FLUCLOXACILLIN 125MG/5ML ORAL SOLUTION

Active substance: FLUCLOXACILLIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
Flucloxacillin OS
P150

Flucloxacillin OS
P150

Date : 17.11.12 / Version : 03

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flucloxacillin 125mg/5ml Oral solution
(flucloxacillin sodium)
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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Flucloxacillin oral solution is and what it is used for
2. Before you take Flucloxacillin oral solution
3. How to take Flucloxacillin oral solution
4. Possible side effects
5. How to store Flucloxacillin oral solution
6. Further information
1.

WHAT FLUCLOXACILLIN ORAL SOLUTION 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
o
Boils, abscesses, carbuncles ( A painful localized bacterial infection of the
skin and subcutaneous tissue that usually has several openings through
which pus is discharged)
o
Cellulitis (inflammation of tissue below the skin)
o
Infected wounds, infected burns
ofor skin grafts
Protection
o condition E.g.ulcer, eczema and acne
Infected skin
o
Furunculosis,( A skin condition characterized by the development of
recurring boils)
o contagious skin disease, esp. of children, usually caused by
Impetigo( a
streptococcal bacteria, marked by a superficial pustular eruption,
particularly on the face)
· tract infections
Respiratory
o (inflammation of the lungs with congestion), lung abscess,
Pneumonia
empyema (a collection of pus in a body cavity, especially in the lung cavity)
oinflammation of a sinus or the sinuses)
Sinusitis (
o (inflammation of the mucous membrane of the pharynx; sore
Pharyngitis
throat)
o
Tonsillitis (inflammation of the tonsils).
o (inflammation of the middle ear)
Otitis media

Black

o
Otitis Externa (Inflammation of the external auditory canal)
o
Quinsy (tonsillar abscess)
·
Other infections
o
Osteomyelitis (affecting the bone and bone marrow)
o
Enteritis (affecting the intestinal tract, especially the small intestine)
o (inflammation of the lining of the heart and its valves),
Endocarditic
o infections
Urinary tract
o(a serious disease characterised by inflammation of the
Meningitis
membranes around the brain or spinal cord)
o (blood poisoning).
Septicaemia
Flucloxacillin oral solution can also be used to prevent infections during major
surgery, particularly heart or orthopaedic surgery.
2.

BEFORE YOU TAKE FLUCLOXACILLIN ORAL SOLUTION

Do not take Flucloxacillin oral solution if you:
·
Are allergic (hypersensitive) to penicillins/flucloxacillin sodium or any of the
other ingredients in the product (see Section 6 and end of Section 2).
·
Have previous history of liver problems from taking flucloxacillin.
Take special care with Flucloxacillin oral solution
Speak to your doctor if you have:
· 50 years old
age over
·
any serious illness other than infection
· kidney function
Impaired
·
Liver problems
Taking other medicines
Please inform your doctor if you are taking or have recently taken any other
medicines, including those obtained without a prescription, particularly
probenecid (used in the treatment of gout) and Oral contraceptives (You will
need to use extra contraceptive precautions such as a condom)
Taking Flucloxacillin oral solution with food and drink
The solution should be taken half to one hour before meals.
Pregnancy and breast-feeding
Flucloxacillin oral solution should only be used by pregnant women if
considered essential by the doctor. Flucloxacillin passes into breast milk, so ask
your doctor for advice before taking any medicine.
Driving and using machines
Flucloxacillin oral solution is not expected to affect your ability to drive or
operate machinery.
Important information about some of the ingredients of Flucloxacillin oral
solution
· Each 5ml spoonful of solution contains approximately 10.72mg
Sodiumof sodium, this is particularly important if you are on a reduced salt diet.
· – if you know you have an intolerance to some sugars, contact
Sucrose
your doctor before use.
· benzoate (E211) - may increase the risk of jaundice in newborn
Sodium
babies

3.

HOW TO TAKE FLUCLOXACILLIN ORAL SOLUTION

Always take Flucloxacillin oral solution exactly as your doctor has told you. The
pharmacist's label should tell you how much to take and how often.
For oral use only.
Take Flucloxacillin oral solution half to one hour BEFORE meals
Adults and children over 10 years: 10ml four times a day
Children 2-10 years: 5ml four times a day.
Children under 2 years: 2.5ml four times a day.
Severe kidney disease: your doctor may reduce the dose.
Make sure you complete your prescribed course; do not stop taking
Flucloxacillin oral solution if you feel better.
If you take more Flucloxacillin oral solution than you should
Contact your doctor or nearest hospital casualty department if you or a child
have swallowed too much medicine. Take this leaflet and any remaining solution
with you, if possible.
Symptoms of overdose include nausea, vomiting, diarrhoea
If you forget to take Flucloxacillin oral solution
If you miss a dose, take the solution as soon as you remember and carry on as
before. If it is almost time for your next dose, skip the forgotten dose and
continue as usual.
If you still feel unwell after finishing the treatment or have further any questions
on use of products, ask your doctor.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Flucloxacillin oral solution can cause side effects, although
not everybody gets them.
You may suffer an allergic reaction, symptoms of which include rash,
itching, difficulty in breathing or swelling of the face, lips, throat or
tongue. If this happens to you, stop taking the solution immediately and
seek medical help.
The following have also been reported:
VERY RARE SIDE EFFECTS: (occurs in lesst than 1 in 10,000 users)
·
Blood abnormalities i.e. neutropenia and thrombocytopenia Haemolytic
anaemia
·
Anaphylactic Shock (severe allergic reaction)
·
Angioneurotic Oedema (rapid swelling)
·
Pseudomembranous colitis (type of inflammation of the colon)
· (inflammation of the liver) and cholestatic jaundice (yellowing of
Hepatitis
the skin and whites of the eyes)
· in liver function tests
Changes
· multiforme (a red rash caused by hypersensitivity to a drug or
Erythema
disease or other allergen),
·
Stevens-Johnson syndrome (severe inflammatory eruption of the skin) and
toxic epidermal necroylsis (skin that resembles burns)
· (pain in a joint) and myalgia (pain in the muscles).
Arthralgia

· nephritis (Nephritis in which the interstitial connective tissue is
Interstitial
chiefly affected)
·
Fever
COMMON SIDE EFFECTS: (occurs in less than 1 in 10 users)
·
Minor gastrointestinal disturbances E.g.: Diarrhoea nausea and Vomiting
UNCOMMON SIDE EFFECTS: (occurs less than 1 in 1000 users)
·
Rash
· (itchy skin eruption)
Urticaria
· (brownish-red spots on the skin)
Purpura
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
5.

HOW TO STORE FLUCLOXACILLIN ORAL SOLUTION

Keep out of the reach and sight of children.
Unopened bottle: Do not store above 25°C. Store in the original container and
keep tightly closed. Do not use after the expiry date is stated on the label.
Reconstituted solution: Store at 2 - 8°C and use within 7 days.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6.

FURTHER INFORMATION

What Flucloxacillin oral solution contains
The active substance is flucloxacillin sodium, 125mg in a 5ml spoonful.
The other ingredients are sodium benzoate (E211), disodium edetate,
saccharin sodium, mono-ammonium-glycyrrhizinate, sodium citrate anhydrous
(E331), flavour pineapple, flavour menthol, erythrosine (E127), sucrose (see
Section 2 'Important information about some of the ingredients of Flucloxacillin
oral solution').
What Flucloxacillin oral solution looks like and contents of the pack
The solution is a pinkish colour free flowing granular powder which on
reconstitution becomes clear red colour solution supplied in a 150ml bottle.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom
APL Swift Services (Malta) Ltd.,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia BBG 3000, Malta
This leaflet was last revised in 11/2012.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)