Keftid 125mg/5ml Suspension
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Each 5 ml of reconstituted suspension contains:
cefador monohydrate Ph Eur equivalentto125mgof cefaclor. For oral administration.
Other ingredients include:
sodium benzoate, Allura Red (E129), sorbitol and aspartame.
KEEP All MEDICINESOUTOFTHE REACH ANDSIGHTOF CHILDREN.
PL 13606/0177
125mg/5ml
SUSPENSION
(CEFACLOR)
MAHolder: Co-pharma Limited Unit4, Metro Centre Tolpits Lane, Watford Herts, UK,WD189SS
Tothepatient:
Take regularlyas directed bythe physician. Shake well before use.
Do not dilute unless instructed. Keep the reconstituted suspension in the fridge (between 2 and 8°C) with the lid tightly closed. Throwawayany suspension that you haven’t used after 14days. Tothepharmacist:
Powder for cefaclor oral suspension 125mg/5ml.
To dispense, add 84ml water, invert bottle and shake well.
Store below25°C in a dry place.
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031676 004929 >y
If you have any further questions on the use ofthis product, askyourdoctoror pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefaclor Suspension can causeside effects, although not everybodygets them.
If you get any of the following side effects you should stop taking Cefaclor and tell your doctor immediately or go to the casualty department of your nearest hospital, as these may designs of aseriousallergicreaction:
• severe skin reactions such as Stevens- Johnson Syndrome- symptoms of a rash with flushing, fever, blisters and ulcers, and Toxic Epidermal Necrolysis- symptoms of reddening, peeling and swelling ofthe skin that resembles burns.
• other skin reactions including itching and red or purple patches
• joint pain
• difficulty breathing or wheezing
• fever
• swelling of the tongue, face, lipsor throat
• feeling Taint accompanied by one or some of the other reactions above
Tell your doctor immediately if you notice the following symptoms as you may require urgent medical attention:
• diarrhoea which becomes severeor contains blood or mucus Rare (affects 1 to 10 users in 10,000)
This medicine may lower the levels of certain blood cells, these will return to normal when you stop taking CefaclorSuspension (symptoms mayincludesore throat, mouth ulcers or feeling weak).
Other rare side effects are kidney problems, raised liver enzymes (which will be seen in a blood test).
Common (affects 1 to 10 users in 100): headache, stomach discomfort, feeling (nausea) or being sick (vomiting), diarrhoea.
Not known (frequency cannot be estimated from the available data): genital Itching, Irritation or inflammation of the vagina, confusion, nervousness, difficulty sleeping, muscle tightness, hyperactivity, seeing and hearing things which are not there (hallucinations), dizziness, drowsiness, jaundice (yellowing ofthe skin and the whites ofthe eyes), liver problems, positive Coomb's test.
If you consider any of these side effects to beseriousor if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOWTO STORE CEFACLORSUSPENSION
Keepout of the reach and sight of children.
Store your Cefaclor Suspension in a refrigerator (between 2”C and 8°C). Store in the original bottle, with the lid tightly closed. Dispose of any suspension that has not been taken after 14 days.
Your pharmacist should not prepare Cefaclor Suspension after the expiry date, which is stated on the label.
Donotuse Cefaclor Suspension If you notice that the bottle is damaged or If the suspension appears to have deteriorated.
Medicines should not be disposed of viawastewaterorhousehold waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cefaclor Suspension contains
The active substance in Cefaclor Suspension is called cefaclor. Each 5ml of suspension contains either 125mg or 250mg of cefaclor as cefaclor monohydrate. The other Ingredients In the suspension are sodium benzoate, silicon dioxide, xanthan gum, sorbitol (E420), aspartame (E951), citric acid (anhydrous), strawberryflavour, banana flavour, pineapple flavour, raspberry flavour, taste modifier and allura red (E129).
What CefaclorSuspension looks like and the contents ofthe pack
Cefaclor Suspension is available as a white toslightly pink coloured dry powder forthe preparation of aplnk fruit flavoured suspension. When prepared bythe pharmacist, each bottleofsuspension contains 100ml.
Marketing Authorisation Holder
Co-pharma Ltd
Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18SS
Manufacturer
AlmacPharma Services Limited
AlmacHouse, 20 Seagoe Industrial Estate, Craigavon, BT635QD, UK
This leaflet was last approved in December2011
Each 5ml of reconstituted suspension contains:
cefaclor monohydrate Ph Eur equivalentto 125mg of cefaclor. For oral administration.
Other ingredients include:
sodium benzoate, Allura Red (E129), sorbitol and aspartame,
KEEP All MEDICINESOUTOFTHE REACH ANDSIGHTOF CHILDREN.
PL 13606/0177
POM
MAHolder: Co-pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Herts,UK,WD18 9SS
125mg/5ml
SUSPENSION
(CEFACLOR)
D 0_
PACKAGE LEAFLET: INFORMATION FORTHE USER
Cefaclor Suspension 125mg/5ml and 250mg/5ml
(Cefaclor Monohydrate)
Read all ofthis leaflet carefully beforeyou starttaking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have anyfurther questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass if on to others. If may harm them, even if their symptoms arefhesame as yours.
• If any of the side effecfsgefs 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 is and what if is used for
2. Beforeyou fake Cefaclor Suspension
3. How to fake CefaclorSuspension
4. Posslbleslde effects
5. Howfosfore Cefaclor Suspension
6. Further information
1. WHAT CEFACLOR IS AND WHAT IT IS USED FOR
The nameoffhis medicine is CefaclorSuspension. Cefaclor Suspension contains the active substance cefaclor, which belongs to agroupof 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. BEFOREYOU TAKE CEFACLORSUSPENSION Do not take CefaclorSuspension
• if you are allergic (hypersensitive) to any cephalosporin antibiotic, such as cefalexin, cefuroxime, cefradineor cefaclor
• if you are allergictoanyoffheotheringredientsof Cefaclor Suspension
• if you sufferfrom porphyria (a rare inherited disorder which affects the blood)
• ifyou have a metabolic disorder called phenylketonuria
Talkfo your doctor before faking this product if anyoffhe above apply to you.
Cefaclorshould not be given to Infants under 1 month old.
Take special care with Cefaclor Suspension
• ifyou are allergicto any penicillin antibiotic, such as penicillin, ampicillin, amoxicillin or flucloxiclllln
• if you have ever suffered from colitis (an inflammation of the bowel)
• ifyou sufferfrom any kidney problems
• ifyou areon kidney dialysis
• ifyou are diabetic (cefaclor can interfere with some urinesugarfests)
Ifanyof fheabove apply to you, if is important that you fell your doctor or pharmacist before faking CefaclorSuspension and they will decide what to do. If may still be safe for you to fake CefaclorSuspension.
Ifyou are having a blood test, if is Important that you tell your doctor that you are taking this medicine as it may affect the result.
Taking other medicines
Please tell your doctor or pharmacist Ifyou are faking or have recently taken anymedicines, including those medicines obtained without a prescription.
This is especially important ifyou are faking:
• a medicine called warfarin (used to thin the blood)
• a medicine called probenecid (used to treat gout)
• combined oral contraceptives (Cefaclor Suspension may reduce the effectiveness of combined oral contraceptives)
If may still be safe for you to fake Cefaclor Suspension; your doctor or pharmacist will be able to adviseyou further.
Pregnancy and breast-feeding
Ifyou are pregnant, think you might be pregnant or are breast-feeding, you should askyour doctororpharmacistfor advice before taking Cefaclor or anyofher medicine.
Driving and using machines
Cefaclor Suspension should not affect your ability to drive and use machines.
Important information for patients with phenylketonuria or an intolerance to some sugars
Cefaclor Suspension contains aspartame (E951), a source of phenylalanine. This may be harmful for people with phenylketonuria, ifyou have phenylketonuria, do not fake Cefaclor Suspension. Please speak to your doctor forfurther advice.
Cefaclor Suspension contains sorbitol (E420). Ifyou have been told byyourdoctorfhatyou have an intolerance fosomesugars, contact your doctor before taking this medicine.
3. HOWTOTAKE CEFACLORSUSPENSION
Always take Cefaclor Suspension exactly as your doctor has fold you. You should check with your doctor or pharmacist ifyou are not sure.
Cefaclor Suspension should betaken by mouth (orally).
The usual dosefor adults and the elderly is250mg every eight hours. In more severe infections the dosage may be doubled to 500mg every eight hours. The usual dose for children will depend on the child's weight. Babies less than one month old should not begiven cefaclor.
Doctors sometimes prescribe different doses to these. If is important to read the label on your medicine, as It will tell you precisely what dose to take.
Ifyou take more CefaclorSuspension than you should
Ifyou fake too much Cefaclor Suspension contact your nearest hospital casualty department or tell your doctoror pharmacist Immediately. Take this leaflet and any remaining suspension with you.
Ifyou forget to take CefaclorSuspension
If you forget to take your medicine, justtake your normal dose assoon asyou remember and then continue as before. Do not fake a double dose to make upforaforgotten dose.
If you stop taking Cefaclor Suspension
Keep taking the medicine until you have finished the full course of treatmentthat your doctor has prescribedforyou. Do not stop faking the medicine, even ifyou feel better. This will make sure that the infection has completely cleared.