Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Liver Function
Terbinafine Teva 250 mg are contraindicated for patients with chronic or active hepatic disease. Before prescribing Terbinafine Teva 250 mg, a liver function test should be performed and any pre-existing liver disease should be assessed.

Hepatotoxicity may occur in patients with and without pre-existing liver disease therefore periodic monitoring (after 4-6 weeks of treatment) of liver function test is recommended. Terbinafine Teva 250 mg should be immediately discontinued in case of elevation of liver function test.

Very rare cases of serious liver failure (some with a fatal outcome, or requiring liver transplant) have been reported in patients treated with oral terbinafine. In the majority of liver failure cases the patients had serious underlying systemic conditions (see sections 4.3 Contraindications and 4.8 Undesirable effects).

Patients prescribed Terbinafine Teva 250 mg should be instructed to report immediately any signs or symptoms suggestive of liver dysfunction such as pruritus, unexplained persistent nausea, decreased appetite, anorexia, jaundice, vomiting, fatigue, right upper abdominal pain, dark urine, or pale stools. Patients with these symptoms should discontinue taking oral terbinafine and the patient's liver function should be immediately evaluated.
Dermatological effects
Serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) have been very rarely reported in patients taking oral terbinafine. If progressive skin rash occurs, Terbinafine Teva  250 mg treatment should be discontinued.

Terbinafine Teva 250 mg should be used with caution in patients with pre-existing psoriasis, as very rare cases of exacerbation of psoriasis have been reported.
Haematological effects
Very rare cases of blood dyscrasias (neutropenia, agranulocytosis,
thrombocytopenia, pancytopenia) have been reported in patients treated with oral terbinafine. Aetiology of any blood dyscrasias that occur in patients treated with Terbinafine Teva 250 mg should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with Terbinafine Teva 250 mg.
Renal function
In patients with renal impairment (creatinine clearance less than 50 mL/min or serum creatinine of more than 300 micro mol/L) the use of oral terbinafine has not been adequately studied, and therefore, is not recommended (see section 5.2 Pharmacokinetic properties).
Other
Terbinafine Teva 250 mg should be used with caution in patients with lupus erythematosus as very rare cases of lupus erythematosus have been reported.

Excipient
This medicine contains 1-1.5 mg, less than 1 mmol sodium (23 mg) per caplet, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7 Effects on ability to drive and use machines

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