Cefalexin Capsules 250mg

Document: leaflet MAH GENERIC_PL 14894-0010 change

Package leaflet: Information for the user

Cefalexin 250mg Capsules Cefalexin 500mg Capsules

(Cefalexin)

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.

- 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 Capsules are and whatthey are used for

2. What you need to know before you take Cefalexin Capsules

3. Howtotake Cefalexin Capsules

4. Possible side effects

5. Howto store Cefalexin Capsules

6. Contents of the pack and other information

1. What Cefalexin Capsules are and whatthey are used for

Cefalexin Capsules contains the active ingredient cefalexin, which belongs to a class of antibiotics called cephalosporins.

Cefalexin Capsules is used to treat the following bacterial infections:

• Respiratory tract (lungs and airways) infections e.g. tonsils, pharyngitis and bronchitis

• Middle earinfection (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 inflammationof the prostate (prostatitis)

• Dental infections

2. What you need to know before you take Cefalexin Capsules

Do not take Cefalexin Capsules if

• you are allergic (hypersensitive) to cefalexin, other cephalosporins (similar 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 ortongue

• you have porphyria, a hereditary metabolic disorder

Warnings and precuations

Tell your doctor or pharmacist before taking Cefalexin Capsuels if:

• you have had an allergic reaction to cefalexin, cephalosporins, penicillins, or any other drugs in the past

• you develop diarrhea. This could be symptom of the inflammation of the large intestine. Other symptoms include pain and fever.

• you have a severe kidney disorder (you may need a reduced dose)

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

Other medicines and Cefalexin Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

• other antibiotics, especially amphotericin, capreomycin, vancomycin, or an aminoglycoside- a broad spectrum, antibiotic (eg. gentamicin orneomycin)

• metformin fortreatment of diabetes

• diuretics (water tablets) such as furosemide, bumetanide

• probenecid fora treatment of gout

• drugsused totreat 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.

Cefalexin Capsules with food and drink

Cefalexin Capsules can be taken with or withoutfood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, as your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cefalexin Capsules are not expected to affect your ability to drive or use machines.

Cefalexin Capsules contain lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. Howtotake Cefalexin Capsules

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

Swallow the capsules whole with water.

Dosage

Adults: The usual total daily dose is 1g to 4g a day, in divided doses.

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

Older people: You should take the normal adult dose, unless you have severe kidney problems, when the maximum daily dose will be 500mg.

Use in children

The usual total daily dose for children is 25-50mg/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: 125mg every 8 hours.

Children 5 years and over: 250mg 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 100mg/kg in 4 doses is required.

If you take more Cefalexin Capsules than you should

Contact your doctor or nearest hospital casualty department immediately for advice if you or a child have swallowed too many capsules. Take this leaflet, the pack or any

capsules 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 Capsules

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 stop taking Cefalexin Capsules

Do not stop taking this medicine without talking to your doctor, even if you feel better. It is important that you take the full course of this medicine prescribed by your doctor.

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

4. Possible side effects

bottle after EXP The expiry date refers to the last day of that month.

Do not store above 25C. Store in the original package in orderto protectfrom moisture.

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 protectthe environment.

6. Contents of the pack and other information

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

If any of the following happen, stop taking Cefalexin Capsules and tell your doctor immediately or go to your nearest hospital emergency department:

• sudden wheeziness, difficulty in breathing

• swelling of the eyelids, face or lips

• rash or itching (especially affecting yourwholebody)

These are signs of an allergic reaction. Stop taking the capsules immediately.

Serious side effects

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience any of the following:

• serious peeling or blistering of the skin

• severe diarrhoea

Other side effects

Tell your doctor if you notice any of the following:

• diarrhea, stomach pain, indigestion

• feeling sick (nausea) or being sick (vomiting)

• measle like rash

• itching

• red wheals on the skin (urticaria)

• rash with wide spread joint pain and/or stiffness, swollen lymph glands, fever and, possibly, cloudy urine

• changes in blood counts, which 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

• yellow skin and eyes (jaundice)

• weakness, fainting

• abnormal excitable behavior

• agitation, tiredness, headache, confusion, dizziness

• seeing or hearing things (hallucinations)

• itching of the vagina or anus caused by thrush (candidiasis)

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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cefalexin Capsules

What Cefalexin Capsules contain:

The active ingredient is cefalexin.

The capsules are available in two strengths, and contain either 250mg or 500mg of cefalexin.

Each Cefalexin 250mg Capsule contains cefalexin, equivalent to anhydrous cefalexin 250mg.

Each Cefalexin 500mg Capsule contains cefalexin, equivalent to anhydrous cefalexin 500mg.

The other ingredients are: lactose monohydrate, magnesium stearate, gelatine, iron oxide yellow (E172), titanium dioxide (E171), FD & C blue 1 (E133), sunset yellow (E110), shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide (E172), potassium hydroxide and purified water.

What Cefalexin Capsules look like and contents of the pack

Cefalexin 250mg Capsules are dark green/white, self locked hard gelatine capsules of size '2' Imprinted with 'RX656' in black edible ink containing white to off white granularpowder/pellets.

Cefalexin 500mg Capsules are dark green/light green, self locked hard gelatine capsules of size 'O' Imprinted with 'RX657' in black edible ink containing white to off white granularpowder/pellets.

Cefalexin Capsules are available in pack sizes of 20, 21, 28,100 capsules. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Ranbaxy(UK) Limited,

Building 4, Chiswick Park,

566 Chiswick High Road,

London, W45YE,

United Kingdom

Manufacturer:

Ranbaxy Ireland Limited,

Spafield, Cork Road,

Cashel, Co. Tipperary,

Republic of Ireland

This leaflet was last revised in January 2015.

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

Do not use this medicine after the expiry date which is stated on the label, carton or