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Package leaflet: Information for the user

Distaclor Capsules 500mg
The name of your medicine is Distaclor Capsules 500mg,
which will be referred to as Distaclor capsules throughout
this document.
Read all of this leaflet carefully before you start
taking this medicine.
I Keep this leaflet. You may need to read it again.
I If you have any further questions, ask your doctor or
I 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.
I 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 Distaclor capsules are and
what they are used for
2. Before you take Distaclor capsules
3. How to take Distaclor capsules
4. Possible side effects
5. How to store Distaclor capsules
6. Further information

1 What Distaclor capsules are and
what they are used for
Distaclor capsules contain the active ingredient cefaclor,
which is an antibiotic.
Distaclor capsules are used to treat the following
infections caused by bacteria that can be killed by cefaclor:


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 Distaclor capsules
Do not take Distaclor capsules if
I you are allergic (hypersensitive) to cefaclor, any
cephalosporin (other similar antibiotics) or any of the
other ingredients of Distaclor 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 Distaclor capsules if you
I have had an allergic reaction to penicillins or other
drugs in the past
I have a history of gastrointestinal disease, especially
inflammation of the colon (colitis)
I have severe kidney problems
Tell your doctor if you are having blood or urine tests.
Distaclor 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 Distaclor capsules:
I warfarin (a blood thinner)
I probenecid (a treatment for gout).

It may still be all right for you to be given Distaclor
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 breastfeeding. Ask your doctor or pharmacist before taking
any medication.
Driving and using machines
Distaclor capsules should not affect your ability to drive or
use machines.

3 How to take Distaclor capsules
Always take Distaclor capsules exactly as your doctor has
told you. You should check with your doctor or pharmacist
if you are not sure.
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.
Distaclor capsules are not recommended for children.
If you take more Distaclor capsules than you should
Go to the nearest accident and emergency department or
tell your doctor straight away.
If you forget to take Distaclor 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, Distaclor 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:
I serious peeling or blistering of the skin
I severe diarrhoea, possibly with blood or mucus.
The following side effects have been reported
I diarrhoea
I feeling sick (nausea)
I vomiting
I measle-like rash, (alone)
I itching
I red wheals on the skin (urticaria) (alone)
I rash with wide spread joint pain and / or stiffness,
swollen lymph glands, fever and, possibly, cloudy urine
I swollen arms or legs
I breathlessness
I changes in blood counts, which may show up as bruising
or a very tired feeling. You will need a blood test to
confirm this.
I damage to your liver or kidneys which can only be
detected by a blood and / or urine test
I jaundice (yellow skin and eyes)
I weakness
I pins and needles in the hands or feet

abnormally excitable behaviour
I agitation
I nervousness
I sleeplessness
I confusion
I tight muscles
I dizziness
I seeing or hearing things (hallucinations)
I 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 Distaclor capsules
Distaclor capsules should be kept out of the sight and
reach of children.
Do not store above 25°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.

6 Further information
What Distaclor 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 Distaclor capsules look like and
contents of the pack
Distaclor capsules are purple and grey capsules.
Distaclor capsules come in plastic bottles with screw caps
containing 20, 50 and 100 capsules or foil blister packs
containing 14 or 21 capsules.
Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
This leaflet was last revised in
December 2007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.