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CO-FLUAMPICIL CAPSULES

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

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CRESCENT PHARMA

DRAFT VERSION

(74)

(67)

PPSL0157/02

Page-1

Page-13

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Some side-effects
may be delayed and may occur after 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)

Page-14

(65)

(67)

(66)

PATIENT INFORMATION LEAFLET

Please read all of this leaflet carefully before you
start taking this medicine.
Keep the leaflet, you may need to read it again.
If you have any questions or are not sure about
anything, 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 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.
IN THIS LEAFLET:
1. What Co-Fluampicil Capsules are and what they are
used for

2. 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. Further 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

Page-2

Page-3

Page-4

Page-5

(Ampicillin 250 mg & Flucloxacillin 250 mg)

(64)

(65)

• 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
• fever or joint or muscle pains (which may develop

- these may be signs of an allergy or a severe
allergic reaction
• other effects on the skin such as rashes, red
patches, peeling, swelling or blistering
• severe bloody diarrhoea with fever and abdominal
pain.
The following other side-effects have been reported:
• feeling or being sick, mild diarrhoea
• inflammation of the kidney (symptoms include
swollen ankles)

Page-15

(62)

CO-FLUAMPICIL Capsules
37mm

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 TWO
DOSES AT THE SAME TIME.

(64)

Page-16

(65)

bone marrow transplant)
• to treat infections associated with difficulties in
childbirth.
2. BEFORE YOU TAKE CO-FLUAMPICIL
CAPSULES
Do not take these capsules if:
• you are allergic to ampicillin, flucloxacillin, any
other penicillin antibiotic or any of the other
ingredients in the capsules which are listed in
Section 6. (An allergic reaction may be recognised

(64)

(65)

as shortness of breath, blocked nose, rash, itching,
swollen face or lips)
• you have ever had liver problems after taking
flucloxacillin
• you have porphyria.
Check with your doctor before taking these
capsules if:
• you have liver or kidney problems
• you have a history of allergy
• you have glandular fever

• you are suffering from leukaemia or any other
serious illness
• you are pregnant or breast feeding
• you are 50 years old or over.
Taking other medicines:
Co-Fluampicil Capsules and other medicines you may
be taking may affect how each other work. Make sure
your doctor or pharmacist knows if you are taking
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, tetracycline,
sulphonamides (e.g.trimethoprim) or cephalosporin
antibiotics (e.g. minocycline, cefotaxime)
• probenecid or allopurinol (used to treat gout)
• methotrexate (a cancer drug which can also be used

Page-7

Page-8

Page-9

Editorial :

Brand Name: CO-FLUAMPICIL CAPSULES
Generic Name:
Ampicillin 250 mg & Flucloxacillin 250 mg
Size: BaseLabel - H-37 x L-110mm
Leaflet H-37 x L-725 mm
Colors:
PANTONE 299 C & BLACK

ERP :
Client:
CRESCENT
Type of Material:
LABEL

Date: 16-07-2015
Item Code: PPSL0157/02
Software: CDR X5
Language: ENGLISH
Packing: 28’s

37mm

Code No.:
TN/DRUGS/TN00002183
BN :
EXP:
Each capsule contains 250 mg
ampicillin (as trihydrate)
and 250 mg flucloxacillin
(as sodium).
Contains penicillin

28 Capsules

Spec.: BaseLabel - 80gsm/Self Adhesive Paper & Leaflet - 90gsm/Art Paper Gumming
Remarks : Leaflet - 10 folding with 20 pages front & back printed

110mm

PL20416/0051
PPSL0157/02

POM

(65)

Keep the capsules in the pack provided. Protect from
heat, light and moisture.
Do not take the capsules if the expiry date on the pack
has passed.
If you have any medicines that are out of date, return
them to your pharmacist for safe disposal.
6. FURTHER INFORMATION
Ingredients:
Each Co-Fluampicil capsule contains 250 mg of

Page-19

(64)

Page-6

(67)

pharmacist or nurse. 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 CAPSULES
KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.

Page-18

725mm

MEDOPHARM

(66)

2 days or more after you have started taking this
medicine)
• dark or discoloured tongue
• high doses, particularly in infants and the elderly
may cause convulsions or symptoms such as
dizziness, drowsiness, numbness or tingling,
eyesight or hearing disturbances.
Reporting of side effects:
If you get any side effects, talk to your doctor,

Page-17

M0192TB

28 Capsules

Product Licence
holder:
Crescent Pharma Ltd,
Overton, Hants
RG25 3ED
PL 20416/0051
M0192TB
POM

For more severe infections your doctor may have
prescribed a higher dose.
Space the doses out as evenly as possible
throughout the day. 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 take too many Co-Fluampicil Capsules:
If you think you have taken too many capsules,

(65)

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

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

(66)

Peel here to open but do not remove

For oral administration
as directed by the
doctor.
Protect from heat,
light and moisture
KEEP OUT OF THE
SIGHT AND REACH
OF CHILDREN

37mm

PROOF FOR APPROVAL - 6th June, 2015
SIZES & TEXT crctd.(ml.17-06-15) - 30th June, 2015
TEXT corrected (ml.15-07-15) - 16th July, 2015

ampicillin (as trihydrate) and 250 mg of flucloxacillin
(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).
What Co-Fluampicil Capsules look like:
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, 50,

Page-20

(66)

to treat psoriasis or arthritis).
Other special warnings
Pregnancy and breast feeding: If you are pregnant or
breast feeding, check with your doctor before taking
this medicine.
Tests: If you need to have any urine or liver function
tests, tell the doctor or nurse you are taking this
medicine as it may affect the results.
Sodium content: Each capsule contains 13 mg of
Page-10

(62)

Page-21

(67)

sodium. This may need to be taken into
consideration in patients on a controlled sodium diet
Driving and using machines: There are no reports of
this medicine affecting your ability to perform skilled
tasks such as driving or operating machinery.
3. HOW TO TAKE CO-FLUAMPICIL CAPSULES
Swallow the capsules with a drink of water, half an
hour to one hour before meals.
Your doctor has decided the dose which is best for you.

Page-11

56, 84, 100, 250, 500 and 1000 capsules. (Not all
pack sizes may be marketed).
Product Licence Holder and Manufacturer is
Crescent Pharma Limited, Units 3 & 4,
Quidhampton Business Units, Polhampton Lane,
Overton, Hants, RG25 3ED.
Date leaflet revised : June 2015.
If you would like this leaflet in a different format,
please contact the licence holder at the above
address.
Page-22

(74)

The pharmacist’s label will tell you how many
capsules to take and how often to take them. If you
are not sure ask your doctor or pharmacist.
The usual doses are as follows:
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.

Page-12

CRESCENT PHARMA

DRAFT VERSION

(74)

(67)

PPSL0157/02

Page-1

Page-13

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Some side-effects
may be delayed and may occur after 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)

Page-14

(65)

(67)

(66)

PATIENT INFORMATION LEAFLET

Please read all of this leaflet carefully before you
start taking this medicine.
Keep the leaflet, you may need to read it again.
If you have any questions or are not sure about
anything, 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 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.
IN THIS LEAFLET:
1. What Co-Fluampicil Capsules are and what they are
used for

2. 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. Further 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

Page-2

Page-3

Page-4

Page-5

(Ampicillin 250 mg & Flucloxacillin 250 mg)

(64)

(65)

• 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
• fever or joint or muscle pains (which may develop

- these may be signs of an allergy or a severe
allergic reaction
• other effects on the skin such as rashes, red
patches, peeling, swelling or blistering
• severe bloody diarrhoea with fever and abdominal
pain.
The following other side-effects have been reported:
• feeling or being sick, mild diarrhoea
• inflammation of the kidney (symptoms include
swollen ankles)

Page-15

(62)

CO-FLUAMPICIL Capsules
37mm

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 TWO
DOSES AT THE SAME TIME.

(64)

Page-16

(65)

bone marrow transplant)
• to treat infections associated with difficulties in
childbirth.
2. BEFORE YOU TAKE CO-FLUAMPICIL
CAPSULES
Do not take these capsules if:
• you are allergic to ampicillin, flucloxacillin, any
other penicillin antibiotic or any of the other
ingredients in the capsules which are listed in
Section 6. (An allergic reaction may be recognised

(64)

(65)

as shortness of breath, blocked nose, rash, itching,
swollen face or lips)
• you have ever had liver problems after taking
flucloxacillin
• you have porphyria.
Check with your doctor before taking these
capsules if:
• you have liver or kidney problems
• you have a history of allergy
• you have glandular fever

• you are suffering from leukaemia or any other
serious illness
• you are pregnant or breast feeding
• you are 50 years old or over.
Taking other medicines:
Co-Fluampicil Capsules and other medicines you may
be taking may affect how each other work. Make sure
your doctor or pharmacist knows if you are taking
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, tetracycline,
sulphonamides (e.g.trimethoprim) or cephalosporin
antibiotics (e.g. minocycline, cefotaxime)
• probenecid or allopurinol (used to treat gout)
• methotrexate (a cancer drug which can also be used

Page-7

Page-8

Page-9

Editorial :

Brand Name: CO-FLUAMPICIL CAPSULES
Generic Name:
Ampicillin 250 mg & Flucloxacillin 250 mg
Size: BaseLabel - H-37 x L-110mm
Leaflet H-37 x L-725 mm
Colors:
PANTONE 299 C & BLACK

ERP :
Client:
CRESCENT
Type of Material:
LABEL

Date: 16-07-2015
Item Code: PPSL0157/02
Software: CDR X5
Language: ENGLISH
Packing: 28’s

37mm

Code No.:
TN/DRUGS/TN00002183
BN :
EXP:
Each capsule contains 250 mg
ampicillin (as trihydrate)
and 250 mg flucloxacillin
(as sodium).
Contains penicillin

28 Capsules

Spec.: BaseLabel - 80gsm/Self Adhesive Paper & Leaflet - 90gsm/Art Paper Gumming
Remarks : Leaflet - 10 folding with 20 pages front & back printed

110mm

PL20416/0051
PPSL0157/02

POM

(65)

Keep the capsules in the pack provided. Protect from
heat, light and moisture.
Do not take the capsules if the expiry date on the pack
has passed.
If you have any medicines that are out of date, return
them to your pharmacist for safe disposal.
6. FURTHER INFORMATION
Ingredients:
Each Co-Fluampicil capsule contains 250 mg of

Page-19

(64)

Page-6

(67)

pharmacist or nurse. 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 CAPSULES
KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.

Page-18

725mm

MEDOPHARM

(66)

2 days or more after you have started taking this
medicine)
• dark or discoloured tongue
• high doses, particularly in infants and the elderly
may cause convulsions or symptoms such as
dizziness, drowsiness, numbness or tingling,
eyesight or hearing disturbances.
Reporting of side effects:
If you get any side effects, talk to your doctor,

Page-17

M0192TB

28 Capsules

Product Licence
holder:
Crescent Pharma Ltd,
Overton, Hants
RG25 3ED
PL 20416/0051
M0192TB
POM

For more severe infections your doctor may have
prescribed a higher dose.
Space the doses out as evenly as possible
throughout the day. 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 take too many Co-Fluampicil Capsules:
If you think you have taken too many capsules,

(65)

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

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

(66)

Peel here to open but do not remove

For oral administration
as directed by the
doctor.
Protect from heat,
light and moisture
KEEP OUT OF THE
SIGHT AND REACH
OF CHILDREN

37mm

PROOF FOR APPROVAL - 6th June, 2015
SIZES & TEXT crctd.(ml.17-06-15) - 30th June, 2015
TEXT corrected (ml.15-07-15) - 16th July, 2015

ampicillin (as trihydrate) and 250 mg of flucloxacillin
(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).
What Co-Fluampicil Capsules look like:
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, 50,

Page-20

(66)

to treat psoriasis or arthritis).
Other special warnings
Pregnancy and breast feeding: If you are pregnant or
breast feeding, check with your doctor before taking
this medicine.
Tests: If you need to have any urine or liver function
tests, tell the doctor or nurse you are taking this
medicine as it may affect the results.
Sodium content: Each capsule contains 13 mg of
Page-10

(62)

Page-21

(67)

sodium. This may need to be taken into
consideration in patients on a controlled sodium diet
Driving and using machines: There are no reports of
this medicine affecting your ability to perform skilled
tasks such as driving or operating machinery.
3. HOW TO TAKE CO-FLUAMPICIL CAPSULES
Swallow the capsules with a drink of water, half an
hour to one hour before meals.
Your doctor has decided the dose which is best for you.

Page-11

56, 84, 100, 250, 500 and 1000 capsules. (Not all
pack sizes may be marketed).
Product Licence Holder and Manufacturer is
Crescent Pharma Limited, Units 3 & 4,
Quidhampton Business Units, Polhampton Lane,
Overton, Hants, RG25 3ED.
Date leaflet revised : June 2015.
If you would like this leaflet in a different format,
please contact the licence holder at the above
address.
Page-22

(74)

The pharmacist’s label will tell you how many
capsules to take and how often to take them. If you
are not sure ask your doctor or pharmacist.
The usual doses are as follows:
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.

Page-12

Expand view ⇕

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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