Package leaflet: Information for the user

Cefaclor 125mg/5ml Oral Suspension Cefaclor 250mg/5ml Oral Suspension

(Cefaclor)

What is in this leaflet

1.    What Cefaclor Suspension is and what it is used for

2.    What you need to know before you use Cefaclor Suspension

3.    Howto use Cefaclor Suspension

4.    Possible side effects

5.    Howto store Cefaclor Suspension

6.    Contents of the pack and other information.

1. What Cefaclor Suspension is and what it is 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 (otitis media), nose (sinusitis) and throat (pharyngitis and tonsillitis); bladder (cystitis) and kidney infections (pyelonephritis) ;and skin infections and soft tissue infections.

2    What you need to know before you use Cefaclor Suspension

Do not use Cefaclor Suspension

•    If you (oryour child) are allergic to cefaclor or any of the other ingredients of this medicine (listed in section 6).

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

Talkto your doctor before taking this medicine if any of the above applies to you.

Warnings and precautions

Talkto the doctor or pharmacist before taking Cefaclor Suspension, if you (or your child):

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

•    have problems with kidney(s)

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

• have diabetes (cefaclor can interfere with some urine sugartests).

Cross resistance has been reported between penicillin and cephalosporin class of antibiotics. You should inform the doctor in case there has been any treatment failure with these groups of medicines in the past.

If any of the above applies to you (or your child), it is important that you tell your doctor before taking Cefaclor Suspension.

If you (or your child) develop new symptoms during the course of an existing infection, inform the doctor, as these may be due to a secondary infection.

If you (or your child) develop severe diarrhoea while on treatment with Cefaclor Suspension, inform the doctor. Treatment should be discontinued if severe diarrhoea develops.

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 (or your child) are taking Cefaclor Suspension.

Other medicines and Cefaclor Suspension

Tell your doctor or pharmacist if you are using, have recently taken or might take any other medicines.

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 forindigestion).

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

Cefaclor with food or drink

Cefaclor Suspension 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 doctor or pharmacist for advice before taking this medicine.

Your doctor will discuss the risks and benefits of using Cefaclor Suspension if you are pregnant or breastfeeding. 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.

Cefaclor Suspension contain sucrose

If you have been told by your doctor that you (or your child) have intolerance to some sugars, contact the doctor before using this medicinal product. Cefaclor Suspension may be harmful to the teeth. Each 5 ml of the constituted suspension contains 2291.20mg sucrose (for 125mg/5ml) & 2136.15mg sucrose (for 250mg/5ml). This should be taken into account in patients with diabetes mellitus.

Cefaclor Suspension contain allura red

This medicin also contains allura red. This is a colouring agent and can cause an allergic reaction.

3 How to take Cefaclor Suspension

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

Do not take (or give your child) more than the doctortold you to.

The recommended dose is:

Use in children and adolescents:

For children, and babies over the age of one month, the usual total daily dosage is 20mg/kg (body weight). This is to be given in three divided doses daily, usually in the morning, afternoon and in the evening. Forthroat and middle ear infections the total daily dose can be divided into two and given twelve hours apart. The suspension can be given with or without food.

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	2.5 ml (1/2 spoonful)
9-18	1-5	5 ml (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 and elderly:

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 or receiving dialysis.

Shake the bottle well before using Cefaclor Oral Suspension.

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

Route and method of administration

For preparation of 100 mL suspension, measure 70 mL of water using a measuring cup. Add this volume of water in two portions to the dry mixture in the bottle. Shake well after each addition.

For preparation of 60 mL suspension, measure 42 mL of water using a measuring cup. Add this volume of water in two portions to the dry mixture in the bottle. Shake well after each addition.

The spoon provided with the package dispenses a volume of 5 mL.

Once reconstituted the suspension should betaken by mouth.

If you take (or give your child) more Cefaclor Suspension than you should

If you take (or give your child) more Cefaclor Suspension than you should, you (or your child) may have symptoms such as feeling or being sick, loose stool and gut problems. Consult the doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken (or given your child)

If you forget to take (or give your child) Cefaclor Suspension

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 forforgotten individual doses.

If you stop taking (or giving to your child) Cefaclor Suspension

It is important to finish the course of treatment the doctor has prescribed, even if you (or your child) start to feel better. If you do not finish the course of treatment, your (oryour child's) infection may get worse again.

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

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 happens, stop using Cefaclor Suspension 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 blistering and peeling of the skin e.g Stevens Jhonson syndrome and toxic epidermal necrolysis.

•    Fever, swelling, skin rash, enlargement of the lymph nodes (Serum Sickness) Such reactions have been reported more frequently in children than in adults.

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

•    Sign and symptoms of low blood cell levels e.g unexplained bruising or bleeding, sore throat, fever, mouth sore, feeling unwell.

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

These are 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.

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

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

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

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

•    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

•    Mental confusion, agitation, 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 in genital area or any discharge from 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.

Reporting of side effects

If you (or your child) get any side effects, talkto the 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 Cefaclor Suspension

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

After it is made up, the suspension should be stored in a refrigerator (2-8°C) and be used within 14 days. The bottle must be kept tightly closed. Any of the suspension that is not used after 14 days should be thrown away.

Do not use this medicine after the expiry date, which is stated on the label or 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 to protect the environment.

6. Contents of the pack and other information

What Cefaclor Suspension contains

The active ingredient is cefaclor.

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

Cefaclor 125mg/5ml Suspension:

Each 5 ml of the constituted suspension contains: cefaclor monohydrate 131.1 mg equivalent to anhydrous Cefaclor 125mg.

Cefaclor 250mg/5ml Suspension:

Each 5 ml of the constituted suspension contains: cefaclor monohydrate 262.2 mg equivalent to anhydrous Cefaclor 250mg.

The other ingredients are xanthan gum, sodium benzoate, sucrose, colloidal anhydrous silica, allura red (E129), sodium citrate, citric acid, simethicone emulsion and strawberry flavouring

What Cefaclor Suspension looks like and contents of the Pack

Cefaclor 125mg/5ml and 250mg/5ml 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. 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, W45YE United Kingdom

Manufacturer:

Ranbaxy Ireland Ltd Spafield, Cork Road,

Cashel, Co. Tipperary,

Ireland

This leaflet was last revised in September 2015.