CO-AMOXICLAV 250/125MG TABLETS

Active substance: POTASSIUM CLAVULANATE

View full screen / Print PDF » Download PDF ⇩

Transcript
CP.CMX.250_125T.SN.V2P1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-Amoxiclav 250/125mg 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.

1.

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.

BEFORE YOU TAKE CO-AMOXICLAV

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.
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.
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.
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.
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.
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.

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.
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.

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

WHAT CO-AMOXICLAV IS AND WHAT IT IS USED
FOR

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 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.
Taking Co-Amoxiclav with food and drink
It is recommended that you take Co-Amoxiclav 250/125mg
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.
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.

HOW TO TAKE CO-AMOXICLAV

Always take Co-Amoxiclav 250/125mg 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.
Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated
with Co-Amoxiclav oral suspension or sachets.
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.
Haemodialysis Patients
Two Co-Amoxiclav 250/125mg 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.

4.

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
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
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). 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)
- 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)
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).

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
250/125mg 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.
Distributor
Kent Pharmaceuticals Limited,
Repton Road, Measham,
DE12 7DT, U.K.
The leaflet was last revised in 06/2014.

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.
CP.CMX.250_125T.SN.V2P1

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
(web2)