Package leaflet: Information tor the user

Cefaclor Capsules 250 mg Cefaclor Capsules 500 mg

(Cefaclor)

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.

•    Ifyou haveany further questions, ask yourdoctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass lion toothers. It may barm them, eveniftheir signs ofiiiness are the same as yours.

•    If you get any side effects, talk toyour doctor or pharmacist.

In this leaflet.

What is in this leaflet:

1.    What Cefaclor Capsules are and whatare they used for

2.    Whatyou need to know before you take Cefaclor Capsules

3.    How to take Cefaclor Capsules

4.    Possible side effects

5.    HowtostoreCefaclorCapsules

6.    Contents of the pack and other information.

1. What Cefaclor Capsules are and what are they used for

Cefaclor capsules is an antibacterial agent (antibiotic) used for treating certain infections caused by bacteria. Itbelongsto a group of medicines called cephalosporins. Antibiotics help the body fight infections.

Cefaclor capsules are used to treat certain bacterial infections including chest infections (bronchitis and pneumonia); infections of ear, nose and throat; urinary tract (e.g. cystitis), and skin infections.

2. Whatyou need to know before you take Cefaclor Capsules

Do nottake Cefaclor Capsules

•    If you are allergic to cefaclor or any of the other ingredients of this medicine (listed in section 6) [An allergic reaction may include rash, itching, swelling of face, lips, orhands/feet orbreathing difficulties]

•    You have previously had an allergic reaction to any other cephalosporin (e g., cefalexin, cefadroxil) group of medicines.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefaclor Capsules

•    If you have previously had an allergic reaction to penicillins or other medicines

•    If you have problems with your kidney(s)

•    If you have or have had colitis (a kind of severe diarrhoea) or gastro-intestinal disease in the past.

•    Ifyouhavesugardiabetes (Cefaclor can interfere with some urine sugartests)

Please consult your doctor, even if these statements were applicable to you at any time in the past.

If you develop new symptoms during the course of an existing infection, inform your doctor, as these may be dueto a secondary infection.

If you require any tests, blood, urine or diagnostic, while taking this medicine please ensure the doctor or nurse knows that you are taking Cefaclor Capsules.

Other medicines and Cefaclor Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Care is needed ifyou are taking:

•    Bloodthinning agents (anticoagulants) such as warfarin

•    Probenecid (used to treat gout, a form of arthritis)

•    Antacids (used for indigestion)

•    Any hormonal contraceptives (oral pills).

Cefaclor with food or drink

Cefaclorcapsules can be given with or without food.

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 doctoror pharmacistforadvice before taking this medicine.

You should take special care with Cefaclor capsules if you are pregnant or currently breastfeeding. Yourdoctor will discuss the risks and benefits of using Cefaclor capsules ifyou are pregnant orbreastfeeding.

Driving and using machines

Cefaclor is not known to affect the ability to drive or use machines. Make sure you know how you react to Cefaclor Capsules before you drive, use machines, or engage in any other activity that could be dangerous if youarenotalert.

Cefaclor capsules also contain small amounts of inactive ingredients called carmoisine (E122) and ponceau 4R (E124), which may cause allergic reactions, and propyl para-hydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) which may cause allergic reaction (possibly delayed).

3 Howto take Cefaclor Capsules

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 nottake more than the doctor told you to. Check the label carefully for how much to take and how often to take.

Usual dosage

Adults:

Usual daily dose would be one Cefaclor Capsule 250 mg taken three times daily. Depending on the type and severity of infection, your doctor may advise you one Cefaclor Capsule 500 mg taken three times daily. Your daily doses should not exceed 4g.

Your daily doses may be different ifyou have kidney problems.

Children:

The usual recommended doses are 20 mg per kg per day in divided doses every eight hours. However your doctor will give appropriate dosage depending upon your Child's condition and severity of illness. Cefaclor oral suspension is availablefor children.

Swallow the capsules with water.

Your doctor will tell you how long to take Cefaclor capsules. Do not stop taking the capsules before your doctortellsyouto, even ifyou feel better, becausethe symptoms may return.

Ifyou take more Cefaclor Capsulesthan you should, you may have symptoms such as feeling orbeing sick, loose stool and gut problems. Consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or some capsules with you so your doctor will know whatyou have taken.

Ifyou forget to take Cefaclor Capsules at the correct time, take them as soon asyou remember However, if it is almosttimeforyour next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up forforgotten individual doses.

If you stop taking Cefaclor Capsules

It is important to finish the course of treatment your doctor has prescribed, even ifyou start to feel better. If you do not finish the course of treatment, yourinfection may get worse again.

If you have any further questions on the use of this medicine, askyourdoctororpharmacist.

4. Possible side effects

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

Serious side effects

If any of the following happen, stop taking Cefaclor Capsules and tell your doctor immediately or go to the casualty department at your nearest hospital.

•    Rashes, hives, itching, chest constriction (tightness of the chest), shortness of breath, fever or swelling of face, lips, hands/feet, fainting

•    Severe skin reactions such as blisters, sores, ulceration or other skin reaction along with painful joint disease/joint pain with or without fever. Such reactions have been reported more frequently in children than in adults.

Allergic reactions may also include unusual weakness, swelling (including face and limb), difficulty in breathing, numbness, fainting, low blood pressure.

These are serious side effects. You may have a serious allergic reaction or other type of reaction to cefaclor You may need urgent medical attention or hospitalization.

Other side effects

Tell yourdoctor as soon as possible if you develop any of the following:

•    Severe diarrhoea (which may contain blood ormucous) along with stomach cramps

•    Convulsions (uncontrolled movements of body/fits)

•    Yellowing of whites of eyes and skin (jaundice), loss of appetite, pain in right upper abdomen, and general feeling of being unwell

•    Dark discoloration of urine, bloody or cloudy urine or any change in your urine output

•    Unusual bleeding or increased tendency to bleed, persistent sore throat and frequent infections

•    Mental confusion, hallucinations (unrealistic sensations/ perception), nervousness, increased muscle tone, lack of sleep, dizziness, sleepiness, hyperactivity

•    Nausea (feeling sick) orvomiting (being sick)

•    Swollen glands in the neck, armpit or groin

•    Itching oranydischargefrom female genital area.

Effect on Laboratory tests

There may be changes in the results of certain laboratory tests

•    Abnormal liverfunction tests

•    Abnormal kidney function tests

•    Abnormal blood cell counts.

Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed inthis leaflet.

5 HowtostoreCefaclorCapsules

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

Do not use this medicine after the expiry date shown on the label.

Store in a dry place at or below 25°C

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer require. These measures will help to protectthe environment.

6 Contents of the pack and other information:

What Cefaclor Capsules contain

Cefaclor Capsules contain the active ingredient cefaclor Cefaclor Capsules are available in two strengths: 250 mg and 500 mg.

Each 250 mg capsule contains:

cefaclor monohydrate 262.2 mg equivalent to anhydrous Cefaclor 250 mg.

Each 500 mg capsule contains:

cefaclor monohydrate 524.4 mg equivalent to anhydrous Cefaclor 500 mg.

The other ingredients are pregelatinised starch, colloidal anhydrous silica, croscarmellose sodium and magnesium stearate. The gelatine capsules contain carmoisine (E122), ponceau 4R (E124), brilliant blue (E133), titanium dioxide (E171), propyl para-hydroxybenzoate (E216), methyl para-hydroxybenzoate (E218), gelatin. The 500 mg capsules also contain black iron oxide (E172).

The black ink contains shellac, propylene glycol, black iron oxide (E172) and potassium hydroxide.

What Cefaclor capsules look like and contents of the Pack

Cefaclor Capsules 250 mg are purple/white hard gelatin self locked capsules of size '2' imprinted 'Cefaclor 250' on cap and body in black edible ink containing white to off-white granular powder.

Cefaclor Capsules 500 mg are purple/grey hard gelatin self locked capsules of size '0 el¹ imprinted 'Cefaclor 500' on cap and body in black edible ink containing white to off-white granular powder.

Cefaclor Capsules are available in blister packs containing 8,12,15,16,20,21,30,50 or 100 capsules.

Bottles containing 100 x250 mg capsules or 50 x500 mg capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ranbaxy (UK) Limited Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE United Kingdom

Manufacturer:

Ranbaxy Ireland Ltd.,

Spafield, Cork Road,

Cashel, Co. Tipperary, Ireland.

This leafletwas last revised in December 2012.