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Co-Amoxiclav 250mg/125mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-Amoxiclav 250mg/125mg 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 (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. See section 4.

In this leaflet:

1.    What Co-Amoxiclav 250mg/125mg film-coated tablets are and what they are used for

2.    What you need to know before you take Co-Amoxiclav 250 mg/125 mg film-coated tablets

3.    How to take your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Contents of the pack and other information

1.    WHAT CO-AMOXICLAV 250 MG/125 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Co-Amoxiclav 250mg/125mg film-coated tablets are an antibiotic and work 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 250mg/125mg film-coated tablets are used in adults and children to treat the following infections:

•    sinus infections

•    urinary tract infections

•    skin infections

•    dental infections.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMOXICLAV 250 MG/125 MG FILM-COATED TABLETS

Do not take your medicine:

•    if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of your 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 your medicine if any of the above apply to you. If

you are not sure, talk to your doctor or pharmacist before taking your medicine.

Take special care with your medicine

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 your 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.

Important information about some of the ingredients in your medicine

This medicine contains 0.63mmol (24.5mg) potassium per tablet, therefore, it may not be suitable if you are on a controlled potassium diet or you have reduced kidney function. Check with your doctor if you are unsure about this.

Conditions you need to look out for

Your medicine 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 your medicine, 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 your medicine. This is because your medicine can affect the results of these types 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 are taking allopurinol (used for gout) with your medicine, 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 your medicine.

If medicines to help stop blood clots (such as warfarin) are taken with your medicine then extra blood tests may be needed.

Your medicine can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) 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

Your medicine 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 YOUR MEDICINE

Always take your medicine 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:

•    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.

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 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 your medicine

•    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 your medicine for more than 2 weeks. If you still feel unwell you should go back to see the doctor.

If you take more of your medicine than you should

If you take too much of your medicine, 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.

If you forget to take your medicine

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 your medicine

Keep taking your medicine 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.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, your 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 your medicine.

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 your medicine before food

•    vomiting

•    diarrhoea (in children)

Uncommon side effects

These may 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 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)

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)

•    Serious skin reaction:

-    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 (exanthe-mous pustulosis)

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 this medicine 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

•    low number of red blood cells (haemolytic anaemia)

•    crystals in 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. Website: www. mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE YOUR MEDICINE

Do not store above 25° C. Keep the tablets in the original packaging. Keep out of the reach and sight of children.

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

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. CONTENTS OF THE PACK AND OTHER INFORMATION What your medicine contains

•    The active substances are: amoxicillin (as trihydrate) 250 mg; clavulan-ic acid (as potassium clavulanate) 125 mg.

•    The other ingredients are microcrystalline cellulose (E460), sodium starch glycollate, magnesium stearate (E572), colloidal silica anhydrous.

•    The film-coating contains: hypromellose (E464), titanium dioxide (E171), propylene glycol, ethylcellulose.

What your medicine looks like and contents of the pack

Co-Amoxiclav 250mg/125mg film-coated tablets are white capsule shaped film-coated tablets.

Your medicine comes either in a blister pack of 21 tablets or as a white plastic bottle with a white pilfer proof polypropylene screw cap with a desiccant capsule, containing 21 tablets.

Marketing Authorisation Holder and manufacturer

Hikma Farmaceutica (Portugal) S.A., Estrada do Rio da Mo, N°8, 8A e 8B, Fervenca, 2705-906 Terrugem SNT, Portugal.

Manufacturer

Infosaude - Instituto de Formagao e Inovagao em Saude Unipessoal, Lda.

Rua das Ferrarias Del Rei, n.°6, Urbanizagao da Fabrica da Polvora, Barcarena, 2730-269, Portugal

Distributed by:

Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.

This leaflet was last revised in 10/2015

Advice/medical education

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.

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 prevent the emergence of resistant bacteria that could stop the antibiotic working.

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 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.

5.    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.


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