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CO-AMOXICLAV 250/125MG TABLETS

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Co-Amoxiclav 250/125 mg Tablets

(Amoxicillin and Clavulanic acid)

Read all of this leaflet carefully before you start taking this medicine.
• 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 (or for your child). Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• 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 Co-Amoxiclav is and what it is used for
2. Before you take Co-Amoxiclav
3. How to take Co-Amoxiclav
4. Possible side effects
5. How to store Co-Amoxiclav
6. Further information

1

• If you are taking allopurinol (used for gout) with Co-amoxiclav,
you may be more likely to 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 may affect how mycophenolate mofetil (a
medicine used to prevent the rejection of transplanted
organs) works.

What Co-Amoxiclav is and what it is 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 substance
(clavulanic acid) stops this from happening.
Co-Amoxiclav is used in adults and children to treat the
following infections:
• sinus infections
• urinary tract infections
• skin infections
• dental infections.

2

Taking Co-Amoxiclav with food and drink
It is recommended that you take Co-Amoxiclav 250/125 mg
Tablets at the start of meals to reduce any possible digestive
discomfort.

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are
breast-feeding, please tell your doctor or pharmacist.

Before you take Co-Amoxiclav

This medicine passes into breast milk in small quantities and
may affect breast-fed infants. Ask your doctor for further advice.

Do not take Co-Amoxiclav:
• if you are allergic (hypersensitive) to amoxicillin, clavulanic
acid, penicillin, or any of the other ingredients of
Co-Amoxiclav (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.

Driving and using machines
Co-Amoxiclav can have side effects and the symptoms, such as
dizziness, may make you unfit to drive. Don’t drive or operate
machinery unless you are sure you are not affected.

3

Do not take this medicine if any of the above applies to you. If
you are not sure, talk to your doctor or pharmacist before taking
Co-Amoxiclav.

Always take Co-Amoxiclav 250/125 mg Tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

Take special care with Co-Amoxiclav:
Talk to your doctor or pharmacist before taking Co-amoxiclav if
you:
• have glandular fever
• are being treated for liver or kidney problems
• are not passing water regularly.

Adults and children weighing 40 kg and over
The usual dose is:
One tablet three times a day. Space the doses evenly during the
day, at least 4 hours apart. Do not take 2 doses in 1 hour.
Swallow each tablet whole with a glass of water at the start of a
meal or slightly before. Do not break, crush or divide a tablet in
half.

If you are not sure if any of the above applies to you, speak to
your doctor or pharmacist before taking Co-amoxiclav. 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 Co-amoxiclav or a different medicine.

Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with
Co-Amoxiclav oral suspension or sachets.

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 this
medicine to reduce the risk of any problems. See ‘Conditions
you need to look out for’ see section 4.

Co-Amoxiclav tablets are not recommended.

Patients with kidney and liver problems
• If you have kidney problems the dose might be changed. A
different strength or 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.

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

Haemodialysis Patients
Two Co-Amoxiclav 250/125 mg Tablets every 24 hours, during
and at the end of the dialysis.

Do not take this medicine for more than 2 weeks. If you still feel
unwell you should speak to your doctor.

Using other medicines
Please tell your doctor or pharmacist if you are using or have
recently used any other medicines. This includes medicines that
can be bought without a prescription and herbal medicines.

draft: 44045260, 44045205
laetus code: 0000
mat.no.: 00000000

How to take Co-Amoxiclav

Continued on the next page >>

Artwork Proof Box
Ref: V049: SL BROMI to register new leaflet size
Proof no.
006.0

Date prepared:
22/12/2017

Colours:
Black
Dimensions: 165 x 310 mm

Font size:
7pt
Fonts:
Helvetica

If you take more Co-Amoxiclav than you should:
If you take too much of this medicine, signs of an overdose are:
feeling or being sick, diarrhoea, abdominal pain, convulsions
(fits). Talk to your doctor as soon as possible. Take the medicine
carton or blister strip with you to show the doctor.

• hyperactivity
• convulsions (in people taking high doses of Co-amoxiclav or
who have kidney problems)
• black tongue which looks hairy
Side effects that may show up in blood or urine tests:
• severe reduction in the numbers of white blood cells
• a low number of red blood cells (haemolytic anaemia)
• crystals in the urine

If you forget to take Co-Amoxiclav:
If you forget to take a dose of this medicine, take the forgotten
dose as soon as you remember. But do not take the next dose
too soon, there must be a minimum of 4 hours between two
doses. Do not take a double dose to make up for the forgotten
individual dose.

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 directly via the Yellow
Card Scheme (www.mhra.gov.uk/yellowcard) or search for
MHRA Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information on
the safety of this medicine.

If you stop taking Co-Amoxiclav:
Keep taking this medicine until the treatment is finished, even if
you feel better. If you stop taking this medicine too soon, the
infection may come back. Also, the bacteria may become
resistant to the medicine. If you have any further questions on
the use of this product, ask your doctor or pharmacist.

4

5

Possible side effects

How to store Co-Amoxiclav

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original container.

Like all medicines, Co-Amoxiclav can cause side effects,
although not everybody gets them.

Do not use Co-amoxiclav after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.

If any of the following side effects occur, stop taking
Co-amoxiclav and go to the hospital at once

Do not use Co-Amoxiclav if the tablets are chipped or damaged.

• Allergic reactions such as:
- skin rash
- inflammation of blood vessels (vasculitis) 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
• Serious skin reactions such as:
- 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 blistering
(exanthemous pustulosis)
- flu-like symptoms with a rash, fever, swollen glands, and
ab normal blood test results (including increased white
blood cells (eosinophilia) and liver enzymes)
(Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS))
- a skin rash which may blister and looks like a small target
(a central dark spot surrounded by a paler area, with a dark
ring around the edge- erythema multiforme)
• Inflammation of the large intestine causing watery diarrhoea
usually with blood and mucus, stomach pain and /or fever
• Inflammation of the protective membrane surrounding the
brain (aseptic meningitis)
• Jaundice, caused by increased bilirubin in the blood (a
substance produced in the liver) which may make your skin
and whites of the eyes appear yellow

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 Co-amoxiclav contains:

The active substances are amoxicillin and clavulanic acid.
• 250 mg amoxicillin as amoxicillin trihydrate
• 125 mg clavulanic acid as potassium clavulanate

Other ingredients are: Magnesium stearate (E572), povidone,
talc, croscarmellose sodium, microcrystalline cellulose, triethyl
citrate, ethyl cellulose, sodium lauryl sulphate, cetyl alcohol,
hypromellose, and titanium dioxide (E171).

What Co-amoxiclav looks like and contents of the pack:
Each tablet is oblong, convex and off-white in colour. The tablets
are scored on both sides. Co-amoxiclav 250/125 mg Tablets are
supplied in blister packs of 15 or 21 tablets and hospital packs
of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria.
The leaflet was last revised in 12/2017.

Very common side effects - (affect more than 1 in 10 people)
• diarrhoea (in adults)

Common side effects - (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 dosages if affected take Co-amoxiclav before food
• vomiting (being sick)
• diarrhoea (children).
Uncommon side effects - (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 blood tests:
• increase in some substances (enzymes) produced by the liver.

Rare side effects that may show up in your blood tests (affect up
to 1 in 1,000 people):
• low number of cells involved in blood clotting
• low number of white blood cells

draft: 44045260, 44045205
laetus code: 0000
mat.no.: 00000000

Other side effects
Other side effects have occurred in a very small number of
people but their exact frequency is unknown
• inflammation of the liver (hepatitis)
• inflammation of tubes in the kidneys
• blood takes longer to clot

00000000
SZ00000LT000

Artwork Proof Box
Ref: V049: SL BROMI to register new leaflet size
Proof no.
006.0

Date prepared:
22/12/2017

Colours:
Black
Dimensions: 165 x 310 mm

Font size:
7pt
Fonts:
Helvetica

PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Co-Amoxiclav 250/125 mg Tablets

(Amoxicillin and Clavulanic acid)

Read all of this leaflet carefully before you start taking this medicine.
• 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 (or for your child). Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• 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 Co-Amoxiclav is and what it is used for
2. Before you take Co-Amoxiclav
3. How to take Co-Amoxiclav
4. Possible side effects
5. How to store Co-Amoxiclav
6. Further information

1

• If you are taking allopurinol (used for gout) with
Co-amoxiclav, you may be more likely to 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 may affect how mycophenolate
mofetil (a medicine used to prevent the rejection
of transplanted organs) works.

What Co-Amoxiclav is and what it is
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 substance
(clavulanic acid) stops this from happening.
Co-Amoxiclav is used in adults and children to treat
the following infections:
• sinus infections
• urinary tract infections
• skin infections
• dental infections.

2

Taking Co-Amoxiclav with food and drink
It is recommended that you take Co-Amoxiclav
250/125 mg Tablets at the start of meals to reduce
any possible digestive discomfort.

Before you take Co-Amoxiclav

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are
breast-feeding, please tell your doctor or pharmacist.

Do not take Co-amoxiclav:
• if you are allergic (hypersensitive) to amoxicillin,
clavulanic acid, penicillin, or any of the other
ingredients of Co-amoxiclav (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.

This medicine passes into breast milk in small
quantities and may affect breast-fed infants. Ask
your doctor for further advice.

Driving and using machines
Co-Amoxiclav can have side effects and the
symptoms, such as dizziness, may make you unfit to
drive. Don’t drive or operate machinery unless you
are sure you are not affected.

3

Do not take this medicine if any of the above applies
to you. If you are not sure, talk to your doctor or
pharmacist before taking Co-Amoxiclav.
Take special care with Co-Amoxiclav:
Talk to your doctor or pharmacist before taking
Co-amoxiclav if you:
• have glandular fever
• are being treated for liver or kidney problems
• are not passing water regularly.

Always take Co-Amoxiclav 250/125 mg Tablets
exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg and over
The usual dose is:
One tablet three times a day. Space the doses
evenly during the day, at least 4 hours apart. Do not
take 2 doses in 1 hour. Swallow each tablet whole
with a glass of water at the start of a meal or slightly
before. Do not break, crush or divide a tablet in half.

If you are not sure if any of the above applies to you,
speak to your doctor or pharmacist before taking
Co-amoxiclav. 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 Co-amoxiclav or a different medicine.

Children weighing less than 40 kg
Children aged 6 years or less should preferably be
treated with Co-Amoxiclav oral suspension or sachets.

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 this medicine to
reduce the risk of any problems. See ‘Conditions you
need to look out for’ see section 4.

Co-Amoxiclav tablets are not recommended.

Patients with kidney and liver problems
• If you have kidney problems the dose might be
changed. A different strength or 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.

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

Haemodialysis Patients
Two Co-Amoxiclav 250/125 mg Tablets every 24
hours, during and at the end of the dialysis.

Using other medicines
Please tell your doctor or pharmacist if you are using
or have recently used any other medicines. This
includes medicines that can be bought without a
prescription and herbal medicines.

draft: 981448, 982465
laetus code: 000
mat.no.: 00000000

How to take Co-Amoxiclav

Do not take this medicine for more than 2 weeks. If
you still feel unwell you should speak to your doctor.
Continued on the next page >>

00000000

Artwork Proof Box
Ref: V048: PIL, SPC updates to align with PRAC recommendations
Proof no.
005.0

Date prepared:
10/10/2017

Colours:
Black
Half-tone 20%
Dimensions: 140 x 315 mm

Font size:
7pt
Fonts:
Helvetica

Other side effects
Other side effects have occurred in a very small
number of people but their exact frequency is
unknown
• inflammation of the liver (hepatitis)
• inflammation of tubes in the kidneys
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of
Co-amoxiclav or who have kidney problems)
• black tongue which looks hairy

If you take more Co-Amoxiclav than you should:
If you take too much of this medicine, signs of an
overdose are: feeling or being sick, diarrhoea,
abdominal pain, convulsions (fits). Talk to your
doctor as soon as possible. Take the medicine
carton or blister strip with you to show the doctor.

If you forget to take Co-Amoxiclav:
If you forget to take a dose of this medicine, take the
forgotten dose as soon as you remember. But do not
take the next dose too soon, there must be a minimum
of 4 hours between two doses. Do not take a double
dose to make up for the forgotten individual dose.

Side effects that may show up in blood or urine tests:
• severe reduction in the numbers of white blood
cells
• a low number of red blood cells (haemolytic
anaemia)
• crystals in the urine

If you stop taking Co-Amoxiclav:
Keep taking this medicine until the treatment is
finished, even if you feel better. If you stop taking this
medicine too soon, the infection may come back.
Also, the bacteria may become resistant to the
medicine. If you have any further questions on the
use of this product, ask your doctor or pharmacist.

4

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 directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard) or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.

Possible side effects

Like all medicines, Co-Amoxiclav can cause side
effects, although not everybody gets them.

If any of the following side effects occur, stop
taking Co-amoxiclav and go to the hospital at once

• Allergic reactions such as:
- skin rash
- inflammation of blood vessels (vasculitis) 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
• Serious skin reactions such as:
- 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
blistering (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))
- a skin rash which may blister and looks like a
small target (a central dark spot surrounded by
a paler area, with a dark ring around the
edge- erythema multiforme)
• Inflammation of the large intestine causing watery
diarrhoea usually with blood and mucus, stomach
pain and /or fever
• Inflammation of the protective membrane
surrounding the brain (aseptic meningitis)
• Jaundice, caused by increased bilirubin in the
blood (a substance produced in the liver) which
may make your skin and whites of the eyes
appear yellow
Very common side effects - (affect more than 1 in
10 people)
• diarrhoea (in adults)

5

How to store Co-Amoxiclav

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original
container.

Do not use Co-amoxiclav after the expiry date which
is stated on the carton. The expiry date refers to the
last day of that month.

Do not use Co-Amoxiclav if the tablets are chipped
or damaged.

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 Co-Amoxiclav contains:
The active substances are amoxicillin and clavulanic
acid.
• 250mg amoxicillin as amoxicillin trihydrate
• 125mg clavulanic acid as potassium clavulanate
Other ingredients are: Magnesium stearate (E572),
povidone, talc, croscarmellose sodium,
microcrystalline cellulose, triethyl citrate, ethyl
cellulose, sodium lauryl sulphate, cetyl alcohol,
hypromellose, and titanium dioxide (E171).

What Co-Amoxiclav looks like and contents of
the pack:
Each tablet is oblong, convex and off-white in colour.
The tablets are scored on both sides. Co-Amoxiclav
250/125 mg Tablets are supplied in blister packs of
15 or 21 tablets and hospital packs of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer:
Sandoz GmbH,
Biochemiestrasse 10,
6250 Kundl, Austria.

Common side effects - (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
dosages - if affected take Co-amoxiclav before food
• vomiting (being sick)
• diarrhoea (children).

The leaflet was last revised in 10/2017.

Uncommon side effects - (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 blood tests:
• increase in some substances (enzymes)
produced by the liver.

draft: 981448, 982465
laetus code: 000
mat.no.: 00000000

Rare side effects that may show up in your blood
tests (affect up to 1 in 1,000 people):
• low number of cells involved in blood clotting
• low number of white blood cells

00000000 SZ00000LT000

Artwork Proof Box
Ref: V048: PIL, SPC updates to align with PRAC recommendations
Proof no.
005.0

Date prepared:
10/10/2017

Colours:
Black
Half-tone 20%
Dimensions: 140 x 315 mm

Font size:
7pt
Fonts:
Helvetica

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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