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

4. possible side effects

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

Stop taking the medicine and tell your doctor straightaway if you notice any of the following very rare serious side effects (may affect up to 1 in 10,000 people):

• 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 swollen lymph nodes. These symptoms may also be due to a severe allergic reaction called DRESS syndrome with additional changes in the blood and liver or kidney function
• Blistering of the skin, mouth, eyes and genitals, other serious skin reactions including itchy reddish purple patches on the skin, hives, 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
• Diarrhoea sometimes containing blood, pain and fever caused by inflammation of the large bowel (colon)
• the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin for Lyme disease and causes fever, chills, headache,

muscle pain and skin rash

• 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.

Tell your doctor or pharmacist if you notice any of the side effects listed in the following sections:

Common: may affect up to 1 in 10 people

• Diarrhoea, feeling sick
• Skin rash.

Uncommon: may affect up to 1 in 100 people

• Itching, hives
• Being sick.

Very rare: may affect up to 1 in 10,000 people

• 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.
• 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
• flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

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.

5. how to store amoxicillin oral suspension

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

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Dry powder: Store in a cool, dry place.

Oral suspension: Store in a cool, dry place. Once made up the suspension should be used within 7 days.

Do not transfer your medicine to another container.

Do not use this medicine if there are visible signs of deterioration.

Do not throw away any medicines via wastewater or 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 Oral Suspension contains

Each 5ml of oral suspension contains 125 mg of the active ingredient, amoxicillin (as trihydrate). The other ingredients are sucrose, carmellose sodium, sodium citrate, colloidal anhydrous silica, quinoline yellow (E104), sodium methyl parahydroxybenzoate (E219), lemon and apricot flavourings (containing maltodextrin, citric acid, gum arabic, natural lemon oil flavour and nature identical flavouring ingredients).

What Amoxicillin Oral Suspension looks like and contents of the pack

After preparation the medicine is a pale yellow coloured suspension.

The bottle contains 100 ml of medicine.

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK.

This leaflet was last revised in December 2017.

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 125mg/5ml Oral Suspension

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

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

• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 2. What you need to know before you take Amoxicillin Oral Suspension

• 3. How to take Amoxicillin Oral Suspension

• 4. Possible side effects

• 5. How to store Amoxicillin Oral Suspension

• 6. Contents of the pack and other information

1. what amoxicillin oral suspension is and what it is used for

This medicine contains 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 Oral Suspension is used to treat infections caused by bacteria in different parts of the body. It may also be used in combination with other medicines to treat stomach ulcers.

2. what you need to know before you take amoxicillin oral suspension

Do not take Amoxicillin Oral Suspension if:

• you know you are allergic to amoxicillin or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen throat, face or lips)
• you have ever had an allergic reaction to another penicillin antibiotic or any other antibiotic in the past.

Warnings and precautions

Talk to your doctor before taking Amoxicillin Oral Suspension if:

• you have glandular fever (a viral infection which causes sore throat, high temperature, tiredness, muscle pains and headache)
• you are not passing water (urine) regularly
• you suffer from any kidney problems.

Urine, blood or other tests

If you are having tests on your water (urine glucose tests), blood tests for liver function or Oestriol test (used during pregnancy to check the baby is developing normally) let the doctor or nurse know you are taking this medicine as it can affect the results of these tests.

If you take this medicine for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.

Other medicines and Amoxicillin Oral Suspension

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

• probenecid (used to treat gout), as your doctor may decide to adjust your dose of amoxicillin
• allopurinol (used to treat gout), as it may be more likely that you will have an allergic skin reaction if taken with amoxicillin
• medicines to help stop blood clots e.g. warfarin as extra blood tests may be needed when taken with amoxicillin
• other antibiotics (such as tetracycline), as amoxicillin may be less effective
• methotrexate (used for the treatment of cancer and severe psoriasis), as amoxicillin may cause an increase in side effects.

Pregnancy, breast-feeding and fertility

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 can have side effects and the symptoms (such as allergic reactions, dizziness and convulsions) may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

Each 5 ml dose of the medicine contains 3.04g of sucrose. This should be taken into account in patients with diabetes mellitus. Also, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Also contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).

3. how to take amoxicillin oral suspension

Shake the bottle well before use. Do not further dilute the prepared product. The dose will be different for different medical conditions and patients. Your doctor has decided the dose which is best for you. Always take this medicine exactly as your doctor has told you. The pharmacist’s label will tell you how much medicine to take and how often to take it. Check with your doctor or pharmacist if you are not sure.

Dosage:

Children weighing less than 40 kg

All doses are worked out depending on the child’s body weight in kilograms.

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

• – The usual dose is 40 mg to 90 mg for each kilogram of body weight a day given in two or three divided doses.

• The maximum recommended dose is 100 mg for each kilogram of body weight a day.

Adults, elderly patients and children weighing 40 kg or more

This suspension is not usually prescribed for adults and children weighing more than 40kg. Ask your doctor or pharmacist for advice.

Kidney problems

If you have kidney problems the dose might be lower than the usual 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.

If you take more Amoxicillin Oral Suspension than you should

If you think you have taken too much medicine, contact your doctor straightaway or go to the nearest hospital casualty department. Take the bottle with you so that the medicine can be identified.

If you forget to take Amoxicillin Oral Suspension

If you forget to take a dose of this medicine, take it as soon as you remember. However if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillin Oral Suspension

• Keep taking this medicine for as long as your doctor has told you to, 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.
• Once you finish treatment, if you still feel unwell you should go back to see the doctor. Sometimes an infection caused by bacteria does not respond to a course of amoxicillin.

AMOXICILLIN

125mg/5ml

ORAL SUSPENSION