Patient leaflet - KEFTID 250 MG / 5ML SUSPENSION, CEFACLOR 250 MG / 5ML SUSPENSION
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– 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, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. see section 4.
What is in this leaflet:
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1. What Cefaclor Suspension is and what it is used for
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2. What you need to know before you take Cefaclor Suspension
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3. How to take Cefaclor Suspension
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4. Possible side effects
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5. How to store Cefaclor Suspension
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6. Contents of the pack and other information
1. what cefaclor suspension is and what it is used for
The name of this medicine is Cefaclor Suspension. Cefaclor Suspension contains the active substance cefaclor, which belongs to a group of medicines called cephalosporin antibiotics.
Cefaclor is used to kill bacteria that cause infections in your body. These include throat, chest and ear infections, sinus infections, infections of the skin and soft tissue and urinary tract infections.
2. what you need to know before you take cefaclor suspension
Do not take Cefaclor Suspension
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– if you are allergic to cefaclor or to any of the other ingredients of this medicine (listed in section 6)
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– if you are allergic to any other cephalosporin antibiotics, such as cefalexin, cefuroxime or cefradine
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– if you have a metabolic disorder called phenylketonuria.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cefaclor Suspension:
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– if you have had an allergic reaction to penicillins, such as penicillin, ampicillin, amoxicillin or flucloxicillin
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– if you have a history of gastrointestinal disease, especially inflammation of the colon (colitis)
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– if you have severe kidney problems.
Tell your doctor if you are having blood or urine tests. Cefaclor Suspension may interfere with these tests.
Other medicines and Cefaclor Suspension
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is especially important for the following, as they may interact with Cefaclor Suspension:
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– warfarin (used to thin the blood)
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– probenecid (used to treat gout).
It may still be all right for you to take Cefaclor Suspension and your doctor or pharmacist will be able to decide what is suitable for you.
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.
Driving and using machines
Cefaclor Suspension should not affect your ability to drive and use machines.
Cefaclor Suspension contains aspartame (E951), sodium benzoate (E211), sorbitol (E420) and sodium
This medicine contains 30 mg aspartame in each 5 ml dose which is equivalent to 6 mg/ml.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains 5 mg benzoate salt in each 5 ml dose which is equivalent to 1 mg/ml.
Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
This medicine contains 600 mg sorbitol in each 5 ml dose which is equivalent to 120 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
This medicine contains less than 1 mmol sodium (23mg) per 5 ml, that is to say essentially ‘sodium-free’.
3.
HOW TO TAKE CEFACLOR SUSPENSION
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Cefaclor Suspension should be taken orally (by mouth).
The recommended dose for adults and the elderly is 250mg every eight hours. In more severe infections the dosage may be doubled to 500mg every eight hours.
Patients with a severe kidney disorder or patients receiving dialysis may need a reduced dose.
Use in children
The recommended dose for children will depend on the child’s weight. Babies less than one month old should not be given cefaclor.
Doctors sometimes prescribe different doses to these. It is important to read the label on your medicine, as it will tell you precisely what dose to take.
If you take more Cefaclor Suspension than you should
If you take too much Cefaclor Suspension contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any remaining suspension with you.
If you forget to take Cefaclor Suspension
If you forget to take your medicine, just take your normal dose as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Cefaclor Suspension
Keep taking the medicine until you have finished the full course of treatment that your doctor has prescribed for you. Do not stop taking the medicine, even if you feel better. This will make sure that the infection has completely cleared.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, lips or limbs, rash or itching (especially affecting your whole body).
Serious side effects
The following side effects are serious. You should stop taking this medicine and contact your doctor immediately if you experience:
- allergic reactions. Symptoms include a rash, itching, red wheals on the skin (urticaria), swelling of the face, tongue, larynx, abdomen, or arms and legs, weakness, breathlessness, pins and needles (paraesthesia), fainting
- a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
- serum sickness-like reactions with fever, rash, joint pain and/or stiffness
- diarrhoea, possibly with blood or mucus
- changes in blood counts, which may show up as bruising or a very tired feeling. You will need a blood test to confirm this
- damage to your kidney which can only be detected by a blood and/or urine test
- damage to your liver which can only be detected by a blood and/or urine test or damage to your liver causing yellowing of your skin and the whites of your eyes (jaundice).
The following other side effects have been reported:
- feeling sick (nausea)
- vomiting
- abnormally excitable behaviour
- agitation
- nervousness
- sleeplessness
- confusion
- tight muscles
- dizziness
- seeing or hearing things (hallucinations)
- drowsiness
- itching of the vagina caused by thrush (candidiasis).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Store in the original bottle, with the lid tightly closed. Dispose of any suspension that has not been taken after 14 days.
Do not use Cefaclor Suspension if you notice that the bottle is damaged or if the suspension appears to have deteriorated.
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 protect the environment.
6. contents of the pack and other information
What Cefaclor Suspension contains
The active substance is cefaclor. Each 5ml of suspension contains either 125mg or 250mg of cefaclor as cefaclor monohydrate. The other ingredients are sodium benzoate (E211) (see section 2), silicon dioxide, xanthan gum, sorbitol (E420) (see section 2), aspartame (E951) (see section 2), citric acid (anhydrous), strawberry flavour, banana flavour, pineapple flavour, raspberry flavour, taste modifier and allura red (E129).
What Cefaclor Suspension looks like and contents of the pack
Cefaclor Suspension is available as a white to slightly pink coloured dry powder for the preparation of a pink fruit flavoured suspension. When prepared by the pharmacist, each bottle of suspension contains 100ml.
Marketing Authorisation Holder
Co-pharma
Unit 4 Metro Centre
Tolpits Lane
Watford
Hertfordshire
WD18 9SS
UK
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last revised in April 2018.
Distributed by
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Approved Prescription Services Limited
Leeds
LS27 0JG
England