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Active substance(s): CEFACLOR MONOHYDRATE

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Package leaflet: Information for the user

Distaclor granules for
suspension 125mg/5ml
& 250mg/5ml
The name of your medicine is Distaclor Granules for
Suspension 125mg/5ml & 250mg/5ml, which will be
referred to as Distaclor suspension throughout this
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.
■ 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Distaclor suspension is and what it is used for
2. What you need to know before you take
Distaclor suspension
3. How to take Distaclor suspension
4. Possible side effects
5. How to store Distaclor suspension
6. Contents of the pack and other information

1 What Distaclor suspension is and
what it is used for
Distaclor suspension is made from granules of the
active ingredient cefaclor, which is an antibiotic. Your
pharmacist will add fresh clean drinking water to the
bottle containing the granules, to make up the
suspension, before you are given it. Distaclor suspension
is 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 What you need to know before you take
Distaclor suspension
Do not take Distaclor suspension:
■ if you are allergic (hypersensitive) to cefaclor, any
cephalosporin (other similar antibiotics) or any of the
other ingredients of this medicine (listed in Section 6).
An allergic reaction may include rash, itching, difficulty
breathing or swelling of the face, lips, throat or tongue.
Warnings and precautions
Talk to your doctor or pharmacist before taking Distaclor
suspension 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.
Distaclor suspension may interfere with these tests.
Other medicines and Distaclor suspension
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.

This is especially important of the following, as they may
interact with your Distaclor suspension:
■ warfarin (a blood thinner)
■ probenecid (a treatment for gout).
It may still be all right for you to be given Distaclor
suspension and your doctor will be able to decide what
is suitable for you.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist before taking this medicine.
Driving and using machines
Distaclor suspension should not affect your ability to
drive or use machines.
Distaclor suspension contains sucrose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.

3 How to take Distaclor suspension
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
For adults and the elderly the usual dose is 250mg three
times daily. For more severe infections the dose may be
doubled. The maximum daily dose is 4g.
Patients with a severe kidney disorder or patients
receiving dialysis may need a different dose.
Use in children
For children, and babies over the age of one month,
the usual total daily dosage is 20mg/kg (body weight).
This total daily dose is usually divided into three and
given eight hours apart. For throat and middle ear
infections the total daily dose can be divided into two
and given twelve hours apart. For more severe infections
the dose may be doubled. The maximum daily dose is 1g.

If you take more Distaclor suspension than you should
Go to the nearest accident and emergency department
or tell your doctor straight away.
If you forget to take Distaclor suspension
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
medicine, ask your doctor or pharmacist.

■ damage

4 Possible side effects
Like all medicines, this medicine 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
■ measles-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.

to your liver or kidneys which can only be
detected by a blood and / or urine test
jaundice (yellow skin and eyes)
pins and needles in the hands or feet
abnormally excitable behaviour
tight muscles
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 suspension
Keep this medicine out of the sight and reach of children.
Store at room temperature (15-25°C).
Keep containers tightly closed and protect from light.
Do not use this medicine after the expiry date which is
stated on the bottle. The expiry date refers to the last
day of that month.
After it is made up, the suspension should be stored in a
refrigerator (2-8°C) and be used within 14 days.
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 protect the environment.

6 Contents of the pack and other information
What Distaclor suspension contains
■ The active substance is cefaclor 125 or 250mg/5ml
■ The other ingredients are: sucrose, erythrosine
aluminium lake, methylcellulose 15, sodium lauryl
sulphate, artificial strawberry flavour, dimeticone,
xanthan gum F and modified starch.
What Distaclor suspension looks like and
contents of the pack
The product is filled into plastic bottles with screw caps
containing 30 or 100ml of strawberry coloured cefaclor
suspension. The granules may also be filled into
individual laminated sachets.
Not all pack sizes may be marketed.
Facta Farmaceutici SpA
Via Laurentina
Km 24,730
Pomezia 00040
Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
This leaflet was last revised in May 2015

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Flynn Pharma Limited
Distaclor Granules for Suspension 125mg/5ml & 250mg/5ml
PL 13621/0009 & PL 13621/0010
180mm x 254mm
Dimensions supplied
30 September 2008
Text edit
20 May 2015
As swatch(es)
FF Zwo
InDesign CS6


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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.