DISTACLOR MR TABLETS 375MG
Active substance(s): CEFACLOR MONOHYDRATE / CEFACLOR MONOHYDRATE / CEFACLOR MONOHYDRATE
Distaclor MR Tablets
The name of your medicine is Distaclor MR tablets
375mg, which will be referred to as Distaclor MR tablets
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.
■ If you have any further questions, ask your doctor
■ 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 MR tablets are and
what they are used for
2. What you need to know before you take
Distaclor MR tablets
3. How to take Distaclor MR tablets
4. Possible side effects
5. How to store Distaclor MR tablets
6. Contents of the pack and other information
1 What Distaclor MR tablets are and
what they are used for
Distaclor MR tablets are a long acting tablet. They contain
the active ingredient cefaclor, which is an antibiotic.
Distaclor MR is 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
■ Skin and soft tissue (e.g. muscle) infections
2 What you need to know before you take
Distaclor MR tablets
warfarin (a blood thinner)
probenecid (a treatment for gout).
■ antacids containing magnesium hydroxide or aluminium
hydroxide, for heartburn and indigestion (these can be
bought without prescription).
It may still be all right for you to be given Distaclor MR
tablets 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 for advice before taking this medicine.
Driving and using machines
Distaclor MR tablets should not affect your ability to drive
or use machines.
Do not take Distaclor MR tablets if:
Distaclor MR tablets contain mannitol
■ you are allergic to cefaclor, any cephalosporin (other
Mannitol may have a mild laxative effect.
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 3 How to take Distaclor MR tablets
of the face, lips, throat or tongue.
Always take this medicine exactly as your doctor or
Warnings and precautions
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Talk to your doctor or pharmacist before taking
Distaclor MR tablets
The tablets should not be cut, crushed or chewed.
■ if you have had an allergic reaction to penicillins or
other drugs in the past
Adults and the elderly:
■ if you have diarrhoea while taking antibiotics
For pharyngitis, bronchitis, tonsillitis, lower urinary tract
Tell your doctor if you are having blood or urine tests.
infections, and skin infections, the usual dose is 375mg
Distaclor capsules may interfere with these tests.
(one tablet) taken orally twice daily.
Other medicines and Distaclor MR tablets
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 MR tablets:
For pneumonia, the usual dose is 750mg (two tablets)
taken orally twice daily.
Patients with a severe kidney disorder or patients
recieving dialysis may need a different dose.
Use in Children
Distaclor MR tablets are not recommended for children.
If you take more Distaclor MR tablets than you should
Go to the nearest accident and emergency department or
tell your doctor straight away.
If you forget to take Distaclor MR tablets
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 MR tablets 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
■ feeling sick (nausea)
■ measle-like rash, (alone)
■ 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
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)
pins and needles in the hands or feet
abnormally excitable behaviour
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 MR tablets
Keep this medicine out of the sight and reach of children.
Store between 15°C and 25°C.
Store in the original container in order to protect
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 MR tablets contain
The active substance is cefaclor.
The other ingredients are:
hydroxypropylcellulose, methacrylic acid copolymer,
stearic acid, magnesium stearate, titanium dioxide (E171),
polyethylene glycol, propylene glycol, indigo carmine
aluminium lake (E132) and talc.
What Distaclor MR tablets look like and
contents of the pack
Distaclor MR is a blue, capsule-shaped, film-coated tablet
Distaclor MR is packaged in foil blister packs of 2 or 14.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Flynn Pharma Ltd
4 Herbert Street
Facta Farmaceutici SpA
This leaflet was last revised in
Date of first artwork:
Reason for request:
Date of revision:
Flynn Pharma Limited
Distaclor MR Tablets 375mg
160mm x 260mm
Revision date edit
30 July 2015
9pt and 10pt FF Zwo
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.