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CO-AMOXICLAV 250/125 MG FILM-COATED TABLETS

Active substance(s): AMOXICILLIN / CLAVULANIC ACID

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Package leaflet: Information for the patient

Uncommon side effects
These may affect up to 1 in 100 people

Skin rash, itching

Raised itchy rash (hives)

Indigestion

Dizziness

Headache

Co-amoxiclav 250 mg/125 mg 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 (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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See
section 4.

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)

What is in this leaflet
1. What Co-amoxiclav is and what it is used for
2. What you need to know before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Contents of the pack and other information

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)

Inflammation of the protective membrane surrounding the brain (aseptic meningitis)

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)

1. What Co-amoxiclav is and what it is used for
The name of the medicine is Co-amoxiclav 250 mg/125 mg Film Coated Tablets. In the rest of this leaflet the medicine will be called
Co-amoxiclav.
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:

Sinus infections

Urinary tract infections

Skin infections

Dental infections.

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 Co-amoxiclav or who have kidney problems)

Black tongue which looks hairy

2. What you need to know before you take Co-amoxiclav
Do not take Co-amoxiclav:

if you are allergic 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

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Co-amoxiclav

Have glandular fever

Are being treated for liver or kidney problems

Are not passing water regularly

If you get side effects
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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-amoxiclav.

Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist. This includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the national reporting system listed in the Yellow Card Scheme at www.mhra at www mhra.gov.uk / yellow
card. By reporting side effects, you can help provide more information on the safety of this medicine.

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
Amoxicillin/clavulanic acid 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
amoxicillin/clavulanic acid, to reduce the risk of any problems. See ‘Conditions you need to look for’ in Section 4.

5. How to store Co-amoxiclav
Do not store this medicine above 25° C. Store in the original package in order to protect from moisture
Keep this medicine out of the sight and reach of children.

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 amoxicillin/clavulanic acid can affect the results of these types of tests.

Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. The expiry date refers to the last day of
that month.
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.

Other medicines and Co-amoxiclav
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that can
be bought without a prescription and herbal medicines.

6. Contents of the pack and other information
What Co-amoxiclav 250 mg/125 mg Film-coated Tablets contains:

The active substances are amoxicillin and clavulanic acid

Each tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin and potassium clavulanate equivalent to 125 mg
clavulanic acid

The other excipients are:
Tablet core: Microcrystalline cellulose (E460), crospovidone type A (E1202), croscarmellose sodium (E468), colloidal anhydrous
silica (E551), magnesium stearate (E470b).
Film-coating: Basic butylated methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000.

If you are taking allopurinol (used for gout) with Co-amoxiclav, it may be more likely that you’ll 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.
Pregnancy, breast-feeding and fertility
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.

What Co-amoxiclav 250 mg/125 mg Film-coated Tablets looks like and contents of the pack
White to off white oblong film-coated tablet with a score line on one side. The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.

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. Do not drive or operate machinery unless you are
feeling well.

OPA/Al/PVC-Al blisters: 4/5/6/10/12/14/16/18/20/21/24/30/36/42/48/54/60/66/72/78/84/90/96/100/500 Film-coated Tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex, RH11 7XA
United Kingdom
Telephone: (01293) 574180
Fax: (01293) 533003
Email: drugsafety@torrentpharma.co.uk

3. How to take Co-amoxiclav
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg and over

The usual dose 1 tablet three times a day
Children weighing less than 40 kg
Co-amoxiclav are not recommended.
Children aged 6 years or less should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.
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.

Manufacturer(s) responsible for batch release in the EEA
Pencef Pharma GmbH
Breitenbachstrasse 13
13409 Berlin, Germany

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 two weeks. If you still feel unwell you should go back to see the doctor.

This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Co-amoxiclav 250 mg/125 mg Film-coated Tablets
MT: Co-amoxiclav 250 mg/125 mg film-coated tablets

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 the medicine carton or bottle to show the doctor.

This leaflet was last revised in month 07/2016
Advice/medical education

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.

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to
occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive
and even multiply despite the antibiotic.

Do not take a double dose to make up for a forgotten 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.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria
becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following
advice will help to prevent the emergence of resistant bacteria that could stop the antibiotic working.

If you have any further questions on the use of this medicine, ask you doctor or pharmacist.
4. Possible side effects

1.

It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the
instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the
infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to
yours.
4. You should not give antibiotics that were prescribed for you to other people.
If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a
pharmacy for appropriate disposal.

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) 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 Co-amoxiclav.
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)

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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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