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Amoxicillin 250 Mg Capsules

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin 250mg Capsules

Amoxicillin 500 mg Capsules

(Amoxicillin)

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 Amoxicillin capsules are and what it is used for

2.    Before you take Amoxicillin capsules

3.    How to take Amoxicillin capsules

4.    Possible side effects

5.    How to store Amoxicillin capsules

6.    Further information

1. WHAT AMOXICILLIN CAPSULES IS AND WHAT IT IS USED FOR

Amoxicillin is an antibiotic (antibacterial medicine) for treating infections. It belongs to a group of antibiotics called “Penicillins”. Amoxicillin works by killing the bacteria that can cause infections. Amoxicillin can also be used to prevent infections.

Your doctor has prescribed Amoxicillin capsules because, it can treat a wide range of infections including those of the:

Ear, Nose and Throat

Ears - (Otitis media)

Nose - Sinuses (Sinusitis)

Throat - Pharynx (Pharyngitis)

Tonsils (Tonsillitis)

Chest (Bronchitis or Pneumonia)

Bladder or Urethra (the tube which carries urine from the bladder)

Bladder - (Cystitis)

Urethra - (Urethritis)

Kidneys (Pyelonephritis)

Abdomen (Gastro-intestinal infections)

Heart (Endocarditis)

2. BEFORE YOU TAKE AMOXICILLIN CAPSULES

Do not take Amoxicillin if:

•    you are allergic to penicillin or similar types of antibiotics such as cephalosporins. If you have ever had an allergic reaction (such as a rash) when taking an antibiotic you should tell your doctor before you take amoxicillin.

•    you have ever had an allergic reaction to amoxicillin or any of the ingredients listed toward the end of this leaflet. (See “Ingredients”)

•    you have a viral infection, cancer of white blood cells (acute lymphatic leukaemia) or glandular fever

•    the expiry date (EXP) printed on the pack has passed.

Take Special Care with Amoxicillin Capsules

Let your doctor know if any of the following apply to you:

•    if you suffering from diarrhoea or sickness

•    if you have asthma

•    if you are breast-feeding

•    if you have been treated for kidney problems

•    if you are pregnant or think you may be pregnant

•    if you are having urine or blood tests because Amoxicillin may affect the results

If any of the above apply to you, let your doctor know. Your doctor may decide that you need a different dose of amoxicillin or a different medicine instead of amoxicillin. If you have not told your doctor about any of these things, tell them before you take Amoxicillin.

Taking other medicines

Amoxicillin capsules may occasionally interfere with other medicines, so it is important that you tell your doctor about all the medicines you are taking, including those obtained without a doctor's prescription. In particular tell your doctor if you are taking any of the following:

•    the contraceptive pills (you may need to use extra birth control methods e.g. condoms.)

•    medicines used to treat gout e.g. allopurinol and probenecid

•    medicine used to treat heart failure e.g. digoxin

•    medicines used to prevent blood clots (anticoagulants) e.g. warfarin

•    any other antibiotics

If you are taking these medicines you should talk to your doctor before taking Amoxicillin capsules.

Taking Amoxicillin capsules with food and drink

Amoxicillin capsules do not have known interactions with any food or drink. Alcohol may irritate your stomach if taken with amoxicillin, so use it with moderation.

Pregnancy and breast-feeding

Ask your Doctor for advice before taking amoxicillin capsules.

Driving and using machines

Amoxicillin capsules have not been shown to have any effect on ability to drive and use machines. Nevertheless, consideration should be given to the potential for amoxicillin to cause dizziness and convulsions

Important information about some of the ingredients of Amoxicillin Capsules

Amoxicillin Capsules contain sunset yellow E110 and carmoisine E122, which may cause allergic reactions, Also, methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

3. HOW TO TAKE AMOXICILLIN CAPSULES.

Follow your doctor's instructions about how and when to take Amoxicillin. Your doctor will advise on dosage strength, number of capsules to be taken each day, and for how long you will need to take Amoxicillin.

Always take Amoxicillin capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not stop taking the medication just because you feel better as the infection can return.

Amoxicillin capsules should be swallowed whole with water.

Adults

For most infections you have to take one 250 mg capsule three times a day. This can be increased to 500 mg amoxicillin three times a day if the infection is severe.

For severe or frequent chest infections your doctor may recommend taking 3 g amoxicillin twice a day

Infections of the bladder or urethra (urine infections) can be treated with two 3 g doses taken with 10-12 hours between doses.

People who have had heart problems may need an antibiotic when they go to the dentist or if they have to go into hospital for surgery to prevent them from getting a heart infection (endocarditis). For prevention of heart infection (endocarditis), patients who are not having general anaesthetic, 3 g amoxicillin are given in the hour preceding the surgical procedure, followed by (6 hours later) a further 3 g dose, if considered necessary.

Children (under 12 years)

For infants and children oral suspensions containing amoxicillin are recommended

Children weighing less than 40 kg who are able to swallow capsules All doses are worked out depending on the child’s bodyweight in kilograms.

•Your doctor will advise you how many Amoxicillin Capsules 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 Kidney Problems

Doses may be lower than those listed above in patients with kidney problems.

If you take more Amoxicillin Capsules than you should

Never take more than the recommended dose each day. If you or someone else swallows several of these capsules all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any capsule left over with you and also the box, as this will allow easier identification of the capsules.

If you forget to take Amoxicillin Capsules

If you miss a dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillin capsules

If you stop taking Amoxicillin capsules without medical advice then discuss what to do with 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, Amoxicllin capsules can cause side effects, although not everybody gets them.

The more common side effects of Amoxicillin that have been reported in more than 1 in 100 people taking it include:

•    Nausea (feeling    of sickness)    or diarrhoea

•    Skin rash.

Uncommon side effects that have been reported in between 1 in 100 and 1 in 1,000 people taking amoxicillin include:

•    Vomiting

•    Allergic skin    reactions with    itching.    If    you start to itch or get a rash,

STOP taking Amoxicillin and tell your doctor at once.

Very rare side effects that have been reported in less than 1 in 10,000 people taking Amoxicillin include:

•    Hypersensitivity or severe allergic reaction including swollen face or breathing problems. Tell your doctor straight away if you notice any of these symptoms and STOP taking Amoxicillin.

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

•    Tooth discoloration. The colour usually returns to normal with brushing Tell your doctor that you are taking Amoxicillin

•    Excessive body movements (hyperkinesia), dizziness or convulsions. People who

are on high doses of Amoxicillin or whose kidneys do not work properly may

experience convulsions

•    A reversible reduction in the number of cells circulating in the blood. This may cause anaemia (a reduction in the number of circulating red blood cells that result in feeling weak or light-headed) or a longer time taken for blood to clot and wounds or cuts to stop bleeding.

•    Crystalluria, forming of crystals in the urine.

See your doctor straight away if you experience any of the following very rare side effects:

•    Severe diarrhoea with bleeding

•    Notice your urine becoming darker or your faeces (body waste) becoming paler

•    Notice your skin or the white of your eyes turning yellow (jaundice)

•    Convulsions

•    Difficulty or discomfort in passing urine or passing urine that is cloudy.

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.

5.    HOW TO STORE AMOXICILLIN CAPSULES

Store below 30°C.

Keep all medicines well out of the reach and sight of children - it’s best to lock them in a cupboard or medicine cabinet.

If your doctor tells you to stop taking this medicine, or if for any other reason you have some capsules left over, please return them to the pharmacist.

Remember, this medicine is just for you. Do not give it to anyone else. It may not be suitable for them, even if their symptoms seem to be the same as yours

6.    FURTHER INFORMATION

What Amoxicillin Capsules contains

The active substance is Amoxicillin Trihydrate.

The other ingredients are Croscarmellose Sodium, Magnesium stearate, Sunset yellow E110, Carmosine E122, Brilliant blue E133, Quinoline Yellow E104, Titanium dioxide E171, Methyl parahydroxybenzoate Propyl parahydroxybenzoate, Shellac, Black iron oxide E172, Gelatin, Propylene glycol and Sodium lauryl sulfate.

What Amoxicillin Capsules looks like and contents of the pack

Amoxicillin 250mg capsules are Red / Buff coloured capsules printed with ‘AMOXY 250’ in black ink.

Amoxicillin 500mg capsules are Red / Buff coloured capsules printed with ‘AMOXY 500’ in black ink.

Amoxicillin 250mg and 500mg are supplied in blister packs of 21 capsules. Marketing Authorization Holder

Morningside Healthcare Ltd

115 Narborough Road,

Leicester, LE3 0PA UK

Site responsible for batch release:

Morningside Pharmaceuticals Ltd

5 Pavilion Way, Castle Business Park,

Loughborough,

Leicestershire, LE11 5GW UK

PL 20117/0214

This leaflet was last revised in June 2012