MAGNAPEN

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.

Blood and lymphatic system disorders:

As with other b-lactam antibiotics haematological effects including reversible leucopenia, reversible thrombocytopenia and haemolytic anaemia have been reported rarely. 4-warnings) has been reported rarely. If any hypersensitivity reaction occurs, the treatment should be discontinued.

Late sensitivity reactions may include serum sickness-like reactions (featuring symptoms such as arthralgia, rash, urticaria, fever, angioedema, lymphadenopathy), haemolytic anaemia and acute interstitial nephritis. ) Psychiatric disorders: There is a potential for hallucinations to occur rarely with flucloxacillin.

Nervous System Disorders Coma may develop with high doses of Flucloxacillin.

Respiratory, thoracic and mediastinal disorders:

Bronchospasm may occur as a result of penicillin allergy. There is a potential for acute, severe dyspnoea to occur with flucloxacillin.

Gastrointestinal disorders:

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

Hepatobiliary disorders:

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.

As with most other antibiotics, a moderate transient increase in transaminases has been reported.

Skin and subcutaneous tissue disorders:

Skin rash, puritis and urticaria have been reported. 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.

Erythema nodosum may occur rarely with flucloxacillin. Potential for pemphigoid reactions to occur rarely with flucloxacillin. There is potential for non-thrombocytopenic purpura to occur rarely with flucloxacillin. Vasculitis may occur rarely with flucloxacillin.

Renal and urinary disorders Interstitial nephritis may occur but it is reversible when treatment is discontinued.

Congenital, familial and genetic disorders:

Potential for acute attacks of porphyria to occur with flucloxacillin.

General disorders and administration site conditions:

Some patients with spirochaete infections such as syphilis or leptospirosis may experience a Jarisch-Herxheimer reaction shortly after treatment with a penicillin is started. Symptoms include fever, chills, headache and reaction at the site of lesions.

The reaction can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Before initiating therapy with co-fluampicil careful enquiries should be made concerning previous hypersensitivity reactions to b-lactam antibiotics. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving b-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 b-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. In case of severe and persistent diarrhoea, the possibility of pseudomembranous colitis should be considered; flucloxacillin therapy should be discontinued.

Care is required when treating some patients with spirochaete infections such as syphilis or leptospirosis because the Jarisch-Herxheimer reaction may occur shortly after treatment with a penicillin is started. Caution is advised when flucloxacillin is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis (HAGMA).

Patients at high risk for HAGMA are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used. After co-administration of flucloxacillin and paracetamol, a close monitoring is recommended in order to detect the appearance of acid–base disorders, namely HAGMA, including the search of urinary 5-oxoproline.

5). 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. Care is necessary if very high doses of flucloxacillin are given, especially if renal function is poor, because of the risk of nephrotoxicity and/or neurotoxicity.

Care is also necessary if large doses of sodium (salts) are given to patients with impaired renal function or heart failure. 8). g. osteomyelitis, endocarditis). 9mg magnesium per 5ml. This should be considered for patients with impaired renal function (creatinine clearance of less than 30ml/min).

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

g. penicillins, cephalosporins) or excipients. Co-fluampicil is contraindicated in patients with a history of flucloxacillin- associated jaundice/hepatic dysfunction.