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

Document: leaflet MAH BRAND_PLPI 33902-0537 change

PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

2. What you need to know before you take Augmentin_

Augmentin® 375mg Tablets

co-amoxiclav (amoxicillin and clavulanic acid)

Your medicine is available using the above name, but will be referred to as Augmentin throughout the remainder of this leaflet.

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 signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Augmentin is and what it is used for

2. What you need to know before you take Augmentin

3. How to take Augmentin

4. Possible side effects

5. How to store Augmentin

6. Contents of the pack and other information

1. What Augmentin is and what it is used for

Augmentin 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.

Augmentin is used in adults and children to treat the following infections:

• sinus infections

• urinary tract infections

• skin infections

• dental infections.

Do not take Augmentin:

• if you are allergic to 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 Augmentin if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Augmentin.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Augmentin 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 Augmentin.

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 Augmentin or a different medicine.

Conditions you need to look out for

Augmentin 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 Augmentin, to reduce the risk of any problems. See ‘Conditions you need to look out for¹ 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 Augmentin. This is because Augmentin can affect the results of these types of tests.

Other medicines and Augmentin

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

• If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Augmentin.

3. How to take Augmentin

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

• Augmentin can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

• Augmentin 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.

Driving and using machines

Augmentin can have side effects and the symptoms may make you unfit to drive.

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

Always take Augmentin exactly as your doctor or pharmacist 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 is:

• 1 tablet three times a day

Children weighing less than 40 kg

Children aged 6 years or less should preferably be treated with Augmentin oral suspension or sachets. Augmentin 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 your liver is working.

How to take Augmentin

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

If you take more Augmentin than you should

If you take too much Augmentin, 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 Augmentin

• 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 around 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Augmentin

Keep taking Augmentin 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 medicine, ask your doctor or pharmacist.

Possible side effects

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 Augmentin.

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 Augmentin 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.

5. How to store Augmentin

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.

Frequency not known

Frequency cannot be estimated from the available data.

• 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).

-» 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 Augmentin or who have kidney problems)

• black tongue which looks hairy.

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 at: www.mhra.aov.uk/vellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

• Keep out of the sight and reach of children.

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

• Do not store above 25°C.

• Store in the original package in order to protect from moisture.

• Do not use 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.

• If your medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.

6. Contents of the pack and other information

What Augmentin contains

• The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 250mg amoxicillin with potassium clavulanate equivalent to 125mg clavulanic acid.

• The other ingredients are:

Tablet core - magnesium stearate, sodium starch glycolate type A, colloidal silica anhydrous, microcrystalline cellulose.

Film-coat - titanium dioxide (E171), hypromellose, macrogol (4000, 6000) and dimeticone (silicone oil).

What Augmentin looks like and contents of the

pack

White to off-white, oval shaped tablets debossed with

“Augmentin” on one side.

Each pack contains blister packs of 21 tablets.

Manufacturer:

SmithKIine Beecham Pharmaceuticals Clarendon Road Worthing, West Sussex BN14 8QH United Kingdom

Procured from within the EU and repackaged by:

Amimed Direct Ltd, Hendon, London, NW9 6AQ. Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.

POM

PL 33902/0537

Leaflet revision date: 12/01/2016

Augmentin® is a registered trademark of the GlaxoSmithKline group of companies.

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 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.

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.

2. What you need to know before you take Co-Amoxiclav

Co-Amoxiclav 250mg/125mg film-coated Tablets

co-amoxiclav (amoxicillin and clavulanic acid)

Your medicine is available using the above name, but will be referred to as Co-Amixiclav throughout the remainder of this leaflet.

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 signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This include any possible side effects not listed in this leaflet. See section 4.

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

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 (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.

Do not take Co-Amoxiclav:

• if you are allergic to 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.

Warnings and Precautions

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 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 for¹ 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.

Other medicines and Co-Amoxiclav

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

• 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.

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.

How to take Co-Amoxiclav

Always take Co-Amoxiclav exactly as your doctor or pharmacist 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 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 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 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 the medicine carton or bottle 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 around 4 hours before taking the next dose. 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

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).

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.

Frequency not known

Frequency cannot be estimated from the available data.

• Allergic reactions (see above)

• Inflammation of the large intestine (see above)

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

• Serious skin reactions:

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).

-» 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.

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

By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Co-Amoxiclav

• Keep out of the sight and reach of children.

• 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 store above 25°C.

• Store in the original package in order to protect from moisture.

• Do not use 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.

• If your medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.

6. Contents of the pack and other information

What Co-Amoxiclav contains

• The other ingredients are:

Tablet core - magnesium stearate, sodium starch glycolate type A, colloidal silica anhydrous, microcrystalline cellulose.

Film-coat - titanium dioxide (E171), hypromellose, macrogol (4000, 6000) and dimeticone (silicone oil).

What Co-Amoxiclav looks like and contents of

the pack

White to off-white, oval shaped tablets debossed with

“Augmentin’’ on one side.