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Amix Capsules 500mg

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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

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.

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.

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).

If you consider any of these side effects to be serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE AMIX

Keep out of the reach and sight of children.

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 and Manufacturer

uniQ Pharma Limited

3M Buckley Innovation Centre

Firth Street

Huddersfield

West Yorkshire

HD1 3BD

Distributed by

Ashbourne Pharmaceuticals Limited

Pitsford

Northampton

NN6 9AA

UK

This leaflet was last approved in March 2011

The following date should be inserted below the in-house PX code on the mock-up:

1.3.1 Package Leaflet 5