Patient leaflet - Amoxicillin 500 mg / 5 ml powder for oral suspension
1. What Amoxicillin Powder for oral suspension is and what it is used for
What Amoxicillin Powder for oral suspension is
Amoxicillin is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called “penicillins”.
What Amoxicillin Powder for oral suspension is used for
Amoxicillin is used to treat infections caused by bacteria in different parts of the body. Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.
2. What you need to know before you take Amoxicillin Powder for oral suspension
Do not take Amoxicillin Powder for oral suspension
if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine
(listed in section 6).
if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling
of the face or throat.
Do not take amoxicillin if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking amoxicillin
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin Powder for oral suspension if you: · have infectious mononucleosis (fever, sore throat, swollen glands and extreme tiredness) · have kidney problems
- are not urinating regularly.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amoxicillin.
Blood and urine tests
If you are having:
- Urine tests (glucose) or blood tests for liver function
- Oestriol tests (used during pregnancy to check the baby is developing normally). Tell your doctor or your pharmacist that you are taking amoxicillin. This is because amoxicillin can affect the results of these tests.
Other medicines and Amoxicillin Powder for oral suspension
Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other medicines.
If you are taking allopurinol (used for 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), concomitant use of probenecid may reduce the
excretion of amoxicillin and is not recommended. Your doctor may decide to adjust your dose of amoxicillin.
If you are taking medicines to help stop blood clots (such as warfarin), you may need extra blood tests. · If you are taking other antibiotics (such as tetracycline) amoxicillin may be less effective. · If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce
the excretion of methotrexate causing a potential 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.
Amoxicillin Powder for oral suspension contains aspartame, maltodextrin, sodium benzoate and benzyl alcohol
This medicine contains 15.000 mg aspartame (E951) in each 5 ml. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
- This medicine contains maltodextrin. Maltodextrin as absorbed as glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains 3.750 mg benzoate (E211) in each 5 ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in new born babies (up to
4 weeks old).
- This medicine contains less than 1 mmol sodium (23 mg) per ml that is to say essentially ‘sodium-free'.
- This medicine contains benzyl alcohol in 5 ml. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
3. How to take Amoxicillin Powder for oral suspension
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- Shake bottle well before each dose.
- Space the doses evenly during the day, at least 4 hours apart.
The usual dose is:
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 medicine is not usually prescribed for adults and children weighing 40 kg or more. Ask your doctor or pharmacist for advice.
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
How long should you take Amoxicillin Powder for oral suspension for?
Keep taking amoxicillin 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.
Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if amoxicillin is used for a long time. If this occurs tell your doctor.
If you take amoxicillin for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.
If you take more Amoxicillin Powder for oral suspension than you should
If you have taken too much of amoxicillin, 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 urinating. Talk to your doctor as soon as possible. Take the medicine to show the doctor.
If you forget to take Amoxicillin Powder for oral suspension
- If you forget to take a dose, take it as soon as you remember.
- Do not take the next dose too soon, wait about 4 hours before taking the next dose. · Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking amoxicillin and see a doctor straight away, if you notice any of the following serious side effects- you may need urgent medical treatment:
The following are very rare (may affect up to 1 in 10,000 people)
allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue,
body or breathing difficulties. 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. 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 surface of the mouth, eyes and genitals. You may have a fever and be very tired
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))
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. 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.
The following side effects occur with undetermined frequency (frequency cannot be estimated from the available data):
- the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain and skin rash.
Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction
(Kounis syndrome).
- A red rash, often occurring on both sides of the buttocks, inner thighs, armpits, and neck (symmetric drug-induced intertriginous and flexural exanthema (SDRIFE)).
Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin.
It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after drug administration). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure.
If any of the above happens 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 (may affect up to 1 in 100 people).
If you have any of these talk to your doctor as amoxicillin will need to be stopped.
The other possible side effects are:
Common (may affect up to 1 in 10 people)
- skin rash
- feeling sick (nausea)
- diarrhoea
Uncommon (may affect up to 1 in 100 people)
- being sick (vomiting)
Very rare (may affect up to 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 · kidney problems
- fits (convulsions), seen in patients on high doses or with kidney problems
- dizziness
- hyperactivity
- teeth may appear stained, usually returning 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 · an excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes · low number of white blood cells
- low number of cells involved with blood clotting
- the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself.
Not known (cannot be estimated from the available data)
- Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease) · Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis)
- Crystals in urine, leading to acute renal injury, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Amoxicillin Powder for 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 carton after “EXP”. The expiry date refers to the last day of that month.
Dry powder: Do not store above 25°C.
Reconstituted Suspension: Store up to 14 days at 2°C - 8°C in a refrigerator.
Keep the medicine in its original bottle. This medicine should not be used beyond 14 days from when it was dispensed.
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 Powder for oral suspension contains
Each 5 ml suspension contains 500 mg of amoxicillin trihydrate.
The active substance is amoxicillin.
The other ingredients are: silicon dioxide, aspartame (E951), xanthan gum, sodium benzoate (E211), tri sodium citrate dihydrate, colloidal silicon dioxide, strawberry flavour, benzyl alcohol. What Amoxicillin Powder for oral suspension looks like and contents of the pack
Amoxicillin Powder for Oral Suspension comes in a carton with HDPE bottles with normal values of 60 ml (for the 115 ml presentation) and 100 ml (for the 150 ml presentation) containing off-white to pale yellow powder which produces off-white to pale yellow coloured suspension upon reconstitution. The bottles are packed in a carton with or without a dosing syringe of 5 ml.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Brown & Burk UK Limited
5, Marryat Close,
Hounslow West,
Middlesex TW4 5DQ
United Kingdom
Manufacturer
Brown & Burk UK Limited
5, Marryat Close,
Hounslow West,
Middlesex TW4 5DQ
United Kingdom
This leaflet was last revised in 10/2025
Other
General advice regarding the use of antibiotics
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused
by viruses.
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest
reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the
chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention
to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
- 1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
- 2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
- 3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
- 4. You should not give antibiotics that were prescribed for you to other people.
- 5. If you have any antibiotics left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.
Instructions for reconstitution
For the bottle with marking
Check cap seal is intact before use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark on the bottle.
Invert and shake well, then top up with water to the mark. Invert and shake again.
Shake well before taking each dose.
Package leaflet: Information for the patients
Amoxicillin 500 mg/ 5 ml Powder for oral suspension
Amoxicillin (as amoxicillin trihydrate)
280 mm
280 mm
BBUK code
Size: 280(L) x 320(W) mm
Front Side