Cefalexin 125 mg/5 ml/250 mg Suspension

CEFALEXIN SUSPENSION AURO contain a medicine called Cephalexin. This belongs to a group of antibacterial medicine. CEFALEXIN SUSPENSION AURO is used to treat Respiratory tract infections (any infectious disease of the upper or lower), Otitis media (inflammation of the ear), Skin and soft tissue infections (microbial invasion of the layers of the skin and underlying soft tissues), Genito-urinary tract infections (infection in any part of your urinary system, which includes your kidneys, bladder, ureters, and urethra) and Dental infections (Mouth infections).

Do not take CEFALEXIN SUSPENSION AURO:

• If you are allergic or sensitive to CEFALEXIN SUSPENSION AURO or any of the ingredients of CEFALEXIN SUSPENSION AURO
• If you are allergic to a group of antibiotics called cephalosporins
• If you are pregnant or breastfeeding

Tell your doctor or healthcare professional before taking CEFALEXIN SUSPENSION AURO:

• If you are a penicillin-sensitive patient (an allergy or sensitive to the antibiotic used to treat or prevent various infections).
• If you have impaired renal function (when your kidneys are not working as well as they should), a dosage reduction may be necessary. Especially in Elderly patient’s, who are more likely to have decreased renal function, care should be taken in dose selection.
• If you observe any diarrhoea while taking CEFALEXIN SUSPENSION AURO. Stop treatment immediately and discuss with your doctor.
• If you have kidney function condition. False high values of creatinine concentrations may be produced.
• If you are taking medication to treat a condition whereby blood is taking too long to form a clot. Use of taking CEFALEXIN SUSPENSION AURO may affect the clotting time further. This may also be seen in patients with reduced kidney or liver function.

Other medicines and CEFALEXIN SUSPENSION AURO

Always tell your healthcare professional if you are taking any other medicine. (This includes all complementary or traditional medicines.) CEFALEXIN SUSPENSION AURO may have an effect on other medicines or other medicines may have an effect on CEFALEXIN SUSPENSION AURO

• Combination of CEFALEXIN SUSPENSION AURO and medicines such as aminoglycosides (antibiotics used to treat severe infections of the abdomen and urinary tract) may cause further damage to the kidneys.
• Taking of probenecid with cephalexin is not recommended. The release of CEFALEXIN SUSPENSION AURO from kidney is prevented.
• Taking CEFALEXIN SUSPENSION AURO with metformin may require a dose adjustment of metformin.
• There may be antagonism between CEFALEXIN SUSPENSION AURO and bacteriostatic anti-bacterials.
• CEFALEXIN SUSPENSION AURO may decrease the effectiveness of oestrogen containing contraceptives.

Taking CEFALEXIN SUSPENSION AURO with food and drink:

CEFALEXIN SUSPENSION AURO can be taken before or after meals.

Do not share medicines prescribed for you with any other person. Always take CEFALEXIN SUSPENSION AURO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with CEFALEXIN SUSPENSION AURO will last. If you have the impression that the effect of CEFALEXIN SUSPENSION AURO is too strong or too weak, talk to your doctor or pharmacist.

Adult dose: The adult dosage ranges from 1-4 g daily in divided doses. The usual adult dosage is 250 mg every 6 hours. For skin and soft tissue infections: usual dosage is 250 mg every 6 hours, or 500 mg every 12 hours. Adults who are not able to take capsules may be given CEFALEXIN SUSPENSION AURO. For more severe infections: larger doses may be needed. If daily doses of CEFALEXIN SUSPENSION AURO, greater than 4 grams are required, injectable cephalosporins, in appropriate doses, should be considered.

Children: The usual recommended dosage for children is 25 mg/kg/day to 50 mg/kg/day in divided doses every six hours. In the treatment of beta-haemolytic streptococcal infections (type of bacteria that grow in culture as pairs or chains), a therapeutic dose should be administered for at least 10 days.

CEFALEXIN SUSPENSION AURO can have side effects. Not all side effects reported for CEFALEXIN SUSPENSION AURO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking CEFALEXIN SUSPENSION AURO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity reactions including anaphylaxis (an allergic reaction to which the body has become hypersensitive.)
• Anaphylaxis - a severe, life-threatening allergic reaction
• Rash or itching
• Reactions resembling serum sickness-like reactions - immune response that's similar to an allergic reaction. It happens when certain medication cause the immune system to react.

These are all very serious side effects. If you have them, you may have had a serious reaction to CEFALEXIN SUSPENSION AURO. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: The following side effects occur frequently:

• Eosinophilia - increased number of disease-fighting white blood cell.
• Headache
• Nausea
• Vomiting
• Diarrhoea

The following side effects rarely occur:

• Haemolytic anaemia - a disorder in which red blood cells are destroyed faster than they can be made.
• Drug induced neutropenia - decrease in absolute neutrophil counts due to exposure to a medicine.
• Thrombocytopenia - when medicines are the causes of a low platelet count, these cells help blood to clot, hence bleeding is more likely.
• Fever
• Dizziness
• Drowsiness.
• Confusion
• Seizures
• Stomach cramps
• Hepatitis - inflammatory condition of the liver.
• Cholestatic jaundice - impairment in bile formation and/or bile flow.
• Nephrotoxicity - It is a poisonous effect of some substances on kidney function.
• Acute renal tubular necrosis - kidney disorder involving damage to the tubule cells of the kidneys, which can lead to acute kidney failure.
• Acute Interstitial nephritis - kidney condition characterized by swelling in between the kidney tubules.
• Vulval candidiasis – vaginal infection
• Tiredness

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get 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 via https://www.sahpra.org.za/documents/86422f1b6.04_ARF1_Jul16_v4.pdf. By reporting side effects, you can help provide more information on the safety of this medicine.

For Dry powder: Store between at or below 25 °C (15 °C to 25 °C). Protect from light.

For Reconstituted suspension: The reconstituted suspension is stable for 14 days under refrigeration (2 – 8 °C) STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).