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CO-FLUAMPICIL CAPSULES

Active substance(s): AMPICILLIN TRIHYDRATE / AMPICILLIN TRIHYDRATE COMPACTED / FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM COMPACTED / AMPICILLIN TRIHYDRATE / AMPICILLIN TRIHYDRATE COMPACTED / FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM COMPACTED / AMPICILLIN TRIHYDRATE / AMPICILL

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DRAFT VERSION

250/
250mg

Contains penicillin

28 Capsules

KEEP OUT OF THE
SIGHT AND REACH
OF CHILDREN
Protect from heat,
light and moisture
Product Licence holder:
Crescent Pharma Ltd,
Overton, Hants
RG25 3ED, UK.
PL 20416/0051
M0235TB
POM

PPSL0157/02

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Some side-effects

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reaction
• other effects on the skin such as rashes, red patches,
peeling, swelling or blistering
• severe bloody diarrhoea with fever and abdominal pain.

• swollen lymph nodes
• fever or joint or muscle pains (which may develop
2 days or more after you have started taking this
medicine).
Other possible side effects
• feeling or being sick, diarrhoea
• red or purple discolouration of the skin
• inflammation of blood vessels, often with skin rash
• decrease in potassium or increase in certain enzyme
levels in the blood (seen in blood tests)

• hallucinations
• high doses, par ticularly in infants and the elderly may
cause convulsions or symptoms such as dizziness,
drowsiness, numbness or tingling, eyesight or hearing
disturbances, or coma.

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 CAPSULES
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 label after "EXP". The expiry date refers to
the last day of that month.
Store in the original package. Protect from heat, light and
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.

(as flucloxacillin sodium). The other ingredients are
sodium starch glycolate and magnesium stearate. The
capsule shell contains gelatin and the colours titanium
dioxide (E171), erythrosine (E127), black iron oxide
(E172) and patent blue V (E131).

50, 56, 84, 100, 250, 500 and 1000 capsules. (Not
all pack sizes may be marketed).

Tell your doctor straight away if you notice any of the
following effects:
• serious skin reactions - a red, scaly rash with bumps
under the skin and blisters (exanthematous pustulosis)
• inflammation of the kidney (symptoms include

swollen ankles)
• rarely, inflammation of the liver and a type of jaundice
(symptoms include yellowing of the skin or whites of
the eyes, loss of appetite, pale stools and dark urine).
These effects may be delayed and may not occur
until up to 2 months after you have stopped taking
this medicine
• rarely, changes in blood which can cause unexplained
bleeding, bruising, pale skin, weakness, tiredness
and also problems with blood clotting

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Package leaflet: Information for the patient

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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Co-Fluampicil Capsules are and what they are
used for

2. What you need to know before you take Co-Fluampicil
Capsules
3. How to take Co-Fluampicil Capsules
4. Possible side effects
5. How to store Co-Fluampicil Capsules
6. Contents of the pack and other information
1. WHAT CO-FLUAMPICIL CAPSULES ARE AND
WHAT THEY ARE USED FOR
These capsules contain two active ingredients, ampicillin
(as trihydrate) and flucloxacillin (as flucloxacillin sodium).

Ampicillin and flucloxacillin belong to a group of antibiotics
called penicillins. They are used to kill bacteria which
cause infections in your body.
Co-Fluampicil Capsules are used:• to treat a wide range of bacterial infections. These
include infections of the respiratory tract (e.g. chest
and lungs), ear, nose, throat, skin and soft tissues
• to treat infections and prevent blood poisoning
following surgery
• in patients receiving treatment which affects the body’s

immune system (e.g. following organ or bone marrow
transplant)
• to treat infections associated with difficulties in
childbirth.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CO-FLUAMPICIL CAPSULES
Do not take Co-Fluampicil Capsules if:
• you are allergic to ampicillin, flucloxacillin, any
other penicillin antibiotic or any of the other ingredients
of this medicine (listed in section 6). (An allergic

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(Ampicillin 250 mg & Flucloxacillin 250 mg)
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.
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37mm

Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Co-Fluampicil Capsules contain:
Each Co-Fluampicil capsule contains 250 mg of
ampicillin (as trihydrate) and 250 mg of flucloxacillin

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reaction may be recognised as shortness of breath,
blocked nose, rash, itching, swollen face or lips)
• you have ever had liver problems after taking
flucloxacillin
• you have porphyria.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Co-Fluampicil Capsules if:
• you have liver or kidney problems or heart failure
• you have a history of allergy

• you have glandular fever
• you are suffering from leukaemia or an infection
e.g. syphilis or leptospirosis.
Other medicines and Co-Fluampicil Capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
especially:
• oral contraceptives (as it may not work properly
and you will need to use other means of contraception
e.g. a condom)

• other medicines to treat infections such as
chloramphenicol, erythromycin or tetracycline
• probenecid or allopurinol (used to treat gout)
• methotrexate (a cancer dr ug which can also be used
to treat psoriasis or arthritis).
Pregnancy and breast feeding: 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.

Tests: Additional monitoring of blood, kidney and liver
function is recommended for patients during prolonged
and high dose therapy. If you need to have any blood,
urine or liver function tests, tell the doctor or nurse you
are taking this medicine as it may affect the results.
3. HOW TO TAKE CO-FLUAMPICIL CAPSULES
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

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725mm

PL Holder: Crescent Pharma Limited
Overton, Hants, RG25 3ED

CO-FLUAMPICIL Capsules

37mm

may be delayed and may occur af ter you have stopped
taking your capsules.
If any of the following occur STOP TAKING the
capsules IMMEDIATELY and contact your doctor.
• difficulty breathing, sudden wheezing or shortness of
breath, swelling of the face, tongue, mouth or throat,
itching skin or raised itchy red lumps (hives) which
may also be accompanied by fever, chills, headache,
aching muscles or joints and generally feeling unwell
- these may be signs of an allergy or a severe allergic

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Peel here to open but do not remove

37mm

Each capsule contains
250 mg ampicillin
(as trihydrate) and
250 mg flucloxacillin
(as sodium)

If you stop taking Co-Fluampicil Capsules:
Do not stop taking this medicine until you have finished
the course. If you stop too early your condition may
reoccur or get worse.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Please read the leaflet
provided before use.
For oral use as
directed by the doctor.

Capsules

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Code No.:
TN/DRUGS/TN00002183

Co-Fluampicil
Capsules

Each capsule contains
250 mg ampicillin
(as trihydrate) and
250 mg flucloxacillin
(as sodium)

250/
250mg

Contains penicillin

28 Capsules

110mm

PL20416/0051

Co-Fluampicil

(67)

M0235TB

(74)

BN:
EXP.

Area for placement of
2D/unique
identifier information
PPSL0157/02

POM

What Co-Fluampicil Capsules look like and
contents of the pack:
The capsules are powder blue and black and are
printed with “co-fluam” and “RL”. They are available
in pack sizes containing 9, 10, 14, 15, 20, 21, 28, 30,
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Swallow the capsules with a drink of water, half an hour
to one hour before meals.
The recommended dose is:
Adults including the elderly and children over 10 years:
Take one capsule four times a day.
Children under 10 years: Half the usual adult dose, using
a Co-fluampicil syrup.
For more severe infections your doctor may have
prescribed a higher dose.
Space the doses out as evenly as possible throughout the day.
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Marketing Authorisation Holder and Manufacturer is
Crescent Pharma Limited, Units 3 & 4,
Quidhampton Business Units, Polhampton Lane,
Overton, Hants, RG25 3ED, UK.
This leaflet was last revised in August 2017.
If you would like this leaflet in a different format,
please contact the licence holder at the above address.
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If you take more Co-Fluampicil Capsules than you should:
If you think you have taken too many capsules, contact your
doctor straightaway or go to the nearest hospital casualty
department. Take with you any remaining capsules and the pack
so that the medicine can be identified.
If you forget to take Co-Fluampicil Capsules:
If you forget to take a dose of this medicine, take it as soon as
you remember. However, if it is almost time for the next dose,
skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
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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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