Cefaclor Capsules 500mg

Document: leaflet MAH GENERIC_PL 14894-0002 change

Package leaflet: Information for 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.

- 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.

If you stop taking Cefaclor Capsules

It is important to finish the course of treatment your doctor has prescribed, even if you start to feel better. If you do notfinish the course of treatment, your infection may get worse again.

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

4. Possible side effects

What is in this leaflet

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

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

3. Howto take Cefaclor Capsules

4. Possible side effects

5. Howto store Cefaclor Capsules

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. It belongs to 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; bladder (cystitis) and kidney infections; and skin and soft tissue infections.

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

Do not take Cefaclor Capsules:

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

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

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

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.

• If you are diabetic (cefaclor can interfere with some urine sugar tests)

If any of the above applies to you, it is important that you tell your doctor before taking Cefaclor Capsules.

If you develop new symptoms during the course of an existing infection, inform your doctor, as these may be due to 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 if you are taking:

• Blood thinning 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

Cefaclor capsules 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 pharmacistfor advice before taking this medicine.

Your doctor will discuss the risks and benefits of using Cefaclor capsules 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 Capsules before you drive, use machines, or engage in any other activity that could be dangerous if you are not alert.

Cefaclor Capsules contain carmoisine (E122), ponceau 4R (E124), methyl parahydroxybenzoate (E218), and propyl parahydroxybenzoate (E216)

Carmoisine (E122) and ponceau 4R (E124) may cause allergic reactions.

Methyl para-hydroxybenzoate (E218) and propyl para-hydroxybenzoate (E216) may cause allergic reaction (possibly delayed).

3. How to take Cefaclor Capsules

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

Serious side effects

If any of the following happens, 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.

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

• Convulsions (uncontrolled movements of body/fits)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) or vomiting (being sick)

• Swollen glands in the neck, armpit or groin

• Itching 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 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 Cefaclor Capsules

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

Do not store above 25⁰C. Store in the original package protected from light and moisture.

Do not use this medicine after the expiry date, which is stated on the blister 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 protectthe environment.

6 Contents of the pack and other information

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 more than the doctortold you to.

Adults and older patients

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 4 g.

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

Use in 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. Other forms of this medicine such as oral suspension may be more suitable for children; ask your doctor or pharmacist.

Your doctor will tell you how long to take Cefaclor Capsules. Do not stop taking the capsules before your doctor tells you to, even if you feel better, because the symptoms may return.

Patients undergoing haemodialysis (removal of waste products from the blood to treat kidney failure)

Your doctor will give you detailed instructions on how to take your doses of medication around your dialysis sessions.

Taking this medicine

Swallowthe capsules with water.

If you take more Cefaclor Capsules than you should

If you take more Cefaclor Capsules than you should, you may have symptoms such as feeling or being 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 what you have taken.

If you forget to take Cefaclor Capsules

If you forget to take Cefaclor Capsules at the correct time, take them 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.

What Cefaclor Capsules contain

The active substance is cefaclor.

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 250mg Capsules 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 500mg Capsules are purple/grey hard gelatin self locked capsules of size "0 el' 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 100x 250 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, W45YE United Kingdom

Manufacturer:

Ranbaxy Ireland Ltd.,

Spafield, Cork Road,

Cashel, Co. Tipperary, Ireland.

This leaflet was last revised in June 2015.


		Package leaflet: Information for 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.
		- 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 Cefaclor Capsules are and what are they used for 2. What you need to know before you take Cefaclor Capsules 3. Howto take Cefaclor Capsules 4. Possible side effects 5. Howto store Cefaclor Capsules 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. It belongs to 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; bladder (cystitis) and kidney infections; and skin and soft tissue infections. 2. What you need to know before you take Cefaclor Capsules
		Do not take Cefaclor Capsules: • If you are allergic to cefaclor or any of the other ingredients of this medicine (listed in section 6) • You have previously had an allergic reaction to any other cephalosporin (e.g., cefalexin, cefadroxil) group of medicines. Talk to your doctor before taking this medicine if any of the above applies to you. 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. • If you are diabetic (cefaclor can interfere with some urine sugar tests) If any of the above applies to you, it is important that you tell your doctor before taking Cefaclor Capsules. If you develop new symptoms during the course of an existing infection, inform your doctor, as these may be due to 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 if you are taking: • Blood thinning 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 Cefaclor capsules 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 pharmacistfor advice before taking this medicine. Your doctor will discuss the risks and benefits of using Cefaclor capsules 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 Capsules before you drive, use machines, or engage in any other activity that could be dangerous if you are not alert. Cefaclor Capsules contain carmoisine (E122), ponceau 4R (E124), methyl parahydroxybenzoate (E218), and propyl parahydroxybenzoate (E216) Carmoisine (E122) and ponceau 4R (E124) may cause allergic reactions. Methyl para-hydroxybenzoate (E218) and propyl para-hydroxybenzoate (E216) may cause allergic reaction (possibly delayed). 3. How to 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 not take more than the doctortold you to. Adults and older patients 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 4 g. Your daily doses may be different if you have kidney problems. Use in 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. Other forms of this medicine such as oral suspension may be more suitable for children; ask your doctor or pharmacist. Your doctor will tell you how long to take Cefaclor Capsules. Do not stop taking the capsules before your doctor tells you to, even if you feel better, because the symptoms may return. Patients undergoing haemodialysis (removal of waste products from the blood to treat kidney failure) Your doctor will give you detailed instructions on how to take your doses of medication around your dialysis sessions. Taking this medicine Swallowthe capsules with water. If you take more Cefaclor Capsules than you should If you take more Cefaclor Capsules than you should, you may have symptoms such as feeling or being 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 what you have taken. If you forget to take Cefaclor Capsules If you forget to take Cefaclor Capsules at the correct time, take them 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.