Flucloxacillin 500mg capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Flucloxacillin sodium

Commercializzato da:

Arrow Generics Ltd

Codice ATC:

J01CF05

INN (Nome Internazionale):

Flucloxacillin sodium

Dosaggio:

500mg

Forma farmaceutica:

Oral capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05010102; GTIN: 5060034830795

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCLOXACILLIN CAPSULES BP
250 MG AND 500 MG
Flucloxacillin as Flucloxacillin Sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
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 have any further questions, please ask your doctor or
pharmacist
•
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 Flucloxacillin Capsule is and what it is used for
2. What you need to know before you take Flucloxacillin Capsules
3. How to take Flucloxacillin Capsules
4. Possible side effects
5. How to store Flucloxacillin Capsules
6. Contents of the pack and other information
1.
WHAT FLUCLOXACILLIN CAPSULES ARE AND WHAT THEY ARE USED FOR
These capsules are available in two different strengths containing
either 250mg or
500mg of the active ingredient, flucloxacillin (as flucloxacillin
sodium).
Flucloxacillin is one of a group of antibiotics called
penicillinase-resistant penicillins.
It is used to kill bacteria which cause infections in your body.
Flucloxacillin Capsules are used to treat a wide range of bacterial
infections which
may include those affecting the chest and lungs, the pharynx, tonsils,
sinuses and ears.
They are also used to treat skin and soft tissue infections such as
boils, carbuncles,
skin ulcers, abscesses, eczema, acne, infected wounds and burns, and
also for skin-
graft protection. They are also used to treat infections affecting the
intestines, heart
(i.e. endocarditis), membranes of the brain (i.e. meningitis), blood,
bones, joints and
urinary tract (kidney, bladder, urethra).
Flucloxacillin can also be used to prevent an infection occurring
during major
surgery, particularly in heart or orthopaedic s

Scheda tecnica

OBJECT 1
FLUCLOXACILLIN 500MG CAPSULES
Summary of Product Characteristics Updated 16-Sep-2019 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Flucloxacillin 500mg Capsules BP
2. Qualitative and quantitative composition
Flucloxacillin Sodium equivalent to 500mg Flucloxacillin per Capsule
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Capsules
Hard gelatin size '0' capsules with Caramel body and Black cap printed
with 'FLU500 MIL' and filled with
white to almost white granular powder.
4. Clinical particulars
Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of
antibiotics which exerts a bactericidal effect
upon many Gram-positive organisms including
β-lactamase-producing staphylococci and streptococci.
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 i