Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets)

1. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) © The Swiss Pharmacy

2. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) are used to treat fungal infections of the skin and nails caused by Trichophyton, Microsporum canis and Epidermophyton floccosum. Terbinafine tablets are also used for the treatment of Ringworm where oral therapy is considered appropriate due to the site, severity or extent of the infection and Onychomycosis (fungal infections of the fingernails and toenails). © The Swiss Pharmacy

3. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Terbicip Tablets are manufactured by Cipla Limited, India in the strength of 250 mg. © The Swiss Pharmacy

4. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

5. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) The active ingredient contained in Terbicip tablets is Terbinafine Hydrochloride. Each uncoated Terbicip tablet contains Terbinafine Hydrochloride, BP equivalent to 250 mg of Terbinafine. © The Swiss Pharmacy

6. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Uses of Terbicip 250 mg Tablets: Terbicip 250mg Tablets manufactured by Cipla Limited, belong to the group of medicines called antifungals and are used to treat fungal infections of the scalp, body, groin (jock itch), feet (athlete's foot), fingernails, and toenails caused by Trichophyton (e.g. T. rubrum, T.mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Terbinafine tablets are indicated in the treatment of: Ringworm (tinea corporis, tinea cruris and tinea pedis) where oral therapy is considered appropriate due to the site, severity or extent of the infection. They are also used for the treatment of Onychomycosis. Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure. © The Swiss Pharmacy

7. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Recommended Adult Dosage The dosage of Terbicip Tablets Terbicip Tablets (Generic Terbinafine Tablets) is one 250 mg tablet once daily. The bioavailability of Terbinafine is not affected by a light meal. The duration of treatment varies according to the indication and the severity of the infection. The duration of treatment for various indications is as follows: Skin Infections: Skin Infections: Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks Tinea corporis: 4 weeks Tinea cruris: 2 to 4 weeks © The Swiss Pharmacy

8. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Recommended Adult Dosage Onychomycosis: Onychomycosis: The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months can be anticipated in patients with fingernail infection, toenail infection other than of the big toe, or patients of younger age. In the treatment of toenail infections, 3 months is usually sufficient although a few patients may require treatment of 6 months or longer. 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

9. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Contraindications ➔Terbicip tablets are contraindicated in patients with a known hypersensitivity to Terbinafine Hydrochloride or any inactive ingredients contained in this medicine. ➔Terbicip tablets (Terbinafine Hydrochloride tablets) are contraindicated for patients with chronic or active hepatic disease. ➔If you are breast-feeding, you are pregnant or planning to become pregnant, you should not take Terbinafine tablets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

10. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Storage Instructions Terbicip tablets (Generic Terbinafine Hydrochloride tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

11. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Warnings Liver failure, sometimes leading to liver transplant or death, has occurred with the use of Terbinafine tablets. Obtain pretreatment serum transaminases. Discontinue Terbicip Tablets if liver injury develops. Taste disturbance, including taste loss, has been reported with the use of Terbinafine Hydrochloride Tablets. Taste disturbance can be severe, may be prolonged, or may be permanent. Discontinue Terbicip Tablets if taste disturbance occurs. Smell disturbance, including loss of smell, has been reported with the use of Terbinafine Hydrochloride Tablets. Smell disturbance may be prolonged, or may be permanent. Discontinue Terbicip Tablets if smell disturbance occurs. © The Swiss Pharmacy

12. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Warnings The use of Terbicip tablets in renally impaired patients is not recommended. Depressive symptoms have been reported with Terbinafine tablets use. Prescribers should be alert to development of depressive symptoms. Severe neutropenia has been reported. If the neutrophil count is less than 1,000 cells/mm3, Terbicip Tablets should be discontinued. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with oral Terbinafine use. If progressive skin rash occurs, treatment with Terbicip Tablets should be discontinued. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

13. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Possible Side Effects Terbinafine Hydrochloride Tablets (Terbicip Tablets) side effects reported with an incidence rate of 2% or more in patients treated with this medicine include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

14. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Possible Side Effects The following side effects have been most frequently reported in the three US/Canadian placebo-controlled trials: Headache, Diarrhea, Dyspepsia, Abdominal Pain, Nausea, Flatulence, Rash, Pruritus, Urticaria, Liver Enzyme Abnormalities, Taste Disturbance, Visual Disturbance. Postmarketing Experience: Side effects, based on worldwide experience with Terbinafine Hydrochloride tablets (Terbicip tablets) use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis), severe neutropenia, thrombocytopenia, agranulocytosis, pancytopenia, anemia, angioedema, and allergic reactions (including anaphylaxis). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

15. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Possible Side Effects Side effects, based on worldwide experience with Terbinafine Hydrochloride tablets (Terbicip tablets) use, include: Psoriasiform eruptions or exacerbation of psoriasis, acute generalized exanthematous pustulosis and precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Terbinafine Hydrochloride tablets. Cases of taste disturbance, including taste loss, have been reported with the use of Terbinafine Tablets. It can be severe enough to result in decreased food intake, weight loss, and depressive symptoms. Depressive symptoms independent of taste disturbance have been reported with use of Terbinafine Tablets. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

16. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Possible Side Effects Cases of smell disturbance, including smell loss, have been reported with the use of Terbinafine Tablets. Other side effects which have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, rhabdomyolysis, reduced visual acuity, visual field defect, hair loss, serum sickness-like reaction, vasculitis, pancreatitis, influenza-like illness, pyrexia, increased blood creatine phosphokinase, photosensitivity reactions, tinnitus, hearing impairment and vertigo. Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin has been reported. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

17. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Overdosage Clinical experience regarding overdose with Terbinafine Hydrochloride tablets (Terbicip tablets) is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache. The recommended treatment for overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

18. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Terbicip Tablets During Pregnancy Terbinafine Hydrochloride (Terbicip Tablets) has been classified by the US FDA as Pregnancy Category B. Oral doses of Terbinafine Hydrochloride up to 300 mg/kg/day (in terms of mg/m2/day equivalent to 180 and 404 times the maximum potential exposure at the recommended topical human dose) during organogenesis in rats and rabbits, respectively, were not teratogenic. There is no clinical experience with Terbinafine in pregnant women. Terbinafine tablets should not be used during pregnancy unless clearly necessary. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy

19. Terbicip Tablets (Generic Terbinafine Hydrochloride Tablets) Terbicip tablets Terbicip tablets (Generic Terbinafine Hydrochloride tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9742_Terbinafine-Hydrochloride-Tablets.html © The Swiss Pharmacy