Cefalexin 125mg/5ml Powder For Oral Suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER Cefalexin 125mg/5ml Powder for Oral Suspension Cefalexin 250mg/5ml Powder for Oral Suspension
(cefalexin monohydrate)
Read all of this leaflet carefully before you start taking this medicine.
- 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Cefalexin Oral Suspension is and what it is used for
2. Before you take Cefalexin Oral Suspension
3. How to take Cefalexin Oral Suspension
4. Possible side effects
5. How to store Cefalexin Oral Suspension
6. Further information
1. WHAT CEFALEXIN ORAL SUSPENSION IS AND WHAT IT IS USED 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.
2. BEFORE YOU TAKE CEFALEXIN ORAL SUSPENSION
Do not take Cefalexin Oral Suspension if 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 Cefalexin Oral Suspension if you:
• 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.
Tell your doctor if you are having blood and urine tests. Cefalexin Oral Suspension 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 a 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 Cefalexin Capsules and your doctor will be able to decide what is suitable for you.
Taking Cefalexin Oral Suspension with food and drink
This suspension 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 breast-feeding. Ask your doctor or pharmacists for advice before taking any medicine if you are pregnant or planning to become pregnant.
Driving and using machines
Cefalexin Oral Suspension is not expected to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Cefalexin Oral Suspension
Sorbitol - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Sorbitol may have a mild laxative effect Calorific value of sorbitol is2.6 kcal/g. One dose of the Cefalexin suspension contains 900mg of sorbitol
Sodium - This medicinal product contains 3.38 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet
3. HOW TO TAKE CEFALEXIN ORAL SUSPENSION
The doctor will decide on the most appropriate dose for you, based on the nature and severity of your infection. Always take Cefalexin Oral Suspension 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 by 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.
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 Cefalexin Oral Suspension for an ear infection, he or she may have to take 75mg to 10Omg for each kilogram of their weight, split into smaller doses throughout the day.
Take all the suspension your doctor has given you. Do not stop taking them, even if you feel better
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.
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 product, ask your doctor or pharmacist.
. POSSIBLE SIDE EFFECTS
Like all medicines, Cefalexin Oral Suspension can 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, eye lids, tongue
• difficulty in breathing, sudden wheeziness.
These are the signs of an allergic reaction. Stop taking the oral suspension 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 diarrhoea
The following side effects have been reported
• Diarrhoea, stomach pain, heartburn, indigestion
• Lower gut pain, inflammation of colon (colitis), severe diarrhoea 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 wide spread joint pain and/ or stiffness, swollen lymph glands, fever and, possibly, cloudy urine
• Changes in blood counts, witch may show up as bruising ir 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
• Yellow skin and eye whites (jaunudice)
• 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 (candidasis)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE CEFALEXIN ORAL SUSPENSION
KEEP OUT OF 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.
6. FURTHER 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.
Cefalexin 125 mg Suspension : PL 21880/0078 Cefalexin 250 mg Suspension : PL 21880/0081
Marketing Authorisation Holder and Manufacturer MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
This leaflet was last revised in {02/05/2013}
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