AMOXIL 500MG CAPSULES

Active substance: AMOXICILLIN

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ASSESSED AGAINST UK PIL DATED SEPTEMBER 2010

AMOXIL® 500mg CAPSULES
(amoxicillin trihydrate)
Patient Information Leaflet
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 is usually prescribed for adults and for children who are able to swallow capsules.
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.

What Amoxil is used for
Amoxil is used to treat infections in different parts of the body caused by bacteria. It is also used to stop
infections when you have a tooth removed or other surgery. Amoxil may also be used in combination with
other medicines to treat stomach ulcers.
2. Before you take Amoxil
Do not take Amoxil if you:
• are allergic (hypersensitive) to amoxicillin, penicillin or any of the other ingredients of Amoxil
(listed in section 6)
• have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash
or swelling of the face or neck.
Do not take Amoxil if any of the above apply. If you are not sure, talk to your doctor or pharmacist
before taking Amoxil.

WARNING!

Take special care with Amoxil
Check with your doctor or pharmacist before taking this medicine if you:
• have glandular fever
• are being treated for kidney problems
• 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 Amoxil.

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Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine if you think you might be or if you are
pregnant, or if you are breast-feeding.

05-0269

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15/08/11

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3. How to take Amoxil
Always take Amoxil exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.

6464/0073D
CODE:

TO UK PIL DATED SEPTEMBER 2010

Amoil 500mg caps

When taking Amoxil
• Swallow the capsules whole with a glass of water at the start of a meal or slightly before
• Space the doses evenly during the day, at least 4 hours apart
• Never take 2 doses in 1 hour
• The maximum recommended dose is 6 g per day given as 2 x 3 g doses.

PRODUCT:

CUSTOMER: Waymade

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines that can be bought without a prescription and herbal medicines. This is because
Amoxil can affect the way some other medicines work. Also some other medicines can affect the way
Amoxil works.
• If you are taking allopurinol (used for gout) with Amoxil, it may be more likely that you’ll have an
allergic skin reaction.
• If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of
Amoxil.
• If medicines to help stop blood clots (such as warfarin) are taken with Amoxil then extra blood
tests may be needed.
Amoxil may stop the contraceptive pill working. You will need to use extra contraceptive
precautions, such as using a condom. If you need any advice, talk to your doctor or pharmacist.

PRE-PRESS NO.:

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 Amoxil. This is because Amoxil can affect the results of these tests.

The usual dose is:
Children weighing less than 40 kg who are able to swallow capsules.
All doses are worked out depending on the child’s body weight in kilograms.
• Your doctor will advise you how much Amoxil you should give to your baby or child.
• Usual dose – 40 mg to 90 mg for each kilogram of body weight a day, given in two or three
divided doses.
Adults, elderly patients and children weighing more than 40 kg
• Standard dose: 1 x 250 mg 3 times a day.
• Severe infections: 1 x 500 mg 3 times a day.
• Severe or recurrent chest infection: 3 g (6 x 500 mg) twice a day.
• Urinary tract (water) infection: 2 x 3 g doses (6 x 500 mg) 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) with 8
hours between each dose.
• Gonorrhoea (a sexually transmitted infection): 1 x 3 g dose (6 x 500 mg).
• Stomach ulcers: 1 x 750 mg dose (3 x 250 mg or 1 x 500 mg and 1 x 250 mg) or 1 x 1 g dose
(2 x 500mg) 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.
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If you take too much Amoxil
If you have too much Amoxil, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or
crystals in the urine, which may be seen as cloudy urine, or problems passing urine.
Talk to your doctor as soon as possible. Take the medicine to show the doctor.
If you forget to take Amoxil
• If you forget to take a dose don’t worry, take it as soon as you remember.
• Don’t take the next dose too soon, wait about 4 hours before taking the next dose.

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WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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Notes:

1. What Amoxil is and what it is used for
What Amoxil is
Amoxil Capsules 500 mg (called Amoxil in this leaflet) are antibiotics. The capsules contain a medicine
called amoxicillin. This belongs to a group of medicines called ‘penicillins’.

PROOF HISTORY:
v.1 - waymade - 15/08/11

Leaflet Flat Size = 148 x 400

In this leaflet:
1. What Amoxil is and what it is used for
2. Before you take Amoxil
3. How to take Amoxil
4. Possible side effects
5. How to store Amoxil
6. Further information

WARNING!

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ASSESSED AGAINST UK PIL DATED SEPTEMBER 2010
How long should you take Amoxil for?
• Keep taking Amoxil 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 Amoxil 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 Amoxil is used for a long time.
If this occurs and you have been taking Amoxil for longer than recommended, tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Amoxil can cause side effects, although not everybody gets them. The following side
effects may happen with this medicine.

WARNING!

The other possible side effects are:
Common (affects less than 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.

TO UK PIL DATED SEPTEMBER 2010

CODE:

6464/0073D

15/08/11
DATE OF PROOF:

DATE:

DT
ARTWORKER:
Amoil 500mg caps
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

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.
If any of the side effects gets serious, or if you have any side effects not listed in this leaflet, please tell
your doctor or pharmacist.







5. How to store Amoxil
Amoxil 500mg capsules should be stored in a dry place, below 25°C.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers
to the last day of that month.
Keep all medicines out of the reach and sight of children.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for
safe disposal. Only keep the capsules if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist who will tell you what to do.
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. Further information
Your medicine is called Amoxil 500mg capsules. It contains the active ingredient, Amoxicillin 500mg (as
trihydrate) in a maroon and gold, hard gelatin capsule marked ‘GS JVL’ on the cap and on the body.
Amoxil 500mg capsules also contain the following:
magnesium stearate, erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), yellow iron oxide
(E172) and gelatin.
Amoxil 500mg capsules are available as blister packs of 12 and 18 capsules.
POM

PL No: 6464/0073

This product is manufactured by Famar ABE, Lab D, Avlona, Greece and is procured from within the EU
and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 11.8.2011
AMOXIL is a registered trademark of the BEECHAM GROUP plc.

Colour
Swatch

Black

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

DATE:

CUSTOMER
APPROVED:

If any of the above happen, 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 Amoxil will need to be stopped.

WARNING!

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Notes:

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 Amoxil, 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
• serious liver side effects may occur which are often reversible. They are mainly associated with
people having treatment over a long period, males and the elderly. You must tell your doctor
urgently if you get:
- severe diarrhoea with bleeding
- blisters, redness or bruising of the skin
- darker urine or paler stools
- yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which
might result in jaundice.
These can happen when having the medicine or for up to several weeks after.

PROOF HISTORY:
v.1 - waymade - 15/08/11

Leaflet Flat Size = 148 x 400

Stop taking Amoxil and see a doctor straight away, if you notice any of the following serious side
effects – you may need urgent medical treatment:

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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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