Terbinafin Hexal (Terbinafine)
Oral antifungal medication for skin and nail infections
Quick Facts About Terbinafin Hexal
Key Takeaways About Terbinafin Hexal
- Effective antifungal: Terbinafine is a fungicidal allylamine that kills a broad spectrum of dermatophytes causing skin and nail infections
- Liver monitoring required: Your doctor should check liver function before starting treatment and every 4–6 weeks during therapy
- Treatment takes time: Nail infections may require 3–6 months of treatment; healthy nails grow out slowly after therapy
- Drug interactions: Terbinafine can affect or be affected by several common medications including antidepressants, beta-blockers, and caffeine
- Taste disturbances possible: Loss of taste or altered taste is a common side effect that usually resolves after stopping treatment
What Is Terbinafin Hexal and What Is It Used For?
Terbinafin Hexal contains terbinafine, a prescription antifungal medication that kills fungi by blocking a key enzyme (squalene epoxidase) needed for fungal cell membrane synthesis. It is used to treat dermatophyte infections of the skin and nails, including athlete's foot, ringworm, jock itch, and onychomycosis.
Terbinafine belongs to the allylamine class of antifungal agents. Unlike many antifungal medications that merely inhibit fungal growth (fungistatic), terbinafine is fungicidal — it directly kills the fungi responsible for infection. This mechanism of action makes it particularly effective against dermatophytes, the group of fungi most commonly responsible for skin and nail infections in humans.
The drug works by inhibiting squalene epoxidase, an enzyme essential for the biosynthesis of ergosterol in the fungal cell membrane. Without ergosterol, the fungal cell membrane becomes unstable and permeable, leading to an accumulation of toxic squalene within the cell and ultimately causing cell death. Importantly, terbinafine is highly selective for the fungal form of this enzyme and has minimal effect on the corresponding human enzyme, which contributes to its favorable safety profile.
After oral administration, terbinafine is rapidly absorbed with a bioavailability of approximately 70%. It is highly lipophilic, meaning it distributes readily into tissues with high fat content, including the skin, subcutaneous tissue, hair follicles, and nail beds. This tissue-penetrating ability is what makes oral terbinafine particularly effective for nail infections, where topical antifungals often fail to reach the site of infection adequately.
Terbinafin Hexal is indicated for the treatment of the following conditions:
- Onychomycosis (nail fungus): Fungal infection of fingernails or toenails caused by dermatophytes, particularly Trichophyton rubrum and Trichophyton mentagrophytes
- Tinea corporis (ringworm): Fungal infection of the body skin
- Tinea cruris (jock itch): Fungal infection of the groin area
- Tinea pedis (athlete's foot): Fungal infection of the feet, particularly between the toes
- Other dermatophyte infections: Where oral therapy is considered appropriate due to the site, severity, or extent of infection
Oral terbinafine is typically reserved for infections that have not responded to topical therapy or are too extensive for topical treatment alone. For mild, localized skin infections, topical antifungal creams are usually tried first. However, for nail infections (onychomycosis), oral therapy is generally the first-line approach due to poor penetration of topical agents through the nail plate.
What Should You Know Before Taking Terbinafin Hexal?
Before starting Terbinafin Hexal, tell your doctor about any liver or kidney problems, psoriasis, lupus erythematosus, or allergies. Liver function tests are required before and during treatment. This medication is not recommended during pregnancy or breastfeeding, and should not be used in children.
Contraindications
You must not take Terbinafin Hexal if:
- You are allergic to terbinafine or any of the other ingredients in the tablet (sodium starch glycolate type A, hypromellose, colloidal anhydrous silica, potato starch, and magnesium stearate)
- You have severe liver impairment (severe hepatic insufficiency)
If either of these applies to you, inform your doctor before taking terbinafine. If you think you may have had an allergic reaction to this or any similar medication, consult your doctor for advice.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Terbinafin Hexal if any of the following apply to you:
- Kidney problems: Dose adjustment may be necessary in patients with impaired renal function, as terbinafine and its metabolites are partly excreted by the kidneys
- Liver problems: Even mild liver impairment requires careful monitoring. Your doctor should perform liver function tests before initiating treatment and periodically (every 4–6 weeks) during therapy
- Psoriasis: Terbinafine may trigger or worsen psoriasis in some patients. If you have a history of psoriasis, discuss this with your doctor
- Lupus erythematosus: Cases of lupus erythematosus (an autoimmune condition) have been reported in patients taking terbinafine. If you have this condition or a history of it, inform your doctor
Your doctor should check your liver function before you start taking Terbinafin Hexal and every 4 to 6 weeks during treatment. Stop taking this medication immediately and contact your doctor if you develop any of the following symptoms: yellowing of your skin or eyes (jaundice), unusually dark urine, light-colored stools, unexplained persistent nausea, stomach problems, upper right abdominal pain, loss of appetite, or unusual tiredness or weakness. These may be signs of liver dysfunction. In very rare cases, severe liver failure requiring liver transplantation or leading to death has occurred, most often in patients with serious underlying medical conditions.
Use in Children
Terbinafin Hexal tablets are not recommended for use in children due to insufficient data from clinical studies in pediatric populations. The safety and efficacy of oral terbinafine have not been adequately established in patients under 18 years of age. If a child requires antifungal treatment, your doctor will recommend alternative approaches.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Pregnancy: Terbinafin Hexal should not be used during pregnancy unless your doctor specifically prescribes it. Experience with terbinafine in pregnant women is very limited, and the potential risks to the developing fetus have not been fully established. Fungal nail infections are not life-threatening, so treatment can generally be postponed until after pregnancy.
- Breastfeeding: Terbinafin Hexal must not be used during breastfeeding. The active substance terbinafine passes into breast milk and could potentially harm the nursing infant. If treatment is necessary, breastfeeding should be discontinued for the duration of therapy.
Driving and Using Machines
Some patients have reported dizziness while taking Terbinafin Hexal. If you experience dizziness, do not drive, operate machinery, or perform activities that require full alertness until you know how this medication affects you. You are responsible for assessing whether you are fit to drive or perform tasks requiring concentration.
Sodium Content
This medicine contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
How Does Terbinafin Hexal Interact with Other Drugs?
Terbinafine can interact with several medications. Drugs like cimetidine and fluconazole may increase terbinafine levels, while rifampicin may decrease them. Terbinafine can also affect the metabolism of certain beta-blockers, antidepressants, and other medications metabolized by CYP2D6 enzymes. Always inform your doctor about all medications you are taking.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. Terbinafine is metabolized by several cytochrome P450 enzymes and can inhibit CYP2D6, leading to clinically significant drug interactions. Understanding these interactions is essential for safe use of this medication.
Drugs That Affect Terbinafine Levels
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Cimetidine | Increases terbinafine plasma levels | Inhibits terbinafine metabolism; may require dose adjustment |
| Fluconazole | Increases terbinafine plasma levels | Concurrent use of two systemic antifungals requires careful monitoring |
| Ketoconazole | Increases terbinafine plasma levels | CYP3A4 inhibitor; monitor for increased terbinafine effects |
| Amiodarone | May increase terbinafine plasma levels | Both drugs inhibit CYP2D6; enhanced effects possible |
| Rifampicin | Decreases terbinafine plasma levels | Potent CYP enzyme inducer; may reduce terbinafine efficacy |
Drugs Whose Levels May Be Affected by Terbinafine
Terbinafine is an inhibitor of the CYP2D6 enzyme, which means it can slow down the metabolism of drugs that are broken down by this enzyme pathway. The following medications may have increased blood levels when taken with terbinafine:
| Drug / Class | Examples | Clinical Action |
|---|---|---|
| Beta-blockers | Metoprolol | Monitor blood pressure and heart rate; dose adjustment may be needed |
| Antiarrhythmics (Class 1A, 1B, 1C) | Propafenone, amiodarone | Cardiac monitoring recommended; consult cardiologist |
| Tricyclic antidepressants | Desipramine, nortriptyline | Monitor for increased antidepressant side effects |
| SSRIs | Paroxetine, fluoxetine | Watch for serotonergic side effects |
| MAO-B inhibitors | Selegiline, rasagiline | Use with caution; monitor closely |
| Cough suppressants | Dextromethorphan | May increase dextromethorphan side effects |
| Caffeine | Coffee, tea, energy drinks | Reduced caffeine clearance; limit intake if experiencing jitteriness |
| Cyclosporine | Immunosuppressant | Monitor cyclosporine levels; dose adjustment may be needed |
Other Notable Interactions
Oral anticoagulants (warfarin): When terbinafine is taken with certain oral anticoagulants such as warfarin, the time it takes for blood to clot (coagulation time) may be altered in some circumstances. However, a causal relationship has not been established in clinical studies. Regardless, if you are taking warfarin, your doctor should monitor your INR (International Normalized Ratio) more frequently when starting or stopping terbinafine.
Oral contraceptives: Menstrual irregularities (such as irregular periods, breakthrough bleeding, spotting, and absence of menstruation) have been observed in some patients taking terbinafine and oral contraceptives simultaneously. However, these problems did not occur more frequently than in women using oral contraceptives alone. The clinical significance of this finding is considered low.
Drugs with no significant interaction: Terbinafine does not significantly affect the metabolism of phenazone or digoxin. When terbinafine is taken with drugs metabolized by the same enzyme system (such as terfenadine, triazolam, tolbutamide, and ethinylestradiol), no clinically relevant interactions have generally been observed.
Terbinafin Hexal tablets may be taken before or after meals. Food does not significantly affect the absorption of terbinafine from the gastrointestinal tract. You can take the tablet with a glass of water, preferably at the same time each day.
What Is the Correct Dosage of Terbinafin Hexal?
The standard adult dose is one 250 mg tablet once daily. Treatment duration varies: 2–6 weeks for skin infections and 6 weeks to 6 months or more for nail infections. Take the tablet whole with water, preferably at the same time each day. Children should not take this medication.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure about the correct dose. The dosage and duration of treatment depend on the type and severity of infection being treated.
Adults (Including Elderly Patients)
Standard Dose
250 mg (one tablet) once daily
Swallow the tablet whole with a glass of water. It can be taken before or after a meal. Take it at the same time each day for optimal adherence.
| Infection Type | Typical Duration | Notes |
|---|---|---|
| Skin infections (tinea corporis, cruris) | 2–4 weeks | Most skin infections respond within this timeframe |
| Athlete's foot (tinea pedis) | 2–6 weeks | Interdigital type may resolve faster; moccasin-type may require longer |
| Fingernail infections | 6 weeks – 3 months | Fingernails grow approximately 2 mm per month |
| Toenail infections | 3–6 months or longer | Toenails grow approximately 1 mm per month; some patients need 6+ months |
Children
The use of terbinafine tablets in children is not recommended due to limited clinical experience. There is insufficient data on the safety and efficacy of oral terbinafine in pediatric patients. If antifungal treatment is needed for a child, your doctor will recommend an appropriate alternative therapy.
Elderly Patients
There is no evidence that elderly patients (65 years and older) require a different dosage or experience different side effects compared to younger adults. You can take Terbinafin Hexal tablets at the same dose as younger adults. However, since older patients may be more likely to have reduced liver or kidney function, your doctor may wish to monitor these more closely.
Missed Dose
If you forget to take a dose, take it as soon as you remember. However, if it is less than 4 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for a forgotten dose.
Overdose
If you take more Terbinafin Hexal than you should, or if someone else accidentally takes your medication, contact a doctor or hospital immediately. Medical treatment may be needed. Your doctor may administer activated charcoal to help remove the active substance and take further measures as necessary.
Symptoms that have been observed with terbinafine overdose include:
- Headache
- Nausea
- Pain in the upper abdomen
- Dizziness
Curing a fungal infection requires prolonged treatment. It may take several months after completing therapy before the signs and symptoms of the infection disappear completely, as it takes time for healthy nails to grow out. You can monitor your progress by observing the growth of the healthy nail: fingernails typically grow about 2 mm per month, and toenails about 1 mm per month. Using the medication irregularly or stopping treatment prematurely increases the risk of the infection returning. Always discuss with your doctor before stopping treatment.
What Are the Side Effects of Terbinafin Hexal?
Like all medicines, Terbinafin Hexal can cause side effects, although not everybody gets them. Very common side effects include headache, gastrointestinal symptoms (nausea, diarrhea, abdominal pain), skin rash, and joint or muscle pain. Some side effects can be serious — stop taking the medication and seek immediate medical attention if you experience signs of liver problems, severe skin reactions, or severe allergic reactions.
Yellowing of skin or eyes, unusually dark urine or light stools, persistent nausea or upper right abdominal pain (possible liver problems). Severe skin reactions with rash, blistering, or peeling skin. Severe allergic reaction causing difficulty breathing, dizziness, swelling of the face and throat, or widespread hives. Unusual bleeding, bruising, abnormally pale skin, or frequent infections (possible blood disorder). Unexplained muscle weakness and pain, or dark (red-brown) urine (possible muscle breakdown).
Very Common
- Headache
- Digestive problems (dyspepsia)
- Nausea
- Abdominal pain
- Diarrhea
- Feeling of bloating (fullness)
- Loss of appetite
- Itching, rash, or swelling of the skin
- Joint and muscle pain (arthralgia, myalgia)
Common
- Depression
- Taste disturbances (dysgeusia) and taste loss (ageusia) — these usually resolve slowly within weeks after stopping medication; very rarely, they may persist longer
- Visual disturbances
- Dizziness or fatigue
Uncommon
- Decreased red blood cell count
- Anxiety (with symptoms such as sleep disturbance, fatigue, weakness, or difficulty concentrating)
- Numbness or tingling (paresthesia)
- Ringing or buzzing in the ears (tinnitus)
- Increased sensitivity to sunlight (photosensitivity)
- Fever
- Weight loss related to taste disturbances
Rare and Very Rare
- Liver problems: hepatic failure, hepatitis, jaundice, elevated liver enzymes
- Decreased blood cell counts (various types)
- Lupus erythematosus (autoimmune disorder)
- Serious skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis
- Severe allergic reactions (anaphylaxis)
- Hair loss (alopecia)
- Psoriasis-like skin rash or worsening of psoriasis
- Liver failure requiring transplantation or causing death (most cases involved patients with serious underlying conditions)
Side Effects Reported With Unknown Frequency
The following side effects have been reported since the drug became available on the market, but their exact frequency cannot be determined from available data:
- Severe allergic reactions: Anaphylactic reactions, serum sickness-like reactions
- Hearing problems: Decreased hearing
- Vision problems: Blurred vision, reduced visual acuity
- Blood vessel inflammation: Vasculitis
- Smell disturbances: Impaired sense of smell, including permanent loss of smell (anosmia)
- Mood symptoms: Depressive symptoms related to taste disturbances
- Pancreatic inflammation: Pancreatitis (severe upper abdominal pain radiating to the back)
- DRESS syndrome: Drug reaction with eosinophilia and systemic symptoms — a serious drug-induced reaction affecting internal organs
- Muscle damage: Rhabdomyolysis (severe muscle cell breakdown) or elevated creatine phosphokinase levels
- Flu-like symptoms: Fatigue, chills, sore throat, joint or muscle pain
It is important to report suspected side effects after the medicine has been authorized. This allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority.
How Should You Store Terbinafin Hexal?
Store Terbinafin Hexal out of the sight and reach of children. Keep the blister pack in the outer carton or the tablet container in its original packaging to protect from light. Do not use after the expiry date printed on the packaging.
Proper storage of medications is important to maintain their effectiveness and safety. Follow these guidelines for Terbinafin Hexal:
- Keep out of reach of children: Store in a location that is not accessible to children
- Check the expiry date: Do not use this medicine after the expiry date stated on the carton and blister/bottle after “EXP.” The expiry date refers to the last day of that month
- Blister packs: Store the blister pack inside the outer carton to protect from light
- Tablet bottles: Store in the original packaging to protect from light
- Disposal: Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment
What Does Terbinafin Hexal Contain?
Each Terbinafin Hexal tablet contains 250 mg of terbinafine (as terbinafine hydrochloride) as the active ingredient, along with inactive ingredients including sodium starch glycolate, hypromellose, colloidal anhydrous silica, potato starch, and magnesium stearate.
Active Ingredient
The active substance is terbinafine. Each tablet contains 250 mg terbinafine (as terbinafine hydrochloride). Terbinafine hydrochloride is a white to off-white fine crystalline powder that is freely soluble in methanol and ethanol but practically insoluble in water.
Inactive Ingredients (Excipients)
- Sodium starch glycolate (Type A): Functions as a disintegrant, helping the tablet break apart in the gastrointestinal tract for proper absorption
- Hypromellose: A cellulose derivative used as a binder and film-forming agent
- Colloidal anhydrous silica: Used as a glidant to improve powder flow during manufacturing
- Potato starch: Acts as a filler and binder
- Magnesium stearate: A lubricant that prevents the tablet mixture from sticking to manufacturing equipment
Appearance and Pack Sizes
Terbinafin Hexal tablets are white or almost white, round, biconvex tablets with a score line on both sides and the code “TER 250” on one side. The tablet can be divided into two equal halves. They are available in blister packs or tablet bottles in the following sizes: 8, 10, 14, 20, 28, 30, 42, 56, 98, and 100 tablets. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Terbinafin Hexal
Terbinafin Hexal is an oral antifungal medication containing terbinafine 250 mg. It is prescribed for the treatment of fungal infections of the skin (such as athlete's foot, ringworm, and jock itch) and nails (onychomycosis) caused by dermatophyte fungi. It works by inhibiting squalene epoxidase, an enzyme essential for fungal cell membrane integrity, effectively killing the fungi rather than just inhibiting their growth.
Treatment of fingernail infections typically takes 6 weeks to 3 months, while toenail infections may require 3 to 6 months or longer. Even after completing the treatment course, it takes time for the healthy nail to grow out and replace the damaged nail completely. Fingernails grow approximately 2 mm per month and toenails about 1 mm per month, so full visual recovery may take 6 to 12 months after starting treatment.
The most serious risks include liver damage (hepatotoxicity), which is rare but can be severe. Your doctor should monitor liver function before and during treatment. Very rare serious side effects include Stevens-Johnson syndrome (a severe skin reaction), severe blood disorders, and anaphylactic reactions. Report any unusual symptoms to your doctor promptly, especially yellowing of the skin or eyes, severe skin changes, unusual bleeding or bruising, or signs of severe allergic reaction.
While there is no specific contraindication for moderate alcohol use with terbinafine, it is generally advisable to limit alcohol intake during treatment. Since terbinafine is metabolized by the liver and can potentially cause liver-related side effects, adding the additional burden of alcohol to the liver is not recommended. Discuss your alcohol consumption with your doctor, especially if you have any existing liver conditions.
Taste disturbances (dysgeusia) and taste loss (ageusia) are common side effects of terbinafine. If you notice changes in your taste, contact your doctor. In most cases, taste recovers slowly within several weeks after stopping the medication. In very rare cases, taste changes may persist for a longer period. Your doctor will assess whether the benefits of continuing treatment outweigh the impact of the taste disturbance and may recommend stopping treatment if appropriate.
Menstrual irregularities including irregular periods, breakthrough bleeding, and absence of menstruation have been observed in some patients taking terbinafine with oral contraceptives. However, clinical data suggest that these problems do not occur more frequently than in women using oral contraceptives alone. Terbinafine has not been shown to significantly reduce the contraceptive efficacy of oral birth control pills, but if you experience menstrual changes, discuss them with your doctor.
References
This article is based on the following international medical sources and peer-reviewed research:
- European Medicines Agency (EMA). Terbinafine — Summary of Product Characteristics. EMA Medicines Database. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Lamisil (terbinafine hydrochloride) Tablets — Prescribing Information. FDA Drug Database. Available at: www.accessdata.fda.gov
- British National Formulary (BNF). Terbinafine. NICE Evidence Services. Available at: bnf.nice.org.uk
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List (2023). Geneva: WHO; 2023.
- Gupta AK, Versteeg SG, Shear NH. Onychomycosis in the 21st century: an update on diagnosis, epidemiology, and treatment. Journal of Cutaneous Medicine and Surgery. 2017;21(6):525–539. doi:10.1177/1203475417716362
- Kreijkamp-Kaspers S, Hawke K, Guo L, et al. Oral antifungal medication for toenail onychomycosis. Cochrane Database of Systematic Reviews. 2017;(7):CD010031. doi:10.1002/14651858.CD010031.pub2
- Elewski BE, Tosti A. Risk factors and comorbidities for onychomycosis and its treatment with oral terbinafine. European Journal of Dermatology. 2015;25(5):405–414.
- Gupta AK, Mays RR, Versteeg SG, et al. Update on current approaches to diagnosis and treatment of onychomycosis. Expert Review of Anti-Infective Therapy. 2018;16(12):929–938.
About Our Medical Editorial Team
This article has been written and reviewed by qualified medical professionals with expertise in dermatology, clinical pharmacology, and infectious disease medicine. Our editorial team follows international evidence-based guidelines and the GRADE framework for assessing the quality of medical evidence.
Medical Writing
iMedic Medical Editorial Team — Specialists in dermatology and clinical pharmacology
Medical Review
iMedic Medical Review Board — Independent review according to EMA, FDA, and WHO guidelines
Evidence Level
Level 1A — Based on systematic reviews, regulatory data, and randomized controlled trials
Conflict of Interest
None — No commercial funding or pharmaceutical company sponsorship