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Gerard Laboratories

Unit 35/36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13, Ireland
Telephone: +353 1 839 3788
Fax: +353 1 8390040
Medical Information Direct Line:
Medical Information e-mail: sales@gerard-laboratories.ie


Summary of Product Characteristics last updated on medicines.ie: 18/07/2013
SPC Geriflox Capsules 250 mg & 500 mg



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1. NAME OF THE MEDICINAL PRODUCT

Geriflox 250mg Capsules, Hard

Geriflox 500mg Capsules, Hard


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

250mg Capsules:

Each capsule contains Flucloxacillin Sodium equivalent to 250 mg of Flucloxacillin.

Excipients: Each capsule contains approximately 13mg sodium.

500mg Capsules:

Each capsule contains Flucloxacillin Sodium equivalent to 500 mg of Flucloxacillin.

Excipients: Each capsule contains approximately 26mg of sodium.

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

250mg Capsules:

Capsule, hard

Grey and brown, size 2, hard gelatin capsules marked with a 'G' and 'FN 250' in black, containing a white to off-white powder.

500mg Capsules:

Capsule, hard

Grey and brown, size 0E, hard gelatin capsules marked with a 'G' and 'FN 500' in black, containing a white to off white powder.


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4. CLINICAL PARTICULARS

Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of antibiotics which exerts a bactericidal effect upon many Gram-positive organism including β-lactamase-producing staphylococci and streptococci.


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4.1 Therapeutic indications

Geriflox is indicated for the treatment of infections due to sensitive Gram-positive organisms, including β-lactamase-producing staphylococci and streptococci.

Typical indications include:

Skin and soft tissue infection:

Boils, cellulitis, infected burns, abscesses, infected skin conditions (e.g. ulcer, eczema and acne), protection for skin grafts, carbuncles, furunculosis, infected wounds, impetigo

Respiratory tract infections:

Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media and externa, tonsillitis, quinsy

Other infections caused by Flucloxacillin-sensitive organisms:

Osteomyelitis, urinary tract infection, enteritis, meningitis, endocarditis, septicaemia

Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery

Parenteral usage is indicated where oral dosage is inappropriate.


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4.2 Posology and method of administration

Oral administration.

The dosage depends on age, weight, renal function and the severity and nature of the infection.

Adults and Children over 12 years

The usual dose is 250mg four times daily.

Osteomyelitis, endocarditis – up to 8g daily, in divided doses six to eight hourly.

Surgical prophylaxis – 1-2g IV at induction of anaesthesia followed by 500mg six hourly IV, IM or orally for up to 72 hours

Children aged 2-10 years

2-10 years: half adult dose

Under 2 years: quarter adult dose.

Children under 10 years of ages should preferably be treated with Geriflox Elixir Powder for Oral Solution. Geriflox Capsule is not recommended.

Abnormal renal function: In common with other penicillins, Flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance < 10ml/min) a reduction in dose or an extension of dose interval should be considered. Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosage need to be administered either during, or at the end of the dialysis period.


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4.3 Contraindications

Flucloxacillin should not be given to patients with history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins) or excipients.

Flucloxacillin is contra-indicated in patients with previous history of flucloxacillin-associated jaundice/hepatic dysfunction.


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4.4 Special warnings and precautions for use

Before initiating therapy with Flucloxacillin, carefully enquiry should be made concerning previous hypersensitivity reactions to β-lactams.

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

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction, patient ≥ 50 years and those with serious underlying disease. In these patients, hepatic events may be severe, and in very rare circumstances, deaths have been reported see section 4.8)

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

Prolonged use of an anti-infective agent may result in the development of superinfection due to organisms resistant to that anti-infective.

This medicinal product contains 13mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.


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4.5 Interaction with other medicinal products and other forms of interaction

Concurrent administration of probenecid slows down the renal excretion of flucloxacillin.

In common with other antibiotics, flucloxacillin may affect the gut flora, leading to lower oestrogen reabsorption and reduces efficacy of combined oral contraceptives.


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4.6 Fertility, pregnancy and lactation

Pregnancy:

The product should not be used during pregnancy unless considered essential by the physician. Flucloxacillin should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment

Lactation:

The product is excreted in breast milk, presenting risk of candidiasis and also of central nervous system toxicity due to prematurity of the blood brain barrier. Flucloxacillin should only be administered to a breast-feeding mother when the potential benefits outweigh the potential risks associated with the treatment.


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4.7 Effects on ability to drive and use machines

None known


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4.8 Undesirable effects

The following convention has been utilised for the classification of undesirable effects: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000).

Unless otherwise stated, the frequency of the adverse events has been derived from more than 30 years of post-marketing reports

Blood and lymphatic systems disorders

Very rare: Neutropenia (including agranulocytosis) and thrombocytopenia. These are reversible when treatment is discontinued. Haemolytic anaemia.

Immune system disorders

Very rare: Anaphylactic shock (exceptional with oral administration (see Section 4.4 Special warnings and special precautions for use), angioneurotic oedema.

If any hypersensitivity reaction occurs, the treatment should be discontinued, (See also Skin and subcutaneous tissue disorders).

Gastrointestinal disorders

*Common: Minor gastrointestinal disturbances.

Very Rare: Pseudomembranous colitis

If pseudomembranous colitis develops, flucloxacillin treatment should be discontinued and appropriate therapy, e.g. oral vancomycin should be initiated.

Hepato-biliary disorders

Very Rare: Hepatitis and cholestatic jaundice. (See section 4.4 Special Warnings and Special Precautions for Use). Changes in liver function laboratory test results (reversible when treatment is discontinued).

These reactions are related neither to the dose nor to the route of administration. The onset of these effects may be delayed for up to two months post-treatment; in several cases the course of the reactions has been protracted and lasted for some months. Hepatic events may be severe and in very rare circumstances a fatal outcome has been reported. Most reports of deaths have been in patients ≥ 50 years and in patients with serious underlying disease.

Skin and subcutaneous tissue disorders

*Uncommon: Rash, urticaria and purpura.

Very Rare: Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necroylsis

(See also immune system disorders).

Musculoskeletal and connective tissue disorders

Very Rare: Arthralgia and myalgia sometimes develop more than 48 hours after the start of the treatment.

Renal and urinary disorders

Very Rare: Interstitial nephtitis.

This is reversible when treatment is discontinued.

General disorders and administration site conditions

Very Rare: Fever sometimes develops more than 48 hours after the start of the treatment.

*The incidence of these AEs was derived from clinical studies involving a total of approximately 929 adults and paediatric patients taking flucloxacillin


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4.9 Overdose

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

Flucloxacillin is not removed from the circulation by haemodialysis.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

ATC classification: J01CF 05

Pharmacotherapeutic group: Beta-lactamase resistant pencillins

Properties: Flucloxacillin is a narrow-spectrum antibiotic of the group of isoxazolyl penicillins; it is not inactivated by staphylococcal β-lactamases.

Activity: Flucloxacillin, by its action on the synthesis of the bacterial wall, exerts a bactericidal effect on streptococci except those of group D (Enterococcus faecalis) staphylococci. It is not active against methicillin-resistant staphylococci.


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5.2 Pharmacokinetic properties

Absorption: Flucloxacillin is stable in acid media and can therefore be administered either by the oral or parenteral route. The peak serum levels of flucloxacillin reached after one hour are as follows.

- After 250mg by the oral route (in fasting subjects): Approximately 8.8 mg/l.

- After 500mg by the oral route (in fasting subjects): Approximately 14.5mg/l.

- After 500mg by the IM route: Approximately 16.5mg/l.

The total quantity absorbed by the oral route represents approximately 79% of the quantity administered.

Distribution: Flucloxacillin diffuses well into most tissue. Specifically, active concentrations of flucloxacillin have been recovered in bones: 11.6mg/l (compact bone) and 15.6 mg/l (spongy done), with a mean serum level of 8.9mg/l.

Crossing the meningeal barrier: Flucloxacillin diffuses in only small proportion into the cerebrospinal fluid of subjects whose menings are not inflamed.

Crossing into mother's milk: Flucloxacillin is excreted in small quantities in mother's milk.

Metabolism: In normal subjects approximately 10% of the flucloxacillin administered in metabolised to penicilloic acid. The elimination half-life of flucloxacillin is in order of 53 minutes.

Excretion: Excretion occurs mainly through the kidney. Between 65.5% (oral route) and 76.1% (parenteral route) of the urine within 8 hours. A small portion of the dose administered is excreted in the bile. The excretion of flucloxacillin is slowed in cases of renal failure.

Protein Binding: The serum protein-binding rate is 95 %.


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5.3 Preclinical safety data

There is no additional data of relevance to the prescriber


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Capsule contents:

Magnesium stearate.

The capsule shell contains:

Body:

Gelatin

Black iron oxide (E172)

Yellow iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Cap:

Gelatin

Black iron oxide (E172)

Titanium dioxide (E171)

Printing ink contains:

Shellac

Iron Oxide Black (E172)

N-Butyl Alcohol

Propylene Glycol

Isopropyl Alcohol

Ammonium Hydroxide


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6.2 Incompatibilities

Not applicable


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6.3 Shelf life

3 years in securitainers

2 years in blister packs


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6.4 Special precautions for storage

Do not store above 25°C

Blisters: Store in the blister packaging as provided.

Securitainers: Keep the lid tightly closed.


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6.5 Nature and contents of container

Polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) of 15, 100, 250, 500 or 1000 capsules.

PVC/Aluminium foil blister packs of 15, 100, 250, 500 or 1000 capsules.

Not all pack sizes may be marketed


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6.6 Special precautions for disposal and other handling

No special requirements

Any unused product should be disposed of in accordance with local requirements.


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7. MARKETING AUTHORISATION HOLDER

Generics (UK) Limited

12 Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PA 405/10/1

PA 405/10/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 25th July 1988.

Date of last renewal: 25th July 2008


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10. DATE OF REVISION OF THE TEXT

July 2013



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Active Ingredients

 
   Flucloxacillin Sodium