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PACKAGE LEAFLET: INFORMATION FOR THE USER

AMOXICILLIN SUGAR FREE SUSPENSION

250MG/5ML (Amoxicillin Trihydrate)

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. 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.

74 mm

Do not use this product after its ‘EXP’ date.

Space for Batch Details &

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amoxicillin sugar Free suspension #250 mg / #5 ml

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In this leaflet:

1.    What Amoxicillin Suspension is and what it is used for

2.    Before you take Amoxicillin Suspension

3.    How to take Amoxicillin Suspension

4.    Possible side effects

5.    How to store Amoxicillin Suspension

6.    Further information

1. WHAT AMOXICILLIN SUSPENSION IS AND WHAT IT IS USED FOR

gonorrhoea (a sexually transmitted infection) & other gynaecological infections, infections caused by a group of bacteria

The name of your medicine is Amoxicillin Suspension 250mg/5ml. It contains the active ingredient called amoxicillin trihydrate.

Amoxicillin Suspension is an antibiotic for treating infections. They belong to a group of antibiotics called"Penicillins" and work by killing the bacteria that can cause infections. Amoxicillin Suspension can treat a wide range of infections including those of the chest (bronchitis or pneumonia), ears (otitis media), nose, throat, urinary tract, kidneys, heart, skin and soft tissues and teeth and also for prevention of endocarditis (inflammation of the heart lining, heart muscles and heart valves) during dental procedures. They are also used to treat typhoid fever,

called Salmonella, inflammation of abdominal linings (peritonitis), inflammation of the bone and bone marrow (osteomyelitis), blood poisoning (septicaemia) and inflammation of the membranes that cover the brain and spinal cord

(meningitis).

In children with urinary tract infections, the need for further

clinical investigation should be considered.

2. BEFORE YOU TAKE AMOXICILLIN SUSPENSION

Do not take Amoxicillin Suspension if you are allergic (hypersensitive) to amoxicillin trihydrate, penicillin (or cephalosporins or any other antibiotics) or any of the other ingredients in this medicinal product. See section 6.

Take special care with Amoxicillin Suspension:

Seek advice from your doctor before treatment if you

•    have been taking Amoxicillin for a long time

•    have, or think you have glandular fever

•    suffer from kidney problems or have decreased urinary output

•    are to have surgery involving general anaesthesia

•    have heart problems

•    amoxicillin is for a newly born or prematurely born baby

Other precautions you should take:

Amoxicillin may cause a reduction in the efficacy of oral contraceptives. Extra precaution should be taken during antibiotic treatment such as using a condom.

Taking other medicines

You should tell your doctor if you are taking or have taken any ofthe following medicines as they may interact with your Amoxicillin Suspension. Examples of medicines that can affect Amoxicillin Suspension are:

•    Contraceptive pill (in which case you will need to take extra contraceptive precautions such as using a condom)

•    Medicines used to prevent blood clots such as Warfarin

•    Medicines like Methotrexate, used to treat arthritis, psoriasis and certain types of cancer

•    Medicines like Allopurinol, Sulfinpyrazone & Probenecid used in treating gout or excess uric acid in the blood.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained with out prescription.

Pregnancy and Breast-feeding

Before you start to take Amoxicillin Suspension, please tell your doctor or pharmacist if you are pregnant, plan to become pregnant,or are breast-feeding. If you become pregnant while taking Amoxicillin Suspension, please consult your doctor immediately. Ask your doctor or pharmacist for advice before taking any medicine.

Effects on laboratory tests

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to Amoxicillin. If you are being checked for the presence of glucose or sugar in urine, please tell your doctor you are taking Amoxicillin Suspension.

Important information about some of the ingredients of Amoxicillin Suspension

This medicinal product contains

•    Sodium Benzoate (E21); May increase the risk of jaundice in new born babies.

•    Sorbitol (E420) (This medicinal product contains 16 g sorbitol. When taken as recommended, each dose supplies upto 0.8 g soribitol); can have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol.

3. HOW TO TAKE AMOXICILLIN SUSPENSION

Always take Amoxicillin Suspension (reconstituted suspension) exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Keep the suspension tightly closed.

METHOD AND ROUTE OF ADMINISTRATION

Shake the bottle well before taking each dose. Take Amoxicillin Suspension with or after food unless the label advises a specific time. Drink several glasses of water each day of your treatment, unless told other wise by your doctor. Keep taking Amoxicillin Suspension until your prescribed course is finished. Do not stop just because you feel better. If you stop too soon, the infection may start up again.

DOSAGE

Adults (including elderly):

One 5 ml teaspoonful three times a day (every 8 hours).

May be doubled in severe infections Other dosages which may be given are:

For severe or recurrent respiratory tract infections: Upto a maximum of 6 g daily in divided dose, ie.3 g twice daily. For urinary tract infections: - Two 3 g doses with 10-12hours between doses.

Gonorrhea la sexually transmitted infection): - A single 3 g dose (combined with 1 g of Probenecid).

Prevention of endocarditis- inflammation of the heartlining, heart muscles and heart valves lduring dental orocecdures): 3 g orally given one hour before treatment followed by second dose six hours later, if necessary. In some cases different doses may be given depending on other medical conditions.

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Dental abscess: Two 3 g doses with 8 hours between the doses. Dosage may be lower than those listed above in the patients with kidney problems.

Children:

Children weighing less than 40 kg The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen.

Dosing three times daily is associated with enhanced efficacy,thus twice daily dosing is only recommended when the dose is in the upper range.

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

Other dosages which may be given are:

Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media: In areas with high prevalence of

pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations. Early Lyme disease (isolated erythema migrans):

50 mg/kg/dayin three divided doses, over 14-21days. Prophylaxis for endocarditis: 50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure. Impaired renal function: The dose should be reduced. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended.

Children luo to 10 years of age):

Half 5 ml teaspoonful to be taken three times a day (every 8 hours). This may be doubled in more severe infections.

Children aged 5 to 10 years lin dental treatment):

Half 5ml spoonful to be taken three times a day (every 8 hours)

Children under 5 years:

Quarter 5 ml teaspoonful (1.25ml) three times a day (every 8 hour).

If you take more Amoxicillin Suspension than you should

If you take more Amoxicillin Suspension than you should, contact your doctor or nearest hospital emergency department immediately. Show the doctor the medicine bottle.

If you forget to take Amoxicillin Suspension If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillin Suspension Do not stop taking Amoxicillin Suspension without talking to your doctor, even if you feel better. If you stop your medicine before the end of the course, some bacteria may survive and cause the infection to come back.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amoxicillin Suspension can cause some side effects, although not every body gets them.

Very serious side effects - If any of the following happens, stop taking Amoxicillin Suspension and tell your doctor immediately or go to the nearest hospital emergency department:

•    Rare allergic (Hypersensitive) reactions such as difficulty of breathing, swelling of your face, throat or tongue, skin rash, itching and hives.

Common (occur in less than 1 in 100 patients):

•    Nausea (feeling of sickness) or diarrhoea

•    Skin Rash

Uncommon (occur in less than 1 in 100 patients, but

bymore than 1 patient in 1,000 patients):

•    Vomiting

Very Rare side effects ((experienced by fewer that 1

patientin 10,000 patients):

•    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 weakor light-headed) or a longer time taken for blood to clot. Tellyour doctor if you are taking Amoxicillin Suspension if youare having blood tests.

•    Excessive body movement (hyperkinesias), dizziness or convulsions. People who are on high doses of Amoxicillin Suspension or whose kidneys do not work properly experience convulsions.

•    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.

•    Inflammation of the liver and jaundice (yellowing of the skin and whites of your eyes)

•    Inflammation of the kidney

•    Forming of crystals in the urine

•    Colitis (Inflammation in the bowel, causing abdominal pain, diarrhoea, fever, sometimes with bleeding)

•    The tongue may change to yellow, brown or black and it may have a hairy appearance

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.

5. HOW TO STORE AMOXICILLIN SUSPENSION

6. FURTHER INFORMATION

Keep out of sight and reach of children Do not store above 25°C.

Do not use this medicine after the expiry date printed on the pack. Keep the suspension tightly closed.

The expiry date refers to the last day of that month.

The reconstituted sugar free Suspension should be used within 7 days of preparation.

Return any sugar free Suspension not used by this time to the pharmacist.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer

What Amoxicillin Suspension contains

The active ingredient in Amoxicillin Suspension 250 mg/5ml is Amoxicillin Trihydrate EP equivalent to Amoxicillin EP 250 mg.

The other ingredients are Sodium Benzoate (E211), Disodium Edetate, Sodium Citrate, Citric Acid, Colloidal Anhydrous Silica, Sorbitol (E420), Saccharin Sodium, Banana Flavour, Quinoline Yellow (E104), Xanthan Gum. Pack size - 100ml.

Marketing Authorisation Holder and Manufacturer: MEDREICH PLC,

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

Date of last revision: September 2013

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