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

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Flucloxacillin magnesium; Ampicillin trihydrate

MAH:

A A H Pharmaceuticals Ltd

ATC_code:

J01CA51

INN:

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

leaflet_short:

BNF: 05010103

PIL

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 infections may affect the chest, ear, nose, throat, skin and
soft tissues.
In hospital this medicine may also be used to prevent and treat
infections:

which occur after surgery

in patients receiving treatment which affects the immune system

of the blood (septicaemia)

associated with difficulties in childbirth (septic abortion (abortion
complicated by fever,
often leading to sepsis) and puerperal fever (an infection of the
membrane of the uterus
following childbirth or abortion).
2.
BEFORE YOU TAKE CO-FLUAMPICIL SUSPENSION
Do not take Co-fluampicil Suspension if you:

know that you are allergic to penicillin, cephalosporins, any other
antibiotic or any of the
ingredients contained in Co-fluampicil Suspension (see ‘What
Co

SPC

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