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CO-FLUAMPICIL 250/250 MG CAPSULES HARD

Active substance(s): AMPICILLIN TRIHYDRATE / FLUCLOXACILLIN ANHYDROUS

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BASE LABEL

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

Co-Fluampicil 250/250 mg
250/ Capsules, hard
250 mg (ampicillin trihydrate

and flucloxacillin sodium)
28 capsules, hard
CONTAINS PENICILLIN
Each capsule, hard 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. Store below
25°C. Store in the original package and
keep the container tightly closed in order to
protect from moisture.

Lot:

PL 04569/0082 POM 1118709
Mylan, Potters Bar, Herts., EN6 1TL, UK

EXP:

IP P AR T - 1 FRONT
PEEL HERE BUT DO NOT REMOVE

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

Co-Fluampicil 250/250 mg
Capsules, hard
(ampicillin trihydrate
and flucloxacillin sodium)
28 capsules, hard

CONTAINS PENICILLIN
Each capsule, hard 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.
Store below 25°C. Store in the original package and keep the
container tightly closed in order to protect from moisture.
PL 04569/0082 POM 1118709
Mylan, Potters Bar, Herts., EN6 1TL, UK

Patients with kidney problems
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 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

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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 side effects, contact
your doctor straight away or seek emergency help
Immediately
Rare (may affect up to 1 in 1,000 people):
• swelling of the eyelids, lips, face, tongue or throat
which may cause difficulty in breathing and swallowing.
• sudden wheeziness or tightness of chest or
breathing problems.

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• severe diarrhoea with or without bleeding.
• skin problems such as ‘hives’ (nettle rash), itching
or rash which may include widespread blistering or
peeling of the skin and also lips, eye, mouth, nose
and genitals. This may also be accompanied by
fever, chills, headache, aching muscles or joints and
generally feeling unwell.
Contact your doctor as soon as possible if you
experience any of the following side effects:
• swollen glands in the neck, armpit or groin.
• liver problems including jaundice (the colour of
your skin or the whites of your eyes turn yellow)
or inflammation of the liver (hepatitis). This may
happen several weeks after stopping treatment.
• 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

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the skin and/or eyes – signs of destruction of red
blood cells (haemolytic anaemia).
• changes in blood may occur. You may experience
bleeding for longer than usual, tiredness or suffer
from frequent infections, such as sore throat or
fever and generally feeling poorly. If you have a
blood test while taking this medicine, tell your
doctor that you are taking Co-Fluampicil.
• coma.
Other possible side effects:
• increase in blood potassium levels which may be seen
in blood test.
• seeing, feeling or hearing things that are not there
(hallucination).
• red or purple discolouration of the skin.
• fever.
• narrowing or blockage of blood vessels.

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Package leaflet: Information for the patient

Co-Fluampicil 250/250 mg Capsules, hard
(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.

PAGE 01

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 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)
• if you are allergic to penicillin or any other antibiotic
• if you have experienced jaundice (signs include yellowing
of skin and whites of the eyes) or other liver problems
when taking an antibiotic
Warnings and precautions
Talk to your doctor or pharmacist before taking
Co-Fluampicil if:
• you suffer from kidney or liver disease including jaundice
(the skin and whites of the eyes turn yellow)

• you are being treated for heart failure
• you have a history of allergies, especially to antibiotics.
• 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).
During treatment
Talk to your doctor if you suffer from frequent
diarrhoea during treatment with Co-Fluampicil.
Your doctor may carry out frequent blood tests and
monitor your liver function regularly if you are on
long term treatment (such as for bone infection
(osteomyelitis) or for infection of muscle around the
heart (endocarditis) with this medicine.
Other medicines and Co-Fluampicil
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other

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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
children over 10 years old is the
same as for adults. These capsules
are not suitable for children under
10 years.

PAGE 06

Capsule shell: gelatin,
quinoline yellow (E104),
patent blue (E131), titanium
dioxide (E171) and iron
oxide yellow (E172), iron
oxide red (E172).
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, 500 and
1000 capsules.
Not all pack sizes may be
marketed.
Marketing Authorisation
Holder
Mylan, Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Generics [UK] Limited, Potters
Bar, Hertfordshire, EN6 1TL,
United Kingdom
This leaflet was last revised
in 02/2017.

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• stomach problems such as
diarrhoea, feeling sick (nausea)
and being sick (vomiting).
• increase in certain enzymes in
the blood (seen in a blood test).
• serious skin reactions - a
red, scaly rash with bumps
under the skin and blisters
(exanthematous pustulosis).
Contact a doctor immediately if
you get any of these symptoms.
Reporting of side effects
If you get any side effects talk
to your doctor or pharmacist.
This includes any possible
side effects not listed in
this leaflet. You can also
report side effects directly

PAGE 1 1

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 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 protect
the environment.
6. Contents of the pack and other
information
What Co-Fluampicil contains
The active substances are
ampicillin trihydrate (equivalent
to 250 mg of ampicillin) and
flucloxacillin sodium (equivalent
to 250 mg of flucloxacillin).
This combination of active
substances is also known as
Co-Fluampicil.
The other ingredients are:
Capsule contents: magnesium
stearate,

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medicines, including medicines obtained without a
prescription, especially any of the following:
• allopurinol or probenecid (used to treat gout)
• 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 (such as chloramphenicol,
erythromycin and tetracycline)
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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+ Expand Transcript

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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