Skip to Content

TEVA TERBINAFINE 250MG TABLETS

Active substance(s): TERBINAFINE HYDROCHLORIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Teva Terbinafine 250 mg 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 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 sings 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. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Terbinafine is and what it is used for
What you need to know before you take Terbinafine
How to take Terbinafine
Possible side effects
How to store Terbinafine
Content of the pack and other information

1. What Terbinafine is and what it is used for



Terbinafine hydrochloride, the active ingredient in Teva Terbinafine 250 mg Tablets, is an
antifungal medicine.
Terbinafine is used to treat a numberof fungal infections of the skin and nails:
• athlete’s foot (tinea pedis)
• ringworm of the body (tinea corporis)
• ringworm of the groin (tinea cruris)
• ringworm of the hand (tinea manuum)
• a nail infection called onychomycosis, which causes thickening, roughening or splitting of
finger and toe nails.

2. What you need to know before you take Terbinafine
Do not take Terbinafine





if you are allergic to the active substance terbinafine or any of the other ingredients of this
medicine (listed in section 6).
if you are breast-feeding.
if you have or have had any liver problems.

Take special care with Terbinafine
Talk to your doctor:
• if you have liver or kidney problems.
• if you have patches of thickened or sore skin (Psoriasis).
• if you have or develop rash .
• if you have illness called lupus erythematosus (autoimmune disease)

Terbinafine may cause liver damage. Stop taking terbinafine immediately and go to your doctor
or the nearest hospital if you feel the following signs of liver damage:
Sickness, poor appetite, tiredness, vomiting, pain in upper right part of your belly, yellowing of the
skin or eyes (jaundice), dark urine or pale stool.
Children and adolescents
Terbinafine tablets are not recommended for use in children and adolescents.
Other medicines and Terbinafine
Tell your doctor if you are taking any of the following medicines:













tricyclic antidepressants e.g. desipramine
selective serotonin reuptake inhibitors (SSRIs)
monoamine oxidase inhibitors (MAOIs)
Beta-blockers (used for treating, angina, high blood pressure and other heart problems) or
antiarrhythmic drugs for heart problems (e.g amiodarone)
Oral contraceptives, as breakthrough bleeding or irregular periods may occur
Rifampicin (antibiotic)
Cimetidine (a stomach drug)
Warfarin (blood thinner)
Fluconazole, ketoconazole (drugs for fungal infections)
Caffeine
Ciclosporine (a medicine used to control your body’s immune system in order to prevent
rejection of transplanted organs)
Medicines used to treat cough (e.g. dextromethorphan)

Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including
medicines obtained without a prescription.
Terbinafine with food
Your medicine can be taken with or without food as this does not affect its clinical effect.
Pregnancy and Breast-feeding:
Do not take Terbinafine if you are breast-feeding. Terbinafine is not recommended if you are
pregnant or planning to become pregnant. Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Some people have reported feeling dizzy while they are taking terbinafine tablets. If you feel like
this you should not drive or operate machinery.

3. How to take Terbinafine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably with a drink of water. The tablets should preferably be
taken at the same time each day and can be taken on an empty stomach or after a meal.
The usual dosage instructions are given below:

Adults (including the elderly):
The recommended dose is one 250 mg tablet daily.
The length of your treatment will depend on the infection you have and how severe it is. The likely
durations of treatments are given below.
Skin infections:
Athlete’s foot:
Ringworm of the body:
Ringworm of the groin:
Ringworm of the hand:

2 to 6 weeks.
4 weeks.
2 to 4 weeks.
2 to 6 weeks.

Nail infections:
Treatment usually lasts between 6 weeks and 3 months.
Some patients with toenail infections may require treatment for 6 months or longer.
Children and adolescents:
Terbenafine is not recommended for use in children and adolescents.
Patients with kidney problems
Terbinafine tablets are not recommended for use in patients with kidney problems.
Patients with liver problems
Terbinafine tablets must not be used in patients with liver problems.
If you take more Terbinafine than you should
If you (or someone else) swallow a lot of the tablets all together or if you think a child has
swallowed any of the tablets, contact your nearest hospital casualty department or your doctor
immediately. An overdose is likely to cause headache, nausea (feeling sick), stomach pain and
dizziness. Please take this leaflet, any remaining tablets and the container with you to the hospital or
doctor so that they know which tablets were consumed.
If you forget to take Terbinafine
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Terbinafine
Do not stop taking your medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Terbinafine can cause side effects, although not everybody gets them.

If the following happens, stop taking tablets and tell you doctor immediately or go to the
casualty department at your nearest hospital:

Rare (may affect up to 1 in 1 000 people)
• Itching, nausea, loss of appetite, tiredness, yellowing of the skin or eyes (jaundice), vomiting,
belly pain, dark urine, or pale stools. These can be signs of liver failure.
• Tiredness, pain in abdomen, joints or muscles caused by inflammation of the liver (hepatitis)
• Obstruction to the normal flow of bile (cholestasis)

Very rare (may affect up to 1 in 10 000 people)
• Allergic condition which causes joint pain, skin rashes and fever (called lupus)
• Swelling of mouth and throat with breathing problems, swelling of hands and feet (angioedema)
• Reduction in white blood cell count (agranulocytosis, neutropaenia), which increases risk of
bacterial infection
• Reduction in blood platelets (thrombocytopenia), which increases risk of bleeding or bruising
• Blisters/bleeding of the lips, eyes, nose, mouth and genitals (called Stevens-Johnson syndrome
and Toxic Epidermal Necrolysis)
• Skin rash with blisters and fever
• Erythema multiforme, a skin disease characterised by itchy pink-red blotches starting on your
feet and hands
• Photosensitivity (usual skin reaction resulting from exposure to sunlight)

Not known (frequency cannot be estimated from the available data)
• Reduction of all cells in blood count (pancytopenia), which makes you tired, bruising easily and
prone to infections
• An allergic reaction (which may consist of swelling of the face, neck, hands, feet, lips, tongue or
throat leading to difficulty in breathing or swallowing; skin rash or hives)
• Fever with rash and swollen mouth, glands, joint and muscle pain (serum sickenss-like reaction)
• Severe belly and back pain with feeling very unwell which can be symptoms of a state called
pancreatitis
• Muscle disorders such as pain, tenderness, weakness or cramps which can progress to a state
called rhabdomyolysis (abnormal muscle breakdown which can lead to kidney problems)
• Vasculitis (inflamed blood vessels which are red, swelled and hurt)
Other possible side effects:

Very common (may affect more than 1 in 10 people)
• Rash
• Hives
• Indigestion/heartburn and a feeling of fullness
• Feeling sick (nausea)
• Belly pain
• Diarrhoea
• Loss of appetite
• Joint and muscle pain

Common side effects (may affect up to 1 in 10 people):
• Headache
Uncommon side effects (may affect up to 1 in 100 people):
• Taste disturbances, taste loss
• Losing weight
Rare side effects (may affect up to 1 in 1,000 people):
• Tingling or numbness in the hands and feet
• Less sensitive to pain or touch
• Dizziness
• Hepatic enzymes increased (which can be seen in blood tests)
• General feeling of being unwell
Very rare side effects (may affect up to 1 in 10,000 people):
• Vertigo
• Hair loss
Not known (frequency cannot be estimated from the available data)
• Anaemia
• Feeling sad (depression)
• Anxiety (worry)
• Smell disturbances
• Reduced or blurred vision
• Hearing problems
• Tinnitus (ringing in the ears)
• Worsening of psoriasis (patches of thickened or sore skin)
• serious skin reactions, drug rash
• Fatigue
• Flu symptoms (high fever, tiredness, muscle and joint pain)
• Fever
• Certain side effects can be seen in blood tests only like certain enzyme increased (creatinine
phosphokinase)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Terbinafine

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 lable/carton after EXP. The
expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw medicines you no longer use. These measures will help protect the environment.

6.

Content of the pack and other information

What Terbinafine contains
• The active substance is terbinafine hydrochloride (281.3 mg), equivalent to 250 mg of
terbinafine.
• The other ingredients are microcrystalline cellulose, sodium starch glycollate (Type A),
hypromellose, colloidal hydrated silica and magnesium stearate.
What Terbinafine looks like and contents of the pack:
• Terbinafine Tablets are white to off white, capsule shaped biconvex tablets. Scored on one side
and debossed “T” on each side of the score. Plain on the other side of the tablet.
• The product is available in pack sizes of 8, 14, 28, 30, 42, 50, 56 and 98 tablets. Not all pack
sizes may be marketed.
The Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in October 2017
PL 00289/0442

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide