TERBINAFINE

Main information

  • Trade name:
  • TERBINAFINE AMNEAL terbinafine (as hydrochloride) 250 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERBINAFINE AMNEAL terbinafine (as hydrochloride) 250 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207959
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207959

TERBINAFINE AMNEAL terbinafine (as hydrochloride) 250 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

20/03/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. TERBINAFINE AMNEAL terbinafine (as hydrochloride) 250 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

2/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ò Treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as Trichophyton (e.g. T.

rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum, where oral therapy is considered

appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy.

ò Onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. TERBINAFINE AMNEAL terbinafine (as hydrochloride) 250 mg tablet blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off-white, uncoated biconvex, bevelled edge tablet, engraved 'TER'

and '250' with a break line on one side and plain on the other

Active Ingredients

terbinafine hydrochloride

281.28 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 11:46:33 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Terbinafine tablets CMI v1.0

Terbinafine AMNEAL Tablets

terbinafine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Terbinafine AMNEAL

tablets. It does not contain information

about other forms of Terbinafine

AMNEAL that are available without a

prescription from your pharmacy.

It does not contain all the available

information about Terbinafine AMNEAL

tablets. It does not take the place of

talking to your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. Some more recent

information on the medicine may be

available.

You should ensure that you speak to

your pharmacist or doctor to obtain

the most up to date information on

the medicine.

Those updates may contain important

information about the medicine and its

use of which you should be aware.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking this medicine against the

benefits they expect it will provide.

If you have any concerns about this

medicine, ask your doctor or

pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Terbinafine AMNEAL

tablets are used for

Terbinafine AMNEAL tablets are used

to treat:

• fungal infections of the finger nails

and toe nails

• tinea (ringworm) infections of the groin

and body

• tinea infections of the feet, commonly

called "athlete's foot." These

infections are caused by a group of

fungi called dermatophytes

Terbinafine, the active ingredient in

Terbinafine AMNEAL tablets, works by

killing the dermatophytes.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it for

another reason.

Terbinafine AMNEAL tablets are only

available with a doctor's prescription.

This medicine is not addictive.

There is not enough information to

recommend the use of this medicine in

children.

Before you take Terbinafine

AMNEAL tablets

When you must not take it

Do not take Terbinafine AMNEAL if

you have ever had an allergic

reaction to:

• terbinafine, the active ingredient, or to

any of the other ingredients listed at

the end of this leaflet

• any other medicines, foods,

preservatives or dyes

Your doctor will want to know if you

are prone to allergies

Some of the symptoms of an allergic

reaction may include:

• shortness of breath

• wheezing or difficulty breathing

• swelling of the face, lips, tongue or

other parts of the body

• rash, itching or hives on the skin

Do not take Terbinafine AMNEAL

tablets:

• if you have any problems with your

kidneys

• if you have or ever had a problem with

your liver

This medicine is not recommended if

you currently have a liver problem

because it may make the problem

worse. If you had a liver problem in the

past and your liver is functioning

normally now, your doctor may

prescribe Terbinafine AMNEAL tablets

but may want to check your liver

function before and during treatment

with this medicine.

Do not take Terbinafine AMNEAL

tablets after the expiry date printed

on the pack, or if the packaging is

torn or shows signs of tampering.

In that case, return it to your

pharmacist.

Before you start to take it

Tell your doctor if you:

1. are pregnant or intend to

become pregnant

There is no experience with use

of Terbinafine AMNEAL tablets during

pregnancy. If your doctor thinks it is

necessary for you to take it, he/she will

discuss with you the benefits and risks

involved.

2. are breast-feeding

Breastfeeding is not recommended

since terbinafine, the active ingredient

in Terbinafine AMNEAL tablets, passes

into breast milk. There is a possibility

that your baby could be affected.

3. have any skin problems

such as rash, red skin, blistering

of the lips, eyes or mouth, skin peeling

4. have any blood disorders

or experience weakness, unusual

bleeding, bruising or frequent infections

If you are not sure whether you

should start taking Terbinafine

AMNEAL tablets, talk to your doctor

or pharmacist.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a prescription

from a pharmacy, supermarket or

health food shop.

Some medicines and Terbinafine

AMNEAL tablets may interfere with

each other.

Terbinafine AMNEAL CMI v1.0

These include:

• some medicines used to treat

depression and other mental

disorders, including obsessive

compulsive disorders and panic

attacks

• some medicines for Parkinson's

Disease

• some medicines used to treat an

irregular heart beat, heart problems,

high blood pressure and migraines

(e.g. metoprolol)

• some medicines used to treat

stomach ulcers (e.g. cimetidine)

• some antibiotics (e.g. rifampicin)

• caffeine

• cyclosporin, a medicine used to help

prevent organ transplant rejection or

to treat certain problems with the

immune system

• oral contraceptives (birth control pills).

You may have problems, such as

bleeding between periods, while you

are taking Terbinafine AMNEAL

tablets

• warfarin, a medicine used to prevent

blood clots

You may need to take different

amounts of your medicines or you may

need to take different medicines.

Your doctor and pharmacist have more

information.

If you have not told your doctor

about any of these things, tell him/

her before you start taking this

medicine.

How to take Terbinafine

AMNEAL tablets

Follow all directions given to you by

your doctor and pharmacist

carefully.

These directions may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

How much to take

Follow your doctor's instructions

on how many Terbinafine AMNEAL

tablets to take.

The usual dose of Terbinafine AMNEAL

is one tablet (250 mg) each day. If you

have kidney problems, the dose may

be reduced to one-half a tablet each

day.

How to take it

Take the Terbinafine AMNEAL tablet

with a full glass of water. If you find

that the Terbinafine AMNEAL tablet

upsets your stomach, try taking it

immediately after a light meal.

Take the tablet at about the same

time each day.

Taking your tablet at the same time

each day will have the best effect. It

will also help you remember when to

take it.

How long to take it

The length of your treatment will

depend on the type of infection you

have, what part of the body is affected

and how well you respond to treatment.

Fungal skin infections (tinea):

If you have a tinea infection of the

feet (athlete's foot), you will usually

take the tablets for 2 to 6 weeks.

If you have a tinea infection of the body

or groin, you will usually take the

tablets for 2 to 4 weeks.

The signs and symptoms of infection

may last for several weeks after the

fungi (dermatophytes) have been killed.

Fungal nail infections:

Fungal nail infections usually take

longer to heal than fungal skin

infections. You will usually take the

tablets for anywhere from 6 weeks to 3

months. But, if you have a nail infection

of the big toe or your nails grow very

slowly, you may need to take the

tablets for up to 6 months.

It may take several months after you

stop taking Terbinafine AMNEAL

tablets for your nail to look completely

normal. That is because the deformed

part of the nail has to grow out and be

replaced by a healthy nail.

If you forget to take it

If it is almost time for your next dose

(within 4 hours), skip the dose you

missed and take the next dose when

you are meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking it as you would normally.

Do not take a double dose to make

up for the one that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

I

f you take too much

(Overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone number 13 11 26), or go

to Accident and Emergency at your

nearest hospital if you think that you

or anyone else may have taken too

many Terbinafine AMNEAL tablets.

Do this even if there are no signs of

discomfort or poisoning. Keep the

telephone numbers for these places

handy.

Some of the symptoms of an overdose

may include headache, nausea (feeling

sick), stomach pain and dizziness.

While you are taking

Terbinafine AMNEAL tablets

Things you must do

Make sure to take your tablet every

day and continue taking it until your

doctor tells you to stop.

This will ensure that all of the infection

is gone and will lessen the chance of

the infection coming back once you

stop taking this medicine.

Make sure to have any blood tests

done that are ordered by your

doctor.

Any side effects on your liver, kidneys

or blood can be detected by blood

tests.

Tell your doctor immediately if

you notice any of the following:

• fever

• sore throat

• mouth ulcers

• "flu-like" symptoms (chills, aching

joints, swollen glands, lack of energy)

• any other signs of infection, apart from

the fungal infection you are being

treated for.

Terbinafine AMNEAL CMI v1.0

If you become pregnant while taking

Terbinafine AMNEAL tablets, tell

your doctor immediately.

Your doctor can discuss with you the

risks and benefits of taking it during

pregnancy.

Remind your doctor and pharmacist

that you are taking Terbinafine

AMNEAL tablets if you are about to

be started on any new medicine.

Tell any other doctor, dentist or

pharmacist who treats you that

you are taking Terbinafine AMNEAL

tablets.

Things you must not do

Do not give this medicine to anyone

else, even if their condition seems

similar to yours.

Do not use it to treat any other

complaints unless your doctor tells

you to.

Things to be careful of

Be careful driving, operating

machinery or doing jobs that

require you to be alert while you

are taking Terbinafine AMNEAL

tablets until you know how it affects

you.

This medicine can cause tiredness,

sleepiness, dizziness or

lightheadedness in some people. If you

have any of these symptoms, do not

drive, use machines, or do anything

else that could be dangerous.

Be careful to keep the infected areas

dry and cool and change clothing

that is in direct contact with the

infected areas every day.

This will help to clear up the infection

and make sure that it does not return.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Terbinafine

AMNEAL tablets, even if you do not

think it is connected with the

medicine.

All medicines can have side effects.

Sometimes they are serious, but most

of the time they are not. You may need

medical treatment if you get some of

the side effects.

Do not be alarmed by these lists of

possible side effects. You may not

experience any of them. Ask your

doctor or pharmacist to answer any

questions you may have.

Tell your doctor immediately or go to

Accident and Emergency at your

nearest hospital if you notice any of

the following:

• chest pain

• signs of a severe allergic reaction

such as swelling of the face, lips,

tongue, throat or other part of the

body; shortness of breath, wheezing

or troubled breathing; dizziness,

redness, itching or rash on the skin;

flushing, crampy abdominal pain, loss

of consciousness; joint pain, stiffness,

rash, fever or swollen/ enlarged

lymph nodes

• possible signs of a serious liver

problem such as persistent nausea,

loss of appetite, unusual tiredness,

vomiting, pain in the upper right

abdomen, yellowing of the skin and/or

eyes, dark urine or pale bowel

motions

• possible signs of a serious skin

reaction such as painful red areas,

large blisters, peeling of layers of

skin, bleeding in the lips, eyes,

mouth, nose or genitals. These signs

may be accompanied by fever and

chills, aching muscles and feeling

generally unwell

• possible signs of a blood problem

such as constant "flu-like" symptoms

(fever, sore throat, mouth ulcers,

chills, swollen glands, lack of energy)

• possible signs of diseases that affect

certain types of blood cells: unusual

bleeding or bruising

• possible signs of a disease that

affects the level of red blood cells

including abnormal pale skin,

mucosal lining or nail beds, unusual

tiredness or weakness or

breathlessness on exertion

• possible signs of blood vessel

inflammation: rash, fever, itching,

tiredness or if you notice appearance

of purplish-red spots under the skin

surface

• possible signs of pancreas

inflammation: severe upper stomach

pain with radiation to the back

• possible signs of muscle necrosis:

unexplained muscle weakness and

pain or dark (red-brown) urine.

The above are serious side effects that

need medical attention. Serious side

effects are rare.

Tell your doctor if you notice any

of the following and they worry

you:

• nausea (feeling sick) or vomiting

• upset stomach (heartburn, cramps,

wind, belching)

• loss of appetite

• diarrhea

• aching joints or muscles

• headache

• light headedness

• tiredness, sleepiness

• loss of or change in sense of taste,

which usually returns to normal within

several weeks of stopping Terbinafine

AMNEAL tablet treatment

• other skin problems

• psoriasis (thickened patches of

red skin, often with silvery scales)

• hair loss

• tingling or numbness

• decreased physical sensitivity

• smell disorders or loss of smell

• anxiety (with symptoms such as sleep

disturbances, fatigue, loss of energy

or diminished ability to think or

concentrate) and depressive

symptoms (e.g. depressed mood) due

to taste disturbances

• decreased hearing, impaired hearing

and/or perception of noises in the

absence of sound (e.g. hissing,

ringing) in ears

Tell your doctor if you notice

anything else that is making you

unwell.

Some people may have other side

effects not yet known or mentioned

in this leaflet.

After using Terbinafine

AMNEAL tablets

Storage

Keep your medicine in the original

container until it is time to take it.

Store it in a cool, dry place below

30°C and protected from light.

Terbinafine AMNEAL CMI v1.0

Do not store Terbinafine AMNEAL

tablets or any other medicine in the

bathroom or near a sink.

Do not leave it in the car or on

window sills.

Keep the medicine where children

cannot reach it.

A locked cupboard at least one-and a-

half metres above the ground is a good

place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or the expiry date has

passed, ask your pharmacist what to

do with any medicine you have left

over.

Product description

What it looks like

Terbinafine AMNEAL tablets are white

to off-white coloured, round, biconvex

bevel edged tablet engraved “TER”

and ‘250’ with a break line on one side

and plain on the other side.

Terbinafine AMNEAL tablets are

available in blister packs of 42 tablets.

Ingredients

Active Ingredient

Terbinafine AMNEAL tablets contain

250 mg terbinafine hydrochloride salt

per tablet.

Inactive ingredients

Cellulose-microcrystalline, sodium

starch glycollate, hypromellose, silica

colloidal anhydrous, magnesium

stearate

Sponsor

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra VIC 3141

Australia

AUST R: 207959

This leaflet was prepared in July 2016.

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EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety