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AMOXICILLIN CAPSULES BP 500MG

Active substance(s): AMOXICILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE

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Package leaflet: Information for the user
Amoxicillin Capsules BP 250 mg
Amoxicillin Capsules BP 500 mg
(Amoxicillin Trihydrate)
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 section. See section 4.
What is in this leaflet:
1. What Amoxicillin Capsules are and what are they used for
2. What you need to know 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 are they used for?
Amoxicillin is one of the penicillin group of antibiotics. It is a broad spectrum antibiotic.
It is used to treat infections in different parts of the body caused by bacteria that are
susceptible to amoxicillin. It is mostly used to treat respiratory, middle ear infections and
urinary tract infections. It is also used to stop infections when you have a tooth removed
or other surgery. Amoxicillin may also be used in combination with other medicines to
treat stomach ulcers.
2. What you need to know before you take Amoxicillin Capsules
Do not take Amoxicillin Capsules if you
 are allergic (hypersensitive) to amoxicillin trihydrate, penicillin or to any of the
ingredients of the capsules listed in Section 6.
 have ever had an allergic reaction to any antibiotic. This can include a skin rash or
swelling of the face or neck.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin Capsules.

Take special care and consult your doctor before taking Amoxicillin Capsules if
you:
 suffer from kidney problems
 are suffering from lymphatic leukaemia or HIV infection. You may be more at risk of
developing a rash.
 have glandular fever
 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 Amoxicillin.
Having urine or blood tests
If you are having tests on your water (urine glucose tests) or blood tests for liver function,
let the doctor or nurse know that you are on Amoxicillin. This is because Amoxicillin can
affect the results of these tests.
Other Medicines and Amoxicillin Capsules:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including products you do not need a prescription for as they may
interfere with this product.




If you are taking allopurinol (used for gout) with amoxicillin, it may be more likely
that you’ll have an allergic skin reaction.
If you are taking probenecid (used to treat gout, a form of arthritis), your doctor may
decide to adjust your dose of amoxicillin.
If medicines to help stop blood clots (anticoagulants such as warfarin or
acenocoumarol) are taken with amoxicillin, then extra blood tests may be needed.

If the product is given at the same time as the oral contraceptive the contraceptive may
not be as effective and extra precautions should be taken e.g. use of condoms.
Pregnancy, breast feeding and fertility
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 any medicine.
Driving and using machines
Amoxicillin has not been shown to have any effect on ability to drive and
use machines.
Amoxicillin Capsules contain methyl paraben and propyl paraben
Methyl Paraben and Propyl Paraben may cause hives. There may be a delayed reaction
such as contact dermatitis. There is rarely an immediate reaction with hives and
bronchospasm.

3. How to take Amoxicillin Capsules
Always take Amoxicillin Capsules exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
The maximum recommended dose is 6 g per day given as 2 x 3 g doses.
The usual dose is:
Adults, elderly patients and children weighing over 40 kg
Standard dose: 1 x 250 mg capsule 3 times a day
Severe infections: 1 x 500 mg capsule 3 times a day
Severe or recurrent chest infection: 3 g (6 x 500 mg capsules) twice a day
Urinary tract (water) infection: 2 x 3 g doses (6 x 500 mg capsules) with 10 to 12 hours
between each dose
Dental abscess (infection under the gums and teeth): 2 x 3 g doses (6 x 500 mg
capsules) with 8 hours between each dose
Gonorrhoea (a sexually transmitted infection): 1 x 3 g dose (6 x 500 mg capsules)
Stomach ulcers: 1 x 750 mg dose (3 x 250 mg capsules or 1 x 500 mg capsule and 1 x
250 mg capsule) or 1 x 1 g dose (2 x 500 mg capsules) twice a day for 7 days with other
antibiotics
To stop infection during surgery
 The dose will vary according to the type of surgery. Other medicines may also be
given at the same time.
 Your doctor, pharmacist or nurse can give you more details.
Your doctor will decide on the appropriate dose to suit the severity and type of infection
you have.
Children weighing <40kg.
The daily dosage for children is 40-90mg/kg/day in two to three divided doses (not
exceeding 3g/day) depending on the indication, severity of the disease and the
susceptibility of the pathogen.
Severe or recurrent ear infections particularly inflammation of the middle ear (acute
otitis media): 750 mg twice daily for two days may be prescribed as an alternative course
of treatment in children aged 3 to 10 years.

Kidney problems
The dose may be reduced in those with kidney problems.
Amoxicillin Mixture BP 125mg/5ml or 250mg/5ml may be required to achieve the
recommended dose.
NOTE:
Always follow your doctor’s advice about when and how to take your medicine and
always read the label. It is important that you complete the full course of antibiotics.
How long should you take Amoxicillin for?
 Keep taking Amoxicillin 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. Treatment should be continued for 2 to 3 days after the
symptoms have gone.
 Do not take Amoxicillin for more than 2 weeks. If you still feel unwell you should go
back to see the doctor.
Thrush (a yeast infection of moist areas of the body) may develop if Amoxicillin is used
for a long time. If this occurs and you have been taking Amoxicillin for longer than
recommended, tell your doctor.
If you take more Amoxicillin Capsules than you should contact your doctor or
pharmacist who will recommend what action you should take. Signs of an overdose
include upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine,
which may be seen as cloudy urine, or problems passing urine. Take the medicine to
show the doctor.
If you forget to take Amoxicillin Capsules at the correct time, take it as soon as you
remember and carry on as before. If it is almost time for your next dose, skip the missed
dose and continue as usual. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets
them. The following side effects may happen with this medicine.
Stop taking amoxicillin and see a doctor straight away, if you notice any of the
following serious side effects – you may need urgent medical treatment:

The following are very rare (affects less than 1 in 10,000 people)














allergic reactions, the signs may include: skin itching or rash, swelling of the face,
lips, tongue, body or breathing difficulties. These can be serious and occasionally
deaths have occurred
rash or pinpoint flat red round spots under the skin surface or bruising of the skin.
This is due to inflammation of blood vessel walls due to an allergic reaction. It can be
associated with joint pain (arthritis) and kidney problems
a delayed allergic reaction can occur usually 7 to 12 days after having amoxicillin,
some signs include: rashes, fever, joint pains and enlargement of the lymph nodes
especially under the arms
a skin reaction known as ‘erythema multiforme’ where you may develop: itchy
reddish purple patches on the skin especially on the palms of the hands or soles of the
feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the
mouth, eyes and private parts. You may have a fever and be very tired
other severe skin reactions can include: changes in skin colour, bumps under the skin,
blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated
with fever, headaches and body aches
high temperature (fever), chills, a sore throat or other signs of an infection, or if you
bruise easily. These may be signs of a problem with your blood cells
inflammation of the large bowel (colon) with diarrhoea sometimes containing blood,
pain and fever
liver disease characterized by nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions,
dark coloured urine, rise in liver enzymes (AST, ALT) [hepatitis, cholestatic
jaundice]

If any of the above happens stop taking the medicine and see your doctor straight
away.
Sometimes you may get less severe skin reactions such as:
 a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms,
legs, palms, hands or feet. This is uncommon (affects less than 1 in 100 people).
If you have any of these talk to your doctor as amoxicillin will need to be stopped.
The other possible side effects are:
Common (affects less than 1 in 10 people)
 skin rash
 feeling sick (nausea)



diarrhoea

Uncommon (affects less than 1 in 100 people)
 being sick (vomiting)
Very rare (affects 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
 kidney problems
 fits (convulsions), seen in patients on high doses or with kidney problems
 dizziness
 hyperactivity
 crystals in the urine, which may be seen as cloudy urine, or difficulty or discomfort in
passing urine. Make sure you drink plenty of fluids to reduce the chance of these
symptoms
 teeth may appear stained, usually returning to normal with brushing (this has been
reported in children)
 the tongue may change to yellow, brown or black and it may have a hairy appearance
 an excessive breakdown of red blood cells causing a form of anaemia. Signs include:
tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the
skin and the whites of the eyes
 the blood may take longer to clot than it normally would. You may notice this if you
have a nosebleed or cut yourself.
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.
5. How to store Amoxicillin Capsules
Keep this medicine out of reach and sight of children.
Do not use this medicine after the expiry date shown on the label.
Store in a dry place at or below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information:
What Amoxicillin Capsules contain
These capsules are called Amoxicillin Capsules BP 250mg or 500mg.
Each capsule contains the active ingredient Amoxicillin Trihydrate BP equivalent to
250mg or 500mg of Amoxicillin.
Each capsule also contains Magnesium Stearate (E572), Colloidal Anhydrous Silica,
Titanium Dioxide (E171), Iron Oxides (E172), Erythrosine (E127), Indigo Carmine
(E132), Methyl Paraben (E218), Propyl Paraben (E216), Sodium Lauryl Sulphate and
gelatin. The ink is composed of Shellac, Isopropyl Alcohol, Purified Water, N-Butyl
alcohol, Black iron Oxide (E172), Propylene Glycol, Strong Ammonia Solution,
Potassium Hydroxide and Dehydrated Alcohol.
What Amoxicillin Capsules look like and contents of the pack
Amoxicillin Capsules BP 250mg are hard gelatine size 1 buff/scarlet capsules identity
marked RAMX250
Amoxicillin Capsules BP 500mg are hard gelatine size 0 elongated buff/scarlet capsules
identity marked RAMX500
Amoxicillin Capsules BP 250mg are available in packs of 15, 20, 21, 50, 100, 500 and
1000 capsules and the Amoxicillin Capsules BP 500mg are available in packs of 15, 20,
21,100, 500 and 1000 capsules. Both products are also available in blister strips of 15 and
21 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Focus Farma B.V.
Lagedijk 1-3
1541 KA Koog aan de Zaan
The Netherlands
Manufacturer:
Ranbaxy Ireland Ltd.,
Spafield,
Cork Road,
Cashel,
Co. Tipperary,
Ireland.
Date of Revision:

November 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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