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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 because it contains important
information for you.
■ Keep this leaflet. You may need to read it again.
■ f you have any further questions, ask your doctor
or pharmacist.
■  his 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.
■ f you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Distaclor capsules are and
what they are used for
2. What you need to know before you take
Distaclor capsules
3. How to take Distaclor capsules
4. Possible side effects
5. How to store Distaclor capsules
6. Contents of the pack and other information

1 What Distaclor capsules are and
what they are used for

Other medicines and Distaclor capsules
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
Distaclor capsules contain the active ingredient cefaclor,
including medicines obtained without a prescription.
which is an antibiotic.
This is especially important of the following, as they may
Distaclor capsules are used to treat the following
infections caused by bacteria that can be killed by cefaclor: interact with your Distaclor capsules:
■ warfarin (a blood thinner)
■ Bronchitis
■ probenecid (a treatment for gout).
■ Infection of lung tissue (pneumonia)
It may still be all right for you to be given Distaclor
■ Bladder (cystitis) and kidney infections
capsules and your doctor will be able to decide what is
■ Throat infections including tonsillitis and pharyngitis
suitable for you.
■ Middle ear infections (otitis media)
Pregnancy and breast-feeding
■ Skin and soft tissue (e.g. muscle) infections
If you are pregnant or breast-feeding, think you may be
■ Infection of the sinuses (sinusitis).
pregnant or are planning to have a baby, ask your doctor

2 What you need to know before you take
Distaclor capsules

or pharmacist for advice before taking this medicine.

Driving and using machines
Distaclor capsules should not affect your ability to drive or
use machines.

Do not take Distaclor capsules:
■  f you are allergic to cefaclor, any cephalosporin (other
similar antibiotics) or any of the other ingredients of
3 How to take Distaclor capsules
this medicine (listed in Section 6). An allergic reaction
may include rash, itching, difficulty breathing or swelling Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
of the face, lips, throat or tongue.
pharmacist if you are not sure.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Adults and the elderly:
Distaclor capsules
The usual dose is one capsule taken orally three times a
■  f you have had an allergic reaction to penicillins or
day. Your doctor will tell you if you need a different dose.
other drugs in the past
Patients with a severe kidney disorder or patients
■  f you have a history of gastrointestinal disease,
receiving dialysis may need a reduced dose.
especially inflammation of the colon (colitis)
Use in Children
■  f you have severe kidney problems
Cefaclor capsules are not recommended for children.
Tell your doctor if you are having blood or urine tests.
Distaclor capsules may interfere with these tests.

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. Do not take a
double dose to make up for a forgotten dose.
If you have any further questions on the use of this
medicine, 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:
■ 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)
■  ash with wide spread joint pain and / or stiffness,
swollen lymph glands, fever and, possibly, cloudy urine
■ swollen arms or legs
■ breathlessness

■  hanges

in blood counts, which may show up as
bruising or a very tired feeling. You will need a blood
test to confirm this.
■  amage 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).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme Website:
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Distaclor capsules
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging in order to protect
from light.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last day
of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help to
protect the environment.

6 Contents of the pack and other 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Facta Farmaceutici SpA
Via Laurentina
Km 24,730
Pomezia 00040
This leaflet was last revised in
August 2015

Artwork for:
Flynn Pharma Limited
Product name:
Distaclor Capsules 500mg
PL/PA no:
Type: Leaflet
Artwork dimensions: 160mm x 260mm
Profile supplied: Assumed
Date of first artwork: 27 May 2010
Reason for request:
Revision date edit
Version no:
5 DB
Date of revision:
30 July 2015
As swatch(es)
9pt and 10pt FF Zwo
Artwork software:
InDesign CS5.5
BAC ref: S803


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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.