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PACKAGE LEAFLET: INFORMATION FOR THE USER AMOXICILLIN 250mg CAPSULES _AMOXICILLIN 500mg CAPSULES_

Read all of this leaflet carefully before you start taking this medicine. Even if you have used this medicine or a similar product before, you should read this text carefully as the information may have changed.

•    Keep this leaflet. You may need to read it again.

•    If you have any further queries, 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 effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible Side Effects

5.    How to store this medicine.

6.    Further Information._

1. What this medicine is and what it is used for

•    Amoxicillin is an antibiotic used for treating infections. It belongs to a group of antibiotics called 'PENICILLINS'.Amoxicillin works by killing the bacteria that can cause infections.

•    Amoxicillin can treat a wide range of infections including those of the chest (bronchitis or pneumonia), chronic bronchial sepsis, tonsils (tonsillitis), ears (otitismedia), sinuses (sinusitis), the bladder or the urethra (the tube that carries urine from the bladder), kidneys, the female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic abortion), abdomen (intra-abdominal sepsis and peritonitis), heart (endocarditis), blood (septicaemia), skin and soft tissue, teeth and gums (abscesses).

•    Amoxicillin can also be used to treat gonorrhoea (a sexually transmitted

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infection), infections associated with pregnancy and typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella).

•    Amoxicillin may also be used in combination with other medicines to treat duodenal and gastric ulcer disease.

|    2. Before you take this medicine    |

Do not take Amoxicillin Capsules if you:

•    have ever had a bad reaction or are allergic to any PENICILLIN type of antibiotics or history of allergy to beta-lactam antibiotics (e.g. cephalosporins)

•    have ever been told you are allergic to amoxicillin or any other ingredients (these are listed in section 6, Further Information)

If the answer is YES to any of these questions, you MUST tell your doctor before taking this medicine.

Take special care with Amoxicillin:

Check with your doctor or pharmacist before taking this medicine if you:

•    suffer from any kidney problems

•    are not passing water regularly

•    have or think you have glandular fever

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

Special care will be taken by the doctor or nurse if Amoxicillin is being given to your premature or newborn baby.

Having urine or blood tests:

If you are having tests on your water (urine glucose tests) or blood tests for liver function, let the doctor or nurse know that you are on Amoxicillin. This is because Amoxicillin can affect the results of these tests.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop. This is because Amoxicillin can affect the way some other medicines work. Also some other medicines can affect the way Amoxicillin works.

•    If you are taking allopurinol (used to treat gout) with Amoxicillin, it may be more likely that you will have an allergic skin reaction.

•    If you are taking probenecid (used to treat gout), your doctor may decide to adjust your dose of Amoxicillin.

•    If Anti-coagulants (medicines to prevent blood clotting such as warfarin) are taken with Amoxicillin then extra blood tests may be needed. Amoxicillin may stop the contraceptive pill working. You will need to use extra contraceptive precautions, such as using a condom. If you need any advice, talk to your doctor or pharmacist.

Pregnancy and breast-feeding

•    Ask your doctor or pharmacist for advice before taking any medicine if you think you might be or if you are pregnant, or if you are breast-feeding.

Important information about some of the ingredients of these

capsules

•    The colours sunset yellow (E 110) and carmoisine (E 122) in the

capsule shell can cause allergic type reactions.

•    This medicine also contains Methylparaben(E218) and Propylparaben

(E216) which may cause allergic reactions._

|    3.How to take this medicine    |

•    Always take this medicine as advised by your doctor. you should check with your doctor or pharmacist if you are not sure.

•    Complete the prescribed course of treatment; as if you stop the condition may recur.

The usual doses are as follow:

When taking Amoxicillin

•    Swallow the capsules 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

•    Never take 2 doses in one hour

•    The maximum recommended dose is 6g per day given as 2 x 3g doses.

The usual dose is:

Children weighing less than 40kg who are able to swallow capsules

All the doses are worked out depending on the child's bodyweight in kilograms.

•    Your doctor will advise you how much Amoxicillin you should give to your baby or child.

•    Usual dose - 40mg to 90mg for each kilogram of body weight a day given in two or three divided doses.

•    Amoxicillin Paediatric Suspension is recommended for children under six months of age.

Adults, elderly patients and children weighing over 40kg

•    Standard dose: 1 x 250mg capsule 3 times a day.

•    Severe infections: 1 x 500mg capsule 3 times a day.

•    Severe or recurrent chest infection: 3g (6 x 500mg capsules) twice a day.

•    Urinary tract (water) infection: 2 x 3g doses (6 x 500mg capsules) with 10 to 12 hours between each dose.

•    Dental abscess (infection under the gums and teeth): 2 x 3g doses (6 x 500mg capsules) with 8 hours between each dose.

•    Gonorrhoea (a sexually transmitted infection): 1 x 3g dose (6 x 500mg capsules).

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

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.

Kidney problems

•    Doses may be lower than usual dose in patients with kidney problems. It is important that you take your medicine at the right times of day. Space the doses out as evenly as possible throughout the day.

Your doctor may prescribe a slightly different dose to the usual dose stated above; you should always follow your doctor's instructions for taking medicines.

If you take more medicines than you should

If you accidently take too many Amoxicillin capsules, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems passing urine.Tell your doctor immediately or contact your nearest Hospital Casualty/Accident and Emergency Department even if there are no signs of discomfort.

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Take this medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

If you forget to take this medicine:

•    Take it as soon as you remember. Don't take the next dose soon; wait about 4 hours before taking the next dose.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

How long should you take Amoxicillin for?

•    Keep taking Amoxicillin 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. Treatment should be continued for 2 to 3 days after the symptoms have gone.

•    Do not take Amoxicillin for more than 2 weeks. If you still feel unwell you should go back to see the doctor.

Thrush (a yeast infection of moist areas of the body) may develop if Amoxicillin is used for a longer time. If this occurs and you have been taking Amoxicillin for longer than recommended, tell your doctor.

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

|    4. Possible Side Effects    |

Like all medicines, Amoxicillin Capsules may sometimes cause side effects, although not everybody gets them.

STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following serious side effects - you may need urgent medical treatment:

The following are very rare (affects less than 1 in 10,000 people)

•    allergic reaction, the signs include: skin rash or itching, swelling of the face, lips, tongue, body or breathing difficulties.These can be serious and occasionally deaths have occured

•    rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems

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

•    a skin reaction known as 'erythema multiforme' where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or 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 a fever and be very tired

•    a severe form of allergic reaction called DRESS syndrome which may show up with the following symptoms: fever, skin rash, joint pain, swelling of glands, abnormalities of blood including increase in blood cells called eosinophils, abnormalities of kidney and liver function.

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

•    high temperature (fever), chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells

•    inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever

•    serious liver side effects may occur which are often reversible. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get:

-    severe diarrhoea with bleeding

-    blisters, redness or bruising of the skin

-    darker urine or paler stools

-    yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice.

These can happen when having the medicine or for up to several weeks after.

If any of the above happen stop taking the medicine and see your doctor straight away. Sometimes you may get less severe skin reactions such as:

a mildly itchy rash (round, pink-red patches), 'hive-like' swollen areas on forearms, legs, palms, hands or feet. This is uncommon (affects less than 1 in 100 people).

If you have any of these talk to your doctor as Amoxicillin will need to be stopped.

•    severe diarrhoea with bleeding (pseudomembranous colitis and haemorrhagic colitis)

The other possible side effects that have been reported are:

Common (affects less than 1 in 10 people)

•    diarrhoea and nausea (feeling sick)

•    skin rash

Uncommon (affects less than 1 in 100 people)

•    being sick (vomiting)

Very rare side effects less than 1 in 10,000 people)

•    thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist

•    tooth discolouration, the colour usually returns to normal with brushing (this has been reported in children)

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

•    kidney problems like interstitial nephritis (inflammation of the kidney)

•    fits (convulsions), seen in patients on high doses or with kidney problems

•    excessive body movements such as hyperkinesias (excessive activity or hyperactivity), dizziness

•    an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and whites of the eyes

•    the blood may take longer to clot than it normally would (leucopenia). You may notice this if you have a nosebleed or cut yourself.crystalluria ( forming of 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.

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.

I    5. How to store this medicine    |

•    Keep the medicine in a safe place where children can not see or reach it.

•    Store in a cool dry place, below 25⁰C. Store in the original container. Do not transfer your medicine to another container.

•    Do not use the medicine after the expiry date shown on the label.

•    Return any left over medicine back to your pharmacist for safe disposal.

|    6. Further Information    |

What Amoxicillin Capsules contain:

•    The active substance is Amoxicillin Trihydrate

•    The other ingredient of the powder is magnesium stearate

•    The capsule shell for both strengths contains gelatin, sunset yellow (E 110), carmoisine (E 122), brilliant blue (E 133),quinoline yellow (E 104), titanium dioxide (E171), Methyl hydroxybenzoate (E218) and Propyl hydroxybenzoate (E216).

What Amoxicillin Capsules look like and contents of the pack:

•    Amoxicillin 250mg Capsules -Red/buff coloured, hard gelatin capsule containing a white to off white powder. Printed with “AMOXY 250''.

•    Amoxicillin 500mg Capsules -Red/buff coloured, hard gelatin capsule containing a white to off white powder. Printed with ''AMOXY 500''

•    Amoxicillin Capsules are supplied to your pharmacist in packs containing 21, 100, 250, 500 and 1000 capsules.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address:

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted,

Hertfordshire, United Kingdom, HP4 1EG Telephone: 0044 (0) 1442 200922 Fax:    0044 (0) 1442 873717

Email:    info@bristol-labs.co.uk

Amoxicillin 250mg Capsules; PL 17907/0006 Amoxicillin 500mg Capsules; PL 17907/0007 This leaflet was last revised in March 2015

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V7 25-03-2015 D0

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