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AMIX CAPSULES 250MG

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amix Capsules 250mg and 500mg
(Amoxicillin Trihydrate)
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. 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 Amix is and what it is used for
2. Before you take Amix
3. How to take Amix
4. Possible side effects
5. How to store Amix
6. Further information
1.

WHAT AMIX IS AND WHAT IT IS USED FOR

The name of this medicine is Amix. The active substance in Amix is called
amoxicillin, which belongs to a group of antibiotics called broad-spectrum penicillins.
Amix is used to kill bacteria that cause infections in your body, for example,
infections of the chest, bladder or stomach/intestines, ear infections, and skin
infections. Amoxicillin is also used to treat a sexually transmitted infection called
gonorrhoea and may also be used in some patients to prevent infections associated
with dental procedures.
2.

BEFORE YOU TAKE AMIX

Do not take Amix
• if you are allergic (hypersensitive) to any penicillin antibiotic such as penicillin,
ampicillin, amoxicillin or flucloxicillin
• if you are allergic to any cephalosporin antibiotic such as cefaclor, cefalexin or
cefradine
• if you are allergic to any of the other ingredients of Amix (see section 6 for a full
list of ingredients)
Talk to your doctor before taking this product if any of the above apply to you.
Take special care with Amix
• if you have another type of allergy, other than those mentioned earlier, especially
if you are allergic to other medicines
• if you are pregnant or breast-feeding
• if you suffer from kidney disease

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if you suffer from a condition called chronic lymphatic leukaemia

If any of the above apply to you, it is important that you tell your doctor or pharmacist
before taking Amix and they will decide what to do. It may still be safe for you to
take Amix.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
medicines, including those medicines obtained without a prescription.
This is especially important if you are taking:
• anticoagulants, e.g. warfarin (medicine to prevent blood clots)
• medicines called probenecid or allopurinol (used to treat gout)
• combined oral contraceptives (Amix Capsules may reduce the effectiveness of
combined oral contraceptives. You may need to take additional precautions while
taking Amix and for seven days after finishing your treatment, refer to the leaflet
that comes with the contraceptive for more information)
• methotrexate (used in cancer and certain inflammatory diseases like rheumatoid
arthritis)
It may still be safe for you to take Amix Capsules; your doctor or pharmacist will be
able to advise you further.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking Amix or any other medicine,
during pregnancy or while breast-feeding.
3.

HOW TO TAKE AMIX

Always take Amix exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Amix should be taken by mouth (orally), with a drink of water.
Children under six years old and older children who cannot swallow capsules should
be prescribed an amoxicillin suspension.
Use in children weighing less than 40kg
• All doses are worked out depending on the child’s bodyweight in kilograms
and the type and severity of the infection. Your doctor will advise you how
much Amix you should give to your child
• The usual dose is 40mg to 90mg for each kilogram of body weight per day,
given in two or three divided doses, at regular intervals.
Use in adults, the elderly and children weighing over 40kg
The usual dose is 250mg three times a day, although in more severe infections the
dosage may be increased to 500mg three times a day.

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Your doctor may prescribe a different dosing schedule, depending on the type of
infection and any other medical conditions you may have, for example:
• Severe or recurring chest infections: the usual dose is 3g every 12 hours
• Dental abscesses: the usual dose is 3g repeated after 8 hours
• Bladder infections: the usual dose is 3g repeated after 10-12 hours
• Gonorrhoea (a sexually transmitted infection): a single dose of 2-3g is given
with another drug called probenecid
• Endocarditis: Patients at risk of developing a condition called endocarditis
(which is an inflammation of the heart and/or valves) may be given
amoxicillin to prevent infection during dental procedures
Dosage for dental procedures:
• Dental procedures under local or no anaesthesia:
- The usual dose is 3g of amoxicillin given 1 hour before the procedure (as long as
the patient has not had more than one dose of penicillin in the last month, and as
long as they have not previously had endocarditis)
- In patients who have had endocarditis, amoxicillin will be given intravenously
with another antibiotic before the procedure, followed by an oral dose of 500mg
amoxicillin 6 hours later
• Dental procedures under general anaesthesia:
- The usual dose is 3g of amoxicillin 4 hours before the procedure and another 3g
dose as soon as possible after the procedure (as long as they have not had more
than one dose of penicillin in the last month, and as long as they have not
previously had endocarditis)
- Patients who have had endocarditis will be given amoxicillin with another
antibiotic intravenously at the time of anaesthesia, followed by an oral dose of
500mg amoxicillin 6 hours later
The following information applies to all patients (adults, the elderly and children).
Where you are giving this medicine to your child, read ‘your child’ for ‘you’.
Patients with kidney problems
Patients with kidney problems may be prescribed a lower dose than those described
above.
Always make sure you read the label on your medicine, as it will tell you precisely
what dose to take.
If you take more Amix than you should
If you take too many capsules contact your nearest hospital casualty department or tell
your doctor or pharmacist immediately. Take this leaflet and any remaining capsules
with you.
If you forget to take Amix
If you forget to take your prescribed dose, just take your normal dose as soon as you
remember and then continue as before. Do not take a double dose to make up for a
forgotten dose.

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If you stop taking Amix
Keep taking the medicine until you have finished the full course of treatment that your
doctor has prescribed for you. This will make sure that the infection has completely
cleared. Do not stop taking the medicine just because you feel better.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Amix Capsules can cause side effects, although not everybody
gets them.
If you get any of the following side effects you should stop taking Amix and tell your
doctor immediately or go to the casualty department of your nearest hospital, as these
may be signs of a serious allergic reaction:
• a skin rash resembling hives or nettle rash
• itchy and/or scaly skin
• red or purple patches on the skin
• joint pain
• difficulty breathing or wheezing
• fever
• swelling of the tongue, face, lips or throat
• feeling faint accompanied by one or some of the other reactions above
Tell your doctor immediately if you notice the following as you may require urgent
medical attention:
• diarrhoea which becomes severe or contains blood or mucus
Other side effects of Amix Capsules include:
• diarrhoea
• feeling sick or being sick
• kidney problems
• convulsions
Very rarely this medicine may lower the levels of certain blood cells, these will return
to normal when you stop taking Amix Capsules (symptoms may include sore throat,
mouth ulcers or feeling weak).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 AMIX

Keep out of the reach and sight of children.

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Do not use Amix after the expiry date that is stated on the carton and blister foil. The
expiry date refers to the last day of that month.
Store your capsules below 25oC. Store in the original packaging in order to protect
the capsules from light and moisture.
Do not use Amix if you notice that the pack or any of the capsules are damaged.
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 Amix contains
• The active substance in Amix is called amoxicillin. The capsules contain either
250mg or 500mg of amoxicillin as amoxicillin trihydrate
• The other ingredients are sodium lauryl sulphate and magnesium stearate
• The capsule shells are made of gelatin and contain erythrosine (E127), indigotine
(E132) and titanium dioxide (E171) as colouring agents
• The printing ink on the capsule shells contains shellac, black iron oxide (E172)
and propylene glycol
What Amix looks like and the contents of the pack
Amix Capsules 250mg are white and maroon and are printed “AMOXICILLIN 250”.
Amix Capsules 500mg are white and maroon and are printed “AMOXICILLIN 500”.
Amix Capsules 250mg and 500mg are available in
− containers of 3, 100, 250, 500 and 1000 capsules
− blister packs of 15 and 21 capsules
Not all pack sizes may be marketed. (Delete this section as appropriate.)
Marketing Authorisation Holder
Flamingo Pharma UK Ltd
1st Floor Kirkland House
11-15 Peterborough Road
Harrow,
Middlesex,
HA1 2AX

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon BT63 5QD Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon

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BT63 5QD
UK
Distributed by
Ashbourne Pharmaceuticals Limited
Pitsford
Northampton
NN6 9AA
UK
This leaflet was last revised in 05/2015

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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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