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Amoxicillin 500mg Capsules

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CP.AMO.JNT.C.ML.V1P1 PATIENT INFORMATION LEAFLET

AMOXICILLIN 250mg AND 500mg CAPSULES



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 signs of illness are the same as yours.

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


IN THIS LEAFLET

1.    What Amoxicillin Capsules are and what they are used for

2.    Before you take Amoxicillin Capsules

3.    How to take Amoxicillin Capsules

4.    Possible side effects

5.    How to store Amoxicillin Capsules

6.    Contents of the pack and other information


1


WHAT AMOXICILLIN CAPSULES ARE AND WHAT THEY ARE USED FOR


Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin works by killing the bacteria that cause the infection. Amoxicillin Capsules are used to treat a wide range of bacterial infections including infections of the:

•    chest (e.g. bronchitis or pneumonia)

•    throat (e.g. tonsillitis)

•    sinuses (sinusitis)

•    ears (e.g. otitis media)

•    teeth and gums (abscesses)

•    blood (septicaemia)

•    skin and soft tissue (e.g. acne)

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

•    kidneys

•    stomach and bowel

Amoxicillin Capsules are also used:

•    to treat gonorrhoea (a sexually transmitted infection)

•    to prevent endocarditis (inflammation of the lining of the heart and its valves) after surgery or a dental procedure

•    in combination with other medicines to treat stomach ulcers


•    Oral typhoid vaccine

•    Anticoagulants (used to prevent blood clots e.g. Warfarin)

•    Muscle relaxant drugs used with anaesthetic for surgery. If you are due to have a surgery, which involves having an anaesthetic tell your doctor that you are taking amoxicillin.

Pregnancy and 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 Amoxicillin Capsules.

Driving and using machines

Amoxicillin may cause dizziness or convulsions. If you are affected by these very rare side effects, do not drive or operate machines.

Blood or urine tests

If you are having urine tests for glucose or blood tests for liver function tell the doctor or nurse that you are taking Amoxicillin Capsules as amoxicillin can affect the results of these tests.


3


HOW TO TAKE AMOXICILLIN CAPSULES


. BEFORE YOU TAKE AMOXICILLIN CAPSULES


Do not take Amoxicillin Capsules if you are:

• allergic to amoxicillin, other penicillin-type products, cephalosporins or any of the other ingredients of this medicine (listed in section 6)


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

Swallow Amoxicillin Capsules with a glass of water. Take the capsules before, during or after food.

During your treatment with Amoxicillin Capsules it is important that you drink plenty of water in order to reduce the risk of developing crystalluria (formation of crystals in the urine).


Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin Capsules if you:

•    suffer from kidney problems or kidney disease

•    have glandular fever

Prolonged use of Amoxicillin may result in infections due to bacteria resistant to amoxicillin.

Use in children

It is recommended that children be given Amoxicillin as a suspension instead of the capsule form.


The recommended doses are detailed below.

Adults (including the elderly)

The usual adult dose for infections is 250mg three times a day. This may be increased to 500mg three times a day for more severe infections. The maximum daily dose is 6g, in divided doses.

   Urinary tract infections

The usual dose is two 3g doses with 10 to 12 hours between the doses.

   Gonorrhoea

The usual dose is one 3g dose.


Other medicines and Amoxicillin Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines bought without a prescription.

In particular tell your doctor if you are taking any of the following:

•    The contraceptive pill - extra contraceptive measures must be taken, e.g. using a condom

•    Other antibiotics (e.g. chloramphenicol, erythromycin, sulfonamide, neomycin or tetracycline as these can reduce the effect of amoxicillin)

•    Probenecid, allopurinol or sulfinpyrazone (used to treat gout)

•    Methotrexate (used in the treatment of cancer, rheumatoid arthritis, Crohn's disease or psoriasis)


•    Surgery or dental procedure

The usual dose is one 3g dose one hour before the surgery or dental procedure.

   Stomach ulcers

The usual dose of Amoxicillin combined with other antibiotics is 750mg - 1g twice a day for 7 days.


Children

It is recommended that children be given Amoxicillin as a suspension instead of the capsule form.

•    For children weighing more than 40kg, the usual adult dose should be given.

•    For children weighing less than 40kg, and who are able to swallow capsules, the usual daily dose is 40-90mg/kg/day in two or three divided doses.

You should always follow your doctor's instructions about how much medicine to give your child.

Patients with kidney problems

Your doctor will prescribe a suitable dose for you if you suffer from kidney problems.

If you take more Amoxicillin Capsules than you should

If you take more capsules than you should, tell your doctor immediately or go to the nearest hospital emergency department. Take this leaflet with you and any capsules you still have to show the doctor or nurse. Symptoms of an overdose include feeling sick, vomiting and diarrhoea.

If you forget to take Amoxicillin Capsules

If you forget to take a dose, take it as soon as you remember and carry on as before unless it is one hour before your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillin Capsules

Keep taking this medicine until your course of treatment is finished or your doctor tells you to stop. Do not stop taking it just because you feel better as your infection may come back or get worse.

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


•    inflammation of the kidney which may lead to kidney failure if untreated

•    crystalluria (forming of crystals in the urine)

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


. HOW TO STORE AMOXICILLIN CAPSULES


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original package.

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


. POSSIBLE SIDE EFFECTS


Like all medicines, Amoxicillin Capsules can cause side effects although not everybody gets them.

STOP taking Amoxicillin Capsules and contact your doctor IMMEDIATELY or go to your nearest hospital emergency department if you experience any of the following side effects:

•    an allergic reaction - symptoms include swollen face, mouth, throat or tongue, skin rash, itching, hives, ulcers of the mouth, lips and skin, flaking, reddening or blistering of the skin, breathing difficulties, joint pain and fever

•    skin reactions including severe blistering and peeling of the skin

•    convulsions (fits)

•    inflammation of the colon (symptoms include stomach pain, loss of appetite, fever, severe diarrhoea with bleeding)

•    inflammation of the liver (hepatitis) and jaundice (symptoms include the skin and whites of the eyes turning yellow)

Talk to your doctor or pharmacist if you notice any of the following less serious side effects.

Common side effects (affects 1 in 10 people to 1 in 100 people)

•    stomach upset

•    nausea (feeling sick)

•    indigestion

•    diarrhoea

Uncommon side effects (affects 1 in 100 people to 1 in 1,000 people)

•    vomiting (being sick)

Very rare side effects (affects less than 1 in 10,000 people)

•    thrush (a yeast infection of the mouth, skin, vagina or penis)

•    blackening of the tongue

•    tooth discolouration

•    headache

•    dizziness

•    excessive body movements (hyperkinesia)

•    low blood cell count (e.g. anaemia, thrombocytopenia and leucopenia - symptoms include bruising more easily, nose bleeds and bleeding gums, fever, more susceptible to infections, feeling weak, tired and generally feeling unwell)


What Amoxicillin Capsules contain

Each capsule contains 250mg or 500mg of the active ingredient amoxicillin as amoxicillin trihydrate.

The other ingredients are sodium lauryl sulfate and magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171), red iron oxide (E172) and erythrosine (E127).

What Amoxicillin Capsules look like and contents of the pack

Amoxicillin 250mg and 500mg Capsules are red and white capsules.

Amoxicillin 250mg and 500mg Capsules are available in blister packs containing 15, 21 and 28 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturers responsible for batch release

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

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

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

PL 30464/0013 and PL 30464/0014

This leaflet was last revised in November 2012.


CPAMO.JNTC.ML.V1P1