Terbinafine 250mg Tablets
Patient Information Leaflet
Terbinafine 250mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
_possible side effects not listed in this leaflet._
What is in this leaflet:
1. What Terbinafine tablets are and what are they used for
2. What you need to know before you take Terbinafine tablets
3. How to take Terbinafine tablets
4. Possible side effects
5. How to store Terbinafine tablets
6. Contents of the pack and other information.
The name of the medicine is Terbinafine 250 mg Tablets (referred to as Terbinafine tablets or terbinafine throughout this leaflet).
1. What Terbinafine tablets are and what are they used for
Terbinafine belongs to a family of medicines called antifungals. Anti-fungal agents help the body fight infections caused by fungi/ yeasts.
Terbinafine tablets are used for treatment of fungal infections of the skin and nails.
2. What you need to know before you take Terbinafine tablets
Do not take Terbinafine tablets
• If you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of face, lips, tongue, or hands/feet or breathing difficulties.
Warnings and precautions
Talk to your doctor or pharmacist before taking Terbinafine tablets, if you
• are pregnant, or planning to become pregnant
• are breast feeding
• have a skin condition known as psoriasis (manifests as dry, red, itchy patches on the skin covered with silvery scales)
• have problems with your kidneys and/or liver.
If you develop serious skin reactions like severe blisters and bleeding in the lips, eyes, mouth, nose and genitals, talk to your doctor.
Blood related problems like symptoms of frequent infections such as fever, severe chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal have been reported in patient taking this medicine.
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Your doctor may order blood tests before starting treatment with this medicine and during the course of your treatment to check the functioning of your liver.
Children
Terbinafine tablets are not recommended for use in children.
Other medicines and Terbinafine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Care is needed if you are taking:
• rifampicin (used to treat tuberculosis)
• cimetidine (used to treat indigestion and for healing of peptic ulcers)
• antidepressants [e.g., imipramine, desipramine amitriptyline, clomipramine, desipramine (tricyclic antidepressants); citalopram, fluoxetine, sertraline (selective serotonin reuptake inhibitors); selegiline, moclobemide (monoamine oxidase inhibitors)] [used to treat depression]
• beta blockers (e.g., propranolol, atenolol, metoprolol) or anti-arrhythmics (e.g. quinidine, verapamil, amiodarone) for heart problems
• warfarin, a medicine used to thin your blood
• oral contraceptive pills (as irregular periods and breakthrough bleeding may occur in some female patients)
• 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 (eg fluconazole, ketoconazole)
• medicines used to treat cough (eg dextromethorphan)
• caffeine.
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.
Pregnancy
Terbinafine tablets have not been studied in pregnant women, and thus should not be taken during pregnancy unless the benefits of treatment are more than the risks involved. Tell your doctor if you are pregnant, you think you might be pregnant or you are planning to become pregnant.
Breast-feeding
Terbinafine passes into breast milk. You should not take Terbinafine tablets if you are breast feeding currently.
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.
3. How to take Terbinafine tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
Dosage
The recommended dose is one Terbinafine 250 mg Tablet taken once a day.
Duration of treatment
The duration of treatment will depend on the type and severity of your infection. For skin infections terbinafine is usually taken for 2 to 6 weeks. For nail infections the treatment usually lasts between 6 weeks to 3 months. However, some patients with toenail infections may need to be treated for 6 months or longer.
Method of Administration
Swallow the tablet whole with a glass of water. The tablet may be taken at any time of the day without regard to food intake.
For Patients with Kidney and/or Liver Problems
If you have kidney and/or liver problems, please follow your doctor’s instructions.
Use in Children
Terbinafine tablets are not recommended for use in children.
If you have the impression that the effect of Terbinafine tablets is too strong or too weak, talk to your doctor or pharmacist.
If you have taken more Terbinafine tablets
If you have taken too many tablets, you may develop symptoms such as headache, nausea, upper abdominal pain and dizziness. Consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or the tablets with you, so your doctor will know what you have taken.
If you forget to take Terbinafine tablets
At the right time, take them as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.
If you stop taking Terbinafine tablets
Take your tablets as directed and for as long as directed; do not stop them, even if you feel better, as otherwise the symptoms may return. You should aim to take the tablet at the same time each day.
Possible side effects
4.
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 Stevens-Johnson syndrome (severe form of skin rash with flushing, fever, blisters or ulcers) or toxic epidermal necrolysis (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns), 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).
The side effects listed below have also been reported.
Tell your doctor if you notice any of the following:
Very common side effects (may affect more than 1 in 10 people)
• stomach problems such as loss of appetite, ache, indigestion, feeling bloated or sick
• diarrhoea
• Pains in the muscles and joints
• rash, hives.
Common side effects (may affect up to 1 in 10 people)
• headache.
Uncommon side effects (may affect up to 1 in 100 people)
• loss of taste or altered sense of taste. This usually disappears when you stop taking the medicine. However, a very small number of people, (may affect up to 1 in 10,000 people), 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 1,000 people)
• feeling unwell, dizzy
• numbness or tingling, decreased feeling or sensitivity, especially in the skin.
Very rare side effects (may affect up to 1 in 10,000 people)
• 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
• lose of hair
• feeling tired
• spinning sensation (vertigo)
• 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 cannot be estimated from the available data)
• disorders of sense of smell which may be permanent; impaired or loss of hearing, hissing and/or ringing in the ears
• influenza like illness, fever
• increase in blood of a muscle enzyme called creatine phosphokinase (may be found on a blood test)
• psoriasis like skin eruptions, or worsening of any psoriasis including a rash or eruption of small pus containing blisters
• a hypersensitivity reaction to the administration of a foreign serum. Symptoms are fever, swelling, skin rash, enlargement of the lymph nodes.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5 How to store Terbinafine tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister label and the carton label after {Exp}. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Terbinafine tablets contain
- The active substance is terbinafine. Each tablet contains terbinafine hydrochloride equivalent to Terbinafine 250mg.
- The other ingredients are:: microcrystalline cellulose, sodium starch glycollate, hypromellose, colloidal anhydrous silica, magnesium stearate and talc.
What Terbinafine tablets look like and contents of the pack
Terbinafine 250 mg tablets are white to off-white, capsule shaped, biconvex tablets debossed with ‘T’ and ‘250’ on either side of the breakline on one side and a deep breakline on the other side.
The Terbinafine 250 mg tablets are available in PVC/ PVdC blister packs.
Pack sizes: 14, 28, 42, 56 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ranbaxy (UK) Limited 5 th floor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB3 4AZ United Kingdom
Manufacturer
Terapia S.A.
124 Fabricii Street 400 632 Cluj Napoca Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132JH Hoofddorp The Netherlands