AMOCLAN 250 MG /125 MG FILM-COATED TABLETSView full screen / Print PDF » Download PDF ⇩
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.
Amoclan 250 mg/125 mg
Read all of this leaﬂet carefully before you start taking this
• Keep this leaﬂet. You may need to read it again.
• If you have any further questions, ask your doctor or
• 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
In this leaﬂet:
1. What Amoclan 250 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 250 MG/125 MG FILM-COATED TABLETS
ARE AND WHAT THEY ARE USED FOR
Amoclan 250 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
Amoclan 250 mg/125 mg ﬁlm-coated tablets are used in adults and
children to treat the following infections:
• sinus infections
• urinary tract infections
• skin infections
• dental 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
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
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
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
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
Amoclan tablets are not recommended.
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
• 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
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
• 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
• fever, joint pain, swollen glands in the neck, armpit or groin
• swelling, sometimes of the face or mouth (angioedema), causing
difﬁculty in breathing
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.
Contact your doctor as soon as possible for advice if you get
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
• feeling sick (nausea), especially when taking high doses
if affected take your medicine before food
• diarrhoea (in children).
Uncommon side effects
These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
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
- widespread red skin rash with small pus-containing blisters
(bullous exfoliative dermatitis)
- a red, scaly rash with bumps under the skin and blisters
Contact a doctor immediately if you get any of these
• 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
• 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
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)
250 mg; clavulanic acid (as potassium clavulanate)
• 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 250 mg/125 mg ﬁlm-coated tablets are white capsule
shaped ﬁlm-coated tablets.
Your medicine comes either in a blister pack of 21 tablets or as a
white plastic bottle with a white pilfer proof polypropylene screw
cap with a desiccant capsule, containing 21 tablets.
Marketing Authorisation Holder and manufacturer
Hikma Farmaceutica (Portugal) S.A., Estrada do Rio da Mo, Nº8,
8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal.
This leaﬂet was last approved in 12/2009
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.
Source: Medicines and Healthcare Products Regulatory Agency