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 P-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 P-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 P-lactam antibiotics (e.g. penicillins, cephalosporins) or excipients.

Co-fluampicil is contraindicated in patients with a history of flucloxacillin-associated jaundice/hepatic dysfunction.

4.4 Special warnings and precautions for use

Before initiating therapy with co-fluampicil careful enquiries should be made concerning previous hypersensitivity reactions to P -lactam antibiotics.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving P-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to P-lactam antibiotics.

Co-fluampicil contains ampicillin and should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

Co-fluampicil should be used with caution in patients with evidence of hepatic dysfunction (see Section 4.8).

Special caution is essential in the newborn because of the risk of hyperbilirubinemia. Studies have shown that, at high dose following parenteral administration, flucloxacillin can displace bilirubin from plasma protein binding sites, and may therefore predispose to kernicterus in a jaundiced baby. In addition, special caution is essential in the newborn because of the potential for high serum levels of flucloxacillin due to a reduced rate of renal excretion.

During prolonged treatments (e.g. osteomyelitis, endocarditis), regular monitoring of hepatic and renal functions is recommended.

Prolonged use may occasionally result in the selection of resistant strains of organisms.

Magnesium Content: Co-fluampicil Syrup contains 6.9 mg magnesium per 5 m1. This should be considered for patients with impaired renal function (creatinine clearance of less than 30 ml /min).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Bacteriostatic drugs may interfere with the bactericidal action of ampicillin and flucloxacillin.

In common with other oral broad-spectrum antibiotics, co-fluampicil may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Probenecid decreases the renal tubular secretion of co-fluampicil. Concurrent use with co-fluampicil may result in increased and prolonged blood levels of both ampicillin and flucloxacillin.

Concurrent administration of all allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.

Co-fluampicil contains ampicillin. It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used because false positive readings are common with chemical methods due to the high urinary concentrations of ampicillin.

4.6 Pregnancy and lactation

Pregnancy: Animal studies with co-fluampicil have shown no teratogenic effects. The product has been in clinical use since 1971 and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effects. The decision to administer any drug during pregnancy should be taken with the utmost care. Therefore co-fluampicil should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Lactation: Trace quantities of ampicillin and flucloxacillin can be detected in breast milk. The possibility of hypersensitivity reactions must be considered in breast-fed infants. Therefore co-fluampicil should only be administered to a breast-feeding mother when the potential benefit outweigh the potential risks associated with treatment.

4.7 Effects on ability to drive and use machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable effects

Hypersensitivity reactions:

If any hypersensitivity reaction occurs, the treatment should be discontinued.

Skin rash, puritis and urticaria have been reported occasionally. The incidence of rash is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura, fever, eosinophilia and sometimes angioneurotic oedema have also been reported. Rarely, skin reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Reactions such as fever, arthralgia and myalgia can develop more than 48 hours after the start of the treatment.

Anaphylaxis (see Item 4.4 -Warnings) has been reported rarely.

Gastrointestinal reactions:

Minor gastrointestinal disturbances, including occasionally nausea, vomiting and diarrhoea may occur during treatment. Pseudomembranous colitis has been reported rarely.

Hepatic effects:

Hepatitis and cholestatic jaundice have been reported rarely. These may be delayed for up to two months after withdrawal of treatment. In some cases the course of these conditions has been protracted and lasted for several months. Very rarely deaths have been reported from hepatic effects but are mostly limited to patients with serious underlying disease.

A moderate transient increase in transaminases has been reported.

Renal effects:

Interstitial nephritis may occur but it is reversible when treatment is discontinued.

Haematological effects:

As with other p-lactam antibiotics, haematological effects including reversible leucopenia, reversible thrombocytopenia and haemolytic anaemia have been reported rarely

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Co-fluampicil contains flucloxacillin. Haemodialysis does not lower the serum levels of flucloxacillin.

Co-fluampicil contains ampicillin, which may be removed from the circulation by haemodialysis.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Infections encountered in medical practice can involve mixed strains of bacteria and may include P-lactamase-producing strains. Co-fluampicil provides broad spectrum activity.

5.2 Pharmacokinetic properties

Both ampicillin and flucloxacillin have been shown to attain therapeutic serum levels following oral administration of co-fluampicil and the serum levels achieved are comparable with those which could be expected as a result of administering each antibiotic separately

5.3 Preclinical safety data

Not relevant

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Disodium Edetate Blood Orange Dry Flavour Menthol Dry Flavour Monoammonium Glycyrrhizinate Sodium Benzoate (E211)

Carmellose Sodium Dried Sodium Citrate, Anhydrous Saccharin Sodium, Dried Sucrose.

6.2 Incompatibilities

None known

Shelf life

Powder: Three years

Once dispensed, Co-fluampicil Syrup remains stable for 14 days.

6.4    Special precautions for storage

Co-fluampicil Syrup powder should be stored in a dry place at, or below 25°C. Once dispensed Co-fluampicil Syrup should be stored at 2-8°C.

6.5    Nature and contents of container

Clear glass Winchester bottles fitted with 28 mm Flavor-Lok caps. Original pack of 100ml with Patient Information Leaflet.

6.6 Special precautions for disposal

If dilution of the reconstituted suspension is required, Syrup BP should be used.

7    MARKETING AUTHORISATION HOLDER

Wookhardt UK Limited Ash Road North Wrexham Industrial estate Wrexham LL13 9UF United Kingdom

MARKETING AUTHORISATION NUMBER(S)

PL 29831/0053

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/06/2007

DATE OF REVISION OF THE TEXT

03/10/2012