Document: leaflet MAH GENERIC_PL 40170-0001 change

• leaflet MAH BRAND_PL 20532-0161
• leaflet MAH BRAND_PL 33155-0040
• leaflet MAH BRAND_PLPI 15814-1228
• leaflet MAH GENERIC_PL 20117-0281
• leaflet MAH GENERIC_PL 20532-0161
• leaflet MAH GENERIC_PL 25298-0008
• leaflet MAH GENERIC_PL 36687-0183
• leaflet MAH GENERIC_PL 40170-0001
• leaflet MAH GENERIC_PL 40170-0002
• leaflet MAH GENERIC_PL 40170-0003
• leaflet MAH GENERIC_PL 42357-0006

---

Package leaflet: Information for the patient

Co-amoxiclav 500 mg/125 mg Film-coated Tablets

Amoxicillin Clavulanic acid

What is in this leaflet

1.    What Co-amoxiclav 500 mg/125 mg Film-coated Tablets is and what it is used for

2.    What you need to know before you take Co-amoxiclav 500 mg/125 mg Film-coated Tablets

3.    How to take Co-amoxiclav 500 mg/125 mg Film-coated Tablets

4.    Possible side effects

5.    How to store Co-amoxiclav 500 mg/125 mg Film-coated Tablets

6.    Contents of the pack and other information

1.    What Co-amoxiclav 500 mg/125 mg Film-coated Tablets is and what it is used for

Co-amoxiclav 500 mg/125 mg Film-coated Tablets 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 500 mg/125 mg Film-coated Tablets is used in adults and children to treat the following infections:

•    Middle ear and sinus infections

•    Respiratory tract infections

•    Urinary tract infections

•    Skin and soft tissue infections including dental infections

•    Bone and j oint infections.

2.    What you need to know before you take Co-amoxiclav 500 mg/125 mg Film-coated Tablets Do not take Co-amoxiclav 500 mg/125 mg Film-coated Tablets:

• if you are allergic (hypersensitive) 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 500 mg/125 mg Film-coated Tablets if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav 500 mg/125 mg Film-coated Tablets.

Warnings and precautions

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 Co-amoxiclav 500 mg/125 mg Film-coated Tablets.

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 500 mg/125 mg Film-coated Tablets or a different medicine.

Conditions you need to look out for

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 amoxicilline/clavulanic acid, to reduce the risk of any problems. See ‘Conditions you need to look 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 Co-amoxiclav 500 mg/125 mg Film-coated Tablets. This is because amoxicillin/clavulanic acid can affect the results of these types of tests.

Other medicines and Co-amoxiclav 500 mg/125 mg Film-coated Tablets

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.

If you are taking allopurinol (used for gout) with Co-amoxiclav 500 mg/125 mg Film-coated Tablets, 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 500 mg/125 mg Film-coated Tablets.

If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav 500 mg/125 mg Film-coated Tablets then extra blood tests may be needed.

Co-amoxiclav 500 mg/125 mg Film-coated Tablets can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

Amoxicillin/Clavulanic acid can affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Co-amoxiclav 500 mg/125 mg Film-coated Tablets can have side effects and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

3. How to take Co-amoxiclav 500 mg/125 mg Film-coated Tablets

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

•    Children aged 6 years or less should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.

•    Ask your doctor or pharmacist for advice when giving Co-amoxiclav 500 mg/125 mg Film-coated Tablets tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

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 Co-amoxiclav 500 mg/125 mg Film-coated Tablets

•    Swallow the tablets whole with a glass of water at the start of a meal or slightly before. Tablets can be broken along the score line to make them easier to swallow. You must take both pieces of the tablet at the same time.

•    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 500 mg/125 mg Film-coated Tablets for more than two weeks. If you still feel unwell you should go back to see the doctor.

If you take more Co-amoxiclav 500 mg/125 mg Film-coated Tablets than you should

If you take too much Co-amoxiclav 500 mg/125 mg Film-coated Tablets, 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 500 mg/125 mg Film-coated Tablets

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 Co-amoxiclav 500 mg/125 mg Film-coated Tablets

Keep taking Co-amoxiclav 500 mg/125 mg Film-coated Tablets 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.

4. Possible side effects

Like all medicines, Co-amoxiclav 500 mg/125 mg Film-coated Tablets 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 500 mg/125 mg Film-coated Tablets.

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 500 mg/125 mg Film-coated Tablets 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)

•    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 Co-amoxiclav 500 mg/125 mg Film-coated Tablets 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

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.

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 Yellow Card Scheme at: 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 Co-amoxiclav 500 mg/125 mg Film-coated Tablets

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.

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.

6. Contents of the pack and other information

What Co-amoxiclav 500 mg/125 mg Film-coated Tablets contains:

•    The active substances are amoxicillin and clavulanic acid

•    Each tablet contains amoxicillin trihydrate equivalent to 500 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, colloidal anhydrous silica (E551), magnesium stearate (E470b).

Film-coating: Basic butylated methacrylate co polymer, titanium dioxide (E171), talc (E553b), macrogol 6000.

What Co-amoxiclav 500 mg/125 mg Film-coated Tablets looks like and contents of the pack

White to off-white oblong film-coated tablet with score line.

OPA/Al/PV C-Al: 4/5/6/10/12/14/15/16/18/20/21/24/30/36/42/48/54/60/66/72/78/84/90/96/100/500 film-coated tablets.

Not all packages or pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder

DSM SINOCHEM PHARMACEUTICALS NETHERLANDS B.V

Manufacturer PenCef Pharma GmbH Breitenbachstrasse 13 13509 Berlin, Germany

This leaflet was last revised in month 07/2015