Cefalexin 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:

Cefalexin

Available from:

DE Pharmaceuticals

ATC code:

J01DB01

INN (International Name):

Cefalexin

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201

Patient Information leaflet

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFALEXIN CAPSULES 250 MG
CEFALEXIN CAPSULES 500 MG
(cefalexin monohydrate)
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 Cefalexin Capsules are and what they are used for
2. Before you take Cefalexin Capsules
3. How to take Cefalexin Capsules
4. Possible side effects
5. How to store Cefalexin Capsules
6. Further information
1. WHAT CEFALEXIN CAPSULES ARE AND WHAT THEY ARE
USED FOR
Cefalexin Capsules contain cefalexin as the active ingredient, which
belongs to a class of antibiotics called ‘cephalosporins’. The
capsules
are used to treat a variety of bacterial infections. These include
infections of the airways from nose to lungs, ear, bones and joints,
and urine or reproduction systems, incuding inflammation of the
prostate gland. They are also used to treat dental infections.
2. BEFORE YOU TAKE CEFALEXIN CAPSULES
DO NOT TAKE CEFALEXIN CAPSULES IF YOU HAVE:
•
an allergy (hypersensitivity) to the cephalosporin or penicillin
group of antibiotics, or to any of the ingredients in the product
_(see Section 6)._
•
porphyria; a hereditary metabolic disorder.
TAKE SPECIAL CARE WITH CEFALEXIN CAPSULES IF YOU HAVE:
•
kidney problems.
•
inflammation of the large intestine, symptoms include:
diarrhoea, pain and fever.
You should be aware that Cefalexin Capsules may give a false result
for:
•
certain blood tests
•
tests for glucose in the urine.
TAKING OTHER MEDICINES
Please inform your doctor if you are taking or have recently taken
any other medicines, including those obtained without a
prescription.
In particular, tell your doctor i
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cefalexin 250 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains Cefalexin (Monohydrate) equivalent
to 250 mg of
Cefalexin.
_Excipient with known effect: _Lactose anhydrous 20.06 mg/capsule
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule Hard.
White to off white powder filled in dark green cap and dark green body
of size ‘2’
hard gelatin capsule printed “CEP” on cap and “250” on body
with black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefalexin is indicated in the treatment of the following infections
due to susceptible
micro-organisms (see also section 4.4 and 5.1):
Skin and soft tissue infections
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cefalexin is administered orally.
Adults: For skin and soft tissue infections, the usual dosage is 250mg
every 6 hours or
500 mg every 12 hours.
The elderly and patients with impaired renal function: As for adults.
Reduce dosage if
renal function is markedly impaired (see section 4.4).
Children > 5 years to 12 years and adolescents.
250mg every 8 hours
In severe infections, the dosage may be doubled.
This medicine is not recommended for the use in the children under 5
years of age.
4.3
CONTRAINDICATIONS
Cefalexin is contra-indicated in patients with known allergy to the
cephalosporin
group of antibiotics.
Cefalexin is contraindicated in patients with previous immediate and
severe
hypersensitivity reactions to penicillin or any other type of
beta-lactam drug
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Special caution is required to determine any other type of previous
hypersensitivity _
_reactions to penicillin or to other beta-lactam-medicinal products
because of _
_potential cross-allergy._
In case of severe acute hypersensitivity reactions (e.g. anaphylaxis)
treatment with
cefalexin capsules 250 mg must be discontinued
                                
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