Skip to Content

CO-AMOXICLAV 875 MG/125 MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN TRIHYDRATE / POTASSIUM CLAVULANATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PXXXXXXX
Co-amoxiclav film-coated tablets

5 mm

PXXXXXXX
Co-amoxiclav film-coated tablets

60 mm

Pharmacode position can change as per Supplier’s m/c requirement
& additional small pharma code may appear on the front/back panel

5 mm

Review 1
10 mm

Co-amoxiclav FC Tablets (UK)

If you are taking allopurinol (used for gout) with Co-amoxiclav, it may be more
likely that you will have an allergic skin reaction.

Co-amoxiclav 500 mg/125 mg film-coated tablets
Co-amoxiclav 875 mg/125 mg film-coated tablets
(Amoxicillin/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. 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.
1.
2.
3.
4.
5.
6.

WHAT IS CO-AMOXICLAV AND WHAT IS IT USED FOR
BEFORE YOU TAKE CO-AMOXICLAV
HOW TO USE CO-AMOXICLAV
POSSIBLE SIDE EFFECTS
HOW TO STORE CO-AMOXICLAV
FURTHER INFORMATION

1. WHAT IS CO-AMOXICLAV AND WHAT IS IT 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:

middle ear and sinus infections

respiratory tract infections

urinary tract infections

skin and soft tissue infections including dental infections

bone and joint infections.
2. BEFORE YOU TAKE CO-AMOXICLAV
Do not take Co-amoxiclav

if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins
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.
ĺ 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.
Take special care with Co-amoxiclav
Talk to your doctor or pharmacist before taking this medicine 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 Co-amoxiclav.
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 Co-amoxiclav
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
Co-amoxiclav, to reduce the risk of any problems. See ‘Conditions you need to
look out for’ in section 4.
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), let the doctor or nurse know that you are
taking Co-amoxiclav. This is because Co-amoxiclav can affect the results of
these types of tests.
Taking other medicines
Please tell your doctor or your pharmacist if you are taking or have recently
taken any other medicines. This includes medicines that can be bought without a
prescription and herbal medicines.

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 new organs following a transplant operation) works.
Pregnancy and breast-feeding
If you are pregnant, you think you might be pregnant or if you are breast-feeding,
please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any 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
Always take Co-amoxiclav 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
500 mg/125 mg film-coated tablets
The usual dose is:

1 tablet three times a day
875 mg/125 mg film-coated tablets
The usual dose is:

Usual dose – 1 tablet two times a day

Higher dose – 1 tablet three times a day
Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with co-amoxiclav
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

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 than you should
If you take too much Co-amoxiclav, signs might include an upset stomach
(feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon
as possible. Take this medicine carton to show the doctor.
If you forget to take Co-amoxiclav
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.
If you stop taking Co-amoxiclav
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 product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-amoxiclav 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) which may be visible as red or

5 mm
Size: 210 x 360 mm, Pantone Black
Date: 04/09/15

Front

Variation number: NL/H/2241/001-002/IB/011

PACKAGE LEAFLET: INFORMATION FOR THE USER

5 mm

10 mm

Review 1

60 mm

5 mm

Co-amoxiclav FC Tablets (UK)

Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually with blood
and mucus, stomach pain and/or fever.
ĺ Contact your doctor as soon as possible for advice if you get these
symptoms.
Very common side effects [affects more than 1 user in 10]

diarrhoea (in adults).
Common side effects [affects 1 to 10 users in 100]
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
ĺ if affected take Co-amoxiclav before food

vomiting

diarrhoea (in children)
Uncommon side effects [affects 1 to 10 users in 1,000]

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 [affects 1 to 10 users in 10,000]

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)
ĺ 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 [frequency cannot be estimated from the available data]
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)

Inflammation of the layers lining the brain and spinal cord called meninges
(aseptic meningitis)

Inflammation of the bile tube (cholangitis)

allergic acute cardiac syndrome (kounis syndrome)

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).
ĺ 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 the eyes
appear yellow

inflammation of tubes in the kidney

blood takes longer to clot

hyperactivity

convulsions (in people taking high doses of amoxicillin/clavulanic acid or
who have kidney problems)

black tongue which looks hairy

stained teeth (in children), usually removed by brushing.
Side effects that may show up in your blood or urine tests:

severe reduction in the number of white blood cells

lower number of red blood cells (haemolytic anaemia)

crystals in urine.

If you get side effects
ĺ Tell your doctor or pharmacist if any of the side effects become severe or
troublesome, or if you notice any side effects not listed in this leaflet.
5. HOW TO STORE CO-AMOXICLAV
Keep out of the reach and sight of children.
Do not use Co-amoxiclav after the expiry date printed on the box after ‘EXP’. The
expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
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 trihydrate and potassium clavulanate.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 500mg
amoxicillin with potassium clavulanate equivalent to 125mg clavulanic acid.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875mg
amoxicillin with potassium clavulanate equivalent to 125mg clavulanic acid.

The other ingredients are:
Core:
Microcrystalline cellulose (E460), colloidal anhydrous silica, magnesium stearate
(E470b), sodium starch glycolate (Type A).
Film coating:
Hypromellose (E464), macrogol 400, titanium dioxide (E171).
What Co-amoxiclav looks like and contents of the pack
Film-coated tablets.
Co-amoxiclav 500/125 mg tablets are white, oval, film-coated tablets inscribed
with ‘A’ on one side and ‘64’ on the other side.
Co-amoxiclav 875/125 mg tablets are white, capsule shaped, film-coated
tablets inscribed with ‘A’ on one side and with a score line in between ‘6’ and ‘5’
on the other side.
The score line is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
Co-amoxiclav tablets are available in Alu/Alu (polyamide/aluminium/PVC aluminium foil) blister packs with 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21, 25, 30,
35, 40, 50, 100 and 500 film-coated tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
APL Swift Services (Malta) Limited.,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA
under the following names:
Denmark
Netherlands
Norway
Sweden
UK

Klaximol 500 mg/125 mg, 875 mg/125 mg
filmovertrukne tabletter
Amoxicilline/clavulaanzuur Amneal 500/125 mg en
875/125 mg, filmomhulde tabletten
Klaximol 500 mg/125 mg, 875 mg/125 mg tabletter,
filmdrasjerte
Klaximol 500 mg/125 mg, 875 mg/125 mg
filmdragerade tabletter
Co-amoxiclav 500 mg/125 mg and 875 mg/125 mg
film-coated tablets

This leaflet was last revised in 09/2015

5 mm
Size: 210 x 360 mm, Pantone Black
Date: 04/09/15

Back

Variation number: NL/H/2241/001-002/IB/011

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

allergic acute cardiac syndrome (kounis syndrome).
ĺ Contact a doctor immediately if you get any of these symptoms. Stop
taking Co-amoxiclav.



Expand view ⇕

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.

Hide