PACKAGE LEAFLET: INFORMATION FOR THE USER CEFACLOR ORAL SUSPENSION 125mg/5ml CEFACLOR ORAL SUSPENSION 250mg/5ml

(Cefaclor)

Read all of this leaflet carefully before you start taking this medicine_

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

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

2.    Before you take Cefaclor Suspension

3.    How to take Cefaclor Suspension

4.    Possible side effects

5.    How to store Cefaclor Suspension

6.    Further Information

1    WHAT CEFACLOR SUSPENSION ARE AND WHAT ARE THEY USED FOR

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

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

2    BEFORE YOU TAKE CEFACLOR SUSPENSION Do not take Cefaclor Suspension

•    If you (or your child) are allergic to cefaclor or any of the ingredients of Cefaclor Suspension listed at the end of the leaflet (An allergic reaction may include rash, itching, swelling of face, lips, or hands/feet or breathing difficulties)

•    If you (or your child) have previously had an allergic reaction to amoxicillin, or to other antibiotics of penicillin (e.g. ampicillin), or cephalosporin (e.g. cefalexin, cefadroxil) group.

Take special care with Cefaclor Suspension if you (or your child):

•    Are pregnant, or planning to become pregnant, or are breast feeding

•    Have problems with your kidney(s)

•    Have or have had colitis (a kind of severe diarrhoea).

•    Have sugar diabetes (Cefaclor can interfere with some urine sugar tests)

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

If you (or your child) require any tests, blood, urine or diagnostic, while taking this medicine please ensure the doctor or nurse knows that you are taking Cefaclor Suspension

Taking other medicines

Please inform your doctor or pharmacist if you (or your child) are taking, or have recently taken, any other medicines, even those not prescribed but bought/ obtained without a prescription.

Care is needed if you (or your child) are taking:

•    Anticoagulants (used to thin the blood) such as warfarin

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

•    Antacids (used for indigestion)

Inform your doctor if you are taking birth control pills (oral contraceptives) before taking Cefaclor suspension.

Taking Cefaclor with food or drink

Cefaclor Suspension can be given with or without food.

Pregnancy and Breast-feeding

You should take special care with Cefaclor Suspension if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before talking any medicine.

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 Suspension before you drive, use machines, or engage in any other activity that could be dangerous if you are not alert.

Important information about some of the ingredients of Cefaclor Suspension

Cefaclor Suspension contains sucrose. If you have been told by your doctor that you (or your child) have intolerance to some sugars, contact your doctor before taking this medicinal product.

Cefaclor suspension also includes certain inactive ingredients namely sodium benzoate and sodium citrate. This medicinal product contains less than 1 mmol sodium 8.1 mg per dose for the 125mg/ 5 ml strength and 16.2 mg per dose for the 250mg/ 5ml strength, i.e. essentially ‘sodium-free’.

3 HOW TO TAKE CEFACLOR SUSPENSION

Take or give your child this medicine as instructed by your doctor. Do not take (or give your child) more than the doctor told you to. Check the label carefully for how much to take and how often. Your pharmacist or doctor can help if you are not sure.

Usual dosage

Children:

The dose of cefaclor depends on your child's weight in kilograms and is usually approximately 20 mg for each kilogram body weight given daily. This is to be given in three divided doses daily, usually in the morning, afternoon and in the evening. The suspension can be given with or without food.

The usual doses of Cefaclor suspension are as given below:

Weight (in kg)	Age (in years)	Dosage in mL or number of spoonful (three times daily)
		Cefaclor 125mg/5mL suspension	Cefaclor 250mg/5mL suspension
9	under 1	2.5ml(1/2 spoonful)
9-18	1-5	5ml(one spoonful)
	over 5		5 ml (one spoonful)

The daily doses may be different depending on the type and severity of infection.

The maximum recommended daily dose should not exceed 1 gm.

Adults:

One spoonful (5 ml) of Cefaclor suspension 250 mg/5 ml taken three times a day. The dose may be increased to two spoonful of Cefaclor suspension 250 mg/5 ml taken three times a day, depending on the type and severity of the infection. Your maximum daily dose should not exceed 4 g.

Your daily doses may be different if you have kidney(s) problems.

Shake the bottle well before taking Cefaclor Oral Suspension.

Cefaclor Suspension is usually given for up to 10 days. Your doctor will tell for how long to take Cefaclor. Do not stop taking the suspension before your doctor tells you to, even if you (or your child) feel better, because the symptoms may return.

Taking Cefaclor with food or drink

Cefaclor Suspension can be given with or without food.

If you forget to take (or give your child) Cefaclor Suspension at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

If you have taken (or given your child) more Cefaclor Suspension than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken

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

4 POSSIBLE SIDE EFFECTS

Like all medicines, cefaclor can have side effects, although not everybody gets them. Very serious side effects

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

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

•    Severe skin reactions such as blisters, sores or ulceration

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

Serious side effects

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

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

•    Any irregular or fast heart beat

•    Sudden, severe abdominal pain, nausea and vomiting (pancreatitis)

•    Convulsions

•    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

Other side-effects.

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

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

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

•    Itching or any discharge from female genital area.

Effect on Laboratory tests

There may be changes in the results of certain laboratory tests

•    Abnormal liver function tests

•    Abnormal kidney function tests

•    Increase in blood sugar.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5 HOW TO STORE CEFACLOR SUSPENSION

Keep out of reach and sight of children.

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

Keep your suspension stored in the refrigerator and keep the bottle tightly closed. Throw away any that you have not used after 14 days.

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 protect the environment.

6 FURTHER INFORMATION

What Cefaclor Suspension contains

The active ingredient in Cefaclor Oral Suspension 125mg/5ml or 250mg/5ml is cefaclor.

Cefaclor Suspension is available in two strengths: 125mg/5ml and 250mg/5ml.

Cefaclor Suspension also contains some inactive ingredients: these are xanthan gum, sodium benzoate, sucrose, colloidal anhydrous silica, allura red (E129), sodium citrate, citric acid, simethicone emulsion and strawberry flavouring

What Cefaclor Suspension look like and contents of the Pack

Cefaclor 125mg/ 5ml and 250mg/ 5 ml suspension is white to off-white granular powder forming a red suspension on constitution with water and has a strawberry flavour.

Cefaclor 125mg/ 5ml and 250mg/ 5 ml suspension is available as 60 or 100 ml. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Ranbaxy (UK) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom.

Manufacturer: Ranbaxy Ireland Limited., Spafield, Cork Road, Cashel, Co. Tipperary, Republic of Ireland.

This leaflet was last approved in: September 2008