Cefalexin 500 Mg Capsules
Cefalexin 500mg Capsules
Cefalexin
The name of your medicine is Cefalexin 500 mg capsules, which will be referred to as Cefalexin throughout the rest of this document.
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 sid ects gets serious, or ifyou notice any si ects not listed in this lraflet, please tell your doctor or pharmacist.
In this leaflet:
1 What Cefalexin is and what it is used for
2 Before you take Cefalexin
3 How to take Cefalexin
4 Possible side effects
5 How to store Cefalexin
6 Further information
1 What Cefalexin is and what it is used for
Cefalexin is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotics are similar to penicillin.
Cefalexin kills bacteria and it can be used against various sorts of infections. Like all antibiotics, Cefalexin is only effective against some types of bacteria. So, it is only suitable for treating some types of infection.
Cefalexin can be used to treat:
• Acute throat and ear infections
• Chest infections such as acute bronchitis and some types of pneumonia
• Kidney and bladder infections
• Acute infection of the prostate gland
• Infections in the skin and layers just under the skin
• Infections of the bones and joints
2 Before you take Cefalexin Do not take Cefalexin if:
• you are allergic (hypersensitive) to cefalexin, or
to any of the other ingredients of this medicine (see Further Information in Section 6).
• you are allergic (hypersensitive) to any other cephalosporin type of antibiotic or to any sort of penicillin antibiotic.
Not all people who are allergic (hypersensitive) to penicillins are also allergic to cephalosporins. However, you should not take this medicine if you ever had a severe allergic reaction to any penicillin. This is because you might also be allergic to this medicine.
An allergic (hypersensitive) reaction may include rash, itching, di culty in breathing or swelling of the face, lips, throat or tongue.
Take special care with Cefalexin if you:
• ever have had an allergic (hypersensitive) reaction to any antibiotic . Tell your doctor or pharmacist before you take this medicine.
• have ever had inflammation of your bowel, called colitis or any other severe disrase affecting your gut.
• have ever been told that your kidneys do not work very well. You may take Cefalexin but you may need a lower dose.
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This medicine can alter the results of some blood tests (such as cross-matching blood and the Coombs' test). It is important to tell your doctor that you are taking this medicine if you have to have these tests.
This medicine can also alter the results of urine tests for sugar (such as Benedict's or Fehling's tests or with copper sulphate test tablets). If you have diabetes and routinely test your urine, tell your doctor. This is because other tests may have to be used to monitor your diabetes while you are having this medicine.
Cefalexin is not suitable for everyone. Before treatment with Cefalexin, talk to your doctor or pharmacist if any of the above applies to you.
If you have been on Cefalexin treatment for a prolonged period, it may result in the overgrowth of organisms on which Cefalexin does not act. This may need for you to be treated by other antimicrobial agents.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking the following medicines which are known to interact with Cefalexin:
• probenecid (a medicine used in the treatment of gout)
• metformin ( a medicine used in the treatment of diabetes)
It may still be all right for you to be given Cefalexin and your doctor will be able to decide what is suitable for you.
Taking Cefalexin with food and drink
Cefalexin can be taken regardless of meals.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Before starting treatment, you must tell your doctor if you are pregnant or if you intend to become pregnant. Cefalexin is not known to harm the unborn child, but has not been deemed as safe. It will only be given to a pregnant woman if it is absolutely necessary.
Mothers who wish to breast-feed should discuss with their doctor, as small amounts of Cefalexin enters the milk. Inform your doctor if your baby develops diarrhoea or if you notice anything unusual.
Driving and using machines
Cefalexin does not usual ect your ability to drive or use machines. However, if you feel light-headed or dizzy, do not drive or use machines and check with your doctor. Important information about some of the ingredients of Cefalexin
Cefalexin contains colouring agents including Brilliant Blue FCF (E133) and Sunset yellow FCF (E110), which may cause allergic (hypersensitive) reactions.
3 How to take Cefalexin Dosage
Always take Cefalexin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults and the elderly with normal kidney function The recommended adult dosage range for Cefalexin is 1 g to 4 g per day, given daily in divided doses. In the majority of infections, Cefalexin is given in a dose of 500 mg every 8 hours (three times a day).
For treating infections in the skin and the layers just under the skin, streptococcal pharyngitis (sore throat), and mild, uncomplicated urinary tract infections, Cefalexin is given in a dosage of 250 mg every 6 hours (four times a day) or 500 mg every 12 hours (twice daily).
For more severe infections, larger doses may be needed.
Adults (including the elderly) with impaired kidney function
In patients with impaired kidney function, the dosage of Cefalexin is usually reduced.
Children
The dose for children is based on their weight. The usual dosage range for children is 25 mg to 50 mg per kg body weight daily, given in divided doses.
For infections in the skin and the layers just under the skin, streptococcal pharyngitis, and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours.
For most infections, the following schedule is suggested:
• Children under 5 years : 125 mg every 8 hours.
• Children 5 years and over : 250 mg every 8 hours. In severe infections, the dose may be doubled. In the therapy of otitis media (middle ear infection), a daily dose of 75 to 100 mg per kg bodyweight in 4 doses is given.
Method and/or route(s) of administration
Cefalexin comes as a capsule to be taken orally. The capsules should be swallowed whole and taken with a full glass of water.
Frequency of administration
Depending on various factors, you may be asked to take Cefalexin every 6 hours (four times a day) or every 8 hours (three times a day) or every 12 hours (twice a day).
Duration of treatment
Your doctor will advise you on how long your treatment should last. The duration of therapy depends on the type and course of the disease.
In the treatment of beta-haemolytic streptococcal (a type of bacteria) infections in adults and children, treatment with Cefalexin is usually given for at least 10 days.
If you take more Cefalexin than you should
Ifyou or your child have taken more of this medicine than you should, talk to your doctor or contact your nearest hospital emergency department immediately.
Symptoms of overdose may include nausea (feeling sick), severe vomiting, pain in the upper abdomen, diarrhoea and passing blood in the urine. In addition to treatment of the symptoms of overdose, the doctors may also try to reduce the levels of Cefalexin in the blood by dialysis.
If you forget to take Cefalexin If you miss a dose, take it as soon as possible. However if it is nearly time for your 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 Cefalexin
It is important that you take this medicine until you finish the prescribed course. You should not stop the medicine just because you feel better. If you stop too soon, the infection may start up again. If the person being treated still feels unwell at the end of the prescribed course of treatment, or feels worse during treatment, tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Cefalexin can cause side effects, although not everybody gets them.
The following side effects are important and will require immediate action if you experience them.
You should stop taking Cefalexin and see your doctor immediately if the following symptoms occur: Rare side effects affect fewer than 1 in 1,000 patients
• swelling of the face, tongue and windpipe which can cause great di culty in breathing
• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
• severe, extensive, blistering skin rash
• watery and severe diarrhoea that may also be bloody
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The following side-effects have also been reported: Common side effects (affect less than 1 in 10 people) include:
• Nausea
• diarrhoea
Uncommon side effects (affect less than 1 in 100 people) include:
• Skin rash, hives, itching
• changes in blood tests that check how your liver is working
Rare s ects (affect less than 1 in 1000 people)
include:
• fall in the numbers o erent cells in the blood (symptoms can include susceptibility to new infections, easy bruising or bleeding, pallid appearance or shortness of breath caused by anaemia)
• headaches, dizziness
• discharge and itch of the vagina and surrounding skin
• abdominal pain, vomiting, indigestion
• liver problems that may lead to jaundice (yellowing of the skin or whites of the eyes)
• kidney problems
Other s ects (affecting an unknown number of
people) include:
• tiredness, hallucinations, restlessness, confusion
• painful joints
• vaginal thrush
If you are having a blood test or a urine test for any reason, tell the person who is doing the test that you are taking this medicine as it may ect your result.
If any of the side e ects gets serious, or if you notice any side ects not listed in this l et, please tell your doctor or pharmacist.
5 How to store Cefalexin
Keep out of the sight and reach of children.
This medicine does not require any special storage conditions. Keep container tightly closed.
Do not use Cefalexin after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
6 Further information
What Cefalexin contain:
The active substance is Cefalexin. Each capsule contains, as the active ingredient, Cefalexin monohydrate equivalent to 500 mg of Cefalexin base.
The other ingredients are- capsule contents: Cellulose Microcrystalline, Croscarmellose Sodium, Magnesium Stearate; capsule shell: Sodium laurilsulfate, Brilliant Blue FCF (E 133) and Sunset yellow FCF (E110), Titanium dioxide, gelatin and black printing ink (containing shellac, propylene glycol, potassium hydroxide and iron oxide, black (E172)).
What Cefalexin looks like and contents of the pack
Cefalexin capsules are hard gelatin capsules with a green coloured opaque cap and opaque white coloured body, imprinted with black "CEF" on cap & "500" on body lled with white to ^white granular powder.
The products are filled into plastic bottles 20 or 100 capsules, or blister packs of 21 or100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
DAWA Ltd.
5 Sandridge Close,
Harrow, Middlesex HA1 1XD,
United Kingdom.
This lraflet was last revised in August 2012