Flucloxacillin 125mg/5ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flucloxacillin sodium

Available from:

DE Pharmaceuticals

ATC code:

J01CF05

INN (International Name):

Flucloxacillin sodium

Dosage:

25mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010102

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What your medicine is and what it is used for
2.
What you need to know before you take your medicine
3.
How to take your medicine
4.
Possible side effects
5.
How to store your medicine
6.
Contents of the pack and other information
1.
WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Flucloxacillin sodium belongs to a class of antibiotics called
“penicillinaseresistant penicillins” and is used to treat
bacterial
infections including:
•
SKIN AND SOFT TISSUE infections
•
Boils, abscesses, carbuncles (A painful localized bacterial
infection of the skin and subcutaneous tissue that usually
has several openings through which pus is discharged)
•
Cellulitis (inflammation of tissue below the skin)
•
Infected wounds, infected burns
•
Protection for skin grafts
•
Infected skin condition e.g. ulcer, eczema and acne
•
Furunculosis,(A skin condition characterized by the
development of recurring boils)
•
Impetigo( a contagious skin disease, esp. of children,
usually caused by streptococcal bacteria, marked by a
superficial pustular eruption, particularly on the face)
•
RESPIRATORY TRACT infections
•
Pneumonia (inflammation of the lungs with congestion), lung
abscess, empyema (a collection of pus in a body cavity,
especially in the lung cavity)
•
Sinusitis ( inflammation of a sinus or the sinuses)
•
Pharyngitis (inflammation of the mucous membrane of the
pharynx; sore throat)
•
Tonsillitis (inflammation of the tonsils).
•
Otitis media (inflammation of the middle ear)
•
Otitis Externa (In

Summary of Product characteristics

OBJECT 1
FLUCLOXACILLIN 125MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 29-Apr-2019 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
•
4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Flucloxacillin 125mg/5ml Powder For Oral Solution
2. Qualitative and quantitative composition
Each 5ml dose contains Flucloxacillin Sodium equivalent to
Flucloxacillin 125mg.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Powder for oral solution.
Pink free flowing powder.
4. Clinical particulars
4.1 Therapeutic indications
Flucloxacillin Sodium 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 infections_:
Boils, Cellulitis, Infected burns, Abscesses, Infected skin
conditions, e.g. ulcer, eczema, and acne,
Protection for skin grafts, Carbuncles, Furunculosis, Infected wounds
and Impetigo
_Respiratory tract infections_:
Pneumo