- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6. Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Ospexin tablets 500mg/Tenkorex tablets 500mg/Cefalexin tablets 500mg/Kiflone tablets 500mg
2. Qualitative and quantitative composition
Each tablet contains Cefalexin BP equivalent to 500 mg anhydrous cefalexin.For excipients, see 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
Ospexin/Tenkorex/Cefalexin/Kiflone tablets 500 mg 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
Ospexin/Tenkorex/Cefalexin/Kiflone tablets 500 mg are for oral use. Each tablet should be swallowed whole with water.
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.
AdultsThe 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.
ElderlyThe dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.
ChildrenThe 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|
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. If the patient experiences an allergic reaction cefalexin should be discontinued and treatment with the appropriate agents initiated.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.Cefalexin may reduce the effects of oral contraceptives.A potential interaction between cefalexin and metformin may result in an accumulation of metformin and could result in fatal lactic acidosis.
4.6. Pregnancy and lactation
Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient. Small quantities are found in the milk of nursing mothers.
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. 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).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 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.
Symptoms of oral overdose 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 Ospexin/Tenkorex/Cefalexin/Kiflone can be reduced by haemodialysis or peritoneal dialysis.
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 PositiveStaphylococci (coagulase positive as well as penicillinase-producing strains), Streptococci, pneumococci, Corynebacterium diphtheriae, Baccillus anthracis, Clostridia, Listeria monocytogenes, Bacillus subtilis and Bacteroides melaninogenicus.
Gram NegativeEscherichia 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 10-15% 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
6. Pharmaceutical particulars
6.1 List of excipients
CoreMagnesium stearatePovidone (E1201)Sodium starch glycollateMacrogol 6000 LactoseSaccharin sodium (E954)Peppermint oilTalc (E553b)
CoatTitanium dioxide (E171)Hypromellose (E464)
There are no known incompatibilities.
6.3 Shelf life
The shelf life of Ospexin tablets 500mg/Tenkorex tablets 500mg/Cefalexin tablets 500 mg/Kiflone tablets 500 mg is 48 months.
6.4 Special precautions for storage
The following applies to the storage of Ospexin tablets 500mg/Tenkorex tablets 500mg/Cefalexin tablets 500mg/Kiflone tablets;- 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 Ospexin tablets 500 mg/Tenkorex tablets 500 mg/Cefalexin tablets 500 mg/Kiflone tablets 500 mg are polypropylene containers with lids (Securitainers) or blister packs with duplex foil consisting of aluminium hard foil backing and PVC/PVDC blisters.Each securitainer contains 12 or 15 or 20 or 21 or 24 or 28 or 50 or 100 or 250 or 500 tablets.Each blister pack with duplex foil contains 14 or 15 or 20 or 21 or 28 or 30 or 56 tablets.
6.6 Special precautions for disposal and other handling
HandlingThere are no particular handling procedures.
AdministrationOspexin tablet 500 mg/Tenkorex tablets 500 mg/Cefalexin tablets 500 mg/Kiflone tablets 500 mg are to be administered as given under method of administration (Section 4.2).
7. Marketing authorisation holder
Sandoz GmbHBiochemiestrasse 10A-6250 KundlAustria.
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
25th April 1996
10. Date of revision of the text
200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
+44 (0) 1276 698324
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