Amoxicillin 250 mg capsules BP – patient leaflet, side effects, dosage

1. What Amoxicillin Capsule is and what it is used for

These capsules are available in two different strengths containing either 250mg or 500mg of the active ingredient, amoxicillin (as trihydrate). Amoxicillin is one of a group of antibiotics called penicillins. It is used to kill bacteria which cause infections in your body.

Amoxicillin Capsules are used to treat bacterial infections of the ear, respiratory tract (e.g. lungs and chest), urinary tract (e.g. kidneys and bladder), skin and gastrointestinal tract, such as typhoid. It is also used to stop infections when you have a tooth removed or other surgery. Amoxicilln may also be used in combination with other medicines to treat stomach ulcers. It may also be used for other infections determined by your doctor.

2 What you need to know before you take Amoxicillin Capsules

Do not take Amoxicillin Capsules:

• If you know you are allergic to amoxicillin, penicillin or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction (e.g. rash, itching, shortness of breath, swelling of the face or neck) to another antibiotic in the past such as cephalosporins e.g. cefaclor. Warnings and precautions:

Talk to your doctor, pharmacist or nurse before taking Amoxicillin Capsule in case:

• If you have glandular fever or lymphocytic leukaemia
• If you are pregnant or trying to become pregnant
• If you are breastfeeding
• If you are not passing water regularly
• If you suffer from any kidney problems.

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.

Other special warnings

• Thrush (a yeast infection of moist areas of the body) may develop if amoxicillin is used for a longtime. If this occurs, tell your doctor. Other medicines and Amoxicillin Capsules

Tell your doctor if you are taking, have recently taken or might take

any of the following medicines:

• Anticoagulants (to prevent blood clotting) e.g. warfarin or phenindione
• Probenecid or allopurinol (used to treat gout)
• Oral contraceptives (as it may not work properly and you will need to use other means of contraception e.g. a condom)
• Methotrexate (a cancer drug which can also be used to treat psoriasis)
• Dietary fibre supplements.

If you are having tests on your water (urine glucose tests) or blood tests for liver function, let the doctor or nurse know you are taking amoxicillin because amoxicillin can affect the results of these tests. Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor. Amoxicillin Capsule contains - the colours sunset yellow (E110) and carmoisine (E122) in the capsule shell may cause allergic reactions. The capsule shell contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).

Pregnancy and breast-feeding

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

Driving and using machines

Amoxicillin Capsules may very rarely cause dizziness and convulsions. Do not drive or operate machinery if they have this effect on you.

3. How to take Amoxicillin Capsules

The capsules should be swallowed whole with a drink of water. The doctor will decide what dose of capsules you need to take. Always take this medicine exactly as the doctor has told you. Check with your doctor or pharmacist if you are not sure. Carry on taking them for as long as you have been told unless you have any problems. in that case, check with your doctor.

The recommended doses are as follows:

Adults: To treat an infection, you should usually take one 250mg capsule three times a day and in more severe infections it may be increased to 500mg three times a day.

Children: The doctor will advise you of the dose.

Children may be given a mixture of amoxicillin instead of capsules. Adults, elderly patients and children weighing more than 40 kg:

• Severe or recurrent chest infection: 3 g (6 x 500 mg capsules) twice a day.
• Urinary tract (water) infection: 2 x 3 g doses (6 x 500 mg capsules) with 10 to 12 hours between each dose.
• Dental abscess (infection under the gums and teeth): 2 x 3 g doses (6 x 500 mg capsules) with 8 hours between each dose.
• Gonorrhoea (a sexually transmitted infection): 1 x 3 g dose (6 x 500 mg capsules).
• Stomach ulcers: 1 x 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. 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 at least 4 hours apart. Never take 2 doses in 1 hour, the maximum recommended dose is 6 g per day given as 2 x 3 g doses. Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may reoccur or get worse.

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 long time. If this occurs and you have been taking Amoxicillin for longer than recommended, tell your doctor.

If you take more Amoxicillin Capsules than you should

You should contact your doctor or go to your nearest hospital casualty department immediately. Take your capsules or the pack with you so that the doctor knows what you have taken.

If you forget to take a dose of Amoxicillin Capsules

Take it as soon as you remember. Then carry on as before, but do not take two doses within four hours of each other. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillin Capsules:

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

4. Possible side effects

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

Some side effects can be serious. Stop taking the capsules and tell your doctor straight away If you notice the following very rare effects (may occur In less than 1 in 10,000 people):

• Swelling of the face, lips, throat or tongue, body difficulty in breathing or dizziness, skin itching or rash. These may be signs of a severe allergic reaction, these can be serious and occasionally deaths have occurred.
• Rash or pinpoint flat red round spots under the skin surface or bruising of the skin due to inflammation of blood vessel walls caused by an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
• A delayed allergic reaction may occur 7 to 12 days after taking the capsules. Symptoms may include rash, fever, joint pains and enlargement of the lymph nodes especially under the arms
• Blistering of the skin, mouth, eyes and genitals, other serious skin reactions including itchy reddish purple patches on the skin, a skin reaction known as `erythema multiforme' on the palms of the hands or soles of the feet, hives, raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and private parts, pustules, swelling, peeling, redness, pain, itching and scaling. These may be associated with fever, tiredness, headache and aching body
• Blood disorders including severe reduction in the number of white or red blood cells which may cause pale yellow skin, weakness, breathlessness, increased risk of bruising or bleeding, and make infections more likely, high temperature (fever), chills, a sore throat
• 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:
• Diarrhoea sometimes containing blood, pain and fever caused by inflammation of the large bowel (colon)
• Yellowing of the skin or whites of the eyes, pale stools and dark urine, loss of appetite, stomach discomfort caused by liver or blood problems.

The following side effects have also been reported:

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. Less than 1 in 10 people have experienced:
• Diarrhoea, indigestion, feeling sick

• Skin rash.

  Less than 1 in 100 people have experienced:

  • Itching, hives
  • Being sick.

Less than 1 ln 10,000 people have experienced:

• Tiredness, headache, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes. These may be symptoms of a type of anaemia
• Thrush (a yeast infection of the vagina, mouth or skin folds)
• Increased or decreased urine output, fever, rash, swelling of any area of the body or weight gain caused by kidney problems
• Fits (convulsions) which may be seen in patients taking high doses or with kidney problems, hyperactivity, dizziness
• Crystals in the urine which may cause cloudy urine or difficulty or discomfort when passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms
• An increase in the length of time it takes to stop bleeding if you cut yourself or have a nosebleed
• Black hairy tongue
• Tooth discolouration in children which usually returns to normal with brushing.

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 Amoxicillin Capsules

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package (carton) / Keep the container tightly closed (bottle) in order to protect the capsules from moisture. Do not transfer your medicine to another container. Do not use your medicine after the expiry date shown on the label or carton. The expiry date refers to the last day of that month. Do not use this medicine if there are visible signs of deterioration. if your doctor tells you to stop taking the capsules, please take any unused medicine back to your pharmacist to be destroyed. Do not throw away any medicines via household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6. Contents of the pack and other information

What Amoxicillin Capsule contains

Each capsule contains either 250mg or 500mg of the active ingredient, amoxicillin (as trihydrate). The other ingredient is magnesium stearate. The capsule shells contain gelatin and the colours sunset yellow (E110), carmoisine (E122), brilliant blue (E133), quinoline yellow (E104) and titanium dioxide (E171), methyl parahydroxybenzoate (E218) and propyl para hydroxybenzoate (E216).

What Amoxicillin Capsule looks like and contents of the pack

The capsules are red/buff coloured and are printed with “AMOXY 250” (250 mg strength) and “AMOXY 500" (500 mg strength). They are supplied to your pharmacist in packs of 21, 100, 250, 500 or 1000 capsules. Not all pack sizes may be available. Marketing Authorisation Holder: Special Concept Development (UK) Ltd, Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR. Manufacturer: Crescent Pharma Ltd., Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.

Product licence numbers

PL 36722/0001

PL 36722/0002

This Leaflet was last revised in January 2016.

If you would like this leaflet in a different format, please contact the licence holder at the above address.

Package leaflet: Information for the patient Amoxicillin 250mg Capsules BP Amoxicillin 500mg Capsules BP

This medicine will be called Amoxicillin Capsules in this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone else to take. it may harm them, even if their symptoms are the same as yours.
• If you have any further questions, please ask your doctor or pharmacist.

• 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.

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