Keftid 125mg/5ml Suspension
r
Each 5ml cf reconstituted suspension contain
cefedor monohydrate Ph Eur equivalent to 125mg of cefaclor, For oral administration.
Other ingredients include:
sodium benzoate, Allura Red (E129), sorbitol and aspartame.
KEEP AU MEDICINES OUT OF THE REACH AND SKiHT OF CHILDREN.
PL13605D177
MA Holder Co-pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Herts, UK, WD189SS
Keftid is a Trade Marie
POM
125mg/5ml
SUSPENSION
(CEFACLOR
To the patient:
Take regularly as directed by the physician. Shake well before use.
Do not dilute unless instructed. Keep the reconstituted suspension in tne fridge (between 2 and 8°C) with the lid tightly closed.
Throw away any suspension that you haven't used after 14 days, to the pharmacist:
Powder for cefaclor oral suspension 125mg/5ml.
To dispense, add 84ml water, invert bottle and shake well.
Store below 25^ in a dry place.
PL255/5
v
If you have any further questions on the use ofthls product, askyourdoctoror pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Keftid Suspension can cause side effects, although not everybody gets them.
If you get any of the following side effects you should stop faking Keftid and tell your doctor immediately or go to the casualty department of your nearest hospital, as these may designs of aseriousallergicreaction:
•
flushing, fever, blisters and ulcers, and Toxic Epidermal Necrolysis- symptoms of reddening, peeling and swelling of the skin that resembles burns.
•
Tell your doctor immediately if you notice the following symptoms as you may require urgent medical attention:
•
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 oftheskin and the whites of the 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 i n this leaflet, please tell your doctor or pharmacist.
5. HOWTO STORE KEFTID SUSPENSION
Keepoutofthe reach and sightof children.
Store your Keftid Suspension in a refrigerator (between 2°C and 8°C). Store in the original bottle, with thelid tightly closed. Dispose of any suspension that has not been taken after 14 days.
Your pharmacist should not prepare Keftid Suspension after the expiry date, which is stated on the label.
Do not use Keftid 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 Keftid Suspension contains
The active substance in Keftid 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 Keftid Suspension looks like and the contents of the pack
Keftid Suspension is available as a white to slightly pink coloured dry powderforthe preparation ofapinkfruitflavoured suspension. When prepared by the pharmacist, each Pottleofsuspension 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 equivalent to 125mg of cefedor. For oral administration.
Other ingredients include: sodium benzoate, Allura Red (E129), sorbitol and aspartame.
KEEP ALL MEDIQNES OUT Of THE REACH AND SIGKT OF CHILDREN
PL 13606/0177
MA Holder:
Co-pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Herts, UK, WD18 9SS
Keftid is a Trade Mark.
POM
125mg/5ml
SUSPENSION
(CEFACLOR)
D DC
S?
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. 2
PACKAGE LEAFLET: INFORMATION FORTHE USER
Keftid Suspension and 250mg/5ml
(Cefaclor Monohydrate)
Read all of this leaflet carefully betoreyou starttaking this medicine.
them, even if their symptoms arethesame as yours, leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Keftid is and what it is used for
2. Before you take Keftid Suspension
3. How to take Keftid Suspension
4. Possible side effects
5. Howtostore Keftid Suspension
6. Further information
1. WHAT KEFTID ISANDWHAT IT IS USED FOR
The name of this medicine is Keftid Suspension. Keftid 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 KEFTID SUSPENSION Do not take Keftid Suspension
cefuroxime, cefradineor cefaclor
•
Talkto your doctor before taking this product if anyoffhe above apply to you.
Keftid should not be given to infants under 1 month old.
Take special care with Keftid Suspension •
fucloxicillin
•
If anyoffhe aboveapplyfoyou, if is Important that you tell your doctor or pharmacist before faking Keftid Suspension and they will decidewhatto do. It may still besafeforyouto take Keftid Suspension.
If you 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 tellyour doctor or pharmacist Ifyou are taking or have recently taken anymedicines, including those medicines obtained without a prescription.
This is especially important ifyou are faking:
•
combined oral contraceptives)
If may still besafeforyou to fake Keftid Suspension; your doctoror 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 doctoror pharmaastfor advice before taking Keftid or any other medicine.
Driving and using machines
Keftid Suspension should not affect your ability to drive and use machines.
Important information for patients with phenylketonuria or an intolerance to some sugars
Keitid Suspension contains aspartame (E951), a source of phenylalanine. This may be harmful for people with phenylketonuria. If you have phenylketonuria, do not fake keftid Suspension. Please speak to your doctor forfurther advice.
Keftid Suspension contains sorbitol (E420). Ifyou have been fold byyour doctor that you have an intolerance fosomesugars, contact your doctor before taking this medicine.
3. HOWTOTAKE KEFTID SUSPENSION
Always take Keftid Suspension exactly as your doctor has told you. You should checkwith your doctoror pharmacist ifyou are not sure.
Keftid Suspension should be taken orally (by mouth).
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 itwill tellyou precisely what dose to take.
Ifyou take more Keftid Suspension than you should
Ifyou take too much Keftid Suspension contact your nearest hospital casualty department tell yourdoctor or pharmacist immediately. Take this leaflet and anyremaining suspension with you.
Ifyou forget to take Keftid Suspension
If you forget to take your medicine, justtake your normal dose assoon asyou remember and then continue as before. Do not take a double dose to make upforaforgotten dose.
Ifyou stop taking Keftid Suspension
Keep taking the medicine until you have finished the full course of treatmentthat your doctor has prescribedforyou. Do not stop taking the medicine, even ifyou feel better. This will make sure that the infection has completely cleared.