Terbinafine Orifarm – Terbinafine uses, dose and side effects


250 mg tablets

What Terbinafine Orifarm is and what it is used for

Terbinafine Orifarm belongs to a group of medicines called antifungals. Terbinafine Orifarm is used to treat several different fungal infections of the skin and nails in adults.

Terbinafine contained in Terbinafine Orifarm may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.

What you need to know before taking Terbinafine Orifarm

Do not take Terbinafine Orifarm:

  • if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).
  • if you have severely impaired liver function
  • if you have severely impaired kidney function

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Terbinafine Orifarm:

  • if you have impaired liver function or if you have or have had any disease that may have affected the liver
  • if you have psoriasis or lupus erythematosus (a chronic autoimmune rheumatic disease)
  • if you have severe skin reactions ( Stevens-Johnson syndrome, toxic epidermal necrolysis )
  • if you have or have had a blood disorder
  • if you have impaired kidney function

If you develop a fever or a sore throat during treatment with Terbinafine Orifarm, you should contact a doctor.

Please note the following:

You must contact your doctor immediately if you experience any of the following symptoms:

  • Prolonged unexplained nausea, vomiting, stomach pain, loss of appetite, abnormal tiredness, if your skin or the whites of your eyes tend to turn yellow, itching, dark-colored urine, or light-colored stool (signs of liver problems).
  • Rash, redness, if you develop blisters/experience a burning sensation in your lips, eyes, or mouth, skin peeling (signs of serious skin reactions).
  • Thickened reddish spots on the skin ( psoriasis ) or rash on the face, inflammation of the kidneys, fever, joint and muscle pain due to connective tissue disease (lupus erythematosus).
  • Weakness, unusual bleeding, bruising or frequent infections (signs of a blood disorder).

If you experience such symptoms, you must contact your doctor immediately. Treatment with terbinafine should possibly be discontinued.

Your doctor may decide to take a blood test after 4-6 weeks of treatment to check your liver function. If blood tests show liver problems, treatment with terbinafine should be stopped immediately.

Other medicines and Terbinafine Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking any other medicines (prescription or non-prescription), you must know that some medicines can affect the treatment. Therefore, consult a doctor or pharmacist before taking any other medicines. Be especially careful to tell your doctor if you are taking or have recently taken any of the following medicines:

  • Antidepressants
  • Beta-blockers ((drugs for heart disease and/or high blood pressure )
  • Antiarrhythmics class 1A, 1B, and 1C (drugs for irregular heart rhythm)
  • Rifampicin (a drug for tuberculosis )
  • Cimetidine (medicine for stomach ulcers )
  • Fluconazole , ketoconazole (drugs for fungal infections)
  • Dextromethorphan (cough medicine)
  • Cyclosporine (for immunosuppressive treatment)
  • Caffeine
  • Birth control pills (as irregular periods or breakthrough bleeding may occur in some women)

Terbinafine Orifarm with food and drink

Terbinafine Orifarm can be taken with or without food. You should drink a glass of water together with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.


Do not take Terbinafine Orifarm if you are pregnant unless your doctor has judged that treatment is necessary.


Terbinafine passes into breast milk. You should therefore not breastfeed during treatment with Terbinafine Orifarm.

Driving ability and use of machinery

Terbinafine Orifarm has no or negligible effect on the ability to drive or use machines. However, if you experience dizziness during treatment with Terbinafine Orifarm, you should avoid driving or using machinery.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

How to take Terbinafine Orifarm

Always take Terbinafine Orifarm exactly as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Swallow the tablets whole with a glass of water.

For adults and the elderly:

The recommended dose is 250 mg once daily.

The length of treatment depends on the type of infection and how severe the infection is. The following treatment times are recommended:

  • Skin infections: 2 to 6 weeks
  • Nail infections: 6 to 12 weeks. For some patients with toenail infection, treatment for 6 months or more may be necessary.

Use for children and adolescents:

The use of terbinafine in children and adolescents is not recommended.

Patients with impaired renal function:

Use of Terbinafine Orifarm is not recommended in patients with impaired renal function.

Patients with impaired liver function:

Use of Terbinafine Orifarm is not recommended in patients with chronic or active liver disease.

If you have taken too much Terbinafine Orifarm

If you have taken too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.

Symptoms: headache, nausea, upper abdominal pain, and dizziness.

Always follow your doctor’s instructions. Each person has different needs. Do not change or stop treatment without consulting a doctor.

If you forget to take Terbinafine Orifarm

Do not take a double dose to make up for a missed tablet.

Possible side effects

Like all medicines, Terbinafine Orifarm can cause side effects, but not everybody gets them. Side effects are usually mild to moderate and temporary. The following side effects have been reported:

Some rare and very rare side effects and side effects of unknown frequency may be serious; contact a doctor if you experience any of the following symptoms:

Rare (may affect up to 1 in 1,000 users):

  • Impaired liver function including severe liver failure. Symptoms include unexplained persistent nausea, loss of appetite, abnormal tiredness, vomiting, pain in the upper right side of the stomach, yellowish skin or eyes, unusually dark urine or unusual pale stools

Very rare (may affect up to 1 in 10,000 users):

  • Changes in blood counts (unusual bleeding, bruising)
  • Serious skin reactions, such as erythema multiforme (fever, rash on the face, arms, and legs), Stevens-Johnson syndrome (fever, blister-like rash especially on the hands and feet, and inflammation of one or more body openings), peeling of the outermost layer of the skin and acute skin rash with small blisters ( toxic epidermal necrolysis )
  • Anaphylactic reaction/shock (sudden rash, difficulty breathing, and fainting (within minutes to hours) due to hypersensitivity), may be life-threatening including the occurrence of seizure-like fluid accumulation in the skin and mucous membranes (angioedema)
  • Cutaneous and systemic lupus erythematosus (connective tissue disease; symptoms include skin rash, hair loss, joint stiffness and swelling, high blood pressure )

Frequency not known (cannot be estimated from available data):

  • Muscle pain, muscle weakness, or dark urine. This may be a sign of muscle breakdown. This can result in kidney failure.
  • Fever, fatigue, and drowsiness. This may be a sign of inflammation in the blood vessels
  • Severe abdominal pain and fever. This may be a sign of inflammation of the pancreas

Other side effects:

Very common (may affect more than 1 in 10 users):

  • Headache
  • Stomach discomfort (eg, belching, decreased appetite, nausea, indigestion, milder abdominal pain, and diarrhea).
  • Rash
  • Hives
  • Pain in muscles and joints

Common (may affect up to 1 in 10 users):

  • Allergic skin reactions
  • Depression
  • Loss of taste or changes in taste; usually these only last for the duration of the treatment
  • Dizziness
  • Visual disturbances
  • Fatigue
  • General malaise

Uncommon (may affect up to 1 in 100 users):

  • Paleness and fatigue due to anemia ( lack of blood )
  • Anxiety
  • Numbness of the skin or tingling
  • Reduced feel
  • Increased sensitivity to light in the skin
  • Tinnitus
  • Fever
  • Weight loss

Very rare (may affect up to 1 in 10,000 users):

  • Menstrual disorders
  • Decrease in the number of certain blood cells
  • Psoriasis-like rash
  • Exacerbated psoriasis
  • Hair loss

Frequency not known (cannot be estimated from available data):

  • Lack of sense of smell including permanent loss of sense of smell. Impaired sense of smell.
  • Blurred vision, impaired vision
  • A reaction called serum sickness ( hypersensitivity reaction in the form of nausea, fever, rash, and pain)
  • Skin rash due to an increased number of a certain type of white blood cells
  • Flu-like symptoms
  • Impaired hearing
  • Increased blood creatinine phosphokinase

How to store Terbinafine Orifarm

Keep this medicine out of the sight and reach of children.

No special temperature instructions. Use before the expiry date stated on the packaging after the Issue Date. The expiration date is the last day of the specified month.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substance is terbinafine hydrochloride.
  • Other ingredients are magnesium stearate, colloidal anhydrous silica, hypromellose, microcrystalline cellulose, and croscarmellose sodium.

Appearance and package sizes of the medicine

Terbinafine Orifarm is a round, white to off-white, flat tablet with a beveled edge, marked with R250 on one side and scored on the other.

Package sizes:

Blister packs of 14, 20, 28, 30, 50, 56, 60, 90, 98 or 100 tablets and bottles of 60 or 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Orifarm Generics A/S

Energizer 15

5260 Odense S



Local representative:

Orifarm Generics AB

Box 56048

102 17 Stockholm


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