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PACKAGE LEAFLET: INFORMATION FOR THE USER Amoxicillin 250 mg Capsules Amoxicillin 500 mg Capsules

(amoxicillin)

What is in this leaflet:

1.    What Amoxicillin is and what it is used for

2.    What you need to know before you take Amoxicillin

3.    How to take Amoxicillin

4.    Possible side effects

5.    How to store Amoxicillin

6.    Contents of the pack and other information

1. WHAT AMOXICILLIN IS AND WHAT IT IS USED FOR

The name of your medicine is Amoxicillin. It contains the active ingredient amoxicillin trihydrate. Amoxicillin belongs to the penicillin group of medicines called antibiotics. Antibiotics are used to kill the bacteria that cause infections in many different parts of the body.

Amoxicillin can be used to treat a variety of bacterial infections of:

•    the respiratory tract (ear, nose, throat and lungs)

•    the urinary system

•    the reproductive system

•    the digestive system

•    the skin and soft tissue

•    the gums and teeth

•    the blood and abdomen.

Amoxicillin can also be used in combination with other medicines to treat stomach ulcers, as well as in patients with heart valve problems or other damaged heart tissue who need protection from infection during the dental treatment.

2. WHAT YOU NEED TO KNOW BEFORE You TAKE AMOXICILLIN

Do not take Amoxicillin if:

•    you are allergic (hypersensitive) to amoxicillin or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

•    you are allergic (hypersensitive) to the penicillin group of antibiotics e.g. Penicillin, Ampicillin, Flucloxacillin.

•    you have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash, itching, shortness of breath or swelling of the face or neck.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

•    if you suffer from kidney problems: your doctor may have to lower your dose

•    if you have glandular fever

•    if you are not passing urine regularly

•    if you are taking drugs to prevent blood clots forming (anticoagulant).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amoxicillin.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.

This is because Amoxicillin can affect the way some medicines work. Also some medicine can affect the way Amoxicillin works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

•    medicines to thin the blood (anticoagulants) e.g Warfarin. Extra blood tests may be needed as the tendency to bleed may be increased

•    Methotrexate, used to treat cancer

•    Probenecid and Allopurinol, used to prevent gout. Your doctor may decide to adjust the dose

of Amoxicillin as levels may be increased in your blood

•    oral contraceptives (the pill). Amoxicillin may reduce the effectiveness of the contraceptive pill; additional contraceptive precautions should be taken. If you need any advice, talk to your doctor or pharmacist.

Having urine or blood tests

If you are having blood tests or urine tests to check your sugar levels or liver function, tell the doctor you are taking Amoxicillin as it may interfere with the results.

Driving and machinery

Amoxicillin should not affect your ability to drive or operate machinery.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3. HOW TO TAKE AMOXICILLIN

Always take Amoxicillin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important that you complete the course of treatment.

When taking Amoxicillin:

•    Swallow the capsules whole with a glass of water

•    Space the doses evenly during the day, at least 4 hours apart

•    Never take 2 doses in 1 hour.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.

Adults (including the Elderly) and Children who weigh more than 40 kg: The usual dose is 250 mg three times a day. For more severe infections, the dose may be increased to 500 mg three times a day. The maximum recommended dose is 6 grams daily (e.g 12 x 500 mg capsules) given in divided doses.

For the following conditions your doctor may prescribe these doses: Severe or recurrent chest infection,

one 3 gram dose may be given twice a day (6 x 500 mg capsules).

To treat a urinary tract infection, one 3 gram dose may be given, followed 12 hours later by a further 3 gram dose (6 x 500 mg capsules). To treat a dental abscess, one 3 gram dose may be given, followed 8 hours later by a further 3 gram dose (6 x 500 mg capsules). To treat gonorrhoea, a single 3 gram dose may be given (6 x 500 mg capsules).

To prevent infection in heart patients needing dental surgery, your doctor may give you one 3 gram dose one hour before the dental procedure and if necessary, a further 3 gram dose 6 hours later. If you need a general anaesthetic and/or need to be admitted to hospital, it may be necessary to give you the appropriate dose of Amoxicillin by injection.

Stomach ulcers, 1x 750 mg dose (3 x 250 mg capsules or 1 x 500 mg capsule and 1 x 250 mg capsule) or 1 x 1 g dose (2 x 500 mg capsules) twice a day for 7 days with other antibiotics.

Children weighing under 40 kg who are able to swallow capsules:

The usual dose for children under 40 kg is 40-90 mg/kg/day two or three times daily. (not exceeding 3 g/day).

Oral suspensions containing Amoxicillin are recommended for infants, as well as for children who cannot swallow capsules.

If you suffer from kidney problems your doctor may prescribe a lower dose than that stated above.

Date: 28 MAR 2014

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.

If you take more Amoxicillin than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Signs of an overdose may include feeling sick, being sick, diarrhoea or crystals in the urine, which may be seen as cloudy urine, or difficulty in passing urine.

If you forget to take Amoxicillin

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillin

Do not suddenly stop taking your medicine as the infection may come back again. Keep taking your medicine until the course is finished even if you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Amoxicillin can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Amoxicillin and tell your doctor immediately or go to your nearest hospital emergency department:

•    allergic skin reactions which may cause an itchy skin rash, swelling of the face, lips, tongue or throat, difficulty in breathing, speaking or swallowing, dizziness or collapse. These can be serious and occasionally deaths have occurred

•    flat red spots under the skin surface or bruising of the skin. This is a result of an allergic reaction caused by the inflammation

of blood vessel walls. It can be associated with joint pain (arthritis) and kidney problems

•    a delayed allergic reaction can usually occur 7 to 12 days after having Amoxicillin. Some signs include rashes, fever, joint pains and enlargement of lymph nodes especially under the arms

•    itchy reddish purple patches on the skin especially on the palm of the hands and on the 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 fever and feel tired

•    other severe skin reactions such as changes in the skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches

•    blood disorders, causing fever, chills, sore throat, easy bruising or signs of an infection

•    inflammation of the large intestine (colitis), which may cause aches and pain in the stomach area, severe diarrhoea with blood in the stools and fever

•    kidney problems, which may cause a change in the amount of urine passed, blood on the urine, swollen ankles, feeling sick or being sick, or confusion

•    liver problems which may cause yellowing of the skin or whites of the eyes, dark urine and pale faeces, severe diarrhoea with bleeding, blisters, redness or bruising of the skin. These can happen when having the medicine or for several weeks after.

These side effects are rare but serious. You may need medical attention.

If you get any of the following side effects, talk to your doctor as soon as possible.

Common (affects less than 1 in 10 people):

•    mild skin rash

•    diarrhoea

•    feeling sick (nausea).

Uncommon (affects less than 1 in 100 people):

•    being sick (vomiting)

•    mildly itchy rash (pink-red patches).

Very rare (affects less than 1 in 10,000 people):

•    fits (convulsions), seen in patients on high doses

or with kidney problems

•    dizziness

•    feeling unusually excitable (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 (this has been reported in children). This is usually removed by regular brushing

•    the tongue may change to yellow, brown or black and it may have a 'hairy' appearance

•    blood may take longer to clot, you may notice this if you have a nose bleed or if you cut yourself

•    thrush (a yeast infection of the vagina, mouth or skin folds causing soreness and discharge). Your doctor or pharmacist can give you treatment for thrush.

If you get any side effect talk to your doctor or pharmacist. This includes any 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 AMOXICILLIN

Keep this medicine out of the sight and reach of children.

Store in a dry place below 25°C and protect from light.

Do not use Amoxicillin after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Do not use Amoxicillin if there are visible signs of deterioration.

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 Amoxicillin contains:

The active substance is amoxicillin trihydrate.

The other ingredients are talc, magnesium stearate, sodium starch glycollate with microcrystalline cellulose in the 250 mg product only and colloidal silicon dioxide in the 500 mg product only. The capsule shell contains erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171), red iron oxide (E172) and gelatine. The printing ink contains black iron oxide (E172), shellac, isopropyl alcohol, n-butyl alcohol, propylene glycol and ammonium hydroxide.

What Amoxicillin looks like and contents of the pack:

Your medicine comes as a hard capsule with a yellow body and a red cap. The 250 mg capsule is marked 'AX250' and 'G'. The 500 mg capsule is marked 'AX500' and 'G'. Amoxicillin Capsules are available in blisters or bottles of 5, 7, 10, 14, 15, 20, 21,25, 28, 30, 56, 60, 84,

90, 100, 250 and 500 capsules. The 250 mg capsules are also available in blisters or bottles of 50 capsules.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, eN6 1TL, United Kingdom

Manufacturer

Generics [UK] Ltd, Potters Bar, Herts., EN6 1Tl, United Kingdom

This leaflet was last revised 394165 in: March 2014    00000000

Date: 28 MAR 2014