CO-AMOXICLAV 250/125MG TABLETS

Active substance: POTASSIUM CLAVULANATE

View full screen / Print PDF » Download PDF ⇩

Transcript
KENT OLS LEAFLET TEXT
CO-AMOXICLAV 250/125MG TABLETS, PL 04520/0054

PACKAGE LEAFLET: INFORMATION FORTHE USER
Co-Amoxiclav 250/125mg Tablets
(Amoxicillin and Clavulanic acid)
Read all of this leaflet carefully 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 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

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 properly. 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).

KENT OLS LEAFLET TEXT
CO-AMOXICLAV 250/125MG TABLETS, PL 04520/0054

- if you have ever had a severe allergic (hypersensitive) reaction to any other
antibiotic. Including a skin rash or swelling of the face or neck
• if you have, or 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 before taking Co-amoxiclav if you:
• are being treated for liver or kidney problems or if you are aged above 60 years
• have glandular fever
• 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 want to 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
minimise the risk of any problems (see section 4).
Blood and urine tests
If your doctor is giving you any blood tests (e.g. red blood count, liver function tests) or
urine tests (e.g. glucose), tell the doctor or nurse that you are taking Co-amoxiclav, as
Co-amoxiclav can affect the results of these kinds of tests.
Taking other medicines;
Please tell your doctor or pharmacist, if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
• If you are taking allopurinol (to treat gout) with Co-amoxiclav, you may be more likely
to have an allergic skin reaction.
• If you are taking probenecid (to treat gout), your doctor may decide to adjust the dose of
Co-amoxiclav that you take.
• Medicines to stop blood clots (e.g. warfarin) are taken with Co-amoxiclav then you may
need to have additional blood tests.

KENT OLS LEAFLET TEXT
CO-AMOXICLAV 250/125MG TABLETS, PL 04520/0054

• Co-amoxiclav can affect how methotrexate (a medicine used to treat cancer or
rheumatic diseases) works.
• Antibiotics such as macrolides, tetracyclines, the effect of Co-amoxiclav 250/125 mg
Tablets may be reduced.
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.
Ask your doctor or pharmacist for advice before taking any other medicines.
This medicine is excreted in breast milk in small quantities, therefore diarrhoea and
colonisation of the digestive mucosa by yeasts are possible in breast-fed infants; in some
cases it may be necessary to wean the infant.
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 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 more than 40 kg and over
The usual dose is:
One tablet three times a day, the single dose should be taken at regular intervals
throughout the day with 8 hour intervals. Swallow each tablet whole with a glass of
water. 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.

KENT OLS LEAFLET TEXT
CO-AMOXICLAV 250/125MG TABLETS, PL 04520/0054

Patients with liver problems
• If you have liver problems your doctor may give you more frequent blood tests to
check how your liver is working.
Patients with kidney problems
Your doctor may reduce the dose, depending on your weight and severity of the kidney
impairment or may change your medicine.
Haemodialysis Patients
One Co-amoxiclav 250/125 mg Tablet 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.
If you take more Co-amoxiclav than you should:
If you take too much of this medicine (overdose) 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.

If you stop taking Co-amoxiclav
Keep taking this medicine until the course 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

Possible side effects

Like all medicines, Co-amoxiclav can cause side effects, although not everybody gets
them.
Conditions you should look out for:
Allergic reactions:
• skin rash(s)
• inflammation of blood vessels (vasculitis) can cause red and purple raised spots
on the skin, but can affect other parts of the body

KENT OLS LEAFLET TEXT
CO-AMOXICLAV 250/125MG TABLETS, PL 04520/0054





fever, joint pain, swollen glands in the neck, armpit or your groin
swelling of the face or mouth (angioedema) causing breathing difficulties
collapse

Contact a doctor immediately if you get any of these symptoms. Stop taking Coamoxiclav.
Inflammation of the large intestines:
Inflammation of the large intestine causing, watery diarrhoea usually with blood and
mucus in it, pains in the stomach and / or fever.
Contact your doctor as soon as possible for advice should you get these symptoms.
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 (a yeast infection of the vagina, mouth or skin folds)
• feeling sick 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(s), itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache
Uncommon side effects that may show up in blood tests:
• increase in some enzymes in the liver.
Rare side effects - (affect up to 1 in 1000 people)
• skin rashes 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)
If you notice any of these symptoms contact a doctor immediately.
Rare side effects that may show up in your blood tests:
• low number of blood clotting cells
• low number of white blood cells
Other possible side effects:
• allergic reactions (as described above)
• inflammation of the large intestines (as above)

KENT OLS LEAFLET TEXT
CO-AMOXICLAV 250/125MG TABLETS, PL 04520/0054



serious skin reactions:
- a widespread rash with blisters and skin peeling, mainly around the mouth, nose,
eyes and genitals (Stevens-Johnson syndrome), a more severe form that causes
extensive peeling of skin, more than 30% of the body’s surface – toxic epidermal
necrolysis)
- widespread red skin rash with small puss containing blisters (bulbous exfoliative
dermatitis)
- red scaly rash with bumps under the skin and blistering (exanthemous pustulitis)

Contact your doctor immediately if you get any of these symptoms.
• inflammation of the liver (hepatitis)
• jaundice caused by increased bilirubin in the blood (this is produced in the liver and
causes yellowing of the skin and whites of eyes)
• inflammation of tubes in the kidneys
• blood clotting problems
• hyperactivity
• convulsions (in patients taking high doses or who have kidney problems)
• black hairy tongue
• stained teeth (children) normally removed by brushing
Side effects that can show up in blood or urine tests:
• severe reduction in the numbers of white blood cells
• a low number of red blood cells
• crystals in the urine
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.
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 there are other visible signs of
deterioration.
Medicines should not be disposed of via household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the
environment.

KENT OLS LEAFLET TEXT
CO-AMOXICLAV 250/125MG TABLETS, PL 04520/0054

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.
Distributor:
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
The leaflet was last revised in 01/2013.

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
(web5)