Cerlaz Oral 125 mg/5 ml/250 mg Oral Suspension

CERLAZ ORAL SUSPENSION contains a medicine called Cephalexin. This belongs to a group of antibacterial medicine. CERLAZ ORAL SUSPENSION 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 CERLAZ ORAL SUSPENSION:

• If you are allergic or sensitive to CERLAZ ORAL SUSPENSION or any of the ingredients of CERLAZ ORAL SUSPENSION
• 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 CERLAZ ORAL SUSPENSION:

• 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 CERLAZ ORAL SUSPENSION. Stop treatment immediately and discuss with your doctor.
• If you have kidney function condition. False high values of creatinine concentrations may be produced.

Do not share medicines prescribed for you with any other person. Always take CERLAZ ORAL SUSPENSION 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 CERLAZ ORAL SUSPENSION will last. If you have the impression that the effect of CERLAZ ORAL SUSPENSION 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 CERLAZ ORAL SUSPENSION. For more severe infections: larger doses may be needed. If daily doses of CERLAZ ORAL SUSPENSION, 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. Your doctor will tell you how long your treatment with CERLAZ ORAL SUSPENSION will last. Do not stop treatment early because this may reoccurrence of your condition. If you have the impression that the effect of CERLAZ ORAL SUSPENSION is too strong or too weak, tell your doctor or pharmacist.

CERLAZ ORAL SUSPENSION can have side effects. Not all side effects reported for CERLAZ ORAL SUSPENSION 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 CERLAZ ORAL SUSPENSION 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 CERLAZ ORAL SUSPENSION. 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).