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AMOCLAN 500MG/125MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amoclan 500mg/125mg film-coated tablets
Amoxicillin/clavulanic acid
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 (or for your child).
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.
In this leaflet:
1. What Amoclan 500 mg/125 mg film-coated tablets are and what
they are used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Further information
1. WHAT AMOCLAN 500 MG/125 MG FILM COATED TABLETS
ARE AND WHAT THEY ARE USED FOR
Amoclan 500 mg/125 mg film-coated tablets are an antibiotic
and work by killing bacteria that cause infections. It contains
two different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines called “penicillins”
that can sometimes be stopped from working (made inactive).
The other active component (clavulanic acid) stops this from
happening.
Amoclan 500 mg/125 mg film-coated tablets are used in adults and
children to treat the following infections:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections including dental infections
• bone and joint infections.
2. BEFORE YOU TAKE YOUR MEDICINE
Do not take your medicine:
• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid,
penicillin or any of the other ingredients of your medicine (listed
in section 6)
• if you have ever had a severe allergic (hypersensitive) reaction to
any other antibiotic. This can include a skin rash or swelling of the
face or neck
• if you have ever had liver problems or jaundice (yellowing of the
skin) when taking an antibiotic.
Do not take your medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
your medicine.
Take special care with your medicine
Talk to your doctor or pharmacist before taking this medicine if you:
• have glandular fever
• are being treated for liver or 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 your medicine.
In some cases, your doctor may investigate the type of bacteria
that is causing your infection. Depending on the results, you may
be given a different strength of Amoclan or a different medicine.
Important information about some of the ingredients in your
medicine
This medicine contains 0.63mmol (24.5mg) potassium per
tablet, therefore, it may not be suitable if you are on a controlled
potassium diet or you have reduced kidney function. Check with
your doctor if you are unsure about this.
Conditions you need to look out for
Your medicine can make some existing conditions worse, or cause
serious side effects. These include allergic reactions, convulsions
(fits) and inflammation of the large intestine. You must look out for
certain symptoms while you are taking your medicine, to reduce
the risk of any problems. See ‘Conditions you need to look out for’
in Section 4.
Blood and urine tests
If you are having blood tests (such as red blood cell status tests
or liver function tests) or urine tests (for glucose), let the doctor
or nurse know that you are taking your medicine. This is because
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your medicine can affect the results of these types of tests.
Using other medicines
Please tell your doctor or pharmacist if you are using or have
recently used any other medicines. This includes medicines that
can be bought without a prescription and herbal medicines.
If you are taking allopurinol (used for gout) with your medicine, 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 your medicine.
If medicines to help stop blood clots (such as warfarin) are taken
with your medicine then extra blood tests may be needed.
Your medicine can affect how methotrexate (a medicine used to
treat cancer or rheumatic diseases) works.
Pregnancy and breast-feeding
If you are pregnant, you think you might be pregnant or if you are
breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Your medicine can have side effects and the symptoms may make
you unfit to drive.
Don’t drive or operate machinery unless you are feeling well.
3. HOW TO TAKE YOUR MEDICINE
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg and over
The usual dose is:
• 1 tablet three times a day
Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with
Amoclan oral suspension
Ask your doctor or pharmacist for advice when giving Amoclan
tablets to children weighing less than 40 kg.
Patients with kidney and liver problems
• If you have kidney problems the dose might be changed.
A different strength or a different medicine may be
chosen by your doctor.
• If you have liver problems you may have more frequent blood
tests to check how your liver is working.
How to take your medicine
• Swallow the tablets 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. Do
not take 2 doses in 1 hour.
• Do not take your medicine for more than 2 weeks. If you still feel
unwell you should go back to see the doctor.
If you take more of your medicine than you should
If you take too much of your medicine, signs might include an upset
stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk
to your doctor as soon as possible. Take the medicine carton or
bottle to show the doctor.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember. You
should not take the next dose too soon, but wait about 4 hours
before taking the next dose.
If you stop taking your medicine
Keep taking your medicine 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.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, your medicine can cause side effects, although
not everybody gets them.
Conditions you need to look out for
Allergic reactions:
• skin rash
• inflammation of blood vessels (vasculitis) which may be visible as
red or purple raised spots on the skin, but can affect other parts
of the body
• fever, joint pain, swollen glands in the neck, armpit or groin
• swelling, sometimes of the face or mouth (angioedema), causing
difficulty in breathing
• collapse.
Contact a doctor immediately if you get any of these symptoms.
Stop taking your medicine.
Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea
usually with blood and mucus, stomach pain and/or fever.
Continued overleaf

Section 3 continued
Contact your doctor as soon as possible for advice if you get
these symptoms.
Very common side effects
These may affect more than 1 in 10 people
• diarrhoea (in adults).
Common side effects
These may affect up to 1 in 10 people
• thrush (candida - a yeast infection of the vagina, mouth or skin
folds)
• feeling sick (nausea), especially when taking high doses
if affected take your medicine before food
• vomiting
• diarrhoea (in children).
Uncommon side effects
These may affect up to 1 to 100 people
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache.
Uncommon side effects that may show up in your blood tests:
• increase in some substances (enzymes) produced by
the liver.
Rare side effects
These may affect up to 1 in 1000 people
• skin rash, which may blister, and looks like small targets
(central dark spots surrounded by a paler area, with a dark ring
around the edge- erythema multiforme)
if you notice any of these symptoms contact a doctor urgently.
Rare side effects that may show up in your blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells.
Other side effects
Other side effects have occurred in a very small number of
people but their exact frequency is unknown.
• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Serious skin reaction:
- a widespread rash with blisters and peeling skin, particularly
around the mouth, nose, eyes and genitals (Stevens-Johnson
syndrome),and a more severe form, causing extensive peeling
of the skin (more than 30% of the body surface-toxic epidermal
necrolysis)
- widespread red skin rash with small pus-containing blisters
(bullous exfoliative dermatitis)
- a red, scaly rash with bumps under the skin and blisters
(exanthemous pustulosis)
Contact a doctor immediately if you get any of these
symptoms.
• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a
substance produced in the liver) which may make your skin and
whites of the eyes appear yellow.
• inflammation of tubes in the kidney
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of this medicine or
who have kidney problems)
• black tongue which looks hairy
• stained teeth (in children), usually removed by brushing
Side effects that may show up in your blood or urine tests:
• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine.
If you get side effects
Tell your doctor or pharmacist if any of the side effects
become severe or troublesome, or if you notice any side
effects not listed in this leaflet.
5. HOW TO STORE YOUR MEDICINE
Do not store above 25° C. Keep the tablets in the original
packaging.
Keep out of the reach and sight of children.
Do not use your medicine after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
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
What your medicine contains
• The active substances are: amoxicillin (as trihydrate)
500 mg; clavulanic acid (as potassium clavulanate)
125 mg.
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• The other ingredients are microcrystalline cellulose
(E460), sodium starch glycollate, magnesium stearate
(E572), colloidal silica anhydrous
• The film-coating contains: hypromellose (E464), titanium
dioxide (E171), propylene glycol, ethylcellulose.
What your medicine looks like and contents of the pack
Amoclan 500 mg/125 mg film-coated tablets are long white oval
film-coated tablets.
Your medicine comes either in a blister pack of 21 tablets or as
a white plastic bottle with a white tamper proof polypropylene
screw cap with a desiccant capsule, containing 21 tablets.
Marketing Authorisation Holder
Hikma Farmaceutica S.A., Estrada do Rio da Mó, 8, 8 A e 8 B,
Fervença 2705-906 Terrugem – SNT. Portugal
Manufacturer
Kent Pharmaceuticals Ltd, Wotton Road, Ashford, Kent, TN23
6LL, UK.
This medicinal product is authorised in the Member States
of the EEA under the following names:
Belgium - Amoxicilline/Clavulaanzuur Hikma Farmaceutica
500 mg/125 mg filmomhulde tabletten
Germany- Amoclan 500 mg/125 mg Filmtabletten
Netherlands - Amoxicilline/ clavulaanzuur Apotex 500 mg/125
mg, filmomhulde tabletten
This leaflet was last approved in 12/2009

Advice/medical education
Antibiotics are used to treat infections caused by bacteria.
They have no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond
to a course of an antibiotic. One of the commonest reasons
for this to occur is because the bacteria causing the infection
are resistant to the antibiotic that is being taken. This means
that they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many
reasons. Using antibiotics carefully can help to reduce the
chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is
intended to treat only your current illness. Paying attention
to the following advice will help prevent the emergence of
resistant bacteria that could stop the antibiotic working.
1. It is very important that you take the antibiotic at the
right dose, at the right times and for the right number of
days. Read the instructions on the label and if you do not
understand anything ask your doctor or pharmacist to
explain.
2. You should not take an antibiotic unless it has been
prescribed specifically for you and you should use it only to
treat the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed
for other people even if they had an infection that was
similar to yours.
4. You should not give antibiotics that were prescribed for you
to other people.
5. If you have any antibiotic left over when you have taken
the course as directed by your doctor you should take the
remainder to a pharmacy for appropriate disposal.

Expand Transcript

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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