PACKAGE LEAFLET: INFORMATION FOR THE USER
Flukloxacillin Mylan 500 mg film-coated tablets
Flukloxacillin Mylan 750 mg film-coated tablets
flucloxacillin
Read all of this leaflet carefully before you start taking 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.
What Flukloxacillin Mylan is and what it is used for
2.
Before you use Flukloxacillin Mylan
3.
How to take Flukloxacillin Mylan
4.
Possible side effects
5.
How to store Flukloxacillin Mylan
6.
Further information
1.
WHAT FLUKLOXACILLIN MYLAN IS AND WHAT IT IS USED FOR
The active substance in Flukloxacillin Mylan, flucloxacillin, is a penicillin (antibacterial medicine)
that prevents the bacteria from building up a normal cell wall. Without a functioning cell wall the
bacteria dies quickly. Flukloxacillin Mylan differs from ordinary penicillin in that it is stable to an
enzyme (beta-lactamase), which is able to break down ordinary penicillin.
Flukloxacillin Mylan is used for infections in skin and soft tissue as well as infections in bones, joints
and lungs.
2.
BEFORE YOU USE FLUKLOXACILLIN MYLAN
Do not take Flukloxacillin Mylan
if you are allergic (hypersensitive) to flucloxacillin, penicillin or any of the other ingredients of
Flukloxacillin Mylan (see section 6 where other ingredients are listed).
Take special care with Flukloxacillin Mylan
- if you are allergic (hypersensitive) to cephalosporines (another group of antibacterial medicine)
you should consult your doctor before using Flukloxacillin Mylan
Stop taking Flukloxacillin Mylan and immediately contact a doctor if you have any of the following
symptoms (angioedema):
 swelling of the face, tongue or throat
 difficulties in swallowing
 nettle rash and breathing difficulties.
Taking other medicines
Please tell your doctor or pharmacists if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. This is because some medicines can affect or
be affected by Flukloxacillin Mylan, for example, some medicines for tumours and disorders of the
immune system (methotrexate), gout (probenecide) and some blood thinning medicines (warfarin).
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The effect of the oral contraceptive pill may be affected.
Taking Flukloxacillin Mylan with food and drink
Flukloxacillin Mylan is most effective if taken between meals.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
There are no known risks when used during pregnancy. However, Flukloxacillin Mylan should only
be taken on the advice of your doctor.
Flucloxacillin passes into breast milk but probably does not affect the breastfeeding baby. However,
consult your doctor if you use Flukloxacillin Mylan more than just temporarily when you are
breastfeeding.
Driving and using machines
No known effect on the ability to drive or operate machines.
Important information about some of the ingredients of Flucloxacillin Pharmachem
Flukloxacillin Mylan 500 mg contains 29 mg sodium per tablet and Flukloxacillin Mylan 750 mg
contains 44 mg sodium per tablet. This should be taken into consideration by patients on a low salt
diet.
3.
HOW TO TAKE FLUKLOXACILLIN MYLAN
Always take Flukloxacillin Mylan exactly as your doctor has told you. Ask your doctor or pharmacist
if you are unsure.
The tablet can be divided into equal halves
Even if you feel better after a few days it is important that you take all the Flukloxacillin Mylan
prescribed for you by your doctor. Otherwise some bacteria could survive, grow and cause a new
outbreak of the infection.
If you have taken more Flukloxacillin Mylan than you should
If you or someone else has taken too much Flukloxacillin, call a doctor straight away.
The most likely signs of an overdose of Flukloxacillin are nausea, vomiting, diarrhoea, muscle twitch,
cramps and coma.
If you forget to take Flukloxacillin Mylan
Do not take a double dose to compensate for the forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Flukloxacillin Mylan can cause side effects, although not everybody gets them.
Flukloxacillin Mylan may in rare cases affect the white blood cells, reducing defence against
infections. If you get an infection with symptoms such as high temperature with severely impaired
general condition or high temperature with local infection symptoms such as a sore
throat/pharynx/mouth or difficulties in passing urine, you should contact a doctor as soon as
possible for a blood test to rule out any deficiency in white blood cells (agranulocytosis). It is
important that you give information about your medication at this time.
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Common (affects 1 to 10 users in 100): Stomach trouble, mainly nausea or diarrhoea, and skin rash.
Uncommon (affects 1 to 10 users in 1,000): Nettle rash, altered blood picture (eosinophilia).
Rare ( affects 1 to 10 users in 10,000): Severe allergic reaction (anaphylactic reaction), altered blood
picture (agranulocytosis), colitis, effect on the liver.
In the event of long-term or severe diarrhoea you should contact a doctor.
Itching in the genital area may be caused by a fungal overgrowth. A white coating in the mouth,
mainly on the tongue may also be caused by a fungal infection.
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 FLUKLOXACILLIN MYLAN
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Flukloxacillin Mylan after the expiry date which is stated on the carton and blister after
“EXP”. The expiry date refers to the last date of that month.
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 to protect the environment.
6.
FURTHER INFORMATION
What Flukloxacillin Mylan contains
1 tablet contains:
The active substance is: flucloxacillin sodium monohydrate equivalent to flucloxacillin 500 mg and
750 mg respectively
The other ingredients are: Microcrystalline cellulose, povidone, magnesium stearate, collodial,
anhydrous silica, croscarmellose sodium, titanium dioxide (E171), hypromellose, macrogol,
ethylcellulose and carnauba wax.
What Flukloxacillin Mylan looks like and package sizes
500 mg: White, oval, biconvex, film-coated tablet of 18 x 5 mm with “F 500” on one side and a
breakline on the other side.
750 mg: White, oval, biconvex, film-coated tablet of 19,5 x 5,3 mm with “F 750” on one side and a
breakline on the other side.
Blister packs containing 16, 20, 30, 50 or 100 tablets
HDPE bottles containing: 20, 30, 50 or 100 tablets
The HDPE bottle contains 0.5 g silica gel as desiccant. The bottle is sealed with aluminium foil.
Marketing authorisation holder and manufacturer
Mylan AB
Box 23033
3
104 35 Stockholm
Sweden
This package leaflet was last approved on 2012-07-24
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