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CO-FLUAMPICIL 250/250 MG CAPSULES HARD

Active substance(s): AMPICILLIN TRIHYDRATE / FLUCLOXACILLIN ANHYDROUS

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BASE LABEL
250/
250 mg

28

CS500

Caspsules,
hard, Oral use

Each capsule, hard CONTAINS PENICILLIN 614302
A0393/2
contains: ampicillin
trihydrate equivalent to anhydrous ampicillin 250 mg and
flucloxacillin sodium equivalent to anhydrous flucloxacillin 250 mg. For
oral use as directed by a doctor. Read the package leaflet
before use. Keep out of the sight and reach of children. POM
Store below 25°C. Store in the original package and keep PL 04569/0082
the container tightly closed in order to protect from moisture.

Co-Fluampi
-cil #250
/#250 mg
Capsules

Lot:

Almus ® is
a registered
trademark

MA Holder: Mylan, Potters Bar,
Herts, EN6 1TL, UK

Co-Fluampi
-cil #250
/#250 mg
Capsules

5 060057 403938

Co-Fluampicil
Capsules, hard

EXP:

IP PART - 1 FRONT
same as for adults. These capsules are not

PEEL HERE BUT DO NOT REMOVE

Co-Fluampi
28
-cil
#250
/#250 mg
Capsules
Co-Fluampicil
Capsules, hard

250/
250 mg

Patients with kidney disease
If you suffer from severe kidney disease, your
doctor may prescribe a lower dose for you
than that stated above.
If you take more Co-Fluampicil than
you should
Contact your doctor or nearest hospital
emergency department immediately. Take
the container and any remaining capsules
with you. Symptoms of overdose include
feeling sick, being sick, and diarrhoea.
If you forget to take Co-Fluampicil
Take the next dose as soon as you remember
unless it is almost time for your next dose. Do

Caspsules,
CS500
hard, Oral use
Almus ® is a registered trademark
Each capsule, hard contains: ampicillin
CONTAINS PENICILLIN
trihydrate equivalent to anhydrous ampicillin
250 mg and flucloxacillin sodium equivalent to anhydrous flucloxacillin 250 mg.
For oral use as directed by a doctor. Read the package leaflet before use.
614302
Keep out of the sight and reach of children. Store below 25°C.
A0393/2
Store in the original package and keep the container
tightly closed in order to protect from moisture.
PL 04569/0082 POM

MA Holder: Mylan, Potters Bar, Herts, EN6 1TL, UK

PAGE 07

not take a double dose to make up for a forgotten dose.
If you stop taking Co-Fluampicil
Keep taking Co-Fluampicil until the course is finished.
Do not stop taking this medicine just because you feel
better. If you stop too soon, the infection may come
back again. When you have finished the medicine, if
your symptoms persist, tell your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you get any of the following, contact your doctor
straight away or seek emergency help immediately:
• swelling of the eyelids, lips or face

• sudden wheeziness or tightness of chest or breathing
problems
• severe diarrhoea with or without bleeding
• skin problems such as ‘hives’ (nettle rash), itching or
rash which may include blistering or peeling of the
skin
• liver problems including jaundice (the colour of your
skin or the whites of your eyes turn yellow). This may
happen several weeks after stopping treatment
• changes in the colour of urine or faeces inflammation
of the kidneys that can cause blood in the urine,
swollen ankles or high blood pressure
• tiredness, headaches, being short of breath when
exercising, dizziness, looking pale and yellowing of
the skin and/or eyes – signs of destruction of red
blood cells (haemolytic anaemia).

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Other possible side effects:
• red or purple discolourations on the skin
• fever
• changes in blood may occur. You may experience
bleeding for longer than usual or tiredness and
generally feeling poorly. If you have a blood test
while taking this medicine, tell your doctor that
you are taking Co-Fluampicil
• stomach problems such as diarrhoea, feeling sick
(nausea) and being sick (vomiting)
• increase in certain enzymes in the blood (seen in
a blood test)
• Changes in the colour of urine or faeces
• joint pain, muscle pain.
Reporting of side effects
If you get any side effects talk to your doctor or

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Package leaflet: Information for the patient

infections of the chest (bronchitis or pneumonia),
sinuses (sinusitis), ears (otitis media), nose, throat, skin
and soft tissues.
It can also be used to treat chest and wound infections
following surgery or for the treatment of septicaemia
(infections in the blood), treatment of infection
following childbirth or termination of pregnancy. It
can also be used to treat patients who are prone to
infection (e.g. following a bone marrow transplant) or
given before major surgery to prevent infection.
2. What you need to know before you take
Co-Fluampicil
Do not take Co-Fluampicil if:
• you are allergic to ampicillin, flucloxacillin or any
of the other ingredients of this medicine (listed in
section 6)

What is in this leaflet:
1. What Co-Fluampicil is and what it is used for.
2. What you need to know before you take
Co-Fluampicil.
3. How to take Co-Fluampicil.
4. Possible side effects.
5. How to store Co-Fluampicil.
6. Contents of the pack and other information.
1. What Co-Fluampicil is and what it is used for
Co-Fluampicil contains flucloxacillin and ampicillin,
which belong to the group of antibiotics called
‘Penicillins’. Antibiotics are used to kill the bacteria that
cause infections.
Your doctor will have prescribed Co-Fluampicil for
treating an infection. Co-Fluampicil can be used
for treating a wide range of infections, for example

(ampicillin trihydrate and flucloxacillin sodium)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if their signs of
illness are the same as yours. • If you get any side
effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.

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• you are allergic to penicillin or any other antibiotic
• you have experienced liver problems when taking
an antibiotic.
Warnings and precautions
Talk to your doctor before taking Co-Fluampicil if:
• you suffer from kidney or liver disease including
jaundice (the skin and whites of the eyes turn yellow)
• you have a history of allergies
• you have any conditions affecting your white blood
cells (e.g. infectious mononucleosis or lymphoid
leukaemia)
• you are having a urine test (ampicillin can affect tests
for glucose in urine).
Other medicines and Co-Fluampicil
Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines,
including medicines obtained without a prescription,

especially any of the following:
• allopurinol or probenecid (used to treat gout)
• oral contraceptives (‘the pill’); you should take
additional contraceptive precautions as advised by
your doctor
• anti-coagulation therapy (such as warfarin); the
tendency to bleed may increase
• methotrexate (used to treat some types of cancer,
severe psoriasis or severe arthritis
• other antibiotics.
Pregnancy and breast-feeding
Co-Fluampicil should only be given to pregnant or
breast-feeding mothers if the benefits to the mother
outweigh the risks to the baby. If you are pregnant
or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

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3. How to take Co-Fluampicil
Always take this medicine
exactly as your doctor has told
you. Check with your doctor or
pharmacist if you are not sure.
The medicine should be taken
half an hour to one hour before
a meal.
Adults and the Elderly
The recommended dose is one
capsule four times a day. This
dose may be doubled in severe
infections.
Use in children
The recommended dose for

What Co-Fluampicil looks
like and contents of the
pack
Your medicine comes as a
hard gelatin capsule. The
capsules are blue with a
dark grey cap, marked with
“G CS 500”, containing a
white powder.
This medicine is available
in blisters and plastic or
glass containers of 5, 7, 10,
14, 15, 20, 21, 25, 28, 30,
50, 56, 60, 84, 90, 100, 250,

Marketing Authorisation
Holder
Mylan, Potters Bar,
Kingdom
Manufacturer
Generics [UK] Limited, Potters
United Kingdom
This leaflet was last revised in
April 2015

Not all pack sizes may be
marketed.

PAGE 06

CODE:GUJ/DRUGS/G/834

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pharmacist. This includes any
possible side effects not listed
in this leaflet. You can also
report side effects directly via
the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
By reporting side effects
you can help provide more
information on the safety of
this medicine.
5. How to store
Co-Fluampicil
Keep this medicine out of the
sight and reach of children.
Do not use this medicine
after the expiry date, which

PAGE 11

6. Contents of the pack and
other information
What Co-Fluampicil contains
The active substances are
ampicillin trihydrate (equivalent

is stated on the carton or label
after ‘EXP’. The expiry date refers
to the last day of that month.
Store below 25°C.
Store in the original package
and keep the container tightly
closed in order to protect from
moisture.
Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw away
medicines you no longer use.
These measures will help to
protect the environment.

flucloxacillin sodium (equivalent
This combination of active
substances is also known as
Co-Fluampicil.
The other ingredients are
magnesium stearate, gelatin,
quinoline yellow (E104), patent
blue (E131), titanium dioxide
(E171) and iron oxides (E172).

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DIMENSIONS 52 x 303mm
Client:

Almus UK

Project:

10060 / UK
Co-Fluampicil 250 x 28

VERSION: 2 (MYLAN)
BLACK

Item(s):

REVISED ARTWORK FOR MHRA APPROVAL

Colours used:

Carton artwork

PMS
319

PMS
2613

DRAFT ISSUE: 3

PMS
7466

REASON FOR CHANGE: SAFETY TEXT UPDATE
SUPPLIER ISSUE DATE: 30.4.2015
Checked by: Paul Adams

CUTTER
This scale measures 100mm when artwork is 100%
0
10
20
30

40

50

60

Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams

BRAILLE

VARNISH
FREE AREA
(DO NOT PRINT)

70

80

Date: 30.4.2015
90

100

pmdc design llp
Lower Test Studios
Sheardley Lane, Droxford
Hampshire SO32 3QY
+44 (0)1489 878780
www.pmdc.co.uk

BARCODE 5060057403938
PHARMA CODE - TBA
ALMUS CODE A0393/2
SUPPLIER CODE 614302

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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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