TERBIUM 250 mg TABLETS

Category:

Terbinafine Tablets USP

Terbinafine tablets are used for the treatment of fungal infections of:

  • The groin area.
  • The skin (ring worm).
  • Toe and finger nails (yellow, opaque and thickened nails).
  • The feet (athlete’s foot).

What you need to know before you take Terbinafine tablets?

Do not take Terbinafine Tablets

  • are allergic to terbinafine
  • have or have had any liver problems.
  • are breast-feeding

Description

Terbinafine belongs to a group of medicines called antifungal drugs.

Always take this medicine exactly as described in this leaflet or as you doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with water.

The usual dose for adults, including the elderly, is 250 mg once a day.

  • For skin infections continue taking the tablets for 2 to 6 weeks.
  • For nail infections treatment usually lasts for between 6 weeks and 3 months, although some patients with toenail infections may need to be treated for 6 months or longer.
  • If your kidneys are not working very well, your doctor may reduce the dose of Terbinafine tablets you take.

Swallow the tablets whole with a glass of water.

Complete healing of the infection may not occur until several weeks after completing the course of treatment. A healthy nail may take several months to grow back.

If you take more Terbinafine tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

Symptoms of an overdose include headache, feeling sick, pain in the upper part of the stomach (epigastric pain) and dizziness.

If you forget to take Terbinafine tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time

Other medicines and Terbinafine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to tell your doctor about the following:

    • Rifampicin (an antibiotic).
    • Cimetidine (used to treat stomach ulcers).
    • Antidepressants including tricyclic antidepressants, SSRIs or MAOIs.
    • Oral contraceptives 
    • Beta blockers or antiarrhythmics (for heart problems).
    • Medicines to treat heart problems (eg propafenone, amiodarone).
    • Ciclosporin
    • Medicines used to treat fungal infections
    • Medicines used to treat cough
    • Caffeine

You should have blood tests before and during treatment with Terbinafine tablets to monitor your liver function.

Possible side effects  

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:

  • Yellowing of your skin or eyes. Unusually dark urine or pale faeces, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (this may indicate liver problems), increase in liver enzymes which may be noted on a blood test result
  • Severe skin reactions including rash, light sensitivity, blistering or wheals
  • Weakness, unusual bleeding, bruising, abnormal pale skin, unusual tiredness, or weakness or breathlessness on exertion or frequent infections (this may be a sign of blood disorders)
  • Difficulty breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions)
  • Symptoms such as rash, fever, itching, tiredness or if you notice appearance of purplish spots under the skin surface (signs of blood vessel inflammation)
  • Severe upper stomach pain which spreads to the back (possible signs of pancreas inflammation)
  • Unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown)

Other side effects

Tell your doctor if you notice any of the following side effects or any other effects not listed:

Very common (may affect more than 1 in 10 people)

  • Stomach problems such as loss of appetite, ache, indigestion, feeling bloated or sick
  • Diarrhoea
  • Itching, rash or swelling
  • Pains in the muscles and joints

Common (may affect up to 1 in 10 people)

  • Headache

Uncommon side effects (may affect up to 1 in 100 patients)

  • Taste loss and taste disturbance. This usually disappears within several weeks after you stop taking the medicine. However, a very small number of people, (less than 1 in 10,000), have reported that the taste disturbance lasts for some time and, as a result, they go off their food and lose weight. There have also been reports of some people experiencing anxiety or symptoms of depression as a result of these taste disturbances

Rare side effects (may affect up to 1 in 1000 patients)

  • Feeling unwell, dizzy
  • Numbness or tingling

Very rare side effects (may affect up to 1 in 10,000 patients)

  • Feeling tired
  • Decrease in the number of some blood cells. You may notice that you seem to bleed or bruise more easily than normal, or you may catch infections easily and these might be more severe than usual
  • Psoriasis like skin eruptions, or worsening of any psoriasis including a rash or eruption of small pus containing blisters
  • Vertigo
  • Hair loss
  • Onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints)

Not known frequency of side effects (frequency cannot be estimated from the available data)

  • Signs of blood disorders: weakness, unusual bleeding, bruising or frequent infections
  • Anxiety and depressive symptoms.
  • Disorders of sense of smell which may be permanent, impaired hearing, hissing and/or ringing in the ears, flu like symptoms, increase in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test), reduced or blurred vision.

Warnings and precautions

Talk to your doctor or pharmacist before taking Terbinafine tablets if you:

  • are pregnant or trying to become pregnant.
  • have any problems with your kidneys or liver.
  • have psoriasis (scaling skin disease)
  • have systemic lupus erythematosus (SLE) (autoimmune disorder, affecting the skin, joints, kidneys & brain), as it may worsen whilst you are taking Terbinafine tablets.
  • have a rash due to a high level of a specific type of white blood cells

Children and Terbinafine Tablets

Use in children is not recommended.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

If you are breast-feeding, you should not take Terbinafine tablets. If you are pregnant or planning to become pregnant, you should not take Terbinafine tablets unless your doctor decides it is necessary. You must only take Terbinafine tablets according to your doctor’s instructions.

Driving and using machines

Some people have reported feeling dizzy or giddy while they are taking Terbinafine tablets. If you feel like this you should not drive or operate machinery.

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Terbinafine tablets are used for the treatment of fungal infections of:

  • The groin area.
  • The skin (ring worm).
  • Toe and finger nails (yellow, opaque and thickened nails).
  • The feet (athlete’s foot).

What you need to know before you take Terbinafine tablets?

Do not take Terbinafine Tablets

  • are allergic to terbinafine
  • have or have had any liver problems.
  • are breast-feeding

Description

Terbinafine belongs to a group of medicines called antifungal drugs.

Always take this medicine exactly as described in this leaflet or as you doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with water.

The usual dose for adults, including the elderly, is 250 mg once a day.

  • For skin infections continue taking the tablets for 2 to 6 weeks.
  • For nail infections treatment usually lasts for between 6 weeks and 3 months, although some patients with toenail infections may need to be treated for 6 months or longer.
  • If your kidneys are not working very well, your doctor may reduce the dose of Terbinafine tablets you take.

Swallow the tablets whole with a glass of water.

Complete healing of the infection may not occur until several weeks after completing the course of treatment. A healthy nail may take several months to grow back.

If you take more Terbinafine tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

Symptoms of an overdose include headache, feeling sick, pain in the upper part of the stomach (epigastric pain) and dizziness.

If you forget to take Terbinafine tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time

Other medicines and Terbinafine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to tell your doctor about the following:

    • Rifampicin (an antibiotic).
    • Cimetidine (used to treat stomach ulcers).
    • Antidepressants including tricyclic antidepressants, SSRIs or MAOIs.
    • Oral contraceptives 
    • Beta blockers or antiarrhythmics (for heart problems).
    • Medicines to treat heart problems (eg propafenone, amiodarone).
    • Ciclosporin
    • Medicines used to treat fungal infections
    • Medicines used to treat cough
    • Caffeine

You should have blood tests before and during treatment with Terbinafine tablets to monitor your liver function.

Possible side effects  

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:

  • Yellowing of your skin or eyes. Unusually dark urine or pale faeces, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (this may indicate liver problems), increase in liver enzymes which may be noted on a blood test result
  • Severe skin reactions including rash, light sensitivity, blistering or wheals
  • Weakness, unusual bleeding, bruising, abnormal pale skin, unusual tiredness, or weakness or breathlessness on exertion or frequent infections (this may be a sign of blood disorders)
  • Difficulty breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions)
  • Symptoms such as rash, fever, itching, tiredness or if you notice appearance of purplish spots under the skin surface (signs of blood vessel inflammation)
  • Severe upper stomach pain which spreads to the back (possible signs of pancreas inflammation)
  • Unexplained muscle weakness or pain, or dark (red-brown) urine (possible signs of muscle breakdown)

Other side effects

Tell your doctor if you notice any of the following side effects or any other effects not listed:

Very common (may affect more than 1 in 10 people)

  • Stomach problems such as loss of appetite, ache, indigestion, feeling bloated or sick
  • Diarrhoea
  • Itching, rash or swelling
  • Pains in the muscles and joints

Common (may affect up to 1 in 10 people)

  • Headache

Uncommon side effects (may affect up to 1 in 100 patients)

  • Taste loss and taste disturbance. This usually disappears within several weeks after you stop taking the medicine. However, a very small number of people, (less than 1 in 10,000), have reported that the taste disturbance lasts for some time and, as a result, they go off their food and lose weight. There have also been reports of some people experiencing anxiety or symptoms of depression as a result of these taste disturbances

Rare side effects (may affect up to 1 in 1000 patients)

  • Feeling unwell, dizzy
  • Numbness or tingling

Very rare side effects (may affect up to 1 in 10,000 patients)

  • Feeling tired
  • Decrease in the number of some blood cells. You may notice that you seem to bleed or bruise more easily than normal, or you may catch infections easily and these might be more severe than usual
  • Psoriasis like skin eruptions, or worsening of any psoriasis including a rash or eruption of small pus containing blisters
  • Vertigo
  • Hair loss
  • Onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints)

Not known frequency of side effects (frequency cannot be estimated from the available data)

  • Signs of blood disorders: weakness, unusual bleeding, bruising or frequent infections
  • Anxiety and depressive symptoms.
  • Disorders of sense of smell which may be permanent, impaired hearing, hissing and/or ringing in the ears, flu like symptoms, increase in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test), reduced or blurred vision.

Warnings and precautions

Talk to your doctor or pharmacist before taking Terbinafine tablets if you:

  • are pregnant or trying to become pregnant.
  • have any problems with your kidneys or liver.
  • have psoriasis (scaling skin disease)
  • have systemic lupus erythematosus (SLE) (autoimmune disorder, affecting the skin, joints, kidneys & brain), as it may worsen whilst you are taking Terbinafine tablets.
  • have a rash due to a high level of a specific type of white blood cells

Children and Terbinafine Tablets

Use in children is not recommended.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

If you are breast-feeding, you should not take Terbinafine tablets. If you are pregnant or planning to become pregnant, you should not take Terbinafine tablets unless your doctor decides it is necessary. You must only take Terbinafine tablets according to your doctor’s instructions.

Driving and using machines

Some people have reported feeling dizzy or giddy while they are taking Terbinafine tablets. If you feel like this you should not drive or operate machinery.

Reviews

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