KEFLEX contains cefalexin as the active ingredient, which belongs to a class of antibiotics called 'cephalosporins'.

KEFLEX is used to treat the 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.

Do not take KEFLEXif you:

• Are allergic (hypersensitive) to cefalexin, other cephalosporins (similar antibiotics), or penicillin group of antibiotics, or to any of the ingredients in the product (see Section 6 and end of Section 2).                                                                                                                            An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• Have porphyria; a hereditary metabolic disorder.

Take special care with KEFLEX if you:

• Have had an allergic reaction to cefalexin, cephalosporins, penicillins, or other drugs in the past.
• Have a severe kidney disorder (you may need a reduced dose).
• Develop diarrhea. This could be a symptom of the inflammation of the large intestine. Other symptoms include pain and fever.

Tell your doctor if you are having blood and urine tests. Keflex may interfere with these tests.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following:

• Other antibiotics, especially amphotericin, capreomycin, vancomycin, gentamicin, or neomycin.
• Diuretics (water tablets) such as furosemide, bumetanide.
• Probenecid for treatment of gout.
• Metformin for treatment of diabetes.
• Drugs used to treat leukemia.

It may be still be all right for you to be given Keflex and your doctor will be able to decide what is suitable for you.

Taking Keflexwith food and drink

Keflex may be taken before, during, or after your meals.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant or planning to become pregnant or breastfeeding. Caution should be exercised when cefalexin is administered to a nursing woman.

Ask your doctor or pharmacists for advice before taking any medicine if you are pregnant or planning to become pregnant.

Driving and using machines

Keflex is not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Keflex

Keflex suspension contains sucrose, so if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

The doctor will decide on the most appropriate dose for you, based on the nature and severity of your infection. Always take Keflex exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

For oral use only.

Dosage:

Adults: The usual total daily dose is 1g to 4g a day in divided doses.

Most infections can be treated with 500mg every 8 hours. For skin and soft tissue infections, sore throat (Streptococcal pharyngitis), and mild, uncomplicated urinary tract infections, the usual dose is 250mg every 6 hours or 500mg every 12 hours. For more severe infections, larger doses may be needed.

Elderly: You should take the normal adult dose unless you have severe kidney problems when the maximum daily dose will be 500mg.

Keflex Tablets are not recommended for use in children under 5 years of age.

Children: The doctor will calculate the correct dose for your child depending on his or her body weight. The usual daily dose for children is 25mg to 50mg for each kilogram of their weight, split into smaller amounts and taken every 8 or 12 hours.

For most infections, the following is recommended:

Children under 5 years: 125mg every 8 hours.

Children 5 years and over: 250mg every 8 hours.

If your child is taking Keflex for an ear infection, he or she may have to take 75mg to 100mg for each kilogram of their weight, split into smaller doses throughout the day.

Take the full course of your medicine as your doctor has given you. Do not stop taking it, even if you feel better.

If you take more Keflex than you should

Contact your doctor or nearest hospital casualty department if you or a child have swallowed too much medicine. Take the pack of the medicine with you, if possible. Symptoms of overdose include nausea, vomiting, stomach upset, the appearance of blood in the urine.

If you forget to take Keflex

If you miss a dose, take the dose 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 product, ask your doctor or pharmacist.

Like all medicines, Keflexcan cause side effects, although not everyone gets them.

Tell your doctor immediately if you get any of these side effects:

• Rash.
• Fever.
• Itchy skin.
• Swelling of the lips, eyelids, and tongue.
• Difficulty in breathing, sudden wheezing.

These are the signs of an allergic reaction. Stop taking Keflex immediately.

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 diarrhea.

The following side effects have been reported

• Diarrhea, stomach pain, heartburn, indigestion.
• Lower gut pain, inflammation of the colon (colitis), severe diarrhea containing mucus or blood.
• Feeling sick (nausea) or being sick (vomiting).
• Measle-like rash.
• Itching.
• Red wheals on the skin (urticaria).
• Pus in the eyes.
• Blisters in the nose or mouth.
• Rash with widespread 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 can be detected by blood and/ or urine test.
• Yellow skin and eye whites (jaundice).
• Weakness, fainting.
• Feeling confused or agitated, seeing or hearing things that are not there (hallucinations), extreme restlessness.
• Dizziness, tiredness, headache, sleep disorders, nervousness.
• Itching around the anus or genitals, inflamed vagina, discharge from the vagina caused by thrush (candidiasis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Keflex Tablets: Store below 30ºC.

Keflex Suspension (Dry powder): Store below 30°Ctightly closed in the container.