Co-fluampicil 125mg/125mg/5ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flucloxacillin magnesium; Ampicillin trihydrate

Available from:

Wockhardt UK Ltd

ATC code:

J01CA51

INN (International Name):

Flucloxacillin magnesium; Ampicillin trihydrate

Dosage:

25mg/1ml ; 25mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103; GTIN: 5012727903583

Patient Information leaflet

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
Profile
Size
Min. Point Size
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Proof By
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Date
Artwork No.
Pharma
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Wockhardt UK Limited
Co-fluampicil suspension leaflet
101518/4
n-a
170 x 200mm
matt.pirie-scott
4
17/11/2015
609951
FPO
Process Black
Keyline (non-printing)
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UK
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8.5pt
FPO
PACKAGE LEAFLET INFORMATION FOR THE USER
CO-FLUAMPICIL 125MG/125MG/5ML
POWDER FOR ORAL SUSPENSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
− Keep this leaflet. You may need to read it again.
− If you have further questions, please ask your doctor or nurse.
− This medicine has been prescribed for you personally and you
should
not pass it on to others. It may harm them, even if their symptoms are
the same as yours
The name of your medicine is Co-fluampicil 125mg/125mg/5ml Powder
for Oral Suspension. In the rest of this leaflet it is called
Co-fluampicil
Suspension
In this leaflet:
1. What co-fluampicil Suspension is and what it is used for
2. Before you take Co-fluampicil Suspension
3. How to take Co-fluampicil Suspension
4. Possible side effects
5. How to store Co-fluampicil Suspension
6. Further information
1. WHAT CO-FLUAMPICIL SUSPENSION IS AND WHAT
IT IS USED FOR
Co-fluampicil Suspension contains two active ingredients, ampicillin
and
flucloxacillin which together are known as co-fluampicil.
Co-fluampicil
Suspension is an antibiotic medicine. It belongs to the penicillin
group
of antibiotics and work by killing bacteria that cause infections.
Co-fluampicil Suspension is used to treat a wide range of infections
caused by bacteria. These infe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Magnapen
®
125mg/125mg/5ml Powder for Oral Suspension_ _
or Co-fluampicil 125mg/125mg/5ml Powder for Oral Suspension_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5ml contains 125 mg ampicillin as Ampicillin
Trihydrate BP
with 125 mg flucloxacillin as Flucloxacillin Magnesium BP
(co-fluampicil 125/125).
3
PHARMACEUTICAL FORM
Bottle containing powder for the preparation of l00 ml suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-fluampicil is indicated for the treatment of severe infections
where the causative
organism is unknown, and for mixed infections involving
β
_-_lactamase-producing
staphylococci. Typical indications include:
_In general practice: _Chest infections, ENT infections, skin and soft
tissue infections,
and infections in patients whose underlying pathology places them at
special risk.
_In hospital _(prior to laboratory results being available): severe
respiratory tract
infections, post-operative chest and wound infections, septic
abortion, puerperal
fever; septicaemia, prophylaxis in major surgery, infections in
patients receiving
immuno-suppressive therapy.
The spectrum of activity of co-fluampicil also makes it suitable for
the treatment of
many mixed infections, particularly those where
β
-lactamase-producing staphylococci
are suspected or confirmed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
USUAL ADULT DOSAGE (INCLUDING ELDERLY PATIENTS AND CHILDREN OVER 10
YEARS):
_Oral: _l0 ml syrup four times a day.
USUAL CHILDREN’S DOSAGE:
_Oral: _Under 10 years: 5 m1 syrup four times a day.
The above dosages for adults and children may be doubled where
necessary. Oral
doses should be administered half to one hour before meals.
4.3
CONTRAINDICATIONS
Co-fluampicil contains ampicillin and flucloxacillin which are
penicillins, and should
not be given to patients with a history of hypersensitivity to
β
-lactam antibiotics (e.g.
penicillins, cephalosporins) or excipients.
Co-fluampicil is contraindi