CEFALEXIN 250 MG / 5ML POWDER FOR ORAL SUSPENSION - patient leaflet, side effects, dosage

y possible side effects not listed in this leaflet.

IN THIS LEAFLET:

• 1. What Cefalexin Oral Suspension is and what it is used for

• 2. What you need to know 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. Contents of the pack and other information __

1. what cefalexin oral suspension is and what it is used for

Cefalexin belongs to a class of antibiotics called “cephalosporins” which are used to treat a variety of bacterial infections.

Cefalexin Oral Suspension is used to treat infections of the airways from nose to lung, ear, bones and joints and urine or reproduction systems, including inflammation of the prostate gland. It is also used to treat dental infections.

2. what you need to know before you take cefalexin oral suspension

Do not take Cefalexin Oral Suspension if you have :

• an allergy (hypersensitivity) to the cephalosporin group of antibiotics, or to any of the ingredients in the product (see Section 6 and end of Section 2)

3. how to take cefalexin oral suspension

For oral use only.

You must take this medicine exactly as your doctor has told you to. The pharmacist’s label will tell you how much to take and when.

Adults: The usual adult dose is 500mg every 8 hours, although your doctor may advise taking 1g to 4g a day- split into smaller doses. For certain infections, 250mg every 6 hours or 500mg every 12 hours may be required.

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 them depending on their body weight. The usual daily dose is 25mg to 50mg for each kilogram of their weight, split into smaller amounts taken every 8 or 12 hours. If your child is taking this medicine 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.

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 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.

If you take more Cefalexin Oral Suspension then you should

Contact your doctor or nearest hospital casualty department if you (or someone else) has swallowed too much medicine. Take this leaflet and any remaining suspension with you, to the hospital. 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 one).

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 Tablets can cause side effects, although not everyone gets them.

STOP taking your medicine immediately and contact your doctor if you experience:

• rash, fever, itchy skin, swelling of the lips, eyes, tongue or difficulty breathing. These are the signs of an allergic reaction. Stop taking the Tablets immediately

Serious side effects

The following side effects are serious. You should stop taking this medicine and contact your doctor immediately if you experienced them:

• flaky or peeling skin, swelling of the skin, red or purple inflamed skin patches; pus in your eyes; blisters in your nose or mouth, severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome), reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis)
• blood disorders (if you bruise more easily, have a sore throat, fever or a chill)
• lower gut pain, nausea, vomiting, severe diarrhoea containing blood or mucus. Colitis (inflammation of the colon) can also occur during or after treatment
• liver damage, for example jaundice (yellowing of the skin and whites of eyes), transient hepatitis
• nephritis (inflamed kidneys).

Tell your doctor if you suffer from any of the following for more than a few days:

• feeling or being sick, vomiting, heartburn, stomach pains, diarrhoea
• skin rashes
• dizziness, tiredness, headache, sleep disorders, nervousness
• feeling confused or agitated, hallucinations, hyperactivity, nau­sea
• painful or swollen joints, extreme muscle tension
• itching around the anus or genitals, inflamed vagina, discharge from the vagina.

5. how to store cefalexin oral suspension

KEEP OUT OF THE REACH AND SIGHT 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. contents of the pack and other 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 glycyrrhizinate and xanthan gum.

The 125mg/5ml suspension contains colour E127 (erythrosine) and strawberry flavour.

The 250mg/5ml suspension contains colour E104 (quinoline yellow) and orange flavour.

What Cefalexin Oral Suspension 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 orange, free flowing granular powder, which readily disperses in water to give an orange suspension with an odour of orange.

Both suspensions are supplied in plastic bottles of 100ml.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This leaflet was last revised in July 2014.