Cefalexin 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cefalexin

Available from:

Arrow Generics Ltd

ATC code:

J01DB01

INN (International Name):

Cefalexin

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5060034830238 5060034833161

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,
pharmacist or dentist (if the medicine has been
prescribed by your dentist).
•
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, pharmacist or dentist (if the medicine has been
prescribed by your dentist).
IN THIS LEAFLET:
1. WHAT CEFALEXIN TABLETS ARE AND WHAT THEY
ARE USED FOR
2. BEFORE YOU TAKE CEFALEXIN TABLETS
3. HOW TO TAKE CEFALEXIN TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CEFALEXIN TABLETS
6. FURTHER INFORMATION
1
. WHAT CEFALEXIN TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Cefalexin Tablets.
This medicine belongs to a family of medicines called
antibiotics. Antibiotics are used to kill the bacteria or
“germs” which cause infections.
Your doctor, or dentist, will have prescribed this
medicine for treating an infection. Cefalexin Tablets are
used for treating a variety of infections including chest
(respiratory tract), urinary tract, skin and soft tissues, ear,
and other infections.
2. BEFORE YOU TAKE CEFALEXIN TABLETS
DO NOT TAKE THIS MEDICINE BEFORE TELLING YOUR DOCTOR IF:
•
You are allergic to cefalexin or other antibiotics and
medicines.
•
You are allergic to any of the other ingredients in this
medicine.
TAKE SPECIAL CARE WITH CEFALEXIN TABLETS:
•
You are pregnant or breast-feeding. Your doctor will
decide whether it is safe for you to take this medicine
while you are pregnant or breast-feeding.
•
You have problems with your kidneys.
•
You test your urine for glucose using a method which
is not based on glucose oxidation reactions as this
medicine might give a false positive result.
•
You are taking oral contraceptives. Cefalexin may
reduce the efficacy of or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefalexin tablets 500mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Cefalexin BP equivalent to 500 mg anhydrous
cefalexin.
Excipient with known effect:
Each tablet contains 135 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Oblong, biconvex, white to yellowish. Scored on both sides. Odour -
slightly
peppermint to characteristic of the active ingredient.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Tenkorex/Cefalexin 500mg tablets is indicated for the treatment of
respiratory tract
infections (RTI's), urinary tract infections (UTI's), skin and soft
tissue infections, otitis
media and other infections due to sensitive organisms
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The dosage is 1-4 g daily in divided doses. Most infections will
respond to 500 mg
every 8 hours. For skin and soft tissue infections, streptococcal
pharyngitis and mild
uncomplicated UTI's, the usual dosage is 250 mg every 6 hours or 500
mg every 12
hours. For more severe infections or those caused by less susceptible
organisms,
larger doses may be needed.
_Older people _
The dosage is as for adults. The dosage should be reduced if renal
function is
markedly impaired.
_Paediatric population and adolescents _
The usual recommended daily dosage for children is 25-50 mg/kg in
divided doses.
For skin and soft tissue infections, streptococcal pharyngitis and
mild, uncomplicated
urinary tract infections, the total daily dose may be divided and
administered every 12
hours. For most infections the following schedule is suggested:
children under 5 years:
125 mg every 8 hours
children 5 years and over:
250 mg every 8 hours
In severe infections the dosage may be doubled. In the therapy of
otitis media,
clinical studies have shown that a dosage of 75-100mg/kg/day in 4
divided doses is
required. In the treatment of beta-haemolytic streptococcal
infections, a therapeutic
dose should be administe