CEFALEXIN 250 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CEFALEXIN 250 MG FILM-COATED TABLETS

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Cefalexin Tablets are and what they are used for
2. What you need to know before you take Cefalexin Tablets
3. How to take Cefalexin Tablets
4. Possible side effects
5. How to store Cefalexin Tablets
6. Contents of the pack and other information

1. WHAT CEFALEXIN TABLETS ARE AND WHAT THEY ARE USED FOR

Cefalexin Tablets contain cefalexin as the active ingredient, which belongs to a class of antibiotics called ‘cephalosporins’.

Cefalexin Tablets are 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. what you need to know before you take cefalexin tablets

Do not take Cefalexin Tablets :

If you are allergic to cefalexin, other cephalosporins (similar antibiotics) or to any of the ingredients of this medicine (see Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Tell your doctor before taking Cefalexin:

If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefalexin Tablets if you:

Have had allergic reaction to cefalexin, cephalosporins, penicillins or other drugs in the past
Develop severe or prolonged diarrhoea during or after taking cefalexin
Have a severe kidney disorder (you may need a reduced dose)
Have ever developed a severe skin rash or skin peeling,

blistering and/or mouth sores after taking cefalexin or other antibacterials.

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

Take special care with Cefalexin:

Acute generalised exanthematous (AGEP) has been reported with the use of cefalexin. AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localised on the skin folds, trunk, and upper extremities. The highest risk of occurence of this serious skin skin reaction is within the first week of treatment. If you develop a serious skin rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately.

Other medicines and Cefalexin Tablets

Tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines. This includes medicines you buy without a prescription.

This is especially important of the following, as they may interact with your Cefalexin Tablets:

Any other antibiotics (e.g. gentamicin, tobramycin, cefuroxime)
Potent diuretics e.g. furosemide (water tablets used to treat high blood pressure or water retention)
Probenecid (a treatment of gout)
Metformin (a 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.

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.

Driving and using machines

Cefalexin Tablets should not affect your ability to drive or use machines.

3. how to take cefalexin tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Adults and the elderly

The recommended total daily dose is 1–4 g orally, in divided doses.

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

Use in children

The recommended total daily dose for children is 25–50 mg/kg (body weight) in divided doses.

For skin and soft tissue infections, 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 treatment of middle ear infections, a total daily dose of 75 to 100 mg/kg in 4 doses is required.

For oral use.

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Version: 02

Date & Time: 20.09.2021 & 6.10 pm

Submission Code: N14729

If you take more Cefalexin Tablets than you should

Contact your doctor or nearest hospital casualty department immediately for advice if you or a child have swallowed too many tablets. Take this leaflet, the pack or any tablets with you, if you can. Symptoms of overdose include nausea, vomiting, stomach upset, appearance of blood in the urine.

If you forget to take Cefalexin Tablets

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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

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
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using cefalexin if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

The following side effects have been reported

Diarrhoea
Feeling sick (nausea)
Vomiting
Indigestion
Stomach pains
Measles-like rash, (alone)
Itching
Red wheals on the skin (urticaria) (alone)
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 or a very tired feeling. You will need a blood test to confirm this
Damage to your liver or kidneys which can only be detected by a blood and/ or urine test
Jaundice (yellow skin and eye)
Weakness
Fainting
Abnormally excitable behaviour
Agitation
Tiredness
Headache
Confusion
Dizziness
Seeing or hearing things (hallucinations)
Itching of the vagina or anus caused by thrush (candidasis)
– Inflamed vagina (vaginitis)
– Discharge from the vagina caused by thrush
– Arthritis and joint disorder

Frequency not known:

A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using cefalexin if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cefalexin tablets

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Store Cefalexin Tablets in their original package and keep containers tightly closed.

Do not use the tablets after the expiry ‘EXP’ date which is printed on the carton (the expiry date refers to the last day of the month stated).

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 Tablets contain

The active ingredient is cefalexin, 250mg or 500mg.

The other ingredients are pregelatinised starch, colloidal anhydrous silica, magnesium stearate and microcrystalline cellulose. The coating contains hypromellose, polyethylene glycol, titanium dioxide (E171) and erythrosine lake (E127).

What Cefalexin Tablets look like and contents of the pack

Cefalexin Tablets are round, pink and film-coated, embossed with ‘CHX 250’ (250mg) or ‘CHX 500’ (500mg) on one face with twin triangles on the reverse.

They are available in bulk packs of 30, 50, 100 and 500 tablets, as well as in blisters of pack size 21s and 28s (not all pack sizes may be marketed).

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD, United Kingdom.

Manufacturers: