Cefalexin 250mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Cefalexin
Available from:
Flynn Pharma Ltd
ATC code:
J01DB01
INN (International Name):
Cefalexin
Dosage:
250mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 05010201; GTIN: 5060106551368

taken or might take any other medicines, even those not

prescribed, particularly:

Uricosuric drugs (medicines used to treat gout

and other conditions which require lowering of blood uric

acid levels, e.g. probenecid).

Diuretics (medicines which reduce water retention by

increasing the volume of urine, e.g. furosemide,

ethacrynic acid)

Anticoagulants (medicines that prevent the clotting of

blood, e.g. warfarin)

Any other antibiotics (eg. aminoglycosides, polymyxin,

colistin)

If you are taking metformin (a medicine used to treat

diabetes)

Drugs used to treat leukaemia.

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

There are no effects on ability to drive or to operate

machinery.

Cefalexin Tablets contains lactose

If you have been told by your doctor you have an

intolerance to some sugars, contact your doctor before

taking this medicine.

Always take this medicine exactly as your doctor or

pharmacist has told you. Check with your doctor or

pharmacist if you are not sure.

Each dose should be swallowed with a drink of water.

Try to space the doses as evenly as possible throughout

the day. For example, if you have

been told to take Cefalexin Tablets three times a day in 8

hour intervals, then:

Take your first dose when you wake up, e.g.7.00 am

Take your next dose mid-afternoon, e.g. 3.00 pm

Take your last dose just before you go to bed,

e.g. 11.00 pm.

If you have been told to take your medicine four times a day

in approximately 6 hour intervals, then:

Take your first dose when you wake up, e.g. 6.00 am

Take your second dose around noon, e.g. 12.00 pm

Take your third dose early evening, e.g. 6.00 pm

Take your last dose when you go to bed, e.g.

11.00 pm.

Dosage Instructions

Your doctor will tell you how much to take and how often.

Do not take more than the dose your doctor has

recommended.

The name of your medicine is Cefalexin Tablets. This

medicine belongs to a family of medicines called antibiotics.

Antibiotics are used to kill the bacteria or “germs” which

cause infections.

Your doctor, or dentist, will have prescribed this medicine for

treating an infection. Cefalexin Tablets are used for treating

a variety of infections including chest (respiratory tract),

urinary tract, skin and soft tissues, ear, and other infections.

Do not take Cefalexin tablets if you:

are allergic to cefalexin or other cephalosporins

(similar antibiotics) and medicines.

are allergic to any of the other ingredients of this

medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking

Cefalexin tablets if you have had an allergic

reaction to cefalexin, cephalosporins, penicillins, or other

drugs in the past

develop diarrhoea

are pregnant or breast-feeding. Your doctor will

decide whether it is safe for you to take this medicine

while you are pregnant or breast-feeding.

have problems with your kidneys.

test your urine for glucose using a method which is not

based on glucose oxidation reactions as this medicine

might give a false positive result.

are about to have a blood test, as Cefalexin tablets can

interfere with a Coombs test.

have ever developed a severe skin rash or skin

peeling, blistering and/or mouth sores after taking

cefalexin or other antibacterials

If any of the above apply to you or you are unsure, please

talk to your doctor before taking the tablets.

Take special care with cefalexin:

Acute generalised exanthematous pustulosis (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 localized on the skin folds, trunk, and upper

extremities. The highest risk for occurrence of this serious

skin reaction is within the first week of treatment. If you

develop a serious 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, have recently

Cefalexin Tablets 250 mg or 500 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

What is in this leaflet:

1. What Cefalexin Tablets is and what it is 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

(cefalexin)

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, pharmacist or dentist (if the medicine has been

prescribed by your dentist).

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 any of the side effects gets serious, talk to your doctor, pharmacist or dentist (if the medicine

has been prescribed by your dentist). This includes any possible side effects not listed in this

leaflet. See section 4.

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Continued on the next page >>

1

What Cefalexin Tablets is and what

it is used for

2

What you need to know before you

take Cefalexin Tablets

3

How to take Cefalexin Tablets

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Symptoms of blood disorders include tiredness, sore

throat, bruising easily and susceptibility to infection.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the

Yellow Card Scheme (www.mhra.gov.uk/yellowcard) 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.

Keep all medicines out of the sight and reach of children.

Blister packs - Store in the original packaging, in order to

protect the tablets from the light and moisture. Plastic

containers - Keep the container tightly closed, in order to

protect the tablets from light and moisture.

Do not store above 25°C.

Do not use this medicine after the expiry date which is

stated on the carton after EXP. The expiry date refers to the

last day of that month.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help

protect the environment.

What Cefalexin Tablets contain:

The active ingredient of Cefalexin Tablets is either 250 mg

or 500 mg of cefalexin. The film-coated tablets also contain

magnesium stearate, povidone (E1201), sodium starch

glycollate, macrogol 6000, lactose, saccharin sodium

(E954), talc (E553b) and peppermint oil. The tablet coating

contains titanium dioxide (E171) and hypromellose (E464).

Cefalexin Tablets 250 mg come in plastic

containers of 20, 21, 28, 50, 100 and 500 and blister packs

of 20, 21 and 28 tablets.

Cefalexin Tablets 500mg come in plastic containers of 12,

15, 20, 21, 24, 28, 50, 100, 250 and 500 tablets, and blister

packs of 14, 15, 20, 21, 28, 30 and 56 tablets.

Cefalexin Tablets 250 mg are round, film-coated and white

to yellowish in colour. The tablets are scored on one side

and have “CX” above the score and “250” below. The

unscored side is without markings.

Cefalexin Tablets 500 mg are oblong, film-coated and white

to yellowish in colour. The tablets are scored on each side.

Product licence holder and manufacturer:

Sandoz GmbH, A 6250 Kundl, Tirol, Austria.

This leaflet was last revised in July 2018.

Adults

The usual dose for adults is 1-4g daily in divided doses. For

most infections the dose will be 500 mg (2 x 250 mg tablets

or 1 x 500 mg tablet) every 8 hours.

This may vary depending on the type of infection you have.

For example a dose of 250 mg (1 x 250 mg tablet) taken

every 6 hours or 500 mg (2 x 250 mg tablets or 1 x 500 mg

tablet) every 12 hours is used to treat skin, soft tissue,

throat or urinary tract infections, or those caused by less

susceptible organisms.

Older people

The dosage for the elderly is the same as for adults, but

may be reduced if you have poor kidney function.

Use in children and adolescents

For most infections, the usual dose is; 125 mg (half a 250

mg tablet) every 8 hours for children under 5 years, or 250

mg (1 x 250 mg tablet) every 8 hours for children 5 years

and over.

For skin and soft tissue infections, urinary tract infections

and sore/dry throat caused by bacterial infections, the total

daily dose may be divided and administered every 12

hours. In severe infections the dosage may be doubled, for

certain infections such as ear infections doses even higher

than double the normal above may be required. Infections

caused by certain bacteria may require treatment for at

least 10 days.

Keep taking your medicine until the course is finished. Do

not stop taking your medicine just because you feel better.

If you stop too soon the infection may start up again

If your symptoms persist, tell your doctor

If you take more Cefalexin Tablets than you should

Always take your medicine as recommended by your

doctor. If you take too much medicine, tell your doctor

immediately or go to your local hospital

emergency department.

If you forget to take Cefalexin Tablets

If you miss a dose, take another as soon as you remember

and then 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.

Like all medicines, this medicine can cause side effects,

although not everybody gets them. All medicines can cause

allergic reactions, although serious allergic reactions are

very rare. 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).

See also section 2.

Other side effects

The following side effects have been reported

Feeling of sickness or being sick

Indigestion

Diarrhoea (which may be bloody) or stomach pains

Reversible liver disorder or jaundice (yellowing

of the skin and eyes)

Itching

Red wheals on the skin (urticaria) (alone)

Itching around the genitals or anus

Thrush or discharge from the vagina

rash with wide spread joint pain stiffness, swollen

lymph glands, fever and, possibly, cloudy urine

Dizziness

Tiredness

Headache

Agitation, confusion and hallucinations

Pain or swelling in the joints

Kidney disorders or blood disorders, including an

increase or decrease in the number of white

blood cells, and a decrease in the number of platelets.

SZ00000LT000

4

Possible side effects

5

How to store Cefalexin Tablets

6

Contents of the pack and other

information

Proof no.

Colours:

Dimensions:

Date prepared:

Font size:

Fonts:

007.1

18/07/2018

Black

Black 20%

175 x 315 mm

Helvetica

Artwork Proof Box

Ref:

V041 : To update SPC, PIL with PRAC recommendations + RFI

uk-pl

Pg. 2

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