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CO-AMOXICLAV 250 MG/125 MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN / AMOXICILLIN TRIHYDRATE / CLAVULANIC ACID / POTASSIUM CLAVULANATE / POTASSIUM CLAVULANATE MICROCRYSTALLINE CELLULOSE BLEND

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MICRO LABS LIMITED
Bangalore, INDIA

1) Product

: Amoxicillin / Clavulanic acid Tablets - BBUK & Ireland

2) Strength

: 375 mg / 625 mg

3) Component

: Leaflet

4) No of colours

: 1

5) Dimension

: 135 x 250 mm finished (270 x 250 open) size

6) Artwork Code

: NA

7) Pharma code

: NA

8) Font type and Size

: Arial, 9 pt

Colours used

Black

Colours not for printing
Keylines

9) Technical specification : NA

Code No. :

WOA ü
NA
WA

Reason for change
Approved
By

Contract Giver/
PL holder

Regulatory
Affairs

Revision: 00

Common Leaflet For BBUK & Ireland
Packaging
Development

Production
Head (Site)

Date : 17-10-2017
Head
QC (Site)

Head
QA (Site)

Sign/
Date

135 mm

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google
Play or Apple App Store
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

If you are having blood tests (such as red
blood cell status tests or liver function tests)
or urine tests (for glucose), let the doctor or
nurse know that you are taking Coamoxiclav. This is because Co-amoxiclav
can affect the results of these types of tests.

Film coat
Titanium dioxide (E171)
Hypromellose (E464)
Polyethylene glycol
What Co-amoxiclav looks like and
contents of the pack

500mg/125mg Tablets: White, capsuleshaped film-coated tablet, debossed with 'I
06' on one side and plain on the other.

Keep this medicine out of the sight and
reach of children.
Do not store above 25°C.

The tablets are packaged in aluminium
blister strips consisting of: 4, 5, 6, 7, 8, 10,
12, 14, 15, 16, 20, 21, 25, 30, 35, 40, 50, 100
& 500 tablets
Not all pack sizes may be marketed

Do not take this medicine after the expiry
date which is stated on the carton and
blister strip after EXP. The expiry date refers
to the last day of that month.
Do not take this medicine if you notice any
visible signs of deterioration.
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 Co-amoxiclav tablets contains:
• The active substances are Amoxicillin
Trihydrate and Potassium Clavulanate.,
Diluted
250mg/125mg Tablets: Each film-coated
tablet contains 250mg amoxicillin as
amoxicillin trihydrate and 125mg of
clavulanic acid as potassium clavulanate,
diluted.
500mg/125mg Tablets: Each film-coated
tablet contains 500mg amoxicillin as
amoxicillin trihydrate and 125mg of
clavulanic acid as potassium clavulanate,
diluted.

Marketing Authorisation Holder and
Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
UK & IE: Co-amoxiclav 250mg/125mg Filmc o a t e d Ta b l e t s & C o - a m o x i c l a v
500mg/125mg Film-coated Tablets
SE: Amoxicillin/Clavulanic acid BB
250mg/125mg filmdragerade tabletter &
Amoxicillin/Clavulanic acid BB
500mg/125mg filmdragerade tabletter
This leaflet was last approved on
06.09.2017

• The other ingredients are:
Cellulose, microcrystalline (E460)
Sodium starch glycolate, Type A

Blood and urine tests:

Pharma Code

250mg/125mg Tablets: White, capsule
shaped, film coated tablet debossed with 'I
05' on one side and plain on the other.

5. How to store Co-amoxiclav Tablets

250 mm

Silica, Colloidal anhydrous (E551)
Magnesium Stearate (E572)

135 mm

PL0011AB

Pharma Code

UKI-006/A

Package leaflet: Information for the user

Other medicines and Co-amoxiclav
Tablets

Co-amoxiclav 250mg/125mg film-coated Tablets
Co-amoxiclav 500mg/125mg film-coated Tablets
(Amoxicillin/clavulanic acid)

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. 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
leaflets. See section 4.
What is in this leaflet:
1. What Co-amoxiclav Tablets are and what
they are used for
2. What you need to know before you take
Co-amoxiclav Tablets
3. How to use Co-amoxiclav Tablets.
4. Possible side effects
5. How to store co-amoxiclav tablets
6. Content of the pack and other information
1. What Co-amoxiclav Tablets are and
what they are used for
Co-amoxiclav is an antibiotic and works by
killing bacteria that cause infections. It
contains two different medicines called
amoxicillin and clavulanic acid. Amoxicillin
belongs to a group of medicines called
“penicillins” that can sometimes be stopped
from working (made inactive). The other
active component (clavulanic acid) stops
this from happening.
Co-amoxiclav is used in adults and children
to treat the following infections: 250 mg/125
mg film-coated tablets:
• sinus infections
• urinary tract infections
• skin infections
• dental infections.
500 mg/125 mg film-coated tablets:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including

dental infections
• bone and joint infections.
2. What you need to know before you
take Co-amoxiclav Tablets
Do not take Co-amoxiclav:
• if you are allergic (hypersensitive) to
amoxicillin, clavulanic acid, penicillin or
any of the other ingredients of this
medicine (listed in section 6)
• if you have ever had a severe allergic
(hypersensitive) reaction to any other
antibiotic. This can include a skin rash or
swelling of the face or neck
• if you have ever had liver problems or
jaundice (yellowing of the skin) when
taking an antibiotic.
Do not take Co-amoxiclav if any of the
above apply to you. If you are not sure, talk
to your doctor or pharmacist before taking
Co-amoxiclav Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Co-amoxiclav Tablets if you:
• have glandular fever
• are being treated for liver or kidney
problems
• are not passing water regularly.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before taking these tablets.
In some cases, your doctor may investigate
the type of bacteria that is causing your
infection. Depending on the results, you
may be given a different strength of Coamoxiclav or a different medicine.
Conditions you need to look out for:
Co-amoxiclav can make some existing
conditions worse, or cause serious side
effects. These include allergic reactions,
convulsions (fits) and inflammation of the
large intestine. You must look out for certain
symptoms while you are taking Coamoxiclav, to reduce the risk of any
problems. See 'Conditions you need to look
out for' in Section 4.

250 mm

directly (see details below). By reporting
side effects you can help provide more
information on the safety of this medicine.

135 mm

Tell your doctor or pharmacist if you are
using, have recently used or might use any
other medicines. This includes medicines
that can be bought without a prescription
and herbal medicines.
If you are taking allopurinol (used for gout)
with Co-amoxiclav, it may be more likely that
you will have an allergic skin reaction.
If you are taking probenecid (used for gout),
your doctor may decide to adjust your dose
of Co-amoxiclav.
If medicines to help stop blood clots (such
as warfarin) are taken with Co-amoxiclav
then extra blood tests may be needed.
Co-amoxiclav can affect how methotrexate
(a medicine used to treat cancer or
rheumatic diseases) works.
Co-amoxiclav can affect how
mycophenolate mofetil (a medicine used to
prevent the rejection of transplanted organ)
works.
This medicine contains 0.63 mmol (or
24.632 mg) potassium per tablet. To be
taken into consideration by patients with
reduced kidney function or patients on a
controlled potassium diet.
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
Co-amoxiclav can have side effects and the
symptoms may make you unfit to drive.
Don't drive or operate machinery unless you
are feeling well.
3. How to take Co-amoxiclav Tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
Adults and children weighing 40 kg and
over
250 mg/125 mg film-coated tablets:
The usual dose is 1 tablet three times a day
500 mg/125 mg film-coated tablets:
The usual dose is 1 tablet three times a day
Children weighing less than 40 kg
Co-amoxiclav tablets are not
recommended.

Chidren aged 6 years or less should
preferably be treated with
amoxicillin/clavulanic acid oral suspension
or sachets.
Ask your doctor or pharmacist for advice
when giving Co-amoxiclav tablets to
children weighing less than 40 kg.
Patients with kidney and liver problems
• If you have kidney problems the dose
might be changed. A different strength or
a different medicine may be chosen by
your doctor.
• If you have liver problems you may have
more frequent blood tests to check how
your liver is working.
How to take Co-amoxiclav Tablets
• Swallow the tablets whole with a glass of
water at the start of a meal or slightly
before.
• Space the doses evenly during the day, at
least 4 hours apart. Do not take 2 doses in
1 hour.
• Do not take Co-amoxiclav for more than 2
weeks. If you still feel unwell you should
go back to see the doctor.
If you take more Co-amoxiclav Tablets
than you should
If you take too much Co-amoxiclav Tablets,
signs might include an upset stomach
(feeling sick, being sick or diarrhoea) or
convulsions. Talk to your doctor as soon as
possible. Take th medicine carton or bottle
to show the doctor.
If you forget to take Co-amoxiclav
Tablets
If you forget to take a dose, take it as soon
as you remember. You should not take the
next dose too soon, but wait about 4 hours
before taking the next dose.
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Co-amoxiclav Tablets
Keep taking Co-amoxiclav until the
treatment is finished, even if you feel better.
You need every dose to help fight the
infection. If some bacteria survive they can
cause the infection to come back.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Conditions you need to look out for
Allergic reactions:
• skin rash
• inflammation of blood vessels (vasculitis)

135 mm

which may be visible as red or purple
raised spots on the skin, but can affect
other parts of the body
• fever, joint pain, swollen glands in the
neck, armpit or groin
• swelling, sometimes of the face or mouth
(angioedema), causing difficulty in
breathing
• collapse.
Contact a doctor immediately if you get
any of these symptoms. Stop taking Coamoxiclav Tablets.
Inflammation of large intestine
Inflammation of the large intestine, causing
watery diarrhoea usually with blood and
mucus, stomach pain and/or fever.
Contact your doctor as soon as possible
for advice if you get these symptoms.
Very common side effects
These may affect more than 1 in 10 people
• diarrhoea (in adults).
Common side effects
These may affect up to 1 in 10 people
• thrush (candida - a yeast infection of the
vagina, mouth or skin folds)
• feeling sick (nausea), especially when
taking high doses
If affected take Co-amoxiclav before food
• vomiting.
• diarrhoea (in children)
Uncommon side effects
These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache.
Uncommon side effects that may show up in
your blood tests:
• increase in some substances (enzymes)
produced by the liver
Rare side effects
These may affect up to 1 in 1000 people
• skin rash, which may blister, and looks
like small targets (central dark spots
surrounded by a paler area, with a dark
ring around the edge-erythema
multiforme)
If you notice any of these symptoms contact
a doctor urgently.
Rare side effects that may show up in your

blood tests:
• low number of cells involved in blood
clotting
• low number of white blood cells.
Other side effects
Other side effects have occurred in a very
small number of people but their exact
frequency is unknown.
• Allergic reactions (see above)
• Inflammation of the large intestine (see
above)
• Serious skin reactions:
- a widespread rash with blisters and
peeling skin, particularly around the
mouth, nose, eyes and genitals
(Stevens-Johnson syndrome), and a
more severe form causing extensive
peeling of the skin (more than 30% of
the body surface – toxic epidermal
necrolysis)
- widespread red skin rash with small
pus-containing blisters (bullous
exfoliative dermatitis)
- a red, scaly rash with bumps under the
skin and blisters (exanthemous
pustulosis).
- flu-like symptoms with a rash, fever,
swollen glands, and abnormal blood
test results (including increased white
blood cells (eosinophilia) and liver
enzymes) (Drug Reaction with
Eosinophilia and Systemic Symptoms
(DRESS))
• Inflammation of the protective membrane
sorrunding the brain (aseptic meningitis)
Contact a doctor immediately if you get
any of these symptoms:
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the
blood of bilirubin (a substance produced
in the liver) which may make your skin and
whites of eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses
of Co-amoxiclav Tablets or who have
kidney problems)
• black tongue which looks hairy
Side effects that may show up in your blood
or urine tests:
• severe reduction in the number of white
blood cells
• low number of red blood cells (haemolytic
anaemia)
• crystals in urine.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects

+ Expand Transcript

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.

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