CP. AMO . JNT. SuSF. 100 . Sp . AT. V2P2

P513/5

Package leaflet: Information for the patient

AMOXICILLIN 125mg/5ml & 250mg/5ml ORAL SUSPENSION SUGAR FREE 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)

•    skin

•    ears (otitis media)

•    sinuses (sinusitis)

•    kidneys

•    teeth

•    gums (abscesses)

•    heart (endocarditis)

•    blood (septicaemia)

•    bone

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

•    the female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic abortion)

•    abdomen (intra-abdominal sepsis and peritonitis)

•    gonorrhoea (a sexually transmitted infection)

•    infections associated with pregnancy

•    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.

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 or your child 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 Sugar Free BP contains sorbitol

This medicinal product contains sorbitol. Sorbitol may cause stomach upset and diarrhoea.

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

another dose six hours later if necessary

-    If a general anaesthetic is used, 3g given orally 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 go to your nearest hospital 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.

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 which may cause anaemia (may be characterised by feeling weak or light-headed) or a longer time taken for blood to clot. Tell your doctor that you are taking amoxicillin if you are having blood tests.

•    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.

Store in original package. Keep the bottle tightly closed.

Dry powder: Store in a dry place below 25°C. Reconstituted suspension: Store up to 14 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

. POSSIBLE SIDE EFFECTS

WHAT YOU NEED TO KNOW BEFORE . YOU TAKE AMOXICILLIN

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 disease or kidney problems, as you may require a lower dose than normal

•    You have glandular fever

•    You are not passing water regularly

•    You have an intolerance to some sugars as this medicine contains sorbitol

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 e.g. probenecid, allopurinol, sulfinpyrazone

•    Some other antibiotics (e.g. neomycin and

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

Try to give/take this medicine as part of the daily routine, for example at mealtimes. You may give/take amoxicillin before, with or after food, unless the label advises a specific time.

You should make sure you/your child have several more drinks of water each day unless told otherwise by your doctor.

Dosage:

Adults (including the elderly):

The total daily dose should not exceed 6g in total, given in divided doses.

•    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 given orally with 8 hours between doses

-    Gonorrhoea: a single 3g dose

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

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 procedures or other surgery:

-    If a general anaesthetic is not used, 3g given orally one hour before surgery and

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

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

•    Hypersensitivity - symptoms may include swollen face, mouth, lips, throat or tongue, reddening of the skin, breathing problems, joint pain and fever. If these symptoms occur, STOP taking amoxicillin right away and tell your doctor.

•    Severe diarrhoea possibly 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

•    Darker coloured urine, faeces becoming paler

•    Yellowing of the skin or the whites of your eyes (jaundice)

•    Difficulty or discomfort in passing urine or having blood in the urine

The following events 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 (have been reported in more than 1 in 100 people) include:

•    Nausea (feeling sick) or diarrhoea

Uncommon side effects (have been reported in between 1 in 100 and 1 in 1000 people taking amoxicillin) include:

•    Vomiting

Very rare side effects (have been reported in less than 1 in 10,000 people) include:

•    Thrush (a yeast infection of the vagina, mouth

What Amoxicillin Oral Suspension Sugar Free BP contains

•    The active ingredient is amoxicillin. Amoxicillin Oral Suspension Sugar Free BP is available in two strengths containing either 125 mg/5 ml or 250 mg/5 ml of amoxicillin as amoxicillin trihydrate.

•    The other ingredients are sodium benzoate (E211), disodium edetate, sodium citrate, orange bramble flavour, quinoline yellow (E104), citric acid monohydrate, colloidal anhydrous silica, xanthan gum, sorbitol (E420) and saccharin sodium.

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

The suspensions are pale yellow with a characteristic odour.

Amoxicillin Oral Suspensions Sugar Free BP are available in bottles of 100ml.

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 06453/0049    Amoxicillin 125mg/5ml Oral

Suspension Sugar Free BP PL 06453/0050    Amoxicillin 250mg/5ml Oral

Suspension Sugar Free BP

This leaflet was last revised in June 2014

CP.AMO.JNT.SuSF.100.Sp.AT.V2P2

P513/5