TERBINAFINE 125 MG TABLETS

Active substance: TERBINAFINE HYDROCHLORIDE

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Terbinafine tablets, 125mg & 250mg

PACKAGE LEAFLET: INFORMATION FOR THE USER
Terbinafine 125 mg tablets
Terbinafine 250 mg tablets
(Terbinafine)
Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Terbinafine is and what it is used for
Before you use Terbinafine
How to use Terbinafine
Possible side effects
How to store Terbinafine
Further information

1. WHAT TERBINAFINE IS AND WHAT IT IS USED FOR
Terbinafine belongs to a group of medicines called antifungals. It is used for the treatment
of fungal infections of the skin (including those in between the fingers and toes) and of
the nails.
2. BEFORE YOU USE TERBINAFINE
Do not use Terbinafine
if you are allergic (hypersensitivity) to terbinafine or any of the other ingredients of
Terbinafine.
if you have a severe kidney problem.
if you have a severe liver problem
Take special care with Terbinafine
if you have liver problems or a disease which may affect your liver.
if you have psoriasis.
if you have kidney problems.
If any of the above warnings applies to you or has applied to you in the past, consult your
doctor.
Taking other medicines
Please tell to your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
the antibiotic, rifampicin (decreases the level of terbinafine in your blood).

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Terbinafine tablets, 125mg & 250mg

cimetidine (a medicine for stomach ulcers and heartburn) increases the level of
terbinafine in your blood.
medicines used to treat depression such as clomipramine, lofepramine or paroxetine.
certain medicines used to treat Parkinson’s disease such as monoamine oxidase
inhibitors e.g. selegiline.
medicines used to treat high blood pressure or heart problems such as atenolol or
carvedilol (beta blockers),
oral contraceptives (the pill). Irregular periods and abnormal menstrual bleeding
which may be between periods may occur in female patients.
flecainide and propafenone, which are used to treat heart flutters (arrhythmias).
Please note that the above medicines may be known to you by other names. Always
thoroughly check the information leaflet of the medicines you are already using and check
with your doctor or pharmacist before taking Terbinafine if you are taking any of the
above sorts of medicines.
Pregnancy and breast-feeding
If you are pregnant, think you are pregnant or are breast-feeding; you should not take
Terbinafine unless your doctor tells you to. If you become pregnant whilst taking this
medicine, you should tell your doctor as soon as possible.
Ask your doctor or pharmacist for advice before taking any medicine.
Taking Terbinafine with food and drink
Taking food and drink has no influence on terbinafine treatment.
Driving and using machines
Terbinafine should not affect your ability to drive or use machines.
3. HOW TO USE TERBINAFINE
Always take terbinafine exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Dosage
Adults:
The dose you are prescribed will depend on the type of infection and how bad it is.
The usual dose is 250 mg terbinafine daily. You should swallow your tablet whole with a
glass of water. The tablets can be taken with or without food.
If you suffer from kidney problems, your doctor may prescribe half the recommended
dose.
Duration of treatment:
Your doctor will tell you how long your treatment with terbinafine will last.
For general fungal skin infections, your treatment will probably last for 4 weeks.
Treatment for skin infections affecting the groin or body will normally last between 2
to 4 weeks and those involving feet may last between 2 to 6 weeks.
For nail infections your treatment may last between 6 weeks and 3 months, although
treatment for toenail infections may continue for 6 months or longer.
Complete resolution of the signs and symptoms of the infection may not occur until
several weeks after treatment has stopped and the infection has been cured.

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Terbinafine tablets, 125mg & 250mg

If you take more Terbinafine than you should
If you or someone you know has taken more tablets than they should, consult your doctor
or the nearest hospital casualty department immediately. Take this leaflet or some tablets
with you so your doctor will know what you have taken.You may feel dizzy, sick and
have a headache and/or stomach pain.
If you forget to take Terbinafine
If you forget to take terbinafine at the right time, take them as soon as you remember. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Terbinafine
Do not stop taking terbinafine without consultation with your doctor, even if the infection
heals.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, terbinafine can cause side effects, although not everybody gets them.
The following side effects have been observed:
You should stop taking your tablets and see your doctor immediately if
you experience symptoms of angioedema / anaphylaxis, such as:
- swollen face, tongue or pharynx
- difficulty in swallowing
- hives
- difficulties in breathing
- feeling faint
you experience skin reactions such as weals, blisters, or a progressive rash
you have abnormalities of liver function. Symptoms include yellowing of the skin,
itching, unexplained and persistent nausea (feeling sick), tiredness, vomiting (being
sick), dark coloured urine, light coloured stools and abdominal (tummy) pain.
Very common (more than 1 in 10 patients)
Joint pain (arthralgia) and muscle pain (myalgia) can occur in association with
allergic skin rashes.
Rash, reddening of skin with itching and hives (urticaria). If progressive skin rash
occurs, the treatment must be discontinued.
Common (in more than 1 in 100 patients, but less than 1 in 10 patients):
Headache.
Loss of appetite
Stomachache, feeling of fullness, diarrhoea indigestion (dyspepsia), feeling sick
(nausea).
Increased hepatic enzyme levels
Uncommon (in more than 1 in 1,000 patients, but less than 1 in 100 patients):
Loss or decrease of the sense of taste (ageusia or dysgeusia), this usually resolves
slowly once you have stopped taking the medicine. Very rare cases of prolonged taste
disturbances have been reported, sometimes leading to a decrease of food intake and
significant weight loss.

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Terbinafine tablets, 125mg & 250mg

Rare (in more than 1 in 10,000 patients, but less than 1 in 1,000 patients):
Incidence of allergic reactions (including anaphylaxis).
Pins and needles sensation (paraesthesias), numbness (hypesthesia) and dizziness.
Abnormal liver function, including liver inflammation (hepatitis) and jaundice
(yellowing of the skin and eyes).
Tiredness (fatigue), vague illness (malaise).
Very rare (in less than 1 in 10,000 patients, including isolated reports):
Reductions in the number of different types of blood cells which may increase the
risk of severe infection, bleeding or may cause shortness of breath and tiredness
(agranulocytosis, neutropenia, thrombocytopenia).
A Condition which may cause a very wide variety of symptoms such as joint pain,
kidney problems, rash and fever (systemic lupus erythematosus).
Anxiety and depression.
Stevens-Johnson syndrome (a serious illness with blistering of the skin, mouth, eyes
and genitals),
Hair loss.
Toxic epidermal necrolysis (a serious illness with blistering and loss of the skin),
Menstrual disturbance such as abnormal menstrual bleeding which may be between
periods, and an irregular cycle.
Sensation of dizziness (vertigo).
Serious allergic reactions, which causes swelling of the face or throat (angio odema)
Increased sensitivity of your skin to sunlight.
Psoriasiform eruptions or exacerbation of psoriasis.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TERBINAFINE
Keep out of the reach and sight of children.
Do not use terbinafine after the expiry date which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose off medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Terbinafine contains
 The active substance is terbinafine.
Each tablet contains 125 mg of terbinafine (as terbinafine hydrochloride).
Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride).
 The other ingredients are cellulose microcrystalline, sodium starch glycolate (type A),
silica colloidal anhydrous, hypromellose and magnesium steararte.

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Terbinafine tablets, 125mg & 250mg

What Terbinafine looks like and contents of the pack
Tablets.
Terbinafine 125 mg tablets
White to off-white, round uncoated, biconvex bevelled edge tablets having ‘D’
debossed on one side and ‘56’ on the other side.

Terbinafine 250 mg tablets
White to off-white, round uncoated, biconvex bevelled edge tablets with breakline and
‘D’ debossed on one side and ‘74’ on the other side. The tablet can be divided into equal
halves.
Terbinafine 125 mg tablets are available in PVC/PVDC/Aluminum blister
packs of 7, 8, 12, 14, 28, 42 and 56 tablets.
Terbinafine 250 mg tablets are available in PVC/PVDC/Aluminum blister
packs of 7, 8, 14, 28, 30, 42, 56 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10
B-1930 Zaventem, Belgium
or
Pfizer PGM
Zone Industrielle
29, route des Industries
37530 Pocé -Sur-Cisse, France

This leaflet was last approved in 07/2013

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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.

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