AMOXICILLIN 125 MG / 5ML ORAL SUSPENSION BP SUGAR FREE - patient leaflet, side effects, dosage

Swelling of the face, lips or throat, difficulty in breathing or dizziness. These may be signs of a severe allergic reaction

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

A delayed allergic reaction may occur 7 to 12 days after taking the medicine. 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, hives, pustules, swelling, peeling,

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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
• 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.

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The following side effects have also been reported:

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 in 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
• 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.

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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:. By reporting side effects you can help provide more information on the safety of this medicine.

closed to protect from light and moisture.

Do not transfer your medicine to another container.

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

If your doctor tells you to stop taking the medicine, please take any unused medicine back to your pharmacist to be destroyed.

6. Further Information

Ingredients

Each 5ml of medicine contains either 125 mg or 250 mg of the active ingredient, amoxicillin (as trihydrate). The other

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ingredients are Sodium Benzoate (E211), Disodium Edetate, Sodium Citrate, Citric Acid, Colloidal Anhydrous Silica, Sorbitol (E420), Saccharin Sodium, Banana Flavour (containing Gum Arabic, Amyl Acetate, Amyl and Ethyl Butyrates, Euginol, Acetaldehyde, Citral, Ethyl and Allyl Heptanoates, Amyl Valerianate and Orange Oil), Quinoline Yellow E104 and Xanthan Gum.

What the medicine looks like

The medicine is a yellow coloured suspension. This bottle contains 100ml of medicine.

Product licence holder and manufacturer

The product licence holder is Special Concept Development

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(UK) Ltd., Units 1–7 Colonial Way, Watford, Hertfordshire, WD24 4YR

Manufactured by RX Farma Ltd., Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR.

Product Licence Numbers:

PL 36722/0003

PL 36722/0004

Date of revision: September 2014

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

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In this leaflet:

• 1. What Amoxicillin Oral Suspension is and what it is used for

• 2. Before you take Amoxicillin Oral Suspension

• 3. How to take Amoxicillin Oral Suspension

• 4. Possible side effects

• 5. How to store Amoxicillin OralSuspension

• 6. Further information

125mg or 250mg of the active ingredient, amoxicillin (as trihydrate). Amoxicillin is one of a group of antibiotics called penicillins. lt is used to kill bacteria which cause infections in your body.

Amoxicillin Oral Suspension is 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 (e.g. stomach and intestines) such as typhoid. It may also be used for other infections determined by your doctor.

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2. Before you take Amoxicillin Oral Suspension

Some people must not take this medicine.

Do not take this medicine if:

• You know you are allergic to amoxicillin, penicillin or to any of the other ingredients (these are listed in section 6)
• You have ever had an allergic reaction (e.g. rash, itching, shortness of breath) to another antibiotic in the past such as cephalosporins e.g. cefaclor.

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You must be especially careful if:

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

If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.

Taking other medicines

Amoxicillin Oral Suspension and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking any of the following:

• 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.

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.

Other special warnings

Thrush (a yeast infection of moist areas of the body) may develop if amoxicillin is used for a long time. If this occurs tell your doctor.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains sorbitol (E420).

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Driving and using machinery

Amoxicillin Oral Suspension may very rarely cause dizziness and convulsions. Do not drive or operate machinery if it has this effect on you.

The doctor will decide what dose you need to take. Always take the medicine exactly as the doctor has told you. The dose will be on the pharmacist‘s label. If you are not sure, ask your doctor or pharmacist.

Carry on taking the medicine for as long as you have been told unless you have any problems. In that case, check with your doctor.

The usual doses are as follows:

Adults: To treat an infection, you should usually take 250 mg of your medicine three times a day. This is two 5ml spoonfuls of Amoxicillin Oral Suspension 125 mg or one 5ml spoonful of Amoxicillin Oral Suspension 250 mg three times a day.

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Children: The doctor will advise you of the dose.

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. 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.

If you take more medicine than you should

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

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Each 5 ml contains 125 mg Amoxicillin (as tri hydrate) as the active ingredient.

Also includes: Sorbitol E420 (see leaflet for further information).

TO THE PATIENT:

For oral use, use as instructed by a physician.

Please read the leaflet provided.

Store in a refrigerator. Do not freeze.

Keep tightly closed.

Shake well before each use.

Use within 7 days of preparation.

100 ml

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Complete the prescribed course of treatment.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

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AMOXICILLIN 125 MG/ 5 ML ORAL SUSPENSION BP SUGAR FREE

Powder for Oral Suspension

Special Concept Development

135 mm

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TO THE PHARMACIST: II I

Do not store above 25°C.

To prepare, add 84ml of potable water and shake yta until all of the powder is dispersed.

Keep the bottle tightly closed. Store in the original package.

PL 36722 / 0003

PL Holder: Special Concept Development (UK) Ltd., Colonial Way Watford WD24 4YR

Space for Batch details

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Amoxicillin #125 mg/ #5 ml Oral Suspension

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