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Active substance(s): CEFALEXIN MONOHYDRATE

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Cefalexin 250 mg Capsules
Cefalexin 500 mg Capsules
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.

In particular, tell your doctor or pharmacist if you are using any of the following
- Probenecid (a treatment for gout)
- Metformin (a treatment for diabetes)
- aminoglycosides and other cephalosporins (a treatment for infections)
- Furosemide (a medicine to increase urine output)
It may still be all right for you to take Cefalexin and your doctor will be able to
decide what is suitable for you.
Effects on laboratory tests
Tell your doctor if you are taking Cefalexin and plan to have blood or urine tests.
This medicine may change the results of these tests and give false results for:
- Certain blood test (e.g. Coombs Test)
- Test for glucose in urine
- If you are not sure if any of above applies to you, talk to your doctor or
pharmacist before taking this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may get pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before taking
this medicine.

What is in this leaflet
1.What Cefalexin is and what it is used for
2.What you need to know before you take Cefalexin
3.How to take Cefalexin
4.Possible side effects
5.How to store Cefalexin
6.Contents of the pack and other information

This medicine can be used during pregnancy or breast-feeding only after
consulting with your doctor.

1. What Cefalexin is and what it is used for
This medicine contains the active ingredient cefalexin, which is an antibiotic.
Cefalexin is used to fight infections caused by bacteria (germs).
This medicine is used to treat infection of :
• skin and soft tissue (such as wound infections).

Driving and using machines.
This medicine is not likely to affect your ability to drive or use machines.
However, use caution when driving or operating heavy machinery until you are
aware of how this medicine may affect you.
Cefalexin contains lactose
If you have been told by your doctor that you have anintolerance to some
sugars, contact your doctor before taking this medicine.

2. What you need to know before you take Cefalexin

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

Do not take Cefalexin:


How to take Cefalexin

if you are allergic to the cephalosporin group of antibiotics or any of the
other ingredients of this medicine (listed in section 6). An allergic reaction
may include rash, itching, difficulty breathing or swelling of the face, lips,
throat or tongue.
if you had previous immediate and severe hypersensitivity reactions to
penicillin or any other type of beta-lactum drug.

Warning and precautions
Talk to your doctor or pharmacist before taking Cefalexin
- if you have had an allergic reaction to cefalexin, cephalosporins, penicillins,
or other medicines.
- If you have had severe acute hypersensitivity reactions (e.g. anaphylaxis)
- if you develop diarrhoea while using an antibiotic.
- if you have a severe kidney disorder you may need a reduced dose.
- if you have been told by your doctor that you have an intolerance to some
sugars or you have Lapp-lactase deficiency or glucose-galactose
malabsoprtion contact your doctor before taking this medicine
Other medicines and Cefalexin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription.
This is because they may interact with Cefalexin capsules.

Use in Adults

For skin and soft tissue infections, the usual dosage is 250mg every 6 hours
or 500 mg every 12 hours.

Use in patients with impaired kidney function
If you have severe kidney problems, a reduced dose is needed.
Use in elderly patients
The elderly and patients with impaired renal function: As for adults, reduce
dosage if renal function is markedly impaired
Children > 5 years to 12 years and adolescents

250mg every 8 hours

In severe infections, the dosage may be doubled.

This medicine is not recommended for the use in children under 5
years of age.

If you take more cefalexin than you should
Contact your doctor, pharmacist or nearest hospital immediately.

Product: Cefalexin Capsules Insert for 250 mg & 500 mg

Market: Alkem GMBH, Europe

Size : (LXH) 244 x 240 mm
Folding Size 122 x 30 mm

Itemcode: PT 2430-02

Superseed No: PT 2430-01

Mfg Location: Amaliya

Pantone No.:

Version No: 02

Pack Size:


Component: Insert
Change Part No: -


Substrate: ITC Bible Paper 40 GSM

Pharmacode: 2516

Barcode: NA

Reason for Issue: Text change

Change Control No: NA

Date of Initiation : 03-02-2016

Final approval of artwork:

Modification Date:

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
Use all the capsules you doctor has prescribed for you. Do not stop taking
them, even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or


Keep this medicine out of the sight and reach of children.
Store below 30°C.
Store this medicine in original package.
Do not use this medicine after the expiry date which is stated on the blister and
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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.


The following side effects have also been reported:
Common (affect 1 to 10 users in100):
• Nausea and diarrhea.
Uncommon (affect 1 to 10 users of 1000):
• Change in blood tests that check how your liver is working
• Increase in some types of white blood cells.
• Rash, Urticaria, Pruritis.
Rare (affect 1 to 10 users in 10,000):
• Blood problems: drop in the number of different cells in the blood
(symptoms can include new infections and easy bruising or bleeding),
including cells that are needed for clotting of the blood; haemolytic
anaemia, a type of anaemia that can be severe and is caused by red blood
cells breaking up
• Headaches, dizziness
• Abdominal pain, vomiting, indigestion, inflammation of the intestines
causing severe and painful diarrhoea (pseudomembranous colitis)
• Kidney inflammation reversible
• Genital and anal problems: itching and inflammation of the vagina
• Tiredness
• Inflammation of the liver and yellow skin and eyes (jaundice).

Contents of the pack and other information

What cefalexin contain:

If any of the following serious Rare side effects (affect 1 to 10 users in
10,000) happen, stop taking this medicine and tell your doctor
immediately or go to your nearest hospital accident and emergency
• swelling of your face, lips, tongue or throat (angioedema)
• A sudden allergic reaction, with shortness of breath, rash, wheezing and
drop of blood pressure.
• Itchy spots or rash on the arms and legs or severe, extensive, blistering skin
rash (erythema multiforme, Steven-Johnson syndrome)
• Fever, sore throat, and joint pain with a severe blistering, peeling, and red
skin rash (toxic epidermal necrolysis)
• Diarrhoea that is watery or bloody

How to store Cefalexin


The active substance is cefalexin. Each hard gelatin capsule contains
cefalexin monohydrate equivalent to 250 mg or 500 mg of cefalexin.
The other ingredients are:
Capsule content: Lactose Anhydrous (SuperTab 21AN), Colloidal Silicon
Dioxide, Magnesium Stearate.
Capsule shell: Gelatine, Sodium lauryl sulphate, Water, E 133, E 129 (in
250 mg only), E 104, Titanium Dioxide (E 171).
Imprinted Ink: Shellac, Dehydrated alcohol, Isopropyl alcohol, Butyl
alcohol, Propylene Glycol, Strong ammonia solution, Black Iron oxide
(E172), Potassium Hydroxide, Purified water.

What Cefalexin looks like and contents of the pack
Cefalexin 250mg capsules are white to off-white powder filled in dark green
cap and dark green body. Each capsule is a size '2' hard gelatin capsule with
"CEP" printed on cap and "250" on body with black ink.
Cefalexin 500mg capsules are white to off-white powder filled in light green cap
and light green body. Each capsule is a size '0' hard gelatin capsule with "CEP"
printed on cap and "500" on body with black ink.
Pack size:
Cefalexin is available in cartons containing 21, 28, 30, 50, 56, 60 or 100
capsules in blister strips. Not all pack sizes may be marketed
Marketing Authorisation Holder
Gutenbergstraße 13,
24941 Flensburg
Wave Pharma Limited
4th Floor, Cavendish House
369 Burnt Oak Broadway, Edgware,
Middlesex HA8 5AW,
United Kingdom
This leaflet was last revised in 02/2016

Other side effects (affecting an unknown number of users):
• Pain or inflammation of joints
• Infections caused by other germs (for example, thrush may occur)
• Fever
• Hallucinations, agitation, confusion.
If you are having a blood test for any reason, tell the person who is taking your
blood sample that you are taking this medicine as it may affect your result.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

PT 2430-02

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