Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Cefalexin 125mg/5ml Oral Suspension
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Cefalexin monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR Cefalexin Oral Suspension contain cefalexin as the active ingredient, which belongs to a class of antibiotics called 'cephalosporins'. Cefalexin Oral Suspension is used to treat following infections caused by bacteria that can be killed by cefalexin:
- Respiratory tract (lung and airways) e.g. tonsillitis, pharyngitis and bronchitis
- Middle ear infections (otitis media)
- Skin and soft tissue (e.g. muscle) infections
- Bone and joint infections
- Infections of the reproductive organs and urinary tract (e.g. cystitis), including acute inflammation of the prostate gland (prostatitis)
- Dental infections.
What you need to know before you take it
E CEFALEXIN ORAL SUSPENSION Do not take Cefalexin:
- If you are allergic to cefalexin, other cephalosporins (similar antibiotics) or any of the other ingredients of this medicine (listed in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. Tell your doctor before taking Cefalexin: If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterial. Warnings and precautions Talk to your doctor or pharmacist before taking Cefalexin Oral Suspension if you:
- Have had allergic reaction to cefalexin, cephalosporins, penicillins or other drugs in the past
- develop severe or prolonged diarrhoea during or after taking cefalexin
- Have a severe kidney disorder (you may need reduced dose)
- have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials. Tell your doctor if you are having blood and urine tests. Cefalexin Oral Suspension may interfere with these tests. Acute generalised exanthematous (AGEP) has been reported with the use of cefalexin. AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localised on the skin folds, trunk, and upper extremities. The highest risk of occurence of this serious skin skin reaction is within the first week of treatment. If you develop a serious skin
Black Version: 09 Date & Time: 22.03.2024 & 12.50 PM Submission Code: N13171
Cefalexin OS P15XXXX
Pharmacode position may change as per Supplier's m/c requirement & additional small pharma code may appear on the front / back panel
rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately. Other medicines and Cefalexin Oral Suspension Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines you buy without a prescription. This is especially important of the following, as they may interact with your Cefalexin Oral Suspension:
- Any other antibiotics (e.g. gentamicin, tobramycin, cefuroxime)
- Potent diuretics e.g. furosemide (water tablets used to treat high blood pressure or water retention)
- Probenecid (a treatment for gout)
- Metformin (a treatment for diabetes)
- Drugs used to treat leukaemia. It may still be all right for you to be given Cefalexin Oral Suspension and your doctor will be able to decide what is suitable for you. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Cefalexin Oral Suspension should not affect your ability to drive or use machines. Cefalexin contains sodium: This medicine contains 6.50mg sodium (main component of cooking/table salt) in each 5ml of suspension. This is equivalent to 0.33% of the recommended maximum daily dietary intake of sodium for an adult. Cefalexin contains Sorbitol: Cefalexin 125mg/5ml Powder for Oral Suspension This medicine contains 847.240 mg sorbitol in each 5ml of suspension. Cefalexin 250mg/5ml Powder for Oral Suspension This medicine contains 888.490 mg sorbitol in each 5ml of suspension. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Cefalexin contains sodium benzoate: This medicine contains 4.82 mg sodium benzoate in each 5 ml cefalexin oral suspension. Sodium Benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
How to take it
CEFALEXIN ORAL SUSPENSION Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your pharmacist should make up the suspension before you are given it. The bottle is turned upside down and tapped to loosen the powder. Cefalexin 125mg/5mL oral solution: The suspension is prepared by adding 89mL of potable water and shaken until powder is dissolved. Cefalexin 250mg/5mL oral solution: The suspension is prepared by adding 87mL of potable water and shaken until powder is dissolved. The reconstituted solution may be further diluted with sorbitol solution BP, syrup BP or purified water if required. The suspension should be shaken well before use. Dosage Adults and the elderly The recommended total daily dose is 1- 4 g orally, in divided doses.
- Most infections can be treated by 500 mg every 8 hours. For skin and soft tissue infections, sore throat (streptococcal pharyngitis), and mild, uncomplicated urinary tract infections, the usual dose is 250 mg every 6 hours, or 500mg every 12 hours.
- For more severe infections, larger doses may be needed. A reduced dose is needed for patients with severe kidney disorders.
Use in children The recommended total daily dose for children is 25-50 mg/kg (body weight) in divided doses.
- For skin and soft tissue infections, sore throat, 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 dose may be doubled. In the treatment of middle ear infections, a total daily dose of 75 to 100mg/kg in 4 doses is required. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
If you forget to take Cefalexin Oral Suspension If you miss a dose, take the suspension as soon as you remember. If it is almost time to take the next dose, wait until then and then carry on as before. Do not take a double dose to make up for the forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). Serious side effects The following side effects are serious. You should stop taking this medicine and contact your doctor immediately if you experience them:
- serious peeling or blistering of the skin
- severe diarrhoea
- A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). See also section 2. The following side effects have been reported
- Diarrhoea
- Feeling sick (nausea)
- Vomiting
- Indigestion
- Stomach pains
- Measles-like rash, (alone)
- Itching
- Red wheals on the skin (urticaria) (alone)
- Rash with wide spread joint pain and/ or stiffness, swollen lymph glands, fever and, possibly, cloudy urine
- Changes in blood counts, which may show up as bruising or a very tired feeling. You will need a blood test to confirm this
- Damage to your liver or kidneys which can be detected by a blood and/ or urine test
- Jaundice (yellow skin and eyes)
- Weakness
- Fainting
- Abnormally excitable behaviour
- Agitation
- Tiredness
- Headache
- Confusion
- Dizziness
By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
CEFALEXIN ORAL SUSPENSION Keep this medicine out of the sight and reach of children. Dry powder: Store below 25°C, tightly closed in the container. Made-up suspension: Store at 2 – 8°C. Discard any unused medicine after 14 days. Do not use Cefalexin Oral Suspension after the expiry date stated on the pack. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Cefalexin Oral Suspension contains The active substance is cefalexin monohydrate, 125mg or 250mg in a 5ml spoonful. The other ingredients are sodium benzoate (E211). Disodium edetate, citric acid, sodium citrate, sorbitol powder, saccharin sodium, colloidal silicon dioxide, monoammonium glycerrhizinate, and xanthan gum. The 125mg/5ml suspension contains colour E127 (erythrosine) and strawberry flavour. The 250mg/5ml suspension contains colour 104 (quinoline yellow) and orange flavour. What Cefalexin Oral Solution looks like and contents of the pack 125mg/5ml powder – pale pink, free flowing granular powder, which readily mixes in water to give a pink suspension with a flavour of strawberry. 250mg/5ml powder – pale yellow, free flowing granular powder, which readily mixes in water to give a yellow suspension with a flavour of orange. Both suspensions are supplied in plastic bottles of 100ml. Marketing Authorisation Holder Milpharm Limited Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom. Manufacturers: Milpharm Limited Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom. APL Swift Services (Malta) Ltd., Hf26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000. This leaflet was last revised in 03/2024.
N13171
If you take more Cefalexin Oral Suspension than you should Contact your doctor or nearest hospital casualty department if you or a child have swallowed too much medicine. Take this leaflet and any remaining suspension with you, if possible. Symptoms of overdose include nausea, vomiting, stomach upset, appearance of blood in the urine.
Seeing or hearing things (hallucinations) Encephalopathy (non-inflammatory brain disease) Convulsions Myoclonus (muscle-twitching) Itching of the vagina or anus caused by thrush (candidiasis).
Frequently asked questions about Cefalexin 125mg/5ml Oral Suspension
How do I take Cefalexin 125mg/5ml Oral Suspension?
Cefalexin 125mg/5ml Oral Suspension comes as oral solution containing 125mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Cefalexin 125mg/5ml Oral Suspension?
The active substance in Cefalexin 125mg/5ml Oral Suspension is cefalexin monohydrate.
Are there equivalent medicines to Cefalexin 125mg/5ml Oral Suspension?
Medicines with the same active substance, strength and form include: Cefalexin 125mg / 5ml Suspension. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Cefalexin 125mg/5ml Oral Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Cefalexin 125mg/5ml Oral Suspension without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: cefalexin monohydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Cefalexin is a semi synthetic 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 tract infections, including acute prostatitis
Dental infections
4.2. Posology and method of administration
Posology
Adults
The adult dosage ranges from 1-4 g daily in divided doses; most infections will respond to a dosage of 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis and mild, uncomplicated urinary tract infections, 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. If daily doses of cefalexin greater than 4g are required, parenteral cephalosporins, in appropriate doses, should be considered.
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 25-50 mg/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 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 75-100 mg/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
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Cefalexin is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Before instituting therapy with cefalexin, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins or other drugs. Cefalexin should be given cautiously to penicillin-sensitive patients. There is some clinical and laboratory evidence of partial cross-allergenicity of 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 an allergic reaction to cefalexin occurs the drug should be discontinued and the patient treated with the appropriate agents.
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.
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. Careful clinical and laboratory studies should be made because safe dosage may be lower than that usually recommended. If dialysis is required for renal failure, the daily dose of cefalexin should not exceed 500mg. If cefalexin associated neurotoxicity is suspected, discontinuation of cefalexin should be considered.
Concurrent administration with certain other drug substances, such as aminoglycosides, other cephalosporins, or furosemide (frusemide) and similar potent diuretics, may increase the risk of nephrotoxicity.
Positive direct Coombs' tests have been reported during treatment with 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 new-borns 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.
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with cefalexin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered. Most of these reactions occurred most likely in the first week during treatment.
Cefalexin contains sorbitol:
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Cefalexin contains sodium:
This medicinal product contains 6.50mg sodium per 5ml, equivalent to 0.33% of the WHO recommended maximum daily intake of 2g sodium for an adult.
Cefalexin contains sodium benzoate:
This medicine contains 4.82 mg sodium benzoate in each 5 ml cefalexin oral suspension.
Sodium Benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
4.5. Interaction with other medicinal products and other forms of interaction
As with other beta-lactam drugs, renal excretion of cefalexin is inhibited by probenecid.
In a single study of 12 healthy subjects given single 500mg 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.
Breastfeeding
The excretion of cefalexin in human breast milk increased up to 4 hours following a 500 mg 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 relevant.
4.8. Undesirable effects
Gastro-intestinal: Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. The most frequent side-effect has been diarrhoea. It was very rarely severe enough to warrant cessation of therapy. Dyspepsia and abdominal pain have also occurred. As with some penicillins and some other cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely.
Hypersensitivity: Allergic reactions have been observed in the form of rash, urticaria, angioedema, and rarely erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. These reactions usually subside upon discontinuation of the drug, although in some cases supportive therapy may be necessary. Anaphylaxis has also been reported.
Haemic and Lymphatic System: Eosinophilia, neutropenia, thrombocytopenia, haemolytic anaemia have been reported.
Skin and subcutaneous tissue disorders:
Not known – Acute generalised exanthematous pustulosis (AGEP) has been reported with unknown frequency.
Other: These have included genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis and joint disorder . Reversible interstitial nephritis has been reported.rarely.. Slight elevations of AST and ALT have been observed. 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.
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 sequelae have been reported.
💬 Ask about this leaflet
Ask anything about Cefalexin 125mg/5ml Oral Suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.