Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
N.B. Orally administered Terbinafine tablets are not effective against Pityriasis versicolor.
The official local guidelines should be borne in mind, for example, national recommendations relating to the correct use and prescription of antimicrobial drugs".
250mg once daily.
Use of Terbinafine tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population (see section 4.4 Special warnings and precautions for use and section 5.2 Pharmacokinetic properties).
Terbinafine tablets are not recommended for patients with chronic or active hepatic disease (see section 4.4 Special warnings and precautions for use).
The likely durations of treatment for Tinea pedis, Tinea corporis and Tinea cruris are 2–4 weeks.
For Tinea pedis (interdigital, plantar/moccasin-type): recommended treatment periods may be up to 6 weeks.
Complete disappearance of the symptoms of the infection may not occur until several weeks after mycological cure.
In most patients the duration of successful treatment is 6-12 weeks.
Fingernail onychomycosis: In most cases 6 weeks' treatment is sufficient in fingernail onychomycosis.
Toenail onychomycosis: In most cases 12 weeks' treatment is sufficient in toenail onychomycosis although a few patients may require treatment up to 6 months. Poor nail outgrowth during the first weeks of treatment may enable identification of those patients in whom longer therapy is required. Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure and is only seen several months after stopping treatment, which is the time for growth of a healthy nail.
There is no evidence to suggest that elderly patients require different dosages or experience different side effects than younger patients. When prescribing Terbinafine tablets for patients in this age group, the possibility of pre-existing impairment of hepatic or kidney function should be considered (see section 4.4. Special warnings and precautions for use).
Oral use.
The duration of treatment is dependent on the indication and the degree of severity of the infection.
Few cases of overdose (up to 5g) have been reported, giving rise to headache, nausea, epigastric pain and dizziness. Recommended treatment for overdose consists of eliminating the active substance, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy if required.
Al/PVC-PVdC blister: 3 years.
HDPE tablet container with LDPE cap: 18 months.
This medicinal product does not require any special storage conditions.
Al/PVC-PVdC blister and HDPE tablet container with LDPE cap.
Pack Sizes:
HDPE bottles: 14, 28, 500 tablets.
Blisters: 7, 14, 20, 28, 30, 42, 50, 60, 84, 90, 98, 100, 50 × 1 (unit dose) tablets.
* Not all container types or pack sizes may be marketed.
No special requirements.
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