Binacil 125 mg/250 mg Tablets

BINACIL may be used to treat:

• Fungal infections of the skin and nail such as athlete’s foot, ringworm of the groin (jock itch) or ringworm of the body.

Do not take BINACIL:

• If you have ever had an allergic reaction to terbinafine or any of the other ingredients found in BINACIL.
• If you have liver problems.
• If you are pregnant or breast-feeding.

Take special care with BINACIL:

• Check with your doctor at once if you develop any of the following symptoms of liver damage which usually occur within two months of starting treatment with BINACIL: itching, a feeling of sickness that won’t go away (persistent nausea), loss of appetite, tiredness, yellowing of the whites of the eyes or skin, being sick (vomiting), fatigue, stomach/abdominal pain, dark urine or pale coloured stools.
• Before using BINACIL, tell your doctor:

• if you have psoriasis – BINACIL may cause a worsening of psoriasis symptoms.
• if you have kidney problems (see “HOW TO TAKE BINACIL”).

Taking BINACIL with food: BINACIL may be taken with or without food.

Pregnancy and Breast feeding:

• Do not take BINACIL if you are pregnant - Tell your doctor if you are pregnant or plan to become pregnant.
• Do not take BINACIL if you are breast-feeding, since BINACIL passes into breast milk. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking BINACIL.

Driving and using machinery: BINACIL may make you feel dizzy or fatigued. Make sure you are not affected before you drive or operate machinery.

Taking other medicines with BINACIL: Some medicines may interact with terbinafine. Before taking BINACIL, tell your doctor if you are using any of the following medicines:

• Rifampicin for tuberculosis because it may decrease the effectiveness of terbinafine.
• Cimetidine for indigestion or stomach ulcers, because it may increase the risk of side-effects when taken with terbinafine.
• Tricyclic antidepressants (e.g. amitriptyline), β-blockers (e.g. atenolol, metoprolol or propranolol), selective serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine) and monoamine oxidase type B (MAO-B) inhibitors (e.g. selegeline), because the risk of their side-effects may be increased by terbinafine.
• Oral contraceptives – as irregular periods and breakthrough bleeding may occur.
• Ciclosporin.
• Triazolam.

The usual adult (including elderly) oral dose is 250 mg once a day. Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Always take BINACIL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of BINACIL is too strong or too weak, talk to your doctor or pharmacist. Always take BINACIL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of BINACIL is too strong or too weak, talk to your doctor or pharmacist.

The length of your course of treatment will depend on the nature and severity of infection. Your doctor will tell you how long to take your medicine for. Usual course lengths are as follows:

• For skin infections BINACIL is usually taken for between 2 to 6 weeks.
• For nail infections, treatment usually lasts between 6 weeks and 3 months, although some patients with toenail infections may need to be treated for 6 months or longer. Signs of the infection may not disappear until several weeks after completing the course of treatment.

To clear up your infection completely, take BINACIL for the full course of treatment.

Children – The use of BINACIL in children is not recommended.

Patients with kidney problems – Your doctor may prescribe a lower dose.

If you take more BINACIL than you should:

If an overdose has been taken, there may be symptoms such as headache, feeling sick (nausea), pain in upper, middle region of stomach and dizziness.

If you forget to take BINACIL: Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

BINACIL can have side effects. Get emergency medical help at once if you have any of these signs of an allergic reaction:

• hives, skin rash
• difficulty breathing
• swelling of your face, lips, tongue, or throat.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

Call your doctor at once if you have any of these serious side effects:

• Severe blistering, peeling and red skin rash
• Severe skin rash that keeps getting worse
• Unusual bruising or bleeding
• Fever, chills, sore throat, and other signs of infection
• Symptoms of liver problems (e.g. itching, a feeling of sickness that won’t go away (persistent nausea), loss of appetite, tiredness, yellowing of the whites of the eyes or skin, being sick (vomiting), fatigue, stomach/abdominal pain, dark urine or pale coloured stools).

Other possible side effects are: nausea (queasiness); mild abdominal pain or fullness; diarrhoea; loss of taste or changes in taste (which usually resolves on discontinuation of the medicine); indigestion; headache; depression; anxiety; numbness, tingling or pins and needles; feeling unwell, tired or dizzy; oversensitivity to light; psoriasis (skin disease with raised, rough, scaly areas); pains in the muscles and joints, which may occur as part of an allergic reaction along with allergic skin reactions (rash, swelling).

Tell your doctor if any of the above side effects are severe, bothersome, do not go away or about any concerns you have while taking BINACIL.

Store at or below 30 °C (room temperature). Store all medicines out of reach of children.