Cefaclor Capsules 500mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Keftid Capsules 250mg and 500mg
(Cefaclor Monohydrate)
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 or nurse.
- 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 side effects not listed. See section 4.
What is in this leaflet:
1. What Keftid is and what it is used for
2. What you need to know before you take Keftid Capsules
3. How to take Keftid Capsules
4. Possible side effects
5. How to store Keftid Capsules
6. Contents of the pack and other information
1. WHAT KEFTID IS AND WHAT IT IS USED FOR
This medicine is called Keftid Capsules. Keftid Capsules contain 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 KEFTID CAPSULES
Do not take Keftid Capsules
- if you are allergic (hypersensitive) to any cephalosporin antibiotic, such as cefalexin, cefuroxime, cefradine or cefaclor
- if you are allergic to any of the other ingredients of Keftid Capsules
- if you suffer from porphyria (a rare inherited disorder which affects the blood)
Talk to your doctor before taking this product if any of the above apply to you. Keftid should not be given to infants under 1 month old.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Keftid Capsules:
- if you are allergic to any penicillin antibiotic, such as penicillin, ampicillin, amoxicillin or flucloxicillin
- if you have ever suffered from colitis (an inflammation of the bowel)
- if you suffer from any kidney problems
- if you are on kidney dialysis
- if you are diabetic (cefaclor can interfere with some urine sugar tests)
If any of the above apply to you, it is important that you tell your doctor or pharmacist before taking Keftid Capsules and they will decide what to do. It may still be safe for you to take Keftid Capsules.
If you are having a blood test, it is important to tell your doctor that you are taking this medicine as it may affect the result.
Other medicines and Keftid Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking:
- warfarin (used to thin the blood)
- a medicine called probenecid (used to treat gout)
- combined oral contraceptives (Keftid Capsules may reduce the effectiveness of combined oral contraceptives)
- antacids to treat indigestion and heartburn.
It may still be safe for you to take Keftid Capsules; your doctor or pharmacist will be able to advise you further.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, or are breast-feeding, you should ask your doctor or pharmacist for advice before taking Keftid or any other medicine.
Driving and using machines
Keftid Capsules should not affect your ability to drive and use machines.
3. HOW TO TAKE KEFTID CAPSULES
Always take Keftid Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Keftid Capsules should be taken by mouth (orally).
The usual 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.
The usual 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 Keftid Capsules than you should
If you take too many capsules contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any remaining capsules with you.
If you forget to take Keftid Capsules
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 Keftid Capsules
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects you should stop taking Keftid and tell your doctor immediately or go to the casualty department of your nearest hospital, as these may be signs of a serious allergic reaction:
■ 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 of the 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, lips or throat
■ feeling faint accompanied by one or some of the other reactions above
Tell your doctor immediately if you notice the following as you may require urgent medical attention:
■ diarrhoea which becomes severe or 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 Keftid Capsules (symptoms may include sore 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, fungal infection of the vagina ( vaginal moniliasis), confusion, nervousness, difficulty sleeping, muscle tightness, hyperactivity, seeing and hearing things which are not there (hallucinations), dizziness, drowsiness, jaundice (yellowing of the skin and the whites of the eyes), liver problems, positive Coomb’s test.
Seizures have been reported with this type of medicine.
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: 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 KEFTID CAPSULES
Keep out of the sight and reach of children.
Do not use Keftid Capsules after the expiry date, which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
Store your capsules below 25oC. Store in the original packaging in order to protect the capsules from light and moisture.
Do not use Keftid Capsules if you notice that the pack or any of the capsules are damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Keftid Capsules contain
The active substance in Keftid Capsules is called cefaclor. The capsules contain either 250mg or 500mg of cefaclor as cefaclor monohydrate. The other ingredients are pregelatinised maize starch, silicon dioxide and magnesium stearate. The capsule shells are made of gelatin and contain indigotine (E132), erythrosine (E127), black iron oxide (E172) and titanium dioxide (E171) as colouring agents. The printing ink on the capsule shells contains shellac, propylene glycol, strong ammonia solution and yellow iron oxide (E172).
What Keftid Capsules look like and the contents of the pack
Keftid Capsules 250mg are purple and white hard gelatin capsules with ‘CEF250’ printed in gold.
Keftid Capsules 500mg are purple and grey hard gelatin capsules with ‘CEF500’ printed in gold.
Keftid Capsules 250mg and 500mg are available in packs containing 3, 15, 21, 50 and 100 capsules. Not all pack sizes may be marketed. (Delete this section as appropriate.)
Marketing Authorisation Holder
Co-pharma Ltd Unit 4 Metro Centre Tolpits Lane Watford Hertfordshire WD1 8SS
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
This leaflet was last revised in September 2015