Summary of Product Characteristics (SmPC) - Cefalexin 250 mg capsules
1 NAME OF THE MEDICINAL PRODUCT
Cefalexin 250 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Cefalexin monohydrate equivalent to 250 mg Cefalexin
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard
Size 2 grey/orange capsule containing white powder printed CHX 250.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cefalexin is a semisynthetic cephalosporin antibiotic for oral administration.
Cefalexin is indicated in the treatment of the following infections due to susceptible micro-organisms:
Respiratory tract infections
Otitis media
Skin and soft tissue infections
Bone and joint infections
Genito-urinary infections, including acute prostatitis
Dental infections
4.2 Posology and method of administration
Posology
Adults
The adult dosage ranges from 1-4g daily in divided doses; most infections will respond to a dosage of 500mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, the usual dosage is 250mg every 6 hours, or 500mg every 12 hours.
For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cefalexin greater than 4g are required parenteral cephalosporins, in appropriate doses, should be considered.
The elderly and patients with impaired renal function
As for adults. Reduce dosage if renal function is markedly impaired (see section 4.4).
Paediatric population
The usual recommended daily dosage for children is 25-50mg/kg (10- 20mg/lb) 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: 125mg every 8hours.
Children 5 years and over: 250mg 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.
Method of administration
For Oral use
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cefalexin is contraindicated in patients with known allergy to the cephalosporins group of antibiotics.
4.4 Special warnings and precautions for use
Warnings
Before instituting therapy with cefalexin, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cefalexin, cephalosporins, penicillins or other drugs. Cefalexin should be given cautiously to penicillin-sensitive patients, because cross- hypersensitivity, including anaphylaxis, among beta-lactam antibiotics has been clearly documented.
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 usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken.
If an allergic reaction to cefalexin occurs the drug should be discontinued and the patient treated with the appropriate agents.
Precautions
Prolonged use of cefalexin may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
Reports of neurotoxicity have been identified in association with cephalosporin treatment. Symptoms may include encephalopathy, myoclonus and seizures. Elderly patients, patients with severe renal impairment or central nervous system disorders are particularly at risk. Cefalexin should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefalexin in anuric patients is 2.3 to 2.8 hours (compared to 0.6-0.9 hours in normal subjects), dosage adjustments for patients with moderate or severe renal impairment are not usually required. Clinical experience with cefalexin under such conditions is limited; therefore, careful clinical observation and laboratory studies should be made. If cefalexin associated neurotoxicity is suspected, discontinuation of cefalexin should be considered.
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastro-intestinal disease, particularly colitis.
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In 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.
Excipients
Cefalexin capsules contains lactose and therefore should not be used in patients with rare hereditary problems of fructose intolerance, galactose intolerance, galactosaemia or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
As with other beta-lactam drugs, renal excretion of cephalexin is inhibited by probenecid.
In a single study of 12 healthy subjects given single 500 mg doses of cefalexin and metformin, plasma metformin Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin renal clearance decreased by an average of 14%. No side-effects were reported in the 12 healthy subjects in this study. No information is available about the interaction of cefalexin and metformin following multiple dose administration. The clinical significance of this study is unclear, particularly as no cases of “lactic acidosis” have been reported in association with concomitant metformin and cefalexin treatment.
Hypokalaemia has been described in patient taking cytotoxic drugs for leukaemia when they were given gentamicin and cephalexin.
4.6 Fertility, 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.
Breast-feeding
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, since the neonate is presented with the risk of candidiasis and CNS toxicity due to immaturity of the blood-brain barrier. There is a theoretical possibility of later sensitisation.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Gastro-intestinal: The most frequent side-effect has been diarrhoea. It is rarely severe enough to warrant cessation of therapy. Colitis, including rare instances of pseudomembranous colitis, has been reported. Nausea, and vomiting have also occurred.
Hypersensitivity: Allergic reactions such as morbilliform eruptions, pruritus and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness-like reactions (erythema multiforme minor, rashes or other skin manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported
Lymphadenopathy and proteinuria are infrequent, there are no circulating immune complexes and no evidence of sequelae. Occasionally, solitary symptoms may occur, but do not represent a serum sickness-like reaction. Serum sickness-like reactions are apparently due to hypersensitivity and have usually occurred during or following a second (or subsequent) course of therapy with cefalexin. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and usually subside within a few days of cessation of therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome. No serious sequelae have been reported.
There are rare reports of erythema multiforme major (Stevens-Johnson syndrome), toxic epidermal necrolysis, and anaphylaxis. Anaphylaxis may be more common in patients with a history of penicillin allergy. Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, or vasodilatation.
Rarely, hypersensitivity symptoms may persist for several months.
Haematological: Eosinophilia, positive Coombs’ tests and, rarely, thrombocytopenia. Transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance. See ‘Interactions with other Medicaments and other forms of Interaction’.
Hepatic: Transient hepatitis and cholestatic jaundice have been reported rarely, slight elevations in AST, ALT or alkaline phosphatase values.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely. There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy with drugs belonging to the class of cephalosporins. Most cases occurred in patients with renal impairment who received doses that exceeded the recommended dose and resolved following discontinuation of treatment.
Miscellaneous: Genital pruritus, vaginitis and vaginal moniliasis.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms of overdosage may include nausea, vomiting, epigastric distress, diarrhoea and haematuria.
In the event of severe overdosage, general supportive care is recommended including close clinical and laboratory monitoring of haematological, renal and hepatic functions and coagulation status until the patient is stable. Forced diuresis, peritoneal dialysis, haemodialysis, or charcoal haemoperfusion have not been established as beneficial for an overdose of cefalexin. It would be extremely unlikely that one of these procedures would be indicated.
Unless 5 - 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 sequence have been reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, first-generation cephalosporins, ATC Code: J01DB01
In vitro tests demonstrate that cephalosporins are bactericidal because of their inhibition of cell-wall synthesis.
Cefalexin is active against the following organisms in vitro: Beta-haemolytic streptococci
Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains.
Streptococcus pneumoniae
Escherichia coli
Proteus mirabilis
Klebsiella species
Haemophilus influenzae
Branhamella catarrhalis
Most strains of enterococci (Streptococcus faecalis) and a few strains of staphylococci are resistant to cefalexin. It is not active against most strains of Enterobacter species, Morganella morganii and Pr. vulgaris. It has no activity against Pseudomonas or Herellea species or Acinetobacter calcoaeticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics. When tested by in-vitro methods, staphylococci exhibit cross-resistance between cefalexin and methicillin-type antibiotics.
5.2 Pharmacokinetic properties
Absorption
Human pharmacology - cefalexin is acid stable and may be given without regard to meals.
It is rapidly absorbed after oral administration. Following doses of 250 mg, 500 mg and 1g, average peak serum levels of approximately 9, 18 and 32 mg/L respectively were obtained at 1 hour. Measurable levels were present 6 hours after administration.
Cefalexin is almost completely absorbed from the gastro-intestinal tract, and 75-100% is rapidly excreted in active form in the urine. Absorption is slightly reduced if the drug is administered with food.
The half-life is approximately 60 minutes in patients with normal renal function. Haemodialysis and peritoneal dialysis will remove cefalexin from the blood.
Distribution
Peak blood levels are achieved one hour after administration, and therapeutic levels are maintained for 6-8 hours. Approximately 80% of the active drug is excreted in the urine within 6 hours. No accumulation is seen with dosages above the therapeutic maximum of 4 g/day.
The half-life may be increased in neonates due to their renal immaturity, but there is no accumulation when given at up to50 mg/kg/day.
Elimination
Cefalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period peak urine concentrations following the 250 mg,500 mg and 1 g doses were approximately 1000, 2200 and 5000 mg/L respectively.
5.3 Preclinical safety data
The daily oral administration of cefalexin to rats in doses of 250 or 500mg/kg prior to and during pregnancy, or to rats and mice during the period of organogenesis only, had no adverse effect on fertility, foetal viability, foetal weight, or litter size.
Cefalexin showed no enhanced toxicity in weanling and newborn rats as compared with adult animals.
The oral LD50 of cefalexin in rats is 5,000mg/kg.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Magnesium stearate E 572
Capsule shell
Black iron oxide (E172)
Titanium dioxide (E171)
Yellow Iron Oxide (E172)
Red Iron Oxide (E172)
Gelatin
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C.
Keep the container tightly closed (for bottles).
Store in the original package (for blisters).
6.5 Nature and contents of container
Each container consists of a polypropylene tubular container with an open end equipped to accept a polyethylene closure, with a tamper-evident tear strip, or PVC/aluminium blisters, or PVDC coated PVC/ Aluminium blisters (60g/m2 PVDC on 250µm PVC/20µm Al) of an appropriate size to accommodate 7, 14, 20, 21, 28, 30, 50, 56, 60, 100, or 500 capsules. Not all sizes may be marketed.
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
Rudipharm Limited
Unit 6
Salbrook Road Industrial Estate
Salbrook Road
Redhill
Surrey RH1 5GJ, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 49565/0023
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/06/2025
10 DATE OF REVISION OF THE TEXT
01/07/2026