Suprax 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefixime

Available from:

Advanz Pharma

ATC code:

J01DD08

INN (International Name):

Cefixime

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5013011003521

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUPRAX 200MG TABLETS
Cefixime
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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 Suprax is and what it is used for
2. What you need to know before you take Suprax
3. How to take Suprax
4. Possible side effects
5. How to store Suprax
6. Contents of the pack and other information
1. WHAT SUPRAX IS AND WHAT IT IS USED FOR
Suprax 200mg Tablets (called Suprax in this
leaflet) contains a medicine called cefixime.
This belongs to a group of antibiotics called
‘cephalosporins’.
Suprax is used to treat infections caused by
bacteria. These include infections of the:
• Ear
• Nose, sinuses (such as sinusitis)
• Throat (such as tonsillitis, pharyngitis)
• Chest and lungs (such as bronchitis, pneumonia)
• Urinary system (such as cystitis and kidney
infections)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SUPRAX
DO NOT TAKE SUPRAX IF:
You are allergic to cefixime, any other
cephalosporin antibiotics including penicillin
or to any of the other ingredients of this
medicine (listed in section 6).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of the lips, face, throat and tongue.
Do not take this medicine if the above applies
to you. If you are not sure, talk to your doctor or
pharmacist before taking Suprax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Suprax if:
You have ever had colitis
You have kidney problems
If you a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Suprax Tablets 200mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg cefixime (anhydrous).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Convex, off-white, film-coated tablets engraved with ‘ORO’ on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Suprax is an orally active cephalosporin antibiotic which has marked
_in vitro_
bactericidal activity against a wide variety of Gram-positive and
Gram-negative
organisms.
It is indicated for the treatment of the following acute infections
when caused by
susceptible micro-organisms:
UPPER RESPIRATORY TRACT INFECTIONS (URTI): e.g. otitis media; and
other URTI
where the causative organism is known or suspected to be resistant to
other
commonly used antibiotics, or where treatment failure may carry
significant risk.
LOWER RESPIRATORY TRACT INFECTION: e.g. bronchitis.
URINARY TRACT INFECTIONS: e.g. cystitis, cystourethritis,
uncomplicated pyelonephritis.
Clinical efficacy has been demonstrated in infections caused by
commonly occuring
pathogens including _Streptococcus pneumoniae, Streptococcus pyogenes,
Escherichia _
_coli, Proteus mirabilis, Kliebsiella_ species, _Haemophilus
influenzae_ (beta-lactamase
positive and negative), _Branhamella catarrhalis_ (beta-lactamase
positive and
negative) and _Enterobacter_ species. Suprax is highly stable in the
presence of beta-
lactamase enzymes.
Most strains of enterococci (_Streptococcus faecalis_, group D
Streptococci) and
Staphylococci (including coagulase positive and negative strains and
meticillin-
resistant strains) are resistant to Suprax. In addition, most strains
of _Pseudomonas, _
_Bacteriodes fragalis, Listeria monocytogenes_ and _Clostridia_ are
resistant to Suprax.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual course of treatment is 7 days. This may be continued for up
to 14 days if
required.
Posology
Adults and Children over 10 years or weighing more than 50 kg:
The recommended dose i