafine or to any of the excipients of Lamisil tablets. Chronic or active hepatic disease.

Special warnings and precautions for use

Liver Function Lamisil tablets are contraindicated for patients with chronic or active hepatic disease. Before prescribing Lamisil tablets, a liver function test should be performed and any pre-existing ...

Interaction with other medicinal products and other forms of interaction

Effect of other medicinal products on terbinafine The plasma clearance of terbinafine may be accelerated by drugs which induce metabolism and may be inhibited by drugs which inhibit cytochrome P450. Where ...

Fertility, pregnancy and lactation

Pregnancy Foetal toxicity and fertility studies in animals suggest no adverse effects. Since clinical experience in pregnant women is very limited, terbinafine tablets should not be used during pregnancy ...

Effects on ability to drive and use machines

No studies on the effects of Lamisil tablets treatment on the ability to drive and use machines have been performed. Patients who experience dizziness as an undesirable effect should avoid driving vehicles ...

Undesirable effects

Side effects are generally mild to moderate, and transient. The following adverse reactions have been observed in the clinical trials or during post-marketing experience. Adverse reactions are ranked under ...

Overdose

A few cases of overdose (up to 5g) have been reported, giving rise to headache, nausea, upper abdominal pain and dizziness. The recommended treatment of overdosage consists of eliminating the drug, primarily ...

Pharmacodynamic properties

Pharmacotherapeutic group: Oral antifungal agent ATC code: D01BA02 Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against ...

Pharmacokinetic properties

Following oral administration, terbinafine is well absorbed (>70%) and the absolute bioavailability of terbinafine from Lamisil tablets as a result of first-pass metabolism is approximately 50%. A single ...

Preclinical safety data

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 100mg/kg a day. At high oral doses, the liver and possibly also the kidneys ...

List of excipients

Magnesium stearate Colloidal anhydrous silica Hydroxy propyl methylcellulose Sodium carboxy methyl starch Microcrystalline cellulose

Incompatibilities

None known.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Protect from light. Store below 25°C.

Nature and contents of container

PVC blister pack containing 7, 14 or 28 tablets.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

NOVARTIS PHARMACEUTICALS UK LIMITED, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization number(s)

PL 0101/0304

Date of first authorization / renewal of the authorization

01 November 2001

Date of revision of the text

03 January 2017

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