Flucloxacillin 500mg capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Stiahnuť Príbalový leták (PIL)
28-05-2021

Aktívna zložka:

Flucloxacillin sodium

Dostupné z:

Kent Pharma (UK) Ltd

ATC kód:

J01CF05

INN (Medzinárodný Name):

Flucloxacillin sodium

Dávkovanie:

500mg

Forma lieku:

Oral capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 05010102; GTIN: 5015201008521 5015201001126 5015201008514

Príbalový leták

                                CP.FLU.JNT.C.V12P1
P217/20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUCLOXACILLIN 250MG CAPSULES
FLUCLOXACILLIN 500MG CAPSULES
Flucloxacillin
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. • 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 WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Flucloxacillin is an antibiotic used to treat
infections by killing the bacteria that can cause
them. It belongs to a group of antibiotics called
“penicillins”.
Flucloxacillin is used to treat:
• chest infections
• throat or nose infections
• ear infections
• skin and soft tissue infections
• heart infections
• bone and joint infections
• meningitis
• digestive system infections
• blood infections
• kidney, bladder or urethra (the tube which
carries urine from the bladder) infections.
Flucloxacillin can also be used to prevent
infections during major surgery, particularly heart
or orthopaedic surgery. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YOUR MEDICINE
DO NOT TAKE THIS MEDICINE IF:
• You are allergic to flucloxacillin or any other
penicillin antibiotics (see symptoms in section
4).
• You are allergic to any of the other ingredients
of this medicine (listed in section 6).
• You have suffered previously from liver
problems (e.g. jaundice) after taking
flucloxacillin.
• You have had an allergic reacti
                                
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Súhrn charakteristických

                                OBJECT 1
Flucloxacillin 500mg Capsules
Summary of Product Characteristics Updated 29-Oct-2021 | Kent Pharma
UK 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 Fertility, 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
Flucloxin 500mg Capsules
2. Qualitative and quantitative composition
Each capsule contains 500 mg of flucloxacillin as flucloxacillin
sodium Ph. Eur.
Excipients with known effect:
Each capsule has a sodium content of 52.3 mg per gram.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules
4. Clinical particulars
4.1 Therapeutic indications
Treatment of infections due to sensitive Gram-positive organisms,
including infections caused by β-
lactamase-producing Staphylococci and Streptococci.
Typical indications include:
Skin and soft tissue infections:
Boils
Impetigo
Abscesses
Infected wounds
Carbuncles
Infected burns
Furunculosis
Protection for skin grafts
Cellulitis
Infected skin conditions e.g. ulcers, eczema and acne.
Respiratory tract infections:
Pneum
                                
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