TERBINAFINE 125 MG TABLETS

Active substance: TERBINAFINE HYDROCHLORIDE

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P1502860

Terbinafine
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).
• 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.

A/s : 210 x 360

Black

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.
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.

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 tablets contain
• 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.
What Terbinafine tablets look 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 containing 7, 8, 12, 14, 28, 42 or 56 tablets.
Terbinafine 250 mg tablets are available in PVC/PVDC/Aluminum blister
packs containing 7, 8, 14, 28, 30, 42, 56 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Pfizer Limited,
Ramsgate Road,
Sandwich,
Kent CT13 9NJ,
United Kingdom.
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
or
Pfizer Italia s.r.l.
Località Marino Del Tronto,
63100 - Ascoli Piceno (AP)
Italy
This leaflet was last approved in 10/2010.
Ref: TB1_1UK

P1502860

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.
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 m e n s t r u a l b l e e d i n g
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.

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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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