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Cefaclor Capsules 250mg

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Patient Information Leaflet Cefaclor Capsules 250 and 500 mg

Please read this leaflet carefully before you take these capsules. It briefly outlines the most important things you need to know. If you want to know more about this medicine, or you are not sure about anything, ask your pharmacist or your doctor.

The name of your medicine is Cefaclor Capsules 250 and 500 mg.

WHAT IS CEFACLOR?

Each capsule contains either 250 mg or 500 mg of the active ingredient Cefaclor (as cefaclor monohydrate). The other ingredients are sodium starch glycollate and magnesium stearate. The capsules are made of gelatin. In addition, the capsules contain titanium dioxide (E171), erythrosine (E127) patent blue V (E131), shellac, black iron oxide (E172), soya lecithin and simethicone based emulsion.

Cefaclor 250 mg capsules are available in pack sizes1 of 7, 8, 10, 12, 14, 15, 16, 20, 21,24, 28, 49, 50, 98 and 100 capsules.

Cefaclor 500 mg capsules are available in pack sizes1 of 8, 10, 12, 15, 20, 21, 50 and 100 capsules.

See outer packaging for contents i.e. the number of capsules.

Cefaclor is a broad spectrum antibiotic. It belongs to a group of drugs called cephalosporins.

Cefaclor Capsules are manufactured by Teva Pharmaceutical Industries, Jerusalem, Israel on behalf of the marketing authorisation holder Teva Pharma B.V., 3640 AE Mijdrecht, The Netherlands.

WHAT IS CEFACLOR USED FOR?

Cefaclor capsules are used to treat a wide range of bacterial infections. These infections can affect the ears, nose, throat, the chest, the urinary tract or the skin.

•    Are you sensitive to any of the ingredients in the medicine (listed above)?

•    Are you pregnant or breast-feeding?

•    Have you ever had an allergic reaction to antibiotics such as penicillin or cephalosporins or to any other types of medicine? (An allergic reaction may include rash, itching, swelling or breathing difficulties.)

•    Do you have kidney problems?

•    Do you have a history of problems with your digestive system, in particular colitis (inflammation of the large intestine)?

•    Are you diabetic? Cefaclor can interfere with some urine sugar tests.

•    Are you having a blood transfusion?

•    Are you taking any oral anticoagulants e.g. warfarin (a drug to stop the blood clotting)?

•    Are you taking probenecid (a drug to prevent attacks of gout)?

•    Are you taking anti-peristaltics e.g. loperamide?

If the answer to any of these questions is YES, do not take Cefaclor before talking to your doctor or pharmacist.

Do not give to infants aged less than one month.

If you having a blood test be sure to tell your doctor you are taking Cefaclor as it may interfere with the result.

TAKING CEFACLOR

Your doctor has decided the dose which is suited to you. Always follow your doctor's instructions and those which are on the pharmacy label. If you do not understand these instructions, or you are in any doubt, ask your doctor or pharmacist.

The capsule(s) should be swallowed with a drink of water.

The usual dosage instructions are given below:

Adults (including the elderly):

250 mg three times a day, but your doctor may decide to increase the dose for more severe infections. The daily dosage should not be greater than 4 g.

Children under 12 years of age:

20 mg/kg daily in divided doses (the dose will depend on the child’s weight) but the dose can be increased for more severe infections. The daily dosage should not be greater than 1 g.

Infants aged less than one month:

Not recommended.

Cefaclor suspensions are available for use in children.

You should continue to take these capsules for as long as your doctor tells you to. Take the full course. Even if you start to feel better, the original infection may still be present and may recur if the treatment is stopped.

If you forget to take a capsule, take one as soon as you remember, unless it is time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

If you are taking oral contraceptives (the Pill), this medicine could cause contraceptive failure.

If you see another doctor or go into hospital, let him or the staff know what medicines you are taking. Cefaclor may interfere with some clinical tests.

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has accidentally swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately.

AFTER TAKING CEFACLOR

Cefaclor is taken by many patients without any problems. However, like many other medicines, it may occasionally cause side-effects in some people.

As can happen with any medicine, a few people may develop an allergic reaction.

If you experience the following, tell your doctor immediately or go to the casualty department at your nearest hospital:

•    Difficulty breathing, swelling of the lips, face and neck

•    Lethargy, abnormal muscle rigidity, pins and needles or numbness

•    Fainting and vasodilation (widening of blood vessels).

Blood disorders: positive Coombs’ test, unusual bleeding or unexplained bruising, blood disorders which may be characterised by fever or chills, ulcers in the mouth or throat, unusual tiredness or weakness and anaemia.

Immune system

disorders:    allergic reactions such as skin eruptions, nettle

rash, a serum-like sickness characterised by an itchy rash, pains in the joints, fever or swollen glands, increased levels of protein in the urine and Stevens-Johnson syndrome (blisters/bleeding of the lips, eyes, nose, mouth and genitals).

Nervous system

disorders:    reversible hyperactivity, agitation, nervousness, difficulty

sleeping, confusion, increased tightness of muscle tone, dizziness, hallucinations and sleepiness.

Gastrointestinal

disorders:    diarrhoea, nausea (feeling sick), vomiting and inflammation of the

bowel lining.

Liver disorders:    hepatitis (inflammation of the liver) and jaundice characterised by

yellowing of the skin or the whites of the eyes.

Skin disorders:    genital itching.

Kidney and urinary

disorders:    inflammation of the kidneys, reduction in kidney function,

changes in blood and urine tests.

Reproductive system and breast

disorders:    inflammation of the vagina that may cause pain, itching and

discharge.

If you have these or any other effects, tell your doctor immediately. Also, if you feel unwell in any other way, contact your doctor.

STORING CEFACLOR

Do not use this medicine after the expiry date shown on the outside packaging. These capsules should be stored in the package or container supplied. Do not transfer them to another container. Keep them in a secure place where children cannot get at them. This medicine is for you ONLY, do not give it to anyone else. Unless your doctor tells you to, do not keep these capsules for longer than you need. Return all unused medicines to your pharmacist for safe disposal.

FURTHER INFORMATION

This leaflet only gives a brief outline of some of the more important points about cefaclor. If you want to know more about these capsules or their effects, please ask your doctor or pharmacist.

Revised: November 2005

Distributed by Approved Prescription Services Ltd, Leeds LS27 0JG, England.