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TENKOREX CAPSULES 500 MG

Active substance(s): CEFALEXIN ANHYDROUS

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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT
Tenkorex Capsules 500mg/Cefalexin 500mg Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains Cefalexin equivalent to 500 mg anhydrous cefalexin.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Capsules, hard.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Cefalexin 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

Tenkorex capsules 500 mg/Cefalexin 500mg capsules are for oral use. Each capsule should
be swallowed whole with water.
DOSAGE
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 dosages may be needed.
Older people

The dosage is as for adults. The dosage should be reduced if renal function is markedly
impaired.
Use in children 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:
children 5 years and over:

125 mg every 8 hours
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
administered for at least 10 days.
4.3

Contraindications
Cefalexin is contra-indicated in patients with known allergy to the cephalosporin
group of antibiotics.
Severe systemic infections, which require parenteral cephalosporin treatment, should
not be treated orally during the acute stage.

4.4

Special warnings and precautions for use
Cefalexin should be given cautiously to patients who have shown hypersensitivity to
other drugs. Cephalosporins should be given with caution to penicillin-sensitive
patients, as there is some evidence of partial cross-allergenicity between the
penicillins and cephalosporins. Patients have had severe reactions (including
anaphylaxis) to both drugs.
Pseudomembranous colitis has been reported with virtually all broad-spectrum
antibiotics, including macrolides, semisynthetic penicillins and cephalosporins. It is
important, therefore, to consider its diagnosis in patients who develop diarrhoea in
association with the use of antibiotics. Such colitis may range in severity from mild
to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug
discontinuance alone. In moderate to severe cases, appropriate measures should be
taken.
If the patient experiences an allergic reaction cefalexin should be discontinued and
treatment with the appropriate agents initiated.

Prolonged use of cefalexin may result in the overgrowth of non-susceptible
organisms. Careful observation of the patient is essential. If superinfection occurs
during therapy, appropriate measures should be taken.
Cefalexin should be administered with caution in the presence of markedly impaired
renal function as it is excreted mainly by the kidneys. Careful clinical and laboratory
studies should be made because the safe dosage may be lower than that usually
recommended.
Positive direct Coombs' tests have been reported during treatment with cephalosporin
antibiotics. For haematological studies, or in transfusion cross-matching procedures
when antiglobulin tests are performed on the minor side, or in Coombs' testing of
newborns whose mothers have received cephalosporin antibiotics before parturition, it
should be recognised that a positive Coombs' test may be due to the drug.
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's
solutions or with copper sulphate test tablets. Tests based on glucose oxidation reactions may
be safely used.
4.5

Interaction with other medicinal products and other forms of interaction
As cephalosporins like cefalexin are only active against proliferating microorganisms,
they should not be combined with bacteriostatic antibiotics.
Concomitant use of uricosuric drugs (e.g. probenicid) suppresses renal drug
elimination. As a result, cefalexin plasma levels are increased and sustained for longer
periods.
If associated with highly potent diuretics (ethacrynic acid, furosemide) or other
potentially nephrotoxic antibiotics (aminoglycosides, polymyxin, colistin),
cephalosprins may show higher nephrotoxicity.
Combined use of cephalosporins and oral anticoagulants may prolong prothrombin
time.
A potential interaction between cefalexin and metformin may result in an
accumulation of metformin and could result in fatal lactic acidosis.
Hypokalaemia has been described in patient taking cytotoxic drugs for leukaemia
when they were given gentamicin and cefalexin.

4.6

Pregnancy and lactation
Pregnancy
Although laboratory and clinical studies have shown no evidence of teratogenicity,
caution should be exercised when prescribing for the pregnant patient.
Breastfeedings: The excretion of cefalexin in human breast milk increased up to 4
hours following a 500mg dose. The drug reached a maximum level of 4

micrograms/ml, then decreased gradually and had disappeared 8 hours after
administration. Caution should be exercised when cefalexin is administered to a
nursing woman.

4.7

Effects on ability to drive and use machines
There are no effects on ability to drive or to operate machinery.

4.8

Undesirable effects
Side effects of cefalexin include gastro-intestinal disturbances such as nausea,
vomiting, diarrhoea and abdominal discomfort. The most common of these effects is
diarrhoea, but this is rarely severe enough to warrant cessation of therapy. Dyspepsia
has also occurred. Transient hepatitis and cholestatic jaundice have rarely been
reported.
Allergic reactions have been reported such as rash, urticaria, angioedema and rarely
erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
(exanthematic necrolysis). These reactions usually subsided upon discontinuation of
the drug, although in some cases supportive therapy may be necessary. Anaphylaxis
has also been reported.
Other side effects such as genital and anal pruritus, genital candidiasis, vaginitis and
vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations,
arthralgia, arthritis and joint disorders have been reported.
As with other cephalosporins interstitial nephritis has rarely been reported.
Eosinophilia, neutropenia, thrombocytopenia, haemolytic anaemia and slight
elevations in AST and ALT have been reported.
As with other broad-spectrum antibiotics prolonged use may result in the overgrowth
of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis.
There is a possibility of development of pseudomembranous colitis and it is therefore
important to consider its diagnosis in patients who develop diarrhoea while taking
cefalexin. It may range in severity from mild to life threatening with mild case
usually responding to cessation of therapy. Appropriate measures should be taken
with moderate to severe cases.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product, Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms of oral overdose may include nausea, vomiting, epigastric distress,
diarrhoea and haematuria. General management consists of close clinical and
laboratory monitoring of haematological, renal and hepatic functions and coagulation
status until the patient is stable.
Serum levels of Cefalexin can be considerably reduced by haemodialysis or peritoneal
dialysis.
Unless 5 to 10 times the normal total daily dose has been ingested, gastro-intestinal
decontamination should not be necessary.
There have been reports of haematuria without impairment of renal function in
children accidentally ingesting more than 3.5g of cefalexin in a day. Treatment has
been supportive (fluids) and no sequelae have been reported.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Cefalexin is an oral broad-spectrum antibiotic belonging to the group known as
cephalosporins. In adequate concentrations it is bactericidal for sensitive proliferating
microorganisms by inhibiting the biosynthesis of the cell wall. It is active against the
following pathogens:
Gram Positive
Staphylococci (coagulase positive as well as penicillinase-producing strains),
Streptococci, pneumococci, Corynebacterium diphtheriae, Baccillus anthracis,
Clostridia, Listeria monocytogenes, Bacillus subtilis and Bacteroides
melaninogenicus.
Gram Negative
Escherichia coli, Salmonellae, Shigellae, Neisseria, Proteus mirabilis, Haemophilus
influenzae (some strains), Brucellae, Klebsiella species, Treponema pallidum and
actinomycetes.

5.2

Pharmacokinetic properties
Cefalexin is almost completely absorbed from the gastrointestinal tract and produces
peak plasma concentrations about 1 hour after administration.

A dose of 500 mg produces a peak plasma concentration of about 18 μg per ml;
doubling the dose doubles the peak concentration. Cefalexin readily diffuses into
tissues, including bone, joints and the pericardial as well as pleural cavities. Only 1015 % of the dose is bound to plasma proteins. Elimination is mainly renal with 80%
of the dose, recovered from the urine, therapeutically active, in the first 6 hours.
Cefalexin does not enter cerebrospinal fluid in significant quantities. Cefalexin
crosses the placenta and small quantities are found in the milk of nursing mothers.
Therapeutically effective concentrations may be found in the bile and some may be
excreted by this route.
The half-life has been reported to range from 0.5 to 2 hours and this increases with
reduced renal function.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Capsule contents
Magnesium stearate
Cellulose microcrystalline (E460)
Capsule shell
Gelatine
Erythrosine (E127)
Quinoline yellow (E104)
Titanium dioxide (E171)
Black iron oxide (E172)
Printing ink
Shellac (E904)
Black iron oxide (E172)
Propylene Glycol (E1520)

6.2

Incompatibilities

There are no known incompatibilities.

6.3

Shelf life

The shelf life for Tenkorex capsules 500 mg/Cefalexin 500mg capsules is 24 months.

6.4.

Special precautions for storage

The following applies to the storage of Tenkorex capsules 500 mg/Cefalexin 500mg capsules:
- Do not store above 25°C.
- Store in the original packaging (blister pack presentations only).
- Keep the container tightly closed (securitainer presentations only).

6.5.

Nature and contents of container

Containers of Tenkorex capsules 500 mg/Cefalexin 500mg capsules are polypropylene with
lids (Securitainers) or blister packs with duplex foil consisting of aluminium hard foil
backing and PVC/PVDC blisters.
Each Securitainer contains 12, 15, 20, 21, 24, 28, 50, 100, 250 or 500 capsules.
Each blister pack with duplex foil contains 14, 15, 20, 21, 28, 30 or 56 capsules.
6.6

Special precautions for disposal

Handling
There are no particular handling procedures.
Administration
Tenkorex capsules 500 mg/Cefalexin 500mg capsules are to be administered as given under
method of administration (Section 4.2).

7

MARKETING AUTHORISATION HOLDER
Sandoz GmbH
Biochemiesrasse 10
6250 Kundl/Austria

8

MARKETING AUTHORISATION NUMBER(S)
PL 04520/0004

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27 Feb, 1996

10

DATE OF REVISION OF THE TEXT
23/08/2016

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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.

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