Afalex® ( Cefalexin ) capsule 250 mg

Afalex®

Cefalexin

capsule 250 mg & 500 mg

Powder for oral suspension 125 mg/5mL and  250 mg/5mL

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

 

Afalex® is used to treat a variety of bacterial infections.

These include infections of the airways from nose to lungs, ear, bones and joints, skin and urinary or reproduction systems, including inflammation of the prostate gland. They are also used to treat dental infections.

 

Before use this drug, ask your doctor:

• 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, diffculty breathing or swelling of the face, lips, throat or tongue.
• Have porphyria; a hereditary metabolic disorder.
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials.

 

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.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Afalex®:

• Have had allergic reaction to cefalexin, cephalosporins, penicillins or other drugs in the past
• Have a severe kidney disorder (you may need reduced dose)
• Develop diarrhoea. This could be symptom of the inflammation of the large intestine. Other symptoms include pain and fever.
• if you are taking or have recently taken, or might take any other medicines include:
• other antibiotics, especially amphotericin, capreomycin, vancomycin, gentamicin or neomycin
• diuretics (water tablets) such as furosemide, bumetanide
• probenecid for a treatment of gout
• metformin for treatment of diabetes
• drugs used to treat leukemia

 

Driving and using machines

Cefalexin Capsules are not expected to affect your ability to drive or operate machinery.

 

Medical Tests

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

 

Method of administration

• Capsulesshould be swallowed with a glass of water, milk or juice. Your child should not chew the capsule. Swallow tablets whole with a drink of water.
• 125 mg per 5 mL (100 mL when mixed):Prepare suspension at time of dispensing. Add to the bottle a total of 71 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 125 mg cephalexin in each 5 mL (teaspoonful).
• 250 mg per 5 mL (100 mL when mixed):Prepare suspension at time of dispensing. Add to the bottle a total of 71 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful).
• Liquid medicine:Shake the medicine well. Measure out the right amount using a medicine spoon or oral syringe. You can get these from your pharmacist. Do not use a kitchen teaspoon as it will not give the right amount.
• You should start to get better after taking the medicine for 2 or 3 days. If you have a fever (temperature above 38°C), that still do not get better, or you become more unwell, contact your doctor.
• It is important that your child has the whole course of medicine that has been prescribed. Do not stop early.

The recommended dose is:

Adults:

The usual dose is 500mg every 8 hours, although your doctor may tell you to take 1g to 4g a day, split up in to smaller doses.

Elderly:

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

Children over 5 years:

Your doctor will calculate the correct dose, depending on the child’s weight. The usual daily dose is 25mg to 50mg for each kilogram of their weight and is usually split up into smaller amounts taken ever 8 or 12 hours. If your child is taking Cefalexin Capsules for ear infections, he or she may have to take 75mg to 100mg for each kilogram of their weight, split up into smaller doses throughout the day. This medicine is not recommended for use in children under 5 years of age.

 

People with kidney and liver problems

Use with caution. The effects may be increased because of slower removal of the medicine from the body.

 

If you take more Afalex® than you should

Contact your doctor or nearest hospital casualty department IMMEDIATELY for advice if you (or someone else) have swallowed too many capsules. Take this leaflet, any remaining capsules and the pack they were in with you to the hospital.

 

If you forget to take Afalex®

If you miss a dose, take it as soon as you remember. If it is almost time to take the next dose, skip the missed dose and carry on as before. DO NOT take a double dose to make up for a forgotten dose.

 

If you stop taking your medicine

Keep taking this medicine until your doctor tells you to stop. DO NOT stop taking it just because you feel better. If you stop taking this medicine, your infection may return or get worse.

 

Adverse reactions

Like all medicines, Cefalexin Capsules can cause side effects, although not everyone gets them

If any of the following serious side effects occur, stop taking this medicine and tell your doctor or pharmacist immediately, or go to your nearest hospital accident and emergency department taking your medicine with you.

• swelling of your face, lips, tongue or throat (angioedema)
• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
• itchy spots or rash on the arms and legs or severe, extensive, blistering skin rash (erythema multiforme, Steven-Johnson syndrome)

 

Tell your doctor if you experience the following

• Diarrhoea (which may be bloody or have mucus in it)

 

The following side effects have also been reported:

Common: (affecting at least 1 in 100 patients but less than 1 in 10 patients)

• Diarrhoea, nausea

 

Uncommon: (affecting at least 1 in 1,000 patients but less than 1 in 100 patients)

• Changes in blood tests that check how well your liver is working
• Increase in some types of white blood cells (eosinophilia)
• Skin rash, hives or itching

 

Rare: (affecting at least 1 in 10,000 patients but less than 1 in 1,000 patients)

• Blood problems: change in the number of cells in the body responsible for combating infections (symptoms may include infections and abnormal bruising or bleeding), increase in the number of cells responsible for blood clotting; haemolytic anaemia, a type of anaemia caused by the breakdown of red blood cells.
• Dizziness and headache
• Abdominal pain, vomiting, indigestion, inflammation of the intestinal tract (pseudomembranous colitis)
• Reversible kidney inflammation (interstitial nephritis)
• Genital and anal itching, and inflammation of the vagina
• Tiredness
• Inflammation of the liver (hepatitis), yellowing of the skin and eyes (cholestatic icterus)

 

Other side effects: (Frequency not known)

• Pain or inflammation in the joints (arthralgia, arthritis)
• Vaginal thrush (candidiasis)
• Fever
• Hallucinations, confusion and agitation

 

Special precautions for storage

• Keep out of the reach and sight of children.
• Do not use these capsules after the expiry date which is stated on the carton.
• The expiry date refers to the last day of the month.
• Store below 30°C. Store in the original package.
• Made-up suspension: Store at 2 – 8°C. Discard any unused medicine after 14 days
• 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.

 

 

Afalex®

Each Capsule contains: 250 mg & 500 mg Cefalexin (as monohydrate)

Each 5 mL of Suspension contains: 125 mg/5mL and 250 mg/5mL

 

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.