Cefaclor 500mg Capsules
Package leaflet: Information for the user
Cefaclor Capsules 500mg
Cefaclor
Read all of this leaflet carefully before you start
taking this medicine.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects gets 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 capsules are and what they are used for
2. Before you take Cefaclor capsules
3. How to take Cefaclor capsules
4. Possible side effects
5. How to store Cefaclor capsules
6. Further information
1 What Cefaclor capsules are and what they are used for
Cefaclor capsules contain the active ingredient cefaclor, which is an antibiotic.
Cefaclor capsules are used to treat the following infections caused by bacteria that can be killed by cefaclor:
■ Bronchitis
■ Infection of lung tissue (pneumonia)
■ Bladder (cystitis) and kidney infections
■ Throat infections including tonsillitis and pharyngitis
■ Middle ear infections (otitis media)
■ Skin and soft tissue (e.g. muscle) infections
■ Infection of the sinuses (sinusitis).
2 Before you take Cefaclor capsules
Do not take Cefaclor capsules if
■ you are allergic (hypersensitive) to cefaclor, any cephalosporin (other similar antibiotics) or any of the other ingredients of Cefaclor capsules (these are listed in Section 6 of this leaflet). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
Take special care with Cefaclor capsules if you
■ have had an allergic reaction to penicillins or other drugs in the past
■ have a history of gastrointestinal disease, especially inflammation of the colon (colitis)
■ have severe kidney problems
Tell your doctor if you are having blood or urine tests. Cefaclor capsules may interfere with these tests.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is especially important of the following, as they may interact with your Cefaclor capsules:
■ warfarin (a blood thinner)
■ probenecid (a treatment for gout).
It may still be all right for you to be given Cefaclor capsules and your doctor will be able to decide what is suitable for you.
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant or breast-feeding. Ask your doctor or pharmacist before taking any medication.
Driving and using machines
Cefaclor capsules should not affect your ability to drive or use machines.
3 How to take Cefaclor capsules
Always take Cefaclor capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
Adults and the elderly:
The usual dose is one capsule taken orally three times a day. Your doctor will tell you if you need a different dose.
Patients with a severe kidney disorder or patients receiving dialysis may need a reduced dose.
Children:
Cefaclor capsules are not recommended for children.
If you take more Cefaclor capsules than you should
Go to the nearest accident and emergency department or tell your doctor straight away.
FLYNN
PHARMA
LTD
If you forget to take Cefaclor capsules
If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Cefaclor capsules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. 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 them:
■ serious peeling or blistering of the skin
■ severe diarrhoea, possibly with blood or mucus.
The following side effects have been reported
■ diarrhoea
■ feeling sick (nausea)
■ vomiting
■ measle-like rash, (alone)
■ itching
■ red wheals on the skin (urticaria) (alone)
■ rash with wide spread joint pain and / or stiffness, swollen lymph glands, fever and, possibly, cloudy urine
■ swollen arms or legs
■ breathlessness
■ 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 liver or kidneys which can only be detected by a blood and / or urine test
■ jaundice (yellow skin and eyes)
■ weakness
■ pins and needles in the hands or feet
■ fainting
■ abnormally excitable behaviour
■ agitation
■ nervousness
■ sleeplessness
■ confusion
■ tight muscles
■ dizziness
■ seeing or hearing things (hallucinations)
■ itching of the vagina caused by thrush (candidiasis).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 How to store Cefaclor capsules
Cefaclor capsules should be kept out of the sight and reach of children.
Do not store above 2 5°C.
Store in the original packaging and protect from light. 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.
What Cefaclor capsules contain
The active substance is cefaclor.
The other ingredients are: magnesium stearate, dimeticone, starch flowable, erythrosine, patent blue V, black iron oxide, titanium dioxide and gelatin.
What Cefaclor capsules look like and contents of the pack
Cefaclor capsules are purple and grey capsules.
Cefaclor capsules come in plastic bottles with screw caps containing 20, 50 and 100 capsules or foil blister packs containing 14 or 21 capsules.
Manufacturer
Facta Farmaceutici SpA Via Laurentina Km 24,730 Pomezia 00040 Rome Italy.
Marketing Authorisation Holder
Flynn Pharma Ltd Alton House 4 Herbert Street Dublin 2 Ireland.
This leaflet was last revised in
December 2007
F5100319