Product Index

Qualitative and Quantitative Composition

TERBICIP 250 mg Tablets

Each uncoated tablet contains:

Terbinafine Hydrochloride, BP

equivalent to Terbinafine ...................... 250 mg

Dosage Form(S) and Strength(S)

Tablets, 250 mg

Clinical Particulars

Therapeutic Indications

Fungal infections of the skin and nails 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.
• Onychomycosis

Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.

Posology and Method of Administration

Assessment Prior to Initiation

Before administering TERBICIP tablets, evaluate patients for evidence of chronic or active liver disease.

Adults

One tablet of TERBICIP Tablets, once a day.

The duration of treatment varies according to the indication and the severity of the infection.

Skin Infections

Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks

Tinea corporis: 4 weeks

Tinea cruris: 2 to 4 weeks

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.

Special Populations

Patients with hepatic impairment

Terbinafine tablets are contraindicated for patients with chronic or active liver disease.

Patients with renal impairment

The use of terbinafine tablets has not been adequately studied in patients with renal impairment and is, therefore, not recommended in this population.

Paediatric patients

A review of safety experience with oral terbinafine in children, which includes 314 patients involved in a post marketing surveillance study conducted in the UK, has shown that the adverse event profile in children is similar to that seen in adults. No evidence of any new, unusual or more severe reactions to those seen in the adult population has been noted. However, as data is still limited, terbinafine use is not recommended.

Geriatric patients

There is no evidence to suggest that elderly patients (aged 65 years or above) require different dosages or experience side effects different to those of younger patients. The possibility of impairment of liver or kidney function should be considered in this age group.

Contraindications

TERBICIP Tablets are contraindicated in individuals with

• hypersensitivity to terbinafine or to any other ingredients of the formulation
• chronic or active hepatic disease

Special Warnings and Precautions for Use

Food Interactions

An evaluation of the effect of food on terbinafine tablets was conducted. An increase of less than 20% of the AUC of terbinafine was observed when terbinafine tablets were administered with food. TERBICIP Tablets can be taken with or without food.

Renal Impairment

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 terbinafine tablets has not been adequately studied and, therefore, is not recommended.

Hepatic Impairment

Terbinafine tablets are contraindicated for patients with chronic or active liver disease.

Cases of liver failure, some leading to liver transplant or death, have occurred with the use of terbinafine tablets in individuals with and without pre-existing liver disease. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

Before prescribing terbinafine tablets, 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 tablets 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 terbinafine tablets. In the majority of liver failure cases the patients had serious underlying systemic conditions and a causal association with the intake of terbinafine tablets was uncertain.

Patients prescribed terbinafine tablets should be instructed to report immediately any signs or symptoms suggestive of liver dysfunction such as pruritus, unexplained persistent nausea, decreased appetite, anorexia or tiredness, or jaundice, vomiting, fatigue, abdominal pain or 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, erythema multiforme, exfoliative dermatitis, and bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome) have been very rarely reported in patients taking terbinafine tablets. Manifestations of DRESS syndrome may include cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the above drug reactions occur, treatment with TERBICIP Tablets should be discontinued.

TERBICIP Tablets 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 terbinafine tablets. Aetiology of any blood dyscrasias that occur in patients treated with TERBICIP Tablets should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with TERBICIP Tablets.

Taste Disturbance, Including Loss of Taste

Taste disturbance, including taste loss, has been reported with the use of terbinafine tablets. It can be severe enough to result in decreased food intake, weight loss, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment but may be prolonged (greater than one year), or may be permanent. If symptoms of a taste disturbance occur, TERBICIP Tablets should be discontinued.

Smell Disturbance, Including Loss of Smell

Smell disturbance, including loss of smell, has been reported with the use of terbinafine tablets. Smell disturbance may resolve after discontinuation of treatment but may be prolonged (greater than 1 year) or may be permanent. If symptoms of a smell disturbance occur, TERBICIP Tablets should be discontinued.

Depressive Symptoms

Depressive symptoms have occurred during post marketing use of terbinafine Prescribers should be alert to depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.

Lupus Erythematosus

During post marketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking terbinafine tablets. TERBICIP Tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.

Laboratory Monitoring

Measurement of serum transaminases (ALT and AST) is advised for all patients before taking TERBICIP Tablets.

Thrombotic Microangiopathy

Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with terbinafine. Discontinue terbinafine if clinical symptoms and laboratory findings consistent with TMA occur. The findings of unexplained thrombocytopenia and anaemia should prompt further evaluation and consideration of diagnosis of TMA.

Drug Interactions

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 co-administration of such agents is necessary, the dosage of terbinafine may need to be adjusted accordingly.

The following medicinal products may increase the effect or plasma concentration of terbinafine:

Cimetidine decreased the clearance of terbinafine by 30%.

Fluconazole increased the Cmax and AUC of terbinafine by 52% and 69% respectively, due to inhibition of both CYP2C9 and CYP3A4 enzymes. Similar increase in exposure may occur when other drugs which inhibit both CYP2C9 and CYP3A4 such as ketoconazole and amiodarone are concomitantly administered with terbinafine.

The following medicinal products may decrease the effect or plasma concentration of terbinafine:

Rifampicin increased the clearance of terbinafine by 100%.

Effect of terbinafine on other medicinal products

Terbinafine may increase the effect or plasma concentration of the following medicinal products:

Caffeine – Terbinafine decreased the clearance of caffeine administered intravenously by 21%.

Compounds predominantly metabolised by CYP2D6 – In vitro and in vivo studies have shown that terbinafine inhibits the CYP2D6-mediated metabolism. This finding may be of clinical relevance for patients receiving compounds predominantly metabolised by CYP2D6, e.g. certain members of the following drug classes, tricyclic antidepressants (TCA's), β-blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics (including class 1A, 1B and 1C) and monoamine oxidase inhibitors (MAO-Is) Type B, especially if they also have a narrow therapeutic window.

Terbinafine decreased the clearance of desipramine by 82%.

In studies in healthy subjects characterized as extensive metabolisers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increased the dextromethorphan/dextrorphan metabolic ratio in urine by 16- to 97- fold on average. Thus, terbinafine may convert extensive CYP2D6 metabolisers (genotype) to poor metaboliser status (phenotype).

Information on other drug concomitantly used with terbinafine resulting in no or negligible interactions.

Studies undertaken in vitro and in healthy volunteers suggest that terbinafine shows negligible potential to inhibit or induce the clearance of most drugs that are metabolized via other cytochrome P450 enzymes (e.g. tolbutamine, terfenadine, triazolam, oral contraceptives) with exception of those metabolised through CYP2D6.

Terbinafine does not interfere with the clearance of antipyrine or digoxin.

There was no effect of terbinafine on the pharmacokinetics of fluconazole. Further there was no clinically relevant interaction between terbinafine and the potential comedications cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline.

Some cases of menstrual disturbance (breakthrough bleeding and irregular cycle) have been reported in patients taking terbinafine concomitantly with oral contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone.

Terbinafine may decrease the effect or plasma concentration of the following medicinal products:

Terbinafine increased the clearance of ciclosporin by 15%.

Rare cases of changes in INR and/or prothrombin time have been reported in patients receiving terbinafine concomitantly with warfarin.

Use in Special Populations

Pregnant Women

Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risks, TERBICIP Tablets should not be administered during pregnancy.

Lactating Women

Terbinafine is excreted in breast milk; therefore, mothers receiving oral treatment with TERBICIP Tablets should not breastfeed.

Paediatric Patients

A review of safety experience with oral terbinafine in children, which includes 314 patients involved in the post marketing surveillance study conducted in the UK, has shown that the adverse event profile in children is similar to that seen in adults. No evidence of any new, unusual or more severe reactions to those seen in the adult population has been noted. However, as data is still limited, its use is not recommended.

Geriatric Patients

Clinical studies of terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Effects on Ability to Drive and Use Machines

No studies on the effects of terbinafine 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 or using machines.

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 headings of frequency, using the following convention:

Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, <1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000), Not known (frequency cannot be estimated from available data) including isolated reports.

Very common

• Decreased appetite
• Gastrointestinal symptoms (feeling of fullness abdominal distension, dyspepsia, vomiting, nausea, abdominal pain, diarrhoea)
• Non-serious forms of skin reactions (rash, urticaria)
• Musculoskeletal reactions (arthralgia, myalgia)

Common

• Headache

Uncommon

• Taste disturbances, including taste loss, which usually recover within several weeks after discontinuation of the drug. Isolated cases of prolonged taste disturbance have been reported, sometimes leading to a decrease of food intake and significant weight loss.

Rare

• Paraesthesia, hypoaesthesia, dizziness
• Cases of serious hepatic dysfunction, including hepatic failure, idiosyncratic and symptomatic hepatic injury, hepatic enzymes increased, jaundice, cholestasis and hepatitis. If hepatic dysfunction develops, treatment with terbinafine tablets should be discontinued. Very rare cases of serious liver failure have been reported (some with a fatal outcome or requiring liver transplant). In the majority of liver failure cases the patients had serious underlying systemic conditions and a causal association with the intake of terbinafine tablets was uncertain.
• Malaise

Very rare

• Neutropenia, agranulocytosis, thrombocytopenia
• Anaphylactoid reactions (including angioedema), exacerbations of cutaneous and systemic lupus erythematosus,
• Vertigo
• Serious skin reactions (e.g. Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, and bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome)
• Photosensitivity (e.g. photodermatosis, photosensitivity allergic reaction and polymorphic light eruption)
• Alopecia
• If progressive skin rash occurs, terbinafine tablets treatment should be discontinued.

Not known

• Adverse drug reaction such as Acute Generalised Exanthematous Pustulosis (AGEP) has been observed with the use of terbinafine formulations.
• Anaemia Pancytopenia
• Anaphylactic reaction, serum sickness-like reaction
• Anxiety and depressive symptoms secondary to taste disturbances
• Smell disturbance
• Anosmia including permanent anosmia, hyposmia
• Hypoacusis, impaired hearing, tinnitus
• Vasculitis
• Pancreatitis
• Psoriasiform eruptions or exacerbation of psoriasis
• Drug rash with eosinophilia and systemic symptoms
• Rhabdomyolysis
• Fatigue
• Influenza-like illness, pyrexia
• Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and Blood creatine phosphokinase increased
• Visual impairment, vision blurred, visual acuity reduced
• Blood creatine phosphokinase increased

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product.

Overdose

Clinical experience regarding overdose with oral terbinafine 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

Pharmacological Properties

Mechanism of Action

Terbinafine interferes specifically with fungal sterol biosynthesis at an early stage. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death.

Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme, squalene epoxidase, is not linked to the cytochrome (CY) P450 system.

Terbinafine does not influence the metabolism of hormones or other drugs.

Pharmacodynamic Properties

Terbinafine is an allylamine that has a broad spectrum of activity against fungal pathogens of the skin, hair and nails, including dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, and T. violaceum), Microsporum (e.g. M. canis), Epidermophyton floccosum, and yeasts of the genera Candida (e.g. C. albicans) and Pityrosporum. At low concentrations, terbinafine is fungicidal against dermatophytes, moulds, and certain dimorphic fungi. Its activity against yeasts is fungicidal or fungistatic, depending on the species.

When given orally, the drug concentrates in skin, hair and nails at levels associated with fungicidal activity.

Pharmacokinetic Properties

Absorption

Following oral administration, terbinafine is well absorbed (>70%) and the absolute bioavailability of terbinafine as a result of first-pass metabolism is approximately 50%. A single oral dose of 250mg terbinafine resulted in mean peak plasma concentrations of 1.30μg/ml within 1.5 hours after administration. Plasma concentrations decline in a triphasic manor, with a terminal half-life of 16.5 days. At 28 days, when around 70% steady state levels have been achieved, peak concentrations of terbinafine was on average 25% higher and plasma AUC increased by a factor of 2.3 when compared to single dose administration. From the increase in plasma AUC an effective half-life of ~30 hours can be calculated. Terbinafine bioavailability is moderately affected by food (increase in the AUC of less than 20%), but not sufficiently to require dose adjustments.

Distribution

Terbinafine binds strongly to plasma proteins. It rapidly diffuses through the dermis and concentrates in the lipophilic stratum corneum. Terbinafine is also secreted in sebum, thus achieving high concentrations in hair follicles, hair and sebum rich skins. There is also evidence that terbinafine is distributed into the nail plate within the first few weeks of commencing therapy.

Metabolism

Terbinafine is metabolised rapidly and extensively by at least seven CYP isoenzymes, with major contributions from CYP2C9, CYP1A2, CYP3A4, CYP2C8 and CYP2C19. Biotransformation results in metabolites with no antifungal activity, all of which are excreted predominantly in the urine.

Elimination

A plasma elimination half-life varying from 17 to 36 hours has been reported and a terminal elimination half-life of up to 400 hours in patients given prolonged therapy, probably representing elimination from skin and adipose tissue. Fungicidal concentrations in nails are maintained for several weeks after therapy is stopped.  Less than 5% of a topical dose of terbinafine hydrochloride is absorbed.

No clinically relevant, age-dependent changes in pharmacokinetics have been observed, but the elimination rate may be reduced in patients with renal or hepatic impairment, resulting in higher blood levels of terbinafine.

Single-dose pharmacokinetic studies in patients with renal impairment (creatinine clearance <50 ml/min) or with pre-existing liver disease have shown that clearance of terbinafine may be reduced by about 50%.

Special Patient Populations

Renal impairment/ Hepatic impairment

The elimination rate may be reduced in patients with renal or hepatic impairment, resulting in higher blood levels of terbinafine. Single-dose pharmacokinetic studies in patients with renal impairment (creatinine clearance <50 ml/min) or with pre-existing liver disease have shown that clearance of terbinafine may be reduced by about 50%.

Nonclinical Properties

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 28-month oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose tested, 69 mg/kg/day (2 times the MRHD based on AUC comparisons of the parent terbinafine); however, even though dose-limiting toxicity was not achieved at the highest tested dose, higher doses were not tested.

The results of a variety of in vitro (mutations in E. coli and S. typhimurium, DNA repair in rat hepatocytes, mutagenicity in Chinese hamster fibroblasts, chromosome aberration, and sister chromatid exchanges in Chinese hamster lung cells), and in vivo (chromosome aberration in Chinese hamsters, micronucleus test in mice) genotoxicity tests gave no evidence of a mutagenic or clastogenic potential.

Oral reproduction studies in rats at doses up to 300 mg/kg/day (12 times the MRHD based on BSA comparisons) did not reveal any specific effects on fertility or other reproductive parameters. Intravaginal application of terbinafine hydrochloride at 150 mg/day in pregnant rabbits did not increase the incidence of abortions or premature deliveries nor affect fetal parameters.

Animal Toxicology and/or Pharmacology

A wide range of in vivo studies in mice, rats, dogs, and monkeys, and in vitro studies using rat, monkey, and human hepatocytes suggest that peroxisome proliferation in the liver is a rat-specific finding. However, other effects, including increased liver weights and APTT, occurred in dogs and monkeys at doses giving Css trough levels of the parent terbinafine 2-3 times those seen in humans at the MRHD. In a 52-week oral toxicology study conducted in juvenile maturing dogs, increased heart and liver weights were noted in males and signs of CNS disturbance including 3 cases of single episodes of seizures were noted in females at the highest dose tested, 100 mg/kg/day . No treatment related findings were noted at 30 mg/kg/day in this study.

Description

TERBICIP Tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride.

Pharmaceutical Particulars

Incompatibilities

None known.

Shelf-Life

3 years

Packaging Information

TERBICIP Tablets:  Blister pack of 7 tablets

Storage and Handling Instructions

Store below 25°C. Protect from light.

Patient Counselling Information

What is TERBICIP Tablets?

TERBICIP Tablets contain the active ingredient terbinafine, which is an antifungal used to treat a number of fungal infections of the skin and nails.

What is the most important information I should know about TERBICIP Tablets? TERBICIP Tablets may cause serious side effects, including the following:

• Liver problems that can lead to the need for a liver transplant or death. This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of liver problems:

• nausea
• poor appetite
• tiredness

• vomiting   upper right stomach-area (abdomen) pain
• yellowing of your skin or eyes (jaundice)
• dark (tea-coloured) urine
• pale or light-coloured stools

Your doctor should do a blood test to check you for liver problems before you start treatment with TERBICIP Tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking TERBICIP Tablets if you develop liver problems.

Who should not take TERBICIP Tablets?

Do not take TERBICIP Tablets if you

• have had liver disease for a long time (chronic) or have active liver disease; and/or
• have had a severe allergic reaction to terbinafine hydrochloride when taken by mouth.

What should I tell my doctor before taking TERBICIP Tablets?

Before taking TERBICIP Tablets, tell your doctor about all of your medical conditions, including if you

• have or had liver problems;
• have any problems with your kidneys;
• have a weakened immune system (immunocompromised);
• have lupus (an autoimmune disease);
• are pregnant or plan to become pregnant. It is not known if TERBICIP Tablets may harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with TERBICIP Tablets;
• are breastfeeding or plan to breastfeed. Terbinafine passes into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take TERBICIP Tablets;
• have psoriasis; and/or
• have rash due to a high level of a specific type of white blood cells.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TERBICIP Tablets may affect the way other medicines work and other medicines may affect how TERBICIP Tablets work.

Will there be any problems with driving or using machinery?

Patients who experience dizziness as an undesirable effect should avoid driving vehicles or using machines.

How should I take TERBICIP Tablets?

• Take TERBICIP Tablets exactly as your doctor tells you to take it.
• TERBICIP comes as a tablet that you take by mouth.
• TERBICIP Tablets are usually taken as below:
  • One tablet once a day
  • The duration of treatment varies according to the indication and the severity of the infection.
• TERBICIP Tablets can be taken with or without food.
• If you miss a dose of TERBICIP Tablets, take it as soon as you remember. If it is less than 4 hours before your next dose, skip the missed dose. Just take the next dose at your regular time.
• If you take too many TERBICIP Tablets, call your doctor. You may have the following symptoms:

• nausea
• stomach-area (abdomen) pain

• frequent urination  
• rash
• headache

• vomiting
• dizziness

Tell your doctor if you are taking any of the following:

• Rifampicin for infections
• Cimetidine for gastric problems such as indigestion or ulcer
• Antidepressants, including tricyclic antidepressants, SSRIs (selective serotonin-reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors)
• Oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients)
• Beta-blockers or anti-arrhythmics for heart problems
• Warfarin, a medicine used to thin your blood
• Medicines to treat heart problems (e.g. propafenone, amiodarone)
• Ciclosporin, a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs
• Medicines used to treat fungal infections (e.g. fluconazole, ketoconazole)
• Medicines used to treat cough (e.g. dextromethorphan)
• Caffeine

Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor. You should have blood tests before and during treatment with TERBICIP Tablets to monitor your liver function.

What should I avoid while taking TERBICIP Tablets?

Avoid sunlight. TERBICIP Tablets can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You can get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn.

What are the possible side effects of TERBICIP Tablets?

TERBICIP Tablets may cause serious side effects, including the following:

• See “What is the most important information I should know about TERBICIP Tablets?”
• The most common side effects of TERBICIP Tablets include the following:

• headache
• diarrhoea
• rash           
• upset stomach
• abnormal liver function tests
• itching      
• nausea
• stomach-area (abdomen) pain
• gas

• Change in your sense of taste or loss of taste is common with TERBICIP Tablets, but can also be severe. This may improve within several weeks after you stop taking TERBICIP Tablets, but may last for a long time or may become permanent. Tell your doctor if you develop any of the following:

• change in your sense of taste or loss of taste

• poor appetite            
• weight loss
• anxiousness
• change in your mood or depressive symptoms. See the list of depressive symptoms below.

• Change in your sense of smell or loss of smell may happen with TERBICIP Tablets. This may improve after you stop taking TERBICIP Tablets, but may last for a long time or may become permanent. Tell your doctor if you have a change in your sense of smell or loss of smell.
• Depressive symptoms. Tell your doctor right away if you develop any of these signs or symptoms:

• feel sad or worthless
• change in sleep pattern

• mood changes        
• loss of energy or interest in daily activities
• restlessness

• Low white blood cell count. TERBICIP Tablets may decrease your white blood cell count, especially neutrophils. You may have a higher risk of getting an infection when your white blood cell count is low.
• Serious skin or allergic reactions, which may include problems with some of your body organs. Tell your doctor right away or get emergency medical help if you get any of these symptoms:
  • skin rash
  • hives
  • sores in your mouth, or your skin blisters and peels
  • swelling of your face, eyes, lips, tongue or throat
  • trouble swallowing or breathing
  • fever
  • swollen lymph glands

Also tell your doctor about any new symptoms, such as cough, chest pain, fast heartbeat, or blood in your urine.

• New or worsening lupus. Stop taking TERBICIP Tablets and tell your doctor if you get any of the following:
  • a skin rash that gets worse (progresses), is scaly, red, shows scarring, or loss of skin colour
  • unusual sensitivity to the sun that can cause a rash
• Blood clotting problems. When taking TERBICIP Tablets, you may develop a blood clotting problem, that can sometimes cause death. Tell your doctor, if you get any unexplained bleeding or bruising.

These are not all of the possible side effects of TERBICIP Tablets.

If you experience any side-effects, talk to your doctor or pharmacist or write to drugsafety@cipla.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd on 18002677779. By reporting side-effects, you can help provide more information on the safety of this product.

How should I store TERBICIP Tablets?

• Store TERBICIP Tablets below 77°F (25°C).
• Keep TERBICIP Tablets in a cool, dark place.

Keep TERBICIP Tablets and all medicines out of the reach of children.

General information about the safe and effective use of TERBICIP Tablets

Do not use TERBICIP Tablets for a condition for which it was not prescribed. Do not give TERBICIP Tablets to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in TERBICIP Tablets?

Active ingredient: terbinafine hydrochloride

Details of Manufacturer

Cipla Ltd. L-139 to L-146, Verna Industrial Estate, Verna, Salcette, Goa- 403 722.

Details of Permission or License Number With Date

721/(291)/MFG/DFDA/2011/2388 dated 08/08/2011

Date of Revision

15/11/2019