Fucidin

Main information

  • Trade name:
  • Fucidin Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fucidin Tablet
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19910821
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

FUCIDIN

®

TABLET

Sodium Fusidate (250mg)

________________________________________________________________________________________________________

________________________________________________________________________________________________________

Consumer Medication Information Leaflet (RiMUP)

What is in this leaflet

What Fucidin® tablet is used for

How Fucidin® tablet works

Before you use Fucidin® tablet

How to use Fucidin® tablet

While you are using it

Side effects

Storage

Disposal

Fucidin®

tablet

Product Description

Manufacturer and Product

Registration Holder

Date of revision

Serial Number

What Fucidin

®

tablet is used for

Fucidin® tablet contains sodium fusidate.

It is a type of antibiotic.

Fucidin®

tablet

indicated

treatment

infections

caused

susceptible

organisms,

especially

staphylococci, for example:

Infections of the skin and wounds

Infections

blood

such

septicaemia

Infections of the bone and heart tissue

Infections

lungs

such

pneumonia

Infections connected with the condition

cystic

fibrosis,

genetic

disease

that

affects mucus and sweat glands, causing

mucus to become thick and sticky.

Inflammation of the endocardium, the

inner layer of the heart.

How Fucidin

®

tablet works

Fucidin

tablet

work by killing germs

(bacteria) that cause infections.

Before you use Fucidin

®

tablet

When you must not use it

Do not take Fucidin

tablet

allergic

(hypersensitive) to fusidic acid

or sodium fusidate.

allergic

(hypersensitive)

other

ingredients

your

medicine. You can find a list of

these

ingredients

section:

Product

Description

this

leaflet.

taking

statins

(medicines

lower

blood

cholesterol).

Pregnancy and lactation

Please ask your doctor or pharmacist for

advice before taking Fucidin

tablet:

If you are pregnant, or think you

are pregnant

If you are breast-feeding.

Tell your doctor if you become pregnant

while using this medicine.

Before you start to use it

Take special care with Fucidin

tablet

Before you take Fucidin

tablet, tell

your doctor:

If you have problems with your

liver

have

recently

been

jaundiced.

When you are taking Fucidin

Tablets

your doctor may take regular blood tests in

patients on high doses, with liver or bile

problems, taking the medicine for a long

time or taking other medicines that affect

the liver.

Taking other medicines

Please tell your doctor or pharmacist if

you are taking, or have recently taken

any other medicines.

This includes any

medicines

which

have

bought

without

prescription.

Do not take statins (medicines to

lower blood cholesterol) while

using this medicine.

You must tell your doctor or pharmacist

if you are taking any of the following

medicines:

Other

antibiotics,

such

lincomycin and rifampicin.

Oral anti-coagulants (medicines to

“thin” your blood). You may be

likely to bleed more easily. Your

doctor may need to change your

dose.

Medicines

lower

blood

cholesterol, such as statins. This

lead

muscle

weakness,

tenderness or pain.

Ritonavir

saquinavir,

medicines used to treat HIV.

Cyclosporin. This medicine is

used

reduce

body's

immune reactions.

How to use Fucidin

®

tablet

Always take Fucidin

tablet

exactly as

your doctor has told you. You should

check with your doctor or pharmacist if

you are not sure.

How much to use

Your doctor will tell you how many

tablets to take.

Take the tablet with a glass of water.

Adults

children

over

years

tablets

three

times

each day.

Skin infections: the usual dose is

one tablet twice each day.

In severe infections, your doctor

may increase the dose.

When to take it

Your doctor will tell you how many

tablets and how many times each day to

take your medicine.

You should take the medicine at equally

spaced times in the day.

Take Fucidin® tablets with meals to

avoid dyspepsia, nausea and vomiting.

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________________________________________________________________________________________________________

2

Consumer Medication Information Leaflet (RiMUP)

How long to take it

Continue taking Fucidin

tablet

for as

long as your doctor recommends.

If you forget to take it

Consult your doctor or pharmacist on

what you should do if you forget to use

Take the missed dose as soon as you

remember. If it is almost time for your

next dose, wait until then to take the

medicine and skip the missed dose. Do

not take a double dose to make up for the

missed dose.

If you take more than you should

(overdose)

Tell your doctor straight away. You

may need to stop taking this medicine.

- If you stop taking it

It is very important to take all the

medicine that your doctor has told you

to take. You must finish this medicine

even if you feel better. You must do

this because otherwise your infection

may come back.

have

further

questions

about taking this medicine, please ask

your doctor or pharmacist.

While you are using it

Things you must do

Take your medicine exactly as your

doctor has told you.

Tell

doctors,

dentists

pharmacists treating you that you are

taking Fucidin® Tablets.

Tell your doctor immediately if you

become

pregnant

while

taking

this

medication.

Things you must not do

Do not stop taking the medicine unless

advised by your doctor.

take

medicines

without consulting your doctor.

give

Fucidin®

tablet

anyone else, even if they have the

same symptoms or condition as you.

- Things to be careful of

Important information about some of

the ingredients of Fucidin® tablet

Fucidin® tablet contain:

-Lactose. This is a type of sugar. If

cannot

tolerate

sugar

(sometimes called sugar intolerance),

contact your doctor before taking this

medicine.

- Sodium. Each tablet contains 11

milligrams (mg) sodium. You should

take this into consideration if you are

on a controlled sodium diet.

Please ask your doctor if you are

worried about any of the ingredients

in this medicine.

Driving and using machines

Usually your medicine will have very

little effect on your ability to drive or

machines.

Check

with

your

doctor if you feel any side effect that

may stop you from driving or using

machines.

Side effects

Like all medicines, Fucidin® tablet

can cause side effects, although not

everybody gets them.

Serious side effects:

Allergic

reaction:

must

urgent medical help if you have any

of the following symptoms:

difficulty breathing

Swelling

face

throat

swell

skin develops a severe rash.

You must get urgent medical help if

have

following

symptoms. You may be developing a

condition

called

rhabdomyolysis

where you develop:

muscle weakness

muscle pain

muscle tenderness

elevated serum creatine kinase

acute kidney failure

dark urine

Number of people affected not known:

the level of some cells in your blood

change.

should

tell

your

doctor straight away if you have any of

the following symptoms:

develop

unexplained

bruising or bleeding

You develop persistent or repeated

mouth ulcers, sore throats or other

infections.

Number of people affected not known:

problems with your liver or kidneys.

You should tell your doctor straight

away if you have any of the following

symptoms:

Your skin or the whites of your eyes

appear yellow

You are not passing water.

Other possible side effects:

Nausea, vomiting and dyspepsia

If any of the side effects become serious

or you notice any side effects not listed

this

leaflet,

tell

your

doctor

pharmacist.

may report any side effects or

adverse drug reactions directly to the

National

Centre

Adverse

Drug

Reaction Monitoring by calling Tel: 03-

78835550,

visiting

website

npra.moh.gov.my

(Public

Reporting

Medicinal Problems / Side Effects /

AEFI / Vaccine Safety).

Storage

and

Disposal

of

Fucidin®

tablet

Storage

Keep out of the reach and sight of

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3

Consumer Medication Information Leaflet (RiMUP)

children.

Do not use Fucidin® Tablets

after the expiry date on the carton.

The expiry date is the last day of that

month.

Do not store above 30

Shelf-life: 3 years

Disposal

Medicines should not be disposed of

via wastewater or household waste.

Ask your pharmacist how to dispose of

medicines no longer required. These

measures

will

help

protect

environment.

Product Description

- What it looks like

Fucidin®

tablets

white

off-

white

greyish

marbled

film-coated

oval

biconvex

tablet

without

embossing.

Fucidin® tablets come in blister packs

of 20.

- Ingredients

- Active ingredient

Sodium fusidate

Fucidin® tablets contain 250 mg of

sodium fusidate in each tablet.

- Inactive ingredients

Crospovidone

Hypromellose

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

Silica

Talc

Titanium dioxide (E171)

All-rac-α-tocopherol

You can find important information

about some of the ingredients in your

medicine

near

section:

Before you use Fucidin® tablet of this

leaflet.

- MAL number:

MAL19910821AZ

Manufacturer

Laboratoires LEO

39, route de Chartres

28500 Vernouillet, France

Product Registration Holder

DKSH Malaysia Sdn Bhd

B-11-01,The Ascent, Paradigm

No.1, Jalan SS 7/26A, Kelana Jaya,

47301

Petaling

Jaya,

Selangor,

Malaysia.

Date of revision

11/10/2017

Serial Number

BPFK(R4/1)110717/0017