CPAMO.JNT.Su.100.AT.V1P2

P660/1

Package leaflet: Information for the patient

AMOXICILLIN 125mg/5ml & 250mg/5ml ORAL SUSPENSION BP

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 only. Do not pass it on to others. It may harm them even if their symptoms or 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 Amoxicillin is and what it is used for

2.    What you need to know before you take Amoxicillin

3.    How to take Amoxicillin

4.    Possible side effects

5.    How to store Amoxicillin

6.    Contents of the pack and other information

WHAT AMOXICILLIN IS AND WHAT IT . IS USED FOR

Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin works by interfering with the bacteria that cause the infection.

Amoxicillin can treat a wide range of infections including those of the following:

•    chest (bronchitis or pneumonia)

•    tonsils (tonsillitis)

•    ears (otitis media)

•    sinuses (sinusitis)

•    kidneys

•    heart (endocarditis)

•    blood (septicaemia)

•    the bladder or the urethra (the tube which carries urine from the bladder)

•    the female reproductive system including infections associated with pregnancy and childbirth (puerperal sepsis and septic abortion)

•    abdomen (intra-abdominal sepsis and peritonitis)

•    skin, bone, teeth and gums (abscesses)

•    gonorrhoea (a sexually transmitted infection)

•    typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella)

Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.

WHAT YOU NEED TO KNOW BEFORE . YOU TAKE AMOXICILLIN

•    Some other antibiotics (e.g. neomycin and tetracyclines can reduce the effect of amoxicillin)

•    Oral typhoid vaccine (may not work if taken with amoxicillin)

•    Some penicillins may increase the effects of muscle-relaxing drugs given as part of an anaesthetic for surgery. Tell the doctor you are taking amoxicillin if you need to have an anaesthetic.

Having urine or blood tests If you are having urine tests for diabetes (sugar in the urine) or blood tests for liver function let the doctor know. Amoxicillin can affect the results of these tests.

Pregnancy and breast-feeding

Check with your doctor before you take this medicine if you are pregnant or breast-feeding. 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.

Amoxicillin Oral Suspension BP contains sucrose

Amoxicillin 250mg/5ml Oral Suspension BP contains 2.72g of sucrose per 5ml, Amoxicillin 125mg/5ml Oral Suspension BP contains 2.68g of sucrose per 5ml.

•    This should be taken into account in patients with diabetes mellitus.

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Do not take Amoxicillin if

•    You are allergic to amoxicillin or any of the other ingredients of this medicine (listed in section 6)

•    You have ever had a bad reaction or allergy to any penicillin-type antibiotic

•    You have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any antibiotic

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin if:

•    You suffer from kidney problems, as you may require a lower dose than normal

•    You are not passing urine regularly

•    You have glandular fever, cytomegalovirus (CMV) infection or certain types of leukaemia -you may be at greater risk of developing a rash when you take this medicine

•    You have an intolerance to some sugars or have diabetes mellitus, as this medicine contains sucrose.

Other medicines and Amoxicillin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those not prescribed by a doctor. In particular tell your doctor if you are taking any of the following:

•    The contraceptive pill (in which case you will have to take extra contraceptive measures such as using a condom)

•    Anticoagulants e.g. warfarin, phenindione

•    Chemotherapy drugs e.g. methotrexate

•    Drugs used to treat gout (which can be caused by the build up of uric acid) e.g. probenecid, allopurinol, sulfinpyrazone

1 x 750 mg or 1 x 1 g twice a day for 7 days

•    The following are the usual adult dosages for preventing infection during dental or other surgery:

-    If a general anaesthetic is not used, 3g one hour before surgery and another dose six hours later if necessary

-    If a general anaesthetic is used, 3g four hours before anaesthesia and 3g six hours after the initial dose

Children:

•    Children weighing more than 40kg should be given the usual adult dosage.

•    Children weighing less than 40kg:

-    All doses are worked out depending on the child's body weight in kilograms. Your doctor will advise you how much medicine you should give to your baby or child. The usual dose is 40mg to 90mg for each kilogram of body weight a day, given in two or three divided doses.

Patients with kidney problems

If you have kidney problems, the dose prescribed by your doctor may be lower than the usual dose.

If you take more Amoxicillin than you should

If you (or somebody else) accidentally take too much of your medicine, speak to your doctor or pharmacist immediately. You should take this leaflet and any medicine you still have to show the doctor.

Severe cases of nausea, vomiting and diarrhoea can be treated with rehydration therapy, by drinking fluids containing sodium, water and sugar to prevent dehydration.

If you forget to take Amoxicillin

If you forget to take a dose, take it as soon as you remember, unless it is within an hour of your next dose, then carry on as before. Do not take a double dose to make up for the dose you have missed.

If you stop taking Amoxicillin

Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, some bacteria may survive and cause the infection to come back, or your condition may re-occur or get worse.

If you/your child are still unwell after taking all the medicine, go and see your doctor. Never give/take more than the recommended dose each day.

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

•    Vomiting

Very rare side effects (i.e. less than 1 in 10,000 people):

•    Thrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush from your doctor or pharmacist.

•    Tooth discolouration. The colour usually returns to normal with brushing.

•    Blackening of the tongue

•    Inflammation of the kidney

•    Excessive body movements (hyperkinesia) or dizziness

•    Reduction (reversible) in blood cell counts including anaemia (a reduction in the body's red blood cells or haemoglobin which may be characterised by feeling weak or light-headed) or a longer time taken for blood to clot.

•    Crystalluria (forming of crystals in the urine)

Not known: frequency cannot be estimated from available data

•    Meningitis (signs may include stiff neck, fever and vomiting)

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 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.

. HOW TO STORE AMOXICILLIN

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 label. The expiry date to be followed is that included by the pharmacist after the medicine is made up for you.

Protect from light.

Dry powder: Store in a dry place below 25°C. Reconstituted suspension: Store for 7 days at 2°C-8°C in a refrigerator.

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.

CONTENTS OF THE PACK AND . OTHER INFORMATION

. HOW TO TAKE AMOXICILLIN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You may give/take amoxicillin before, with or after food. Space the doses as evenly as possible throughout the day. You should make sure you/your child have several more drinks of water each day unless told otherwise by your doctor.

Dosage

Note: One teaspoon is equivalent to 5ml Adults (including the elderly):

The maximum daily dose should not be more than 6g per day in total.

•    The usual dose for most infections is 5ml of 250mg/5ml suspension to be taken 3 times a day.

•    For more serious infections the dose may be doubled to 10ml of 250mg/5ml suspension 3 times a day.

•    The following doses may be given in the following conditions:

-    Severe or recurrent chest infections: 3g twice daily

-    Simple urinary tract infections: two 3g doses with 10 to 12 hours between doses (short course)

-    Dental abscesses: two 3g doses with 8 hours between doses

-    Gonorrhoea: a single 3g dose

•    For stomach ulcers, the following may be prescribed with other antibiotics:

. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following events STOP taking your medicine, tell your doctor or go to your nearest hospital immediately:

•    Hypersensitivity or severe allergic reaction including swollen face or breathing problems

•    Severe diarrhoea with bleeding

•    Allergic skin reactions with itching e.g. hives, nettle rash, blistering or peeling of the skin. If you start to itch or get a rash, STOP taking amoxicillin and tell your doctor immediately.

•    Convulsions may occur in patients on high doses or with kidney problems

•    Notice your urine becoming darker or your faeces becoming paler

•    Notice your skin or the white of your eyes turning yellow (jaundice)

•    Difficulty or discomfort in passing urine or having cloudy urine

The following symptoms are less serious but you may wish to discuss them with your doctor or pharmacist if they become troublesome or last a long time.

Common side effects (i.e. more than 1 in 100 people):

•    Nausea (feeling sick) or diarrhoea

Uncommon side effects (i.e. between 1 in 100 and 1 in 1,000 people):

What Amoxicillin Oral Suspension BP contains

•    The active ingredient is amoxicillin. Each 5ml spoonful of Amoxicillin 125mg/5ml or 250mg/5ml Oral Suspension BP contains either 125 mg or 250 mg of amoxicillin as amoxicillin trihydrate.

•    The other ingredients are sodium benzoate (E211), disodium edetate, sodium citrate anhydrous, lemon flavour powder, quinoline yellow (E104) and sucrose.

What Amoxicillin Oral Suspension BP looks like and contents of the pack

Amoxicillin 125mg/5ml and 250mg/5ml Oral Suspension BP is available as a pale yellow granular dry powder in a bottle for preparation of a yellow suspension with a lemon odour and flavour. When prepared by the pharmacist, the 125 mg/5 ml bottle contains 100 ml of suspension and the 250 mg/5 ml bottle contains 100 ml of suspension.

Marketing Authorisation Holder and Manufacturer

Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.

The product is distributed by

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

PL 06453/0021 PL 06453/0022

This leaflet was last revised in June 2014.

CP.AMO.JNT.Su.100.AT.V1P2

P660/1